ViewPoints Interview: Janssen’s Andrew Greenspan Shares Insights on the Data Presented at ACR2020

In a recent interview with PharmaShots, Andrew Greenspan, MD, VP Medical Affairs of Janssen Immunology shared his views on Janssen’s commitment to advance research in rheumatic disease.

Shots:

  • Janssen presented clinical trial results in 35 abstracts featuring findings across PsA, RA, and SLE at ACR Convergence 2020 Virtual Scientific Program
  • Sixteen abstracts focus on Tremfya in adults with active PsA, including 52-week safety and efficacy data, axial disease-related endpoints, and more.
  • Other presentations feature new research across Janssen’s portfolio of medications including Simponi Aria (golimumab), Stelara (ustekinumab), and Remicade (infliximab)

Tuba: How was your virtual experience at ACR2020? Can we have an insight on data presented at ACR 2020?

Andrew: Speaking on behalf of those who represented Janssen at the conference – we are so proud of the breadth of data presented at ACR this year. Even though the conference looked a little different than it has in years past, we were still thrilled to share our findings – including 35 abstracts highlighting our research across psoriatic arthritis, rheumatoid arthritis and system lupus erythematosus. Specifically, we presented 16 abstracts focused on TREMFYA in adults with active psoriatic arthritis, including 52-week safety and efficacy data, spinal disease-related endpoints, as well as analyses that highlight patient-reported outcome measures including fatigue. Other presentations featured new research across our portfolio of medications.

Tuba: As the focus of the presentation is Tremfya, give a quick review about the clinical data supporting the therapy?

Janssen’s Tremfya (guselkumab) Receives the US FDA's Approval as the First Selective IL-23 Inhibitor for Active Psoriatic Arthritis
Source: MPR

Andrew: As a company, we’re constantly striving to keep our foot on the gas to create new clinical evidence and innovation. As a testament to this, we were proud to expand our rheumatology portfolio this year with the U.S. FDA approval of TREMFYA for adult patients with active psoriatic arthritis, which was first approved to treat adults with plaque psoriasis in 2017. Let me share some additional information on the compelling data we shared at ACR:

  • Data from two Phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, showed that TREMFYA improved fatigue in adult patients with active psoriatic arthritis and maintained response through 52 weeks of active treatment, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale. TREMFYA is the first and only treatment approved for active psoriatic arthritis to have an improvement in fatigue as measured by FACIT-F in the product label.
  • The positive outcomes in fatigue assessment add to the body of data for TREMFYA, which has shown improvements in multiple clinical outcomes including joint symptoms, skin symptoms, soft tissue inflammation, and physical function.
  • Fatigue is considered one of the three most important symptoms by patients with active psoriatic arthritis, and moderate to severe fatigue occurs in up to 50 percent of these patients.

Tuba: Can we have a glance at Janssen’s immunology portfolio as it is working in immunology over the past two decades?

Source: Janssen

Andrew: At Janssen, we have an unmatched track record of translating science into effective therapeutics. In the past two decades, my colleagues at Janssen have developed five advanced treatments for 31 indications resulting in the treatment of more than 5 million patients living with autoimmune disease. Treatments in our immunology portfolio treat a variety of conditions for various patient populations, such as plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, rheumatoid arthritis, ulcerative colitis and Crohn’s disease. These treatments include TREMFYA (guselkumab), SIMPONIARIA (golimumab), STELARA (ustekinumab), SIMPONI (guselkumab) and REMICADE (infliximab). Looking ahead to potential future treatments, we have a robust pipeline, with 21 first-in-class Phase 2 or 3 trials underway. We’re eager to explore treatment options for less common diseases like hidradenitis suppurativa and Sjogren’s syndrome, where there are fewer or no advanced treatment options currently available.

Tuba: What are Janssens’s efforts in developing biomarkers and co-diagnostics to personalize medicine in the field of rheumatic diseases?

Andrew: We are exploring the development of tools that will better allow us to measure disease activity in patients, including sensors (digital health, actigraphy), novel biomarkers, new endpoints and new patient-reported outcomes to better identify patients appropriate for our medicines and to evaluate the efficacy and safety of them.

 Tuba:  Apart from Tremfya, Simponi, Simponi Aria, and Stelara, what next can we expect from Janssen to transform the lives of patients with autoimmune diseases? What will be your next move (in terms of the combination of internal research and development, external collaborations, and industry consortia) to complement Janssen’s existing portfolio of immunology? Who are Janssen’s potential competitors in the field of autoimmune diseases?

Andrew: I’m very proud of where our research in immunology stands and where it is leading us. While treatments today have made a big difference in the lives of many patients, there certainly remains a significant need for medicines that work better, faster, and longer. Instead of focusing on the competition, we prefer to focus on unmet needs. By unlocking new pathways, mechanisms, and regimens in our treatment options, we strive to provide innovative treatment options to patients. Looking further ahead at our mid-to-late stage pipeline, we have 21 first-in-class Phase 2 or 3 trials underway and we’re eager to explore treatment options for less common diseases like hidradenitis suppurativa and Sjogren’s syndrome, where there are fewer or no advanced treatment options currently available.

Tuba: Can we have a glimpse of Janssen’s work in other therapeutics areas? Can you list out some key advancements for our readers?

Andrew: In addition to immunology, we focus on areas of medicine where we can make the most impact, including Cardiovascular & Metabolism, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension, where we have delivered 18 new medicines in less than nine years. For more information about these specific therapeutic areas, I would be happy to put you in touch with a specialist on our team to learn more about the innovative work being done in these fields.

Tuba: Does the global pandemic affect Janssen’s ongoing as well as future clinical trials?

Andrew: As the world continues to navigate the new normal brought on by COVID-19, there has been an undeniable effort to ensure continuity of care and advance research by a wide range of experts, from healthcare professionals and clinical trial site teams to research partners and regulatory bodies. We at Janssen recognize and remain committed to supporting everyone involved in clinical research. To learn more about Janssen’s commitment to clinical trial research, visit: https://www.janssen.com/clinical-trials/janssen-global-development-leadership-commitment-clinical-research.

Image Source: MIMS Malaysia

About Author:

Andrew Greenspan, MD is a vice president of Immunology Medical Affairs at Janssen and has joined J&J in 2003.

Related Post: ViewPoints Interview: GSK’s Dr. Riju Ray Shares Insights on the Role of Community-Based Pulmonologists in Improving COPD Management Among PCPs

The post ViewPoints Interview: Janssen’s Andrew Greenspan Shares Insights on the Data Presented at ACR2020 first appeared on PharmaShots.

ViewPoints Interview: GSK’s Dr. Riju Ray Shares Insights on the Role of Community-Based Pulmonologists in Improving COPD Management Among PCPs

In a recent interview with PharmaShots, Dr. Riju Ray, MD, PhD, Senior Medical Lead at GSK, leading US medical affairs across asthma and COPD shared his views on how community-based pulmonologists are improving COPD management and education among referring PCPs.

Shots:

  • Pulmonologists identified 12 strong to moderate predictors of future COPD exacerbations, some of which were evaluated less frequently. COPD is frequently underdiagnosed, and this may be partially due to a lack of adequate knowledge and testing at the primary care level, highlighting the need for further education improve patient care
  • When evaluating COPD traits, pulmonologists were most likely to evaluate behavioral traits, exacerbation history and recovery time rather than traits that require testing, as acknowledged by the standard of care (GOLD guidelines). Failure to evaluate testing-based traits creates an overdependence on physician-patient communication, which is already a recognized key challenge
  • Community-based pulmonologists play an important role in the management of COPD, and the majority of respondents were also in a position to influence COPD management practices of colleagues. However, the opportunity to educate primary care physicians on COPD management and exacerbation prevention was not utilized by the majority of survey respondents, suggesting a need to more strongly engage specialists in education efforts

Tuba: Please discuss the epidemiology of the chronic obstructive pulmonary disease (COPD)?

Riju: COPD, or chronic obstructive pulmonary disease, is a progressive lung disease. There are more than 16.4 million people in the U.S. that are diagnosed with COPD, and it is one of the leading causes of death worldwide. While there is no cure for COPD, it is treatable, and with daily management, those with the disease can maintain good quality of life.

Tuba: Can we have a key point of the whitepaper published in Chest Clinical Perspectives in a non-scientific way?

Riju: In the recent study funded by GSK and co-developed by CHEST and GSK, we assessed the approaches pulmonary specialists take when they think of managing COPD exacerbations (or flare-ups) and what clinical perspectives come to mind when they consider future risk of these COPD exacerbations for their patients. These COPD exacerbations, or COPD flare-ups, speed up lung function decline and often lead to hospitalizations, which impact the health and quality of life for people with COPD. Research shows that frequent exacerbations that require hospitalization are also associated with higher mortality. Hospitalizations also lead to greater impact on daily life, decreased ability to work and increased burden on family caregivers, so it is important to help people with COPD reduce their chances of experiencing a COPD exacerbation.

Source: Biophysical Society

Tuba: What were the objectives of the research conducted by CHEST?

Riju: The objectives of the survey were to:

  • Assess the frequency with which pulmonary, extrapulmonary, and behavioral traits of COPD patients are evaluated in pulmonology practices.
  • Assess which disease characteristics pulmonologists use to predict the occurrence and severity of exacerbations in patients with COPD, including those who have no history of exacerbations.
  • Identify barriers to assessing these disease characteristics in pulmonology practices.
  • Assess how often pulmonologists are actively involved sharing their knowledge of COPD treatment and management with their referring primary care physicians.

Tuba: Discuss the role of pulmonologists in improving the management of COPD.

Riju: Pulmonologists work with patients to develop a proper COPD management plan and participate in the development of treatment plans. Pulmonologists are also in a position to better educate their referral primary care physicians. According to the survey, COPD is frequently underdiagnosed, which may be partially due to primary care physicians’ (PCPs) lacking knowledge on the disease. It’s important for pulmonologists to utilize their position to educate PCPs on how to administer tests, and interpret results, and plan tailored disease management plans for their patients with COPD.

Tuba:  What were the findings of the research conducted by CHEST/GSK?

Riju: The survey uncovered a few key insights on COPD exacerbation predictors and the role of pulmonologists in better managing future COPD exacerbation risk:

  • There are 12 strong disease characteristics that pulmonologists determined to be predictors of a COPD exacerbation.
  • Pulmonologists are more likely to evaluate behavioral traits that do not require testing than pulmonary and extrapulmonary factors.
  • Most (71%) of pulmonologists surveyed use a strategy-based approach like the GOLD while 29% said their management approach is dependent on a patient’s symptoms.
  • The opportunity to educate other physicians on COPD management and exacerbation prevention is not utilized.In fact, only 16% of respondents said they make a routine practice of proactively engaging or informally educating referring physicians on how to evaluate and manage COPD.

Tuba: Can you showcase the GOLD guidelines used by the pulmonologist?

Riju: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy document is used broadly by physicians to guide COPD treatment plans. It categorizes patients according to their level of airflow limitation, symptoms, and comorbidities, and disease stages. However, patients symptom burden and exacerbation history are recommended as 2 key guiding principles for determining optimal treatment. Patients grouped in the same stage of the disease often have variation in symptoms, exacerbations, and risk of mortality, so understanding how to identify and test those characteristics is important to developing a personalized treatment plan.

Tuba: What were the different traits evaluated by the pulmonologist during the research?

Riju: In the survey, pulmonologists evaluated various behavioral, pulmonary and extrapulmonary traits and determined 12 strong COPD exacerbation predictors. The behavioral characteristics include treatment adherence, tobacco use, exacerbation history (especially exacerbations leading to hospitalizations), which do not require testing. Pulmonary and extrapulmonary factors include frailty or airflow limitation, which are evaluated less frequently. This study emphasizes the importance of pulmonologists’ recognition of disease characteristics, laboratory testing, in-office assessments and physician education when developing treatment plans. 

  • When testing-based characteristics are not routinely evaluated as indicated by surveyed pulmonologists, it creates an overdependence on physician-patient communication. While this study did not specifically address communication, we know that both patients and physicians think there is room for improvement in terms of physician-patient communication during medical appointments. It is an extremely important component of the patient-physician relationship and should be considered in any disease management plan.

Tuba: What are the different predictors of future COPD exacerbations? What you consider is the best predictor for exacerbation?

Riju: The best predictor for an exacerbation is exacerbation(s) history; however, it is important for pulmonologists to evaluate other disease characteristics, especially in the absence of exacerbation history. A focus on behavioral elements like smoking cessation and adhering to their treatments especially controller medicines also ranked high from the surveyed pulmonologists. Regardless of exacerbation history, recent studies suggest triple therapy with an ICS, LAMA, and LABA showed the greatest benefit for improving both lung function and preventing exacerbations.

Tuba: What are the educational benefits of using an approach to COPD management?

Riju: As mentioned, COPD is frequently under-diagnosed, so it is important for pulmonologists to utilize all tools available to them between in-office testing, reference of GOLD and evaluation of a patient’s health history when treating people with COPD symptoms. It’s also critical pulmonologists engage PCPs in formal or informal education activities to improve patient care from the front line.

Tuba: Why do you think COPD management is necessary to improve the condition of patients?

Riju: Like any disease, proper disease management is essential to ensuring patients receive optimal care and lead a high quality of life as possible. COPD can worsen over time, especially for people who experience frequent exacerbations, but patients don’t have to settle for a life of breathlessness. Better days are possible for people living with COPD through consistent and comprehensive disease management.

Image Source: Dimerix Limited

About Author:

Dr. Riju Ray is an MD, PhD senior medical lead within the Respiratory team at GSK US medical affairs leading teams across both Asthma and COPD. He is based out of Research Triangle Park in North Carolina.

Related Post: ViewPoints Interview: Genentech’s Ted Omachi Shares Insight on the US FDA’s Approval of Xolair in Nasal polyps

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Artificial intelligence in drug discovery: what is realistic, what are illusions? Part 1: Ways to make an impact, and why we are not there yet

This article was originally published by Andreas Bender and Isidro Cortes-Ciriano in Drug Discovery Today under a Creative Commons license. Although artificial intelligence (AI) has had a profound impact on…

The post Artificial intelligence in drug discovery: what is realistic, what are illusions? Part 1: Ways to make an impact, and why we are not there yet appeared first on DrugPatentWatch – Make Better Decisions.

Insights+: COVID-19 Healthcare News Monthly Updates – December 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected in Wuhan City, Hubei Province, China in Dec 2019. Life sciences companies are putting all of their efforts into finding a treatment or developing a vaccine for this disease. PharmaShots is keeping a track of all of the important updates in the Life-sciences sector, where we have covered news updates regarding collaborations, clinical trials, funding, and regulatory guidelines related to the COVID-19 from Jan to date.

01. NeuroRx and Relief Conclude Enrollment in their Phase 2b/3 Trial of RLF-100 for Critical COVID-19 with Respiratory Failure

Dec 29, 2020 | Clinical Trial

02. Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

Dec 29, 2020 | Regulatory

03. Introducing COMIRNATY, the EU Brand Name for Pfizer & BioNTech’s COVID-19 Vaccine, Developed by Brand Institute

Dec 28, 2020 | Regulatory

04. INOVIO Announces Publication of Phase 1 Data from its COVID-19 DNA Vaccine Candidate, INO-4800 in The Lancet’s EClinicalMedicine

Dec 24, 2020 | Collaboration

05. Aurobindo Pharma and COVAXX Sign an Exclusive Agreement to Develop and Commercialize COVID-19 Vaccine UB-612 for India and UNICEF

Dec 24, 2020 | Collaboration

06. Providence Therapeutics COVID-19 Vaccine Receives Health Canada Authorization to Begin Clinical Trials

Dec 23, 2020 | Regulatory

07. Serum Institute Of India And Dynavax Announce First Participants Dosed In The Phase 1/2 Clinical Trial For A COVID-19 Vaccine

Dec 23, 2020 | Clinical Trial

08. Infor and MphRx Announce Global Solution to Help Healthcare Organizations Manage COVID-19 Vaccine Inoculation with Real-World Clinical Data

Dec 22, 2020 | Clinical Trial

09. eTrueNorth Enabling Patient Recruitment in Clinical Trial to Accelerate the Use of Wearable Diagnostics for Early Identification and Containment of COVID-19

Dec 22, 2020 | Clinical Trial

10. RedHill’s Phase 2/3 COVID-19 Study of Opaganib Passes Second DSMB with Unanimous Recommendation to Continue

Dec 22, 2020 | Clinical Trial

11. RDIF, The Gamaleya National Center, AstraZeneca and R-Pharm sign an Agreement to Cooperate on COVID-19 Vaccine Development

Dec 21, 2020 | Collaboration

12. Principle LTC’s Tower Nursing & Rehabilitation Center Joins with Eli Lilly and Company on Phase 3 Drug Trial for COVID-19 Prevention

Dec 21, 2020 | Clinical Trial

13. Positive Results Show that C21 can Become an Important Complement to COVID-19 Vaccines

Dec 21, 2020 | Clinical Trial

14. ImmuneMed’s hzVSF-v13, COVID-19 Clinical Trials Accelerate Development of the Treatment

Dec 20, 2020 | Clinical Trial

15. Data from ACTT-2 Trial of Baricitinib in Hospitalized COVID-19 Patients Supportive of the U. S. FDA EUA Published in New England Journal of Medicine

Dec 19, 2020 | Clinical Trial

16. Lilly to Begin Pragmatic Study of Neutralizing Antibody Bamlanivimab (LY-CoV555) for COVID-19 in New Mexico

Dec 18, 2020 | Clinical Trial

17. Stroke and Altered Mental State Increase Risk of Death for COVID-19 Patients

Dec 18, 2020 | Clinical Trial

18. Beckman Coulter Launches One of the First High-Quality, High-Throughput COVID-19 Antigen Test Ideal for Mass Testing in the U.S.

Dec 18, 2020 | Regulatory

19. Research on Preventative Nasal Spray, Which Protects Against COVID-19 and Common Cold, Published in Leading Peer-Reviewed Academic Journals

Dec 17, 2020 | Clinical Trial

20. New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

Dec 17, 2020 | Clinical Trial

21. Circuit Clinical And The Center for Integrated Global Biomedical Sciences At The University at Buffalo Join Efforts In Regional And Global COVID-19 Clinical Research

Dec 17, 2020 | Collaboration

22. Pathology Lab and Health Information Exchange Partner with iSpecimen to Bring COVID-19 Specimens to Researchers

Dec 17, 2020 | Collaboration

23. Ampion Demonstrates Safety In COVID-19 Patients And Initiates Global Clinical Trial For Intravenous Ampion

Dec 17, 2020 | Clinical Trial

24. Pressure BioSciences PCT Platform at Forefront in Generating Pivotal Findings by Diverse COVID-19 Research Teams in USA, China, and Europe

Dec 17, 2020 | Regulatory

25. BAT progresses COVID-19 candidate vaccine into Phase I human clinical trials

Dec 16, 2020 | Clinical Trial

26. International, Federal, State and Local Agencies Choose Salesforce to Help Manage their COVID-19 Vaccine Efforts

Dec 16, 2020 | Regulatory

27. Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

Dec 15, 2020 | Regulatory

28. RedHill’s Phase 2/3 COVID-19 Candidate Opaganib Reduces ARDS-Related Blood Clotting in Preclinical Model

Dec 15, 2020 | Clinical Trial

29. Muscular Dystrophy Association Releases FAQs for the Neuromuscular Disease Community for Access to the COVID-19 Vaccines

Dec 15, 2020 | Regulatory

30. Medela Announces New Data Demonstrating that Thopaz+ Digital Chest Drain Improves Safety and Helps Prevent Cross-Contamination During the COVID-19 Pandemic and Beyond

Dec 15, 2020 | Clinical Trial

31. Binx Health Receives EUA Authorizing At-Home COVID-19 Sample Collection by Universities and Employers

Dec 15, 2020 | Regulatory

32. Harbour BioMed and Utrecht University Announce License Agreement with AbbVie and Initiation of COVID-19 Antibody Clinical Trials

Dec 14, 2020 | Collaboration

33. Anixa Biosciences Covid-19 Therapy Demonstrates Comparable Potency to Remdesivir in Pre-Clinical Testing

Dec 14, 2020 | Clinical Trial

34. Emmes Announces its Contribution to Second Remdesivir Clinical Trial for COVID-19

Dec 14, 2020 | Clinical Trial

35. HLS Therapeutics Reports Efficacy and Safety Results from Pilot Study Treating COVID-19 Infected Outpatients with Vascepa (Icosapent Ethyl)

Dec 14, 2020 | Clinical Trial

36. Pharmacy Organizations Welcome FDA Authorization of COVID Vaccine: “We Stand Ready to Serve”

Dec 11, 2020 | Regulatory

37. Kintor Proxalutamide’s COVID-19 Clinical Trial Shows Significant Reduction in Hospitalization and Ventilation Rates

Dec 11, 2020 | Clinical Trial

38. Data from ACTT-2 Trial of Baricitinib in Hospitalized COVID-19 Patients Supportive of the EUA Published in New England Journal of Medicine

Dec 11, 2020 | Clinical Trial

39. ADEXUSDx COVID-19 Antibody Test Filed for Point of Care Emergency Use Authorization

Dec 10, 2020 | Regulatory

40. INOVIO and Advaccine Announce First Dosing of Subject in Phase 2 Clinical Trial for COVID-19 DNA Vaccine Candidate INO-4800 in China

Dec 10, 2020 | Clinical Trial

41. The Himalaya Drug Company shares results of a clinical study that evaluated the role of herbal immunomodulators as an adjuvant treatment in the management of COVID-19

Dec 10, 2020 | Clinical Trial

42. Pharming Announces Enrolment of First Patient in US Clinical Trial for the Treatment of COVID-19 with RUCONEST

Dec 10, 2020 | Clinical Trial

43. Cyxone Receives Regulatory Approval to Initiate a Clinical Phase 2 Study with Rabeximod in Covid-19 patients

Dec 08, 2020 | Regulatory

44. NorthShore Joins Fight Against COVID-19 with Convalescent Plasma Trials for Close Contact Exposed and Newly Diagnosed Patients

Dec 08, 2020 | Clinical Trial

45. Vicore Pharma Reports Positive Top Line Data from the ATTRACT Clinical Study in Patients with COVID-19

Dec 08, 2020 | Clinical Trial

46. Eurofins U.S. Clinical Diagnostic Laboratories Partner with Insurance Providers to Cover FDA-Authorized At-Home COVID-19 Test

Dec 07, 2020 | Collaboration

47. INOVIO Doses First Subject in Phase 2 Segment of its INNOVATE Phase 2/3 Clinical Trial for INO-4800, its DNA Medicine to Prevent COVID-19

Dec 07, 2020 | Clinical Trial

48. NeuroRx and Relief Therapeutics Meet 165 Patient Enrollment Target in Phase 2b/3 Trial of RLF-100 for Critical COVID-19 with Respiratory Failure

Dec 07, 2020 | Clinical Trial

49. Hematologists Play Vital Role in Advancing COVID-19 Research, Potential Treatments

Dec 05, 2020 | Clinical Trial

50. New CRISPR-Based Test for COVID-19 Uses a Smartphone Camera

Dec 04, 2020 | Regulatory

51. Lilly and UnitedHealth Group Partner on Pragmatic Study of Neutralizing Antibody Bamlanivimab (LY-CoV555) for COVID-19

Dec 04, 2020 | Collaboration

52. Senhwa Announces the First Patient Enrolled in an Investigator Initiated Trial Of Silmitasertib as a Treatment for COVID-19

Dec 03, 2020 | Clinical Trial

53. Ixlayer and CIC Health Partner to Make COVID-19 Tests More Accessible to School Districts and Universities

Dec 03, 2020 | Collaboration

54. Drawbridge Health Partners with University of Cambridge Researchers for Use of OneDraw Blood Collection Device in COVID-19 and Other Clinical Studies

Dec 03, 2020 | Collaboration

55. Made-in-Canada COVID Testing Now Available: LuminUltra Receives Health Canada Authorization for Rapid, Portable COVID-19 qPCR Testing Solutions

Dec 03, 2020 | Regulatory

56. INOVIO Expands Global Manufacturing Consortium For Its COVID-19 Vaccine Candidate INO-4800 With Addition of Kaneka Eurogentec S.A.

Dec 03, 2020 | Regulatory

57. Octapharma USA Presents Results of Investigational Use of Octagam 10% for Severe COVID-19 Patients at ASH Annual Meeting

Dec 02, 2020 | Clinical Trial

58. Ampio’s Phase I Study For Inhaled Ampion Advances To Completing Enrollment Of COVID-19 Patients With Respiratory Distress

Dec 02, 2020 | Clinical Trial

59. European Based Rapid PCR-COVID19 Home-Test Company Selfdiagnostics is toSubmit Request for Authorisation

Dec 02, 2020 | Regulatory

60. Celularity Announces Positive DMC Safety Review and Continuation of its Phase I/II CYNK-001-COVID-19 (CYNKCOVID) Study

Dec 01, 2020 | Clinical Trial

61. World’s Leading Life Science Companies Now Enrolling COMMUNITY, A Global, Platform Trial For Hospitalized Patients With COVID-19

Nov 30, 2020 | Clinical Trial

62. Harvard’s Wyss Institute Licenses its eRapid Technology to The iQ Group Global to Accelerate the Development of COVID-19 Diagnostics

Nov 30, 2020 | Regulatory

63. LuminUltra Expands Testing Capacity Including Range of COVID-19 Offerings with Acquisition of Source Molecular Corporation

Nov 30, 2020 | Collaboration

64. Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization

Nov 30, 2020 | Clinical Trial

Related Post:-  Insights+: COVID-19 Healthcare News Monthly Updates – November 2020

The post Insights+: COVID-19 Healthcare News Monthly Updates – December 2020 first appeared on PharmaShots.

PharmaShots’ Most Read News of 2020

“Lockdown’ declared Collins Dictionary word of the year. The year 2020, well known as COVID-19 year has been a busy year for global pharma and biotech companies involved in M&A, option & licensing agreements, and gaining approvals. Our team has compiled a list of 30 most read life sciences news on PharmaShots in 2020.

1. Bayer Signs an Exclusive Option to License Agreement with Dare Biosciences to Commercialize Ovaprene in the US

  • Dare to receive up front, $20M as option exercise fee, $310M as commercial milestones, royalties on sales of the product along with access to Bayer’s clinical and market capabilities and remain responsible for development & regulatory activities of Ovaprene
  • Bayer to get exclusive right to commercialize Ovaprene in the US, once approved by the FDA. Dare is expected to file IDE for the therapy in H1’20 and the initiation of its clinical study in H2’20 following FDA’s review and clearance of the IDE
  • Ovaprene is an investigational hormone-free monthly vaginal contraceptive, currently in development for the prevention of pregnancy and if approved, will be the first monthly non-hormonal contraceptive therapy

2. Theramex to Acquire Commercial Rights of MSD’s Zoely to Expand its Footprints

  • Theramax acquires commercialization rights of Zoely, allowing it to commercialize the therapy in 50+ countries globally. Earlier, Theramax has right to commercialize Zoely in eleven countries in the EU while MSD retains rights in the US and Canada
  • The acquisition of further rights of Zoely expands Theramex global footprints by providing innovative therapies to maintain the healthcare of women
  • Zoely is a combined oral contraceptive therapy consisting of two steroid hormones: 17-beta estradiol and nomegestrol acetate

3. Gilead Signs an Exclusive License Agreement with Rockefeller University for its Portfolio of HIV Abs

  • Rockfeller to receive up front, milestones plus royalties on sales and will retain rights to perform non-clinical and early-stage clinical research on the portfolio of HIV Abs. Gilead to get exclusive rights to develop and commercialize Rockefeller’s full portfolio of HIV bNAbs
  • The focus of the agreement is to enhance Gilead’s HIV pipeline and will advance academic programs into potential future products
  • 3BNC117 and 10-1074 are clinical-stage products with the ability to be used as HIV long-acting therapies for treatment and prevention

4. Fujifilm’s CAD EYE Receives CE Mark to Support the Detection of Colonic Polyp Utilizing AI in the EU

  • Fujifilm’s CAD EYE receives CE mark, backing the real-time detection of colonic polyps during colonoscopy utilizing AI, will be available with software EW10-EC01 and the compatible expansion unit EX-1 in combination with the ELUXEO 7000 system
  • CAD EYE utilizes FUJIFILM’s REiLi AI technology and can perform complex segmentation of 2D/3D images, spot lesions & is compatible with various imaging modalities. It automatically engages with white light or LCI mode to improve the accuracy of lesion detection
  • CAD EYE is customized detection support used with the ELUXEO system, aimed to improve lesion detection in the colon at the expert level and is expected to be available with EX-1 in Mar’2020

5. GSK Reports the Acceptance of EMA’s MAA for Zejula (niraparib) as 1L Maintenance Treatment for Platinum-Responsive Advanced Ovarian Cancer

  • The EMA has accepted Type II Variation (T2V) for Zejula as maintenance therapy in a 1L setting for women with advanced platinum-responsive advanced OC, regardless of biomarker status. The validation indicates the acceptance of MAA and the initiation of CHMP’s formal review process
  • The submission is based on P-III PRIMA study assessing Zejula vs PBO in women in a ratio (2:1) as 1L therapy for stage III/ IV platinum-responsive advanced OC. The study demonstrated clinical outcomes of Zejula
  • Zejula (PO, qd) is a PARP inhibitor, indicated as a monothx. for the maintenance treatment of patients with platinum‑sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based CT

6. Esperion’s Nexlizet (bempedoic acid and ezetimibe) Tablet Receives the US FDA’s Approval as LDL-Cholesterol Lowering Medicine

  • The approval is based on P-III trial Fixed Combination Drug Product LDL-C Lowering program, involves assessing of Nexlizet vs PBO when added on to maximally tolerated statins
  • The study resulted in well-tolerated data and lowered LDL-C by 38%, when added on to maximally tolerated statins. Also, the results are published in The European Journal of Preventative Cardiology
  • Nexlizet is an oral qd, non-statin LDL-cholesterol lowering medicine approved by the US FDA on Feb 21, 2020 and will be available in Jul 2020. Nexletol (bempedoic acid) is a novel ATP Citrate Lyase inhibitor involves lowering of LDL-C by cholesterol biosynthesis and up-regulating the LDL receptors, will be available from Mar 30, 2020

7. AstraZeneca Reports Results of Imfinzi + Tremelimumab in P-III CASPIAN Study as 1L Treatment for Extensive-Stage Small Cell Lung Cancer

  • The P-III CASPIAN study involves assessing of Imfinzi + SOC (etoposide and carboplatin/ cisplatin CT) or Imfinzi + Tremelimumab vs CT as monothx. as a 1L treatment for 805 patients with ES-SCLC in 200+ centers across 23 countries
  • The first arm (Imfinzi + SOC) has met its 1EPs of OS in Jun’2019 while the second arm (Imfinzi + tremelimumab) did not meet its 1EPs of OS. The safety profile of each therapy is consistent with the known safety profiles
  • Imfinzi (durvalumab) is mAb targeting PD-L1, acts by blocking the interaction of PD-L1 with PD-1 & CD80 and is currently under review in combination with etoposide and carboplatin/cisplatin as 1L treatment for ES-SCLC in the US, EU and Japan with its anticipated PDUFA date in 2021

8. Novo Nordisk’s Fiasp (insulin aspart injection) Receives Health Canada’s Approval for Children with Diabetes

  • Health Canada has expanded the approval of Fiasp (10mL vials) to include use in insulin infusion pumps for the improvement of glycemic control in pediatric patients aged ≥2yrs with diabetes (T1D/T2D both)
  • The approval is based on data from 7 clinical studies that verified the safety & efficacy of Fiasp in children. The label change for use in insulin infusion pumps is based on Health Canada’s review of data from 5 clinical studies which demonstrated the efficacy of Fiasp used in insulin infusion pumps in adults with diabetes
  • Fiasp is the first and only fast-acting mealtime insulin injection, administered at the beginning of a meal or within 20 minutes after starting a meal and has received FDA’s approval as an IV infusion or SC MDI in adults with diabetes

9. Merck KGaA’s ERBITUX (cetuximab) Receives NMPA’s Approval as a 1L treatment for Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck

  • The approval is based on P-III CHANGE II study assessing extreme regimen (ERBITUX + cisplatin + 5-FU, followed by ERBITUX as maintenance therapy) vs Pt. based CT (cisplatin + 5-FU) in 243 patients aged ≥18 yrs. with R/M SCCHN, prior not treated with any systemic therapy in China
  • The P-III CHANGE II study results: improvement in PFS (5.5 vs 4.2mos.); OS (10.2 vs 8.4mos.), ORR (50% vs 27%) with no new safety findings
  • ERBITUX is an IgG1 mAb targeting the EGFR and is an approved therapy in 100+ countries for RAS wild-type m-CRC and for HNSCC

10. Bausch Health to Initiate Clinical Study Evaluating Virazole (Ribavirin for Inhalation Solution, USP) in Patients with COVID-19 in Canada

  • The clinical study will evaluate the safety and efficacy of Virazole + SOC in hospitalized patients aged ≥18yrs. with respiratory distress due to COVID-19
  • The clinical study has been approved by Health Canada and is expected to initiate within the next few weeks. The company is working with multiple health authorities including the US FDA regarding additional studies to assess Virazole as a treatment for COVID-19 infection
  • Virazole (ribavirin for inhalation solution, USP) aerosol is indicated only for lower respiratory tract infection due to RSV. The Bausch Foundation is working with health authorities in Italy to make Virazole for inhalation available free of charge in compassionate use in hospitals

11. Amgen Signs a Partnership with Adaptive Biotechnologies to Develop Abs for COVID-19

  • Adaptive to expand its platform for selection of B cell receptors of recovered patients from COVID-19. Amgen will utilize its Ab engineering and drug development capabilities to select and develop Abs designed to bind and neutralize SARS-CoV-2. Additionally, Amgen ‘s subsidiary DeCODE Genetics located in Iceland, will provide genetic information from patients infected with COVID-19
  • The focus of the collaboration is to combine expertise to discover and develop fully human neutralizing Abs for SARS-CoV-2 virus to treat COVID-19 where Adaptive’s immunological medicine platform will help in identification of virus neutralizing Abs
  • Additionally, the Abs can be used to treat patients with COVID-19 and can be administered to patients with who are at increased risk of exposure to SARS-CoV-2

12. BioNTech and Pfizer Complete Dosing of BNT162 in First Cohort of P-I/II Study in Germany

  • The companies reported that the first cohort of BioNTech’s P-I/II clinical trial has dosed 12 participants with BNT162 in Germany since dosing began on Apr 23, 2020. Following the regulatory approvals, both the companies plan to initiate the clinical study for BNT162 in the US
  • The dose-escalation portion of the P-I/II study will include ~200 healthy participants aged 18-55yrs. and will target a dose range of 1-100 µg, focusing on determining the optimal dose for further studies and to evaluate the safety and immunogenicity of the vaccine
  • The study will evaluate the effects of repeated vaccination following a prime injection for 3 vaccine candidates that contain uRNA or modRNA. The fourth vaccine candidate contains saRNA will be evaluated following a single dose of vaccine. Additionally, BioNTech is collaborating with Fosun Pharma to develop BNT162 in China, where the companies expect to conduct clinical studies

13. Fresenius Kabi Signs an Agreement with Medec to Commercialize IDACIO (adalimumab, biosimilar) in Germany

  • Fresenius Kabi and Medec collaborated to offer IDACIO as an additional therapy option for rheumatologists and dermatologists to treat rheumatic illnesses. From Jun 01, 2020, Medec’s will market the biosimilar therapy
  • Last year, Fresenius Kabi launched IDACIO in the EU for arthritis and psoriasis. The collaboration offers patients and doctors new benefits and synergies in therapy offerings as well as consulting
  • Medac provides methotrexate (metex PEN, metex FS) as the parenteral treatment of patients with chronic inflammatory diseases, the affected patients are treated with a combination of methotrexate and adalimumab

14. Neurocrine Biosciences Exercises its Option with Idorsia for ACT-709478

  • Idorsia to receive $45M upfront in cash, $365M for development & regulatory milestone, one-time sales threshold and royalties on sales. Additionally, will receive $7M in funding to discover, identify and develop additional novel T-type calcium channel blockers
  • Neurocrine exercises its option to license rights for ACT-709478 (post IND acceptance from the US FDA on Apr 30, 2020) for rare pediatric epilepsy. In 2019, Neurocrine and Idorsia signed a preclinical research collaboraion for ACT-709478 to treat rare pediatric epilepsy
  • ACT-709478 is an selective, orally-active and brain penetrating T-type calcium channel blocker also received the US FDA’s Rare Pediatric Disease designation for rare pediatric epilepsy with completion of P-I in 2019 and expected P-II initiation in in H2’20

15. Moderna Signs a Ten-Year Worldwide Agreement with Lonza to Manufacture mRNA-1273 Against COVID-19

  • The companies intend to establish manufacturing suites at Lonza’s facilities in the US and Switzerland to manufacture mRNA-1273 at both sites. The collaboration will deploy Lonza’s global expertise in technology transfer and manufacturing while the technology transfer expected to begin in Jun’2020
  • The focus of the collaboration is to enable the manufacturing of mRNA-1273 up to 1B doses/year and anticipates the manufacturing of the first batches of mRNA-1273 at Lonza US site in Jul’2020, assuming the currently expected dose of 50µg
  • Manufacturing operations at Lonza US site is covered by Moderna’s agreement with BARDA under which BARDA will support late-stage clinical development programs of mRNA-1273. On Apr 27, 2020, Moderna has submitted IND to the US FDA for P-II studies with its expected initiation in Q2’20

16. Roche’s Enspryng (satralizumab) Receives MHLW’s Approval for Neuromyelitis Optica Spectrum Disorder in Japan

  • The approval is based on two P-III SAkuraStar & SAkuraSky studies involve assessing Enspryng (120mg, SC, q4w) as a monothx & as an add-on therapy to baseline IST vs PBO in 95 & 83 patients aged 20-70 & 13-73yrs. in a ratio (2:1) & (1:1) administered at week 0,2 & 4 in patients with NMOSD respectively
  • In overall population: reduction in the risk of relapse (62% & 55%); In the pre-specified subgroup of AQP4-IgG seropositive patients: reduction in the risk of relapse (79% & 74%) respectively
  • Enspryng is a mAb targeting IL-6 and is under PR in Canada for NMOSD patients who are AQP4-IgG seropositive. In Oct’2019, the FDA & EMA has accepted the MAA for the therapy with expected CHMP & FDA’s decision in 2020

17. Cipla Launches Cipremi (remdesivir lyophilized powder for injection 100 mg) to Treat Patients with Severe COVID-19

  • The US FDA has issued a EUA to Gilead for emergency use of remdesivir to treat hospitalized COVID-19 patients. In May, Gilead has extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla’s Remedisvir called CIPREMI
  • Cipla has received DCGI’s approval for restricted emergency use in India as part of the accelerated approval process. Cipla will provide training on the use of the drug, informed patient consent documents, conduct post-marketing surveillance as well as to conduct a P-IV clinical trial on Indian patients
  • As per ACTT-1 study, 1063 patients were treated with Remdesivir vs PBO over 60 centers across the US, EU and Asia demonstrated faster time to clinical recovery in hospitalized patients with the mortality rate as (7.1% vs 11.9%)

18. Sorrento Submits EUA to the US FDA for its COVI-TRACK Test to Detect COVID-19

  • Sorrento has reported that its EUA is under review at the US FDA for its COVI-TRACK in vitro diagnostic test kit for the detection of IgG and IgM Abs in sera of patients exposed to the SARS-CoV-2 virus
  • Following the issuance of an EUA, the COVI-TRACK test will be available for distribution to clinical testing sites nationwide. The assay develops three clear lines that confirm the assay validity and the qualitative detection & differentiation of IgM and IgG Abs to the COVID-19
  • Sorrento has secured manufacturing capacity to ramp up the production of up to 5M test kits/ month with the availability of results in ≤8mins. The assay showed specificity > 97% and diagnostic sensitivity of > 94% in an analytical validation

19. Dr. Reddy’s and GRA Collaborate with Fujifilm for Avigan (favipiravir) to Treat COVID-19 Outside the Japan

  •  Fujifilm to receive upfront, license fee along with royalties on sales of the therapy. Dr. Reddy’s and GRA to get the exclusive right to develop & commercialize Avigan globally (Ex- Japan). Additionally, Dr. Reddy’s would have exclusive rights for the therapy in India
  • Fujifilm will provide pre/ clinical data of Avigan to Dr. Reddy’s and GRA for utilizing it in clinical studies targeting COVID-19. Moreover, Dr. Reddy’s will get right to use Avigan’s patents of formulation and manufacturing method and will establish a setup for developing drug-like Avigan and utilizes the GRA’s global sales network to supply the manufactured drugs
  • Fujifilm is currently conducting a clinical study on Avigan targeting COVID-19 patients in the US and Japan and is collaborating with multiple companies to increase the drug’s production

20. ViiV Healthcare’s Rukobia (fostemsavir) Receives the US FDA’s Approval for HIV in Patients with Limited Treatment Options

  • The approval is based on P-III BRIGHTE study assessing Rukobia (600mg, ER) + OBT in 371 HTE adults living with multidrug-resistant HIV. Participants were enrolled in either a randomized or nonrandomized cohort
  • In the randomized cohort, 60% adults achieved undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count @96wks., HIV-1 RNA <40 copies/mL @24 & 96wks. (53% & 60%); changes in CD4+ cell count (90 & 205 cells/mm3) respectively
  • In the nonrandomized cohort, 37% achieved HIV-1 RNA <40 copies/mL @24 & 96wks.; HIV-1 RNA <200 copies/mL (42% & 39%); mean changes in CD4+ cell count (41 & 119 cells/mm3) respectively. Fostemsavir is a first-in-class HIV-1 attachment inhibitor, currently under EMA’s review with additional submissions to regulatory authorities anticipated in 2020 & 2021

21. Zydus Launches Cheapest Version of Remdesivir at $37.41 per Vial in India

  • The company has launched Remdec at a price of $37.41 (Rs. 2800) for a 100mg lyophilized injection. The generic version is the most economical Remdesivir brand in India
  • In Jun’2020, Zydus signed a non-exclusive agreement with Gilead to manufacture and commercialize Remdesivir for severe COVID-19 in India. The API of the therapy has been developed and manufactured at the group’s API manufacturing facilities in Gujarat
  • The drug will be made available across India via Zydus’ strong distribution chain reaching out to government and private hospitals treating COVID patient

22. Johnson & Johnson to Acquire Momenta Pharmaceuticals for $6.5B

  • J&J acquires Momenta in all-cash transaction at a price of $52.50/ share, making a total deal value as $6.5B. The transaction is expected to be closed in H2’20
  • The acquisition allows J&J to expand its portfolio for autoimmune diseases with the addition of Momenta’s Nipocalimab (M281) to its pipeline. In addition to nipocalimab, Janssen will acquire Momenta’s pipeline of clinical and pre-clinical assets
  • Janssen plans to retain Momenta’s presence in Cambridge, Massachusetts which will increase J&J footprint and capabilities in the key innovation hub. Nipocalimab provides an opportunity for Janssen to deliver transformative treatments in autoantibody-driven autoimmune diseases

23.  Novartis’ Beovu (brolucizumab) Receives EMA’s Approval for its Safety Label Update to Treat Wet Age-Related Macular Degeneration

  • The EU label update includes additional categorization of retinal vasculitis and/or retinal vascular occlusion, usually in the intraocular inflammation. The approval follows Novartis completion of safety review and initiation of an update to the Beovu prescribing information globally
  • The label update is applicable to all 27 EU member states as well as UK, Iceland, Norway, and Liechtenstein. Beovu is now approved for wet AMD treatment in 40+ countries including in the US, EU, UK, Japan, Canada, and Australia
  • Beovu (brolucizumab) is the clinically advanced humanized single-chain Ab fragment (scFv) that enhances tissue penetration, rapid clearance from the systemic circulation, and drug delivery characteristics. Novartis has established a multidisciplinary panel of internal experts collaborating with external advisors to examine the root cause, potential risk factors, and mitigation of AEs

24. Boehringer Ingelheim Initiates P-II Study of BI 764198 for Patients with Severe Respiratory Illness from COVID-19

  • The P-II trial will assess BI 764198 (qd for ~4wks.) in patients hospitalized for COVID-19 with expected enrollment initiation in Oct’2020. The 1EPs will be the percentage of patients who are alive and free of mechanical ventilation at day 29 of treatment while other EPs include clinical improvement, oxygen saturation & ICU admission
  • The therapy has shown a reduction in cellular damage and lung edema in preclinical studies and may provide similar benefits in patients with severe SARS-CoV-2 infection. BI 764198 was well tolerated in P-I study in healthy adults
  • BI 764198 is potent & selective inhibitor of TRPC6, focusing to reduce the need for ventilator support and to improve patient recovery rate

25. Roche’s Tecentriq in Combination with Avastin Receives China NMPA’s Approval for the treatment of Unresectable Hepatocellular Carcinoma

  • The approval was based on the P-III IMbrave150 study (n=501) assessing the combination of Tecentriq (1200 mg, IV) and Avastin (15 mg/kg, IV) or sorafenib (400 mg, bid) in unresectable HCC patients who had not received prior systemic therapy which included analyses of a cohort of Chinese patients (n=194) from the same study
  • Results: Tecentriq in combination with Avastin reduced the risk of OS by 56% (among Chinese patients) and 42% (global results) & the PFS risk by 40% (among Chinese patients) and 41% (global results) as compared with sorafenib
  • IMbrave150 is the 1st P-III cancer immunotherapy study to show an improvement in OS and PFS in people with unresectable or metastatic HCC compared with sorafenib. Additionally. in May 2020, the US FDA approved Tecentriq in combination with Avastin for the treatment of people with unresectable or metastatic HCC who have not received prior systemic therapy

26. Sanofi Entered into an Agreement with Merck to Conduct a P-II Study of THOR-707 in Sequenced Administration with MSD’s Keytruda (pembrolizumab) in Patients with Various Cancers

  • Sanofi will sponsor the clinical trials while MSD will provide KEYTRUDA. Additionally, Sanofi is separately evaluating the activity of THOR-707 in combination with other anti-PD-1 antibodies, including Libtayo (cemiplimab-rwlc) and with anti-EGFR and anti-CD38 antibodies for various types of cancer tumors
  • In preclinical studies, THOR-707 demonstrated the ability to induce the expansion of CD8+T-cells resulting in anti-tumor effects both as a single agent as well as in combination with an anti-PD1 mAb
  • THOR-707 is currently being evaluated by Sanofi in an ongoing P-I dose escalation and expansion trial assessing THOR-707 and determining its recommended P-II dose alone and in combination with anti-PD-1 and anti-EGFR antibodies

27. AstraZeneca and Fusion Collaborate to Develop and Commercialize Radiopharmaceuticals and Combination Therapies for Cancer

  • Fusion to receive up front, as well as development milestones and other payments. The companies will jointly discover, develop, and have an option to co-commercialize novel TATs in the US while AstraZeneca will lead commercialization in the ROW with equal profit & loss sharing globally
  • The collaboration leverages Fusion’s TAT platform and expertise in radiopharmaceuticals with AstraZeneca’s leading portfolio of Abs and cancer therapies, including DDRis
  • Additionally, the companies will exclusively explore certain specified combination strategies between TATs (including Fusion’s FPI-1434) and AstraZeneca’s therapies for the treatment of multiple cancers. Both companies will retain full rights to their respective assets

28. Lucira’s All-In-One Test Kit Receives the US FDA’s EUA as the First COVID-19 Test for Self-Testing at Home

  • The Lucira’s COVID-19 all-in-one test kit test has been authorized for home use with self-collected nasal swab samples in individuals aged≥ 14yrs. who are suspected of COVID-19 by their HCPs
  • It is also authorized for use in POC settings for all ages, but samples must be collected by an HCP when the test is used at the POC to test individuals <14yrs. The test is currently authorized for prescription use only
  • Lucira plans to amend its EUA or file a new EUA so people who think they’re infected with COVID-19 can communicate with a medical professional online through a website to arrange a prescription and overnight delivery of the test kit by Q2’21

29. UCB Acquires Handl Therapeutics to Augment its Gene Therapy Portfolio

  • The acquisition will bolster UCB’s pipeline program, capabilities, and platforms in the gene therapy space. The Handl Therapeutics will continue to be based in Leuven, Belgium while working closely with UCB’s international research teams
  • In addition, the UCB collaborated with Lacerta to focus on CNS diseases, under which Lacera will lead research, preclinical activities, and the early manufacturing process development, while UCB will complete IND-enabling studies, manufacturing, and clinical development
  • The collaboration will allow UCB to access Lacerta’s expertise in AAV-based CNS targeted gene therapies, fortifying UCB’s ability to produce effective treatments for neurodegenerative diseases

30. Janssen Acquires Rights to Hemera’s HMR59 for Late-Stage Age-Related Macular Degeneration

  • Janssen acquires rights to Hemera’s HMR59, administered as a one-time, outpatient, IVT inj. to help preserve vision in patients with geographic atrophy
  • The acquisition will boost Janssen’s eye disease portfolio & strengthens its gene therapy capabilities
  • HMR59 is designed to increase the ability of retina cells to make a soluble form of CD59, helping to prevent further damage to the retina and preserve vision. The P-I study of the therapy for patients with geographic atrophy is completed while the P-I study exploring HMR59 in patients with wet-AMD is currently conducting follow-up visits to evaluate the long-term safety

Related Post: PharmaShots’ Most Read News of 2019

The post PharmaShots’ Most Read News of 2020 first appeared on PharmaShots.

PharmaShots Wishes you a Merry Christmas and a Happy New Year

Shots:

  • Thank you for your overwhelming affection and support throughout the year. This year we achieved a massive increase in subscribers
  • PharmaShots mobile app is ready and we planned to launch our PharmaShots mobile app in January 2021
  • May this holiday season fills your life with happiness and wealth. Wish you a Merry Christmas and a Happy New Year 2021!

Ref: PharmaShots | Image: Canva

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Insights+: The US FDA New Drug Approvals in November 2020

The US FDA has approved 5 NDAs and 1 BLA in Nov 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 96 novel products so far in 2020, including 6 in Nov 2020. Additionally, last year in 2019, the US FDA has approved 48 novel products. We have compiled a list of a total of 6 new drugs approved by the US FDA in Nov 2020.

Sedor’s Sesquient Received the US FDA’s Approval for Status Epilepticus

Published: Nov 09, 2020 | Tags: Sedor Pharmaceuticals, US FDA approval, Sesquient, Treatment, Status Epilepticus, Adult and Pediatric patients

  • The US FDA has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients
  • Sedor is actively in discussions to license the rights to Sesquient for NA, EU, and other territories, except for the People’s Republic of China, where it has already been licensed
  • Sesquient is the first and only FDA-approved room temperature stable fosphenytoin and can help HCPs to treat status epilepticus patients and reduce hospital costs associated with this condition

Eiger’s Zokinvy (lonafarnib) Received the US FDA’s Approval for Treatment of Progeria and Processing-Deficient PL

Published: Nov 20, 2020 | Tags: approval, Deficient, Eiger, lonafarnib, PL, Processing, Progeria, receives, Treatment Us FDA, Zokinvy

  • The Progeria Research Foundation and Eiger reported the US FDA’s approval of Zokinvy (lonafarnib) for the treatment of HGPS or progeria and processing-deficient progeroid laminopathies
  • Zokinvy reduced the incidence of mortality by 60% & increased the average survival time by 2.5 yrs. Additionally, the FDA has issued an RPD priority review voucher to Eiger
  • Eiger plans to sell the PRV and will share the proceeds equally with PRF, under its supply & collaboration agreement. Zokinvy is a farnesyltransferase inhibitor that has shown a survival benefit in children with Progeria

Alnylam’s Oxlumo (lumasiran) Received the US FDA’s Approval for Treatment of Primary Hyperoxaluria Type 1 in Pediatric and Adult Patients

Published: Nov 23, 2020 | Tags: Adult, Alnylam, approval, Hyperoxaluria, Lumasiran, OXLUMO, patients, Pediatric, Primary, receives, Treatment, Type 1, US FDA

  • The approval is based on P-III ILLUMINATE-A & -B trials. The studies demonstrating reductions in urinary oxalate and encourage safety and tolerability in pediatric and adult patients
  • The ILLUMINATE-A showed that Oxlumo met its 1EP i.e. change in 24hrs. (65% vs 12%) compared to PBO, the study also achieved significant results for all 6 tested 2EPs
  • In ILLUMINATE-B, Oxlumo demonstrated a 72% mean reduction in spot urinary oxalate: creatinine ratio from baseline to 6mos., reduction of oxalate as consistent across all three body wt. categories. Additionally, therapy demonstrated positive results across 2EPs, including additional measures of oxalate

Roche’s Xofluza (baloxavir marboxil) Received the US FDA’s Approval for Post-Exposure Prevention of Influenza

Published: Nov 24, 2020 | Tags: approval, baloxavir marboxil, Contact, Following, Infected, Influenza, Person, Prevention, receives, Roche, Us FDA, Xofluza

  • The approval is based on P-III BLOCKSTONE study assessing a single dose of Xofluza vs PBO in household members who were living with someone with influenza confirmed by a rapid influenza diagnostic test
  • Results: The proportion of household members aged ≥12yrs. who developed influenza (1% vs 13%), well-tolerated with no new safety signals
  • Xofluza is the first single-dose influenza medicine approved to prevent influenza for those who have had contact with an infected person. Roche also plans to file sNDA for Xofluza as a treatment for acute uncomplicated influenza in pediatric patients (1-12yrs.) and for the prevention of influenza in the same age group who have been exposed to influenza

Y-mAbs’ Danyelza (naxitamab-gqgk) Received the US FDA’s Approval for Neuroblastoma

Published: Nov 25, 2020 | Tags: (naxitamab-gqgk), approval, Danyelza, Neuroblastoma, receives, US FDA, Y-mAbs Therapeutics

  • The US FDA has approved Danyelza (40mg/10ml) and is indicated in combination with GM-CSF for pediatric patients aged 1yrs. & older and adult patients with r/r high-risk neuroblastoma in the bone marrow
  • The indication is approved under accelerated approval regulation based on ORR and DOR. Continued approval for the indication may be contingent upon verification and description of clinical benefits in a confirmatory trial
  • Danyelza is a mAb that targets the ganglioside GD2 which is highly expressed in various neuroectoderm-derived tumors and sarcomas and has received PR, ODD, BT and RPD from the US FDA

Rhythm’s Imcivree (setmelanotide) Received the US FDA’s Approval for Chronic Weight Management in Patients with Obesity

Published: Nov 27, 2020 | Tags: Rhythm, Pharmaceutical, IMCIVREE, setmelanotide, Receives, US FDA, Approval, Chronic, Weight, Management, Patients, Obesity

  • The US FDA has approved Imcivree for chronic weight management in adult & pediatric patients aged ≥6yrs. with obesity due to POMC, PCSK1 or LEPR deficiency confirmed via genetic testing
  • The approval is based on results of P-III trials that demonstrated 80% of patients with obesity due to POMC or PCSK1 deficiency achieved >10% weight loss & 45.5% of patients with obesity due to LEPR deficiency achieved >10% weight loss after 1yr of treatment
  • The US FDA issued a Rare Pediatric Disease PRV to Rhythm with the approval. The PRV can be redeemed to receive PR for any marketing application or sold/ transferred to other companies for their programs. The therapy is under EMA’s review for approval

Related Post: Insights+: The US FDA New Drug Approvals in October 2020

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Insights+ Key Biosimilars Events of November 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference product to biologics” possessing similar therapeutic properties. During the month of November, Formycon and Bioeq reported the first patient dosing in the P-III study of FYB202 while Prestige collaborated with Teva to commercialize Tuznue. Our team at PharmaShots has summarized 21 key events of the biosimilar space of Nov 2020.

Celltrion Presented Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020

Published: Nov 03, 2020

Product: CT-P17 (biosimilar, adalimumab)

  • The P-III study involves assessing CT-P17 (40mg, q2w) vs reference adalimumab for up to 24wks. in 648 patients with active moderate-to-severe RA despite MTX treatment
  • Results demonstrated that CT-P17 has equivalent efficacy to reference adalimumab i.e. ACR20 is 82.7% for both, 2EPs include ACR20/50/70 response rates, mean DAS28, CDAI & SDAI & EULAR (CRP) response, Ctrough of adalimumab is higher for CT-P17 & lower in the ADA positive subgroup than the ADA negative subgroup in both treatment groups, the safety profile is comparable
  • Additionally, comparable PK and safety data is presented for CT-P17 in comparison with EU-approved & US-licensed adalimumab in 312 healthy subjects. Celltrion also presented PK and safety data for two delivery methods for CT-P17, the auto-injector (AI) and pre-filled syringe (PFS)

Formycon Reported BLA Resubmission Strategy for FYB201 (biosimilar, ranibizumab)

Published: Nov 06, 2020

Product: FYB201 (biosimilar, ranibizumab)

  • Formycon & Bioeq reported the BLA resubmission strategy for FYB201 (biosimilar referencing Lucentis) has been adjusted
  • With the revised submission strategy, the companies expect a simplification of the approval procedure. The modified submission dossier is anticipated to be filed with the US FDA in H1’21
  • The adjustment of the regulatory strategy while optimizing the commercial supply chain is not expected to have any impact on the timing of the anticipated launch of FYB201 in the US & EU

Formycon and Bioeq Reported First Patient Dosing in P-III Study of FYB202 (biosimilar, ustekinumab)

Published: Nov 09, 2020

Product: FYB202 (biosimilar, ustekinumab)

  • The focus of the P-III study is to demonstrate the comparability of FYB202 & the reference product Stelara in terms of efficacy, safety & immunogenicity in patients with moderate to severe psoriasis vulgaris
  • FYB202 is being developed as part of JV b/w Aristo Pharma & Formycon along with Bioeq. Bioeq is responsible for the clinical studies which were developed in close cooperation with the US FDA & the EMA
  • The ustekinumab is mAb targeting the cytokines IL-12 & IL-23. Stelara is used to treat various severe inflammatory conditions such as mod. to sev. psoriasis, CD & for UC

Alvotech and Cipla Collaborated to Ensure Access to Biosimilars in South Africa

Published: Nov 09, 2020

Product: Biosimilar

  • Alvotech and Cipla entered an exclusive partnership to provide patients with better access to high quality and cost-effective biosimilar medicines in South Africa
  • Alvotech will be responsible for the development and supply of the products and Cipla will be responsible for the registration and commercialization
  • The biosimilar portfolio will include five biosimilars- two for oncology and three for treating auto-immune diseases

Genentech Filed Complaint Against Centus Over Proposed Bevacizumab Biosimilar

Published: Nov 13, 2020

Product: Proposed Bevacizumab Biosimilar

  • Genentech filed a complaint in the Eastern District of Texas alleging that the proposed biosimilar to Avastin (bevacizumab) product infringes 10 US patents
  • Genentech alleges that Centus and partners failed to disclose sufficient information about the proposed biosimilar to enable Genentech to do a sufficient analysis of potential patent infringements
  • Centus has a BLA under review with the FDA for the bevacizumab biosimilar candidate FKB238, and the company has filed a notice of intent to commercialize the agent

Prestige Signed an Exclusive Agreement with Teva to Commercialize Tuznue (biosimilar, trastuzumab) in Israel

Published: Nov 11, 2020

Product: Tuznue (biosimilar, trastuzumab)

  • Teva to get an exclusive right to commercialize Tuznu in Israel, leveraging its marketing capabilities and experience in bringing pharmaceutical products to market and will be responsible for local registration, sales, and marketing in Israel
  • Prestige will assume responsibility for product registration with the EMA and commercial supply of Tuznue from its manufacturing facilities in Osong, Korea
  • Tuznue is biosimilar referencing Roche’s Herceptin (trastuzumab), used to treat HER2-overexpressing BC & m-gastric adenocarcinoma. Additionally, the EMA has accepted an MAA for Tuznue based on the global clinical trial results

Samsung Bioepis Initiated P-I Study of SB16 Proposed Biosimilar to Prolia (denosumab)

Published: Nov 11, 2020

Product: SB16 proposed biosimilar to Prolia

  • The P-I study assesses the PK/PD, safety, tolerability of SB16 (denosumab) vs Prolia in 168 healthy male volunteers for osteoporosis. The study will be 3 arms study that involves dosing with SB16 either the EU or US-sourced Prolia
  • The proposed biosimilar references Amgen’s Prolia which was approved in 2010 for osteoporosis with a high risk of fracture
  • With the initiation, Samsung Bioepis continues to advance its biosimilar portfolio covering immunology, oncology, ophthalmology, and hematology

Henlius Reported First Patients Dosing in P-I Study of HLX14 (denosumab, biosimilar)

Published: Nov 11, 2020

Product: HLX14 (denosumab, biosimilar)

  • The first patient has been dosed in a P-I study of HLX14, conducted in 2 parts, Part 1 is a pilot study assessing PK/PD, safety, tolerability & immunogenicity of HLX14 vs EU-sourced denosumab (SC) in healthy male volunteers
  • Part 2 is a four-arm study assessing the bioequivalence of HLX14 vs US-, EU-, CN-sourced denosumab. The study also evaluates PD, safety, tolerability, and immunogenicity between HLX14 and the reference drug
  • Results from the P-I study will provide reference for the dosing scheme in the clinical studies of HLX14

Xbrane Reported Patient Enrollment Completion in P-lll XPLORE Study of Xlucane (biosimilar, ranibizumab)

Published: Nov 11, 2020

Product: Xlucane (biosimilar, ranibizumab)

  • Xbrane reported that the last patient has been enrolled into the P-III XPLORE study assessing Xlucane vs Lucentis in 580 patients with wet AMD
  • The company will conduct an interim read-out from the XPLORE study when the last patient has reached 6mos. of their treatment schedule. Top-line data is expected to be communicated mid-2021 and filing of the MAA/BLA to EMA and the US FDA anticipated to take place imminently
  • Filing of MAA/BLA is expected to take place mid-2021. With an expected 12mos. regulatory process upon filing, MAA is expected in the EU and the US mid-2022 allowing for the launch of Xlucane

Henlius Reported the NMPA’s Acceptance of HLX15 (biosimilar, daratumumab) to Treat Multiple Myeloma

Published: Nov 16, 2020

Product: HLX15 (biosimilar, daratumumab)

  • The NMPA has accepted HLX15’s IND to be used in the treatment of multiple myeloma. HLX15 is Henlius’ second self-developed product around blood tumor treatment
  • The company evaluated the biosimilar in a head to head clinical studies demonstrating that HLX15 is highly similar to its reference daratumumab while the safety profiles are also similar
  • The company has developed the HLX15 in accordance with the technical guidelines of development and evaluation of biosimilar drugs and EMA guideline on similar biological medicinal products

Samsung Bioepis Presented Results of SB11 Proposed Biosimilar to Lucentis in P-III Study at the AAO 2020 Virtual

Published: Nov 16, 2020

Product: SB11 proposed biosimilar to Lucentis

  • The P-III study involves assessing SB11 vs reference ranibizumab in monthly injections (0.5 mg) in 705 patients in a ratio (1:1) with nAMD while only 634 patients continued to receive treatment up to 48wks.
  • One-year results from the P-III study demonstrated equivalence between SB11 and reference ranibizumab in patients with nAMD
  • The study met its 1EPs i.e. changes from baseline in BCVA @8wks. and CST @4wks. The EMA has accepted for review the MAA of SB11 in Oct’2020

Samsung Bioepis and Biogen Reported the FDA’s Acceptance of BLA for SB11 Proposed Biosimilar to Lucentis

Published: Nov 18, 2020

Product: SB11 proposed biosimilar to Lucentis

  • The US FDA has accepted for review the BLA of SB11, a proposed biosimilar referencing Lucentis (ranibizumab)
  • The EMA has accepted for review the MAA of SB11 in Oct’2020. If approved, SB11 will add to the biosimilars portfolio developed under the collaboration of Samsung Bioepis and Biogen including Benepali, Imraldi & Flixabi
  • In Nov’2019, Samsung Bioepis entered into a commercialization agreement with Biogen for 2 ophthalmology biosimilar candidates, SB11 (ranibizumab) & SB15 (aflibercept) in the US, Canada, Europe, Japan & Australia. Ranibizumab is an anti-VEGF therapy for retinal vascular disorders

The US FDA Draft New Guidelines for Biosimilarity and Interchangeability

Published: Nov 19, 2020

Product: Biosimilar

Shots:

  • The FDA has released a draft guidance for industry entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act”
  • The draft guidance is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable products, as well as describe FDA’s interpretation of statutory requirements added by the BPCI Act
  • The draft guidance is to be published in the Federal Register on Nov 20, 2020

Alvotech Reported the US FDA and EMA’s Acceptance of AVT02 Proposed Biosimilar to Humira (adalimumab)

Product: Nov 20, 2020

Product: AVT02, a proposed biosimilar to Humira

  • The US FDA has accepted the BLA of AVT02 for review and is expected to decide on the filing in Sept’2021 while the EMA has accepted for review an MAA for AVT02 with an EMA decision anticipated in the Q4’21
  • The filings were based on AVT02-GL-101 & AVT02-GL-301 studies demonstrating a high degree of similarity b/w AVT02 and the reference products. AVT02-GL-101 study met its 1EPs of PK similarity while the later study confirmed the efficacy and safety of AVT02 in patients with mod. to sev. chronic psoriasis
  • AVT02 is a proposed biosimilar to the reference product Humira (adalimumab) with high concentration (100mg/mL) dosage forms

Henlius Presented Results of HLX04 (biosimilar, bevacizumab) in P-III Study at ESMO Asia 2020

Published: Nov 20, 2020

Product: HLX04 (biosimilar, bevacizumab)

  • The P-III HLX04-mCRC03 study involves assessing the efficacy, safety and immunogenicity of HLX04 vs reference bevacizumab (7.5 mg/kg, q3w or 5 mg/kg, q2w) + CT (Xelox or mFOLFOX6) as a 1L treatment in patients in the ratio of (1:1) with mCRC
  • Result: PFSR36wk (46.4% vs 50.7%); no significant difference b/w the treatment groups in 2EPs including OS, PFS, ORR, TTR and DoR; safety and immunogenicity profiles were similar b/w HLX04 and the reference
  • The NMPA has accepted the NDA for HLX04. Additionally, Henlius has submitted a patent for a new formulation of HLX04 with potential better safety and stability, designed for ophthalmic use

Samsung Biologics and AstraZeneca Dissolved Rituximab Alliance

Published: Nov 20, 2020

Product: SAIT101 (biosimilar, rituximab)

  • Samsung Biologics and AstraZeneca had decided to suspend long-running research and development activities by a jointly owned subsidiary, Archigen Biotech, which was solely engaged in development of SAIT101 (biosimilar, rituximab)
  • Samsung halted the P-III study of SAIT101 in Oct’2012 and resumed it in 2014 via Archigen. The P-III study similar therapeutic effect to Rituxan in 315 FL patients with ORR (66.3% vs 70.6%)
  • The companies decided to stop commercializing SAIT101 and take step for liquidation of Archigen as the product lacks commercial viability

The US FDA Approved Pfizer’s Oncology Supportive Care Biosimilar Nyvepria (biosimilar, pegfilgrastim)

Product: Nov 20, 2020

Product: Nyvepria (biosimilar, pegfilgrastim)

  • The EC has approved Nyvepria, a biosimilar referencing Neulasta to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic CT for malignancy
  • The EC approval is based data demonstrating a high degree of similarity of Nyvepria to its reference product
  • Pfizer plans to make Nyvepria available to patients in multiple EU countries starting in Q1’21. The EC’s approval follows the US FDA’s approval granted in Jun’2020

Innovent Reported Results of Tyvyt + Byvasda (biosimilar, bevacizumab) in P-lll ORIENT-32 Study as 1L Treatment for HCC

Product: Nov 23, 2020

Product: Byvasda (biosimilar, bevacizumab)

  • The P-lll ORIENT-32 study involves assessing of Tyvyt (sintilimab) + Byvasda vs sorafenib as a 1L treatment in 571 patients in a ratio (2:1) with advanced HCC and the result were released in an oral presentation at the ESMO Asia Virtual Congress 2020
  • Result: Reduction in risk of all-cause mortality (43.1%); the median OS (not reached vs 10.4 mos.); reduction in risk of progression (43.5%); m-PFS (4.6 vs 2.8 mos.), results was presented at ESMO 2020
  • The improved OS and PFS benefits of the dual regimen were generally consistent across all subgroups and showed an acceptable safety profile with no new safety signals

Innovent’s Sulinno (biosimilar, adalimumab) Received NMPA’s Approval for Polyarticular Juvenile Idiopathic Arthritis

Published: Nov 23, 2020

Product: Sulinno (biosimilar, adalimumab)

  • The NMPA has approved Sulinno for the treatment of pJIA which is the fourth approved indication of the therapy in China. Earlier, Sulinno was approved for RA, PS, and psoriasis
  • The launch of Sulinno has provided more Chinese patients with high-quality and relatively affordable adalimumab injection, bringing hope and opportunities to more patients
  • Sulinno is a human anti-TNF-α mAb referencing Humira. The clinical results were published at the Inaugural Issue of The Lancet Rheumatology in 2019

Alvotech and Alvotech & CCHT Signed an Exclusive Commercialization Agreement with Yangtze River for Eight Biosimilars in China

Product: Nov 25, 2020

Product: Biosimilar

  • The companies collaborate with the Yangtze to commercialize eight biosimilars in China. The initial pipeline contains biosimilar candidates for the treatment of autoimmunity, ophthalmology, and oncology
  • Alvotech and Alvotech & CCHT will be jointly responsible for the development, registration, and supply of biosimilars in China while Yangtze River Pharmaceutical will exclusively commercialize the biosimilars
  • The manufacturing of biosimilars will be made in a new state-of-the-art biopharmaceutical facility, currently being built in Changchun, China, through the Alvotech & CCHT. The first phase of the facility is expected to be completed in 2021

Bio-Thera Reported MAA Submission to EMA for BAT1706 a Proposed Biosimilar to Avastin

Product: Nov 26, 2020

Product: BAT1706 (a proposed biosimilar to Avastin)

  • The company has submitted an MAAA for BAT1706 to EMA. Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the EU Member States, Iceland, Norway, and Liechtenstein
  • The submission of the MAA for BAT1706 marks it as the first ex-China MAA/ BLA submission. The BLA of the biosimilar for metastatic carcinoma of the colon or rectum and NSCLC is under NMPA’s review
  • The company plans to submit a BLA for BAT1706 to the US FDA by the end of 2020. Bevacizumab is a mAb that targets VEGF thus reduces neovascularization, thereby inhibiting tumor growth

Related Post: Insights+ Key Biosimilars Events of October 2020

The post Insights+ Key Biosimilars Events of November 2020 first appeared on PharmaShots.

Insights+: COVID-19 Healthcare News Monthly Updates – November 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected in Wuhan City, Hubei Province, China in Dec 2019. Life sciences companies are putting all of their efforts into finding a treatment or developing a vaccine for this disease. PharmaShots is keeping a track of all of the important updates in the Life-sciences sector, where we have covered news updates regarding collaborations, clinical trials, funding, and regulatory guidelines related to the COVID-19 from Jan to date.

1Kantaro Receives FDA Emergency Use Authorization for Semi-Quantitative COVID-19 Antibody Test Kit that Detects the Presence and Level of SARS-CoV-2 IgG Antibodies 

Nov 25, 2020 | Regulatory 

2. CytoSorbents Highlights Largest Published Case Series To Date Using CytoSorb in Critically Ill COVID-19 Patients 

Nov 25, 2020 | Clinical Trial 

3. NeuroRx and Relief Announce Initial Successful Rsults from Expanded Access Use of RLF-100 (aviptadil) in Patients with Critical COVID-19 and Severe Comorbidity: 72% survival seen in ICU patients 

Nov 24, 2020 | Clinical Trial 

4. Vivacelle Bio Receives $5.3 Million Award from the US Navy for a Clinical Trial of VBI-S for Treatment of Hypovolemia of Septic Shock Due to COVID or other Pathogens 

Nov 24, 2020 | Grant 

5. ReiThera Announces its GRAd-COV2 COVID-19 Vaccine Candidate is Well Tolerated and Induces Clear Immune Responses in Healthy Subjects Aged 18-55 Years 

Nov 24, 2020 | Clinical Trial 

6. Longitude Prize Launches AMR Voices: Stories from the frontlines of antibiotic resistance during Covid-19 

Nov 24, 2020 | Launch 

7. Arizona BioTech Company Successfully Completes Pre-Clinical Testing for Vaccine Alternative to Prevent COVID-19 Infection, Ready for Human Trials 

Nov 23, 2020 | Clinical Trial 

8. FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 

Nov 21, 2020 | Regulatory 

9. Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization 

Nov 21, 2020 | Regulatory 

10. Lilly’s Neutralizing Antibody bBmlanivimab (LY-CoV555) Receives Interim Authorization from Health Canada as a Treatment for COVID-19 

Nov 20, 2020 | Regulatory 

11. Persavita is Preparing for a Clinical Trial to Test its Experimental Natural Health Product in Covid-19 

Nov 20, 2020 | Clinical Trial 

12. FDA Grants Emergency Use Authorisation for Baricitinib in Hospitalised COVID-19 Patients Nine Months After Initial Hypothesis was Published by BenevolentAI 

Nov 20, 2020 | Regulatory 

13. Sosei Heptares’ COVID-19 Program Identifies Potent Broad Spectrum Anti-Viral Small Molecules for Further Development 

Nov 20, 2020 | Clinical Trial 

14. Baricitinib Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19 

Nov 19, 2020 | Regulatory 

15. Icahn School of Medicine at Mount Sinai and Boehringer Ingelheim Collaborate on First Study to Evaluate Nintedanib in Patients with Fibrosing ILD following COVID-19 Infection 

Nov 19, 2020 | Collaboration 

16. RedHill Announces Unanimous DSMB Recommendation to Continue Phase 2/3 COVID-19 Study with Opaganib 

Nov 19, 2020 | Regulatory 

17. India’s Indigenous Solution to COVID-19 in Progress 

Nov 19, 2020 |  Pharma

18. In the lab, St. Jude Scientists Identify Possible COVID-19 Treatment 

Nov 18, 2020 |  Pharma

19. LANES, Fulgent Genetics and LA County Department of Health Services Collaborate to Fast-Track COVID-19 Test Results to Local Healthcare Providers 

Nov 18, 2020 | Collaboration 

20. BioLineRx Announces Initiation of Phase 1b Clinical Trial in Patients with Acute Respiratory Distress Syndrome (ARDS) Secondary to COVID-19 and Other Respiratory Viral Infections 

Nov 18, 2020 | Clinical Trial 

21. Diabetes, Hypertension May Increase Risk of COVID-19 Brain Complications 

Nov 18, 2020 |  Pharma

22. FDA Authorizes First COVID-19 Test for Self-Testing at Home 

Nov 17, 2020 | Diagnostic 

23. Ampio’s Phase I Study for Inhaled Ampion Advances to 3rd Group of COVID-19 Patients with Respiratory Distress 

Nov 17, 2020 | Clinical Trial 

24. RedHill Biopharma’s Second COVID-19 Candidate, RHB-107, Cleared by FDA for Phase 2/3 Study in Symptomatic COVID-19 Disease 

Nov 17, 2020 | Clinical Trial 

25. Samsung Biologics Announces Strategic Manufacturing Partnership with Lilly to Accelerate Delivery of COVID-19 Antibody Treatments 

Nov 17, 2020 | Collaboration 

26. TrippBio Reports Positive Results from Investigator-Initiated Clinical Trial of TD213 for the Treatment of Mild to Moderate COVID-19 Infections 

Nov 16, 2020 | Clinical Trial 

27. RedHill Biopharma Completes Enrollment for COVID-19 U.S. Phase 2 Study with Opaganib – Data Expected in the Coming Weeks 

Nov 16, 2020 | Clinical Trial 

28. INOVIO Announces Initiation of Phase 2 Segment of its Phase 2/3 Clinical Trial for its COVID-19 DNA Vaccine Candidate, INO-4800; Trial Will Be Funded by the U.S. Department of Defense 

Nov 16, 2020 | Clinical Trial 

29. Biological E. Limited Starts Phase I/II Clinical Trial of its COVID-19 Vaccine Candidate 

Nov 16, 2020 | Clinical Trial 

30. Johnson & Johnson and U.S. Department of Health & Human Services Expand Agreement to Support Next Phase of COVID-19 Vaccine Candidate Research and Development 

Nov 14, 2020 | Collaboration 

31. NeuroRx and Relief Therapeutics announce enrollment of 150 patients in phase 2b/3 trial of RLF-100 for Critical COVID-19 with Respiratory Failure 

Nov 13, 2020 | Clinical Trial 

32. Medicago and GSK announce start of Phase 2/3 clinical trials of adjuvanted COVID-19 vaccine candidate 

Nov 12, 2020 | Clinical Trial 

33. AstraZeneca Partners with CCT to Conduct COVID-19 Vaccine Clinical Trials in Arizona 

Nov 12, 2020 | Collaboration 

34. Leading Generic Drug Makers Unite to Pledge Capacity for Developing and Delivering Affordable COVID-19 Interventions as Pandemic Intensifies 

Nov 11, 2020 | Collaboration 

35. NYU Langone Health to Enroll Healthy Volunteers In Clinical Trial for COVID-19 Vaccine 

Nov 11, 2020 | Clinical Trial 

36. ADVAITE’s High Complexity CLIA Lab Receives Authorization from Yale University to Offer Highly Accurate COVID-19 SalivaDirect™ Test 

Nov 11, 2020 | Regulatory 

37. Sagent Pharmaceuticals Launches Phase 2 Trial to Evaluate Camostat Mesilate for COVID-19 Treatment 

Nov 11, 2020 | Clinical Trial 

38. Mountain Valley MD Files Patent to Protect Science Achievement in Solubilization of ivermectin Without Organic Solvents and Its Application to COVID-19 and Other Therapies 

Nov 11, 2020 | Regulatory 

39. The first interim data analysis of the Sputnik V vaccine against COVID-19 phase III clinical trials in the Russian Federation demonstrated 92% efficacy 

Nov 11, 2020 | Clinical Trial 

40. Co-Diagnostics Shown to be Effective in COVID-19 Saliva PCR Tests Without Sample Extraction 

Nov 11, 2020 |  Clinical Trial 

41. Ampio’s Phase I Study For Inhaled Ampion Advances To 2nd Group Of COVID-19 Patients With Respiratory Distress 

Nov 10, 2020 | Clinical Trial 

42. CollPlant Announces Early Development Program of Antiviral Agent for Potential Treatment of COVID-19 Patients 

Nov 10, 2020 |  Clinical Trial 

43. New Research Published in The Lancet Psychiatry Finds COVID-19 Associated with Increased Risk for Developing Psychiatric Disorders 

Nov 9, 2020 |  Clinical Trial

44. New COVID Vaccine Clinical Trials Enrolling At Local Lake Charles Research Site 

Nov 9, 2020 | Clinical Trial 

45. CARE GA Receives Study May Proceed Letter from US FDA to Initiate Phase II Clinical Trial of Senhwa’s Silmitasertib in COVID-19 Patients 

Nov 6, 2020 | Clinical Trial 

46. NeuroRx and Relief Therapeutics Announce Continuation of RLF-100 trial for Treatment of COVID-19 Respiratory Failure: Trial is on Track to Complete Enrollment in 2020 

Nov 5, 2020 | Clinical Trial 

47. New Research Study Validates Performance and Accuracy of Truvian Sciences’ Easy Check COVID-19 IgM/IgG Test 

Nov 3, 2020 | Regulatory 

48. Senhwa Announces Multiple IND application submissions to US FDA for Silmitasertib as a Potential Treatment for COVID-19 

Nov 2, 2020 | Regulatory 

49. Emmes Employees Co-Author COVID-19 Vaccine Report for the New England Journal of Medicine 

Nov 2, 2020 |  Clinical Trial 

50. RevImmune Advances New Immunotherapy in COVID-19 

Nov 2, 2020 |  Clinical Trial 

51. Immunic, Inc. Announces 200 Patients Enrolled in Its Phase 2 CALVID-1 Trial of IMU-838 for the Treatment of Moderate COVID-19, Allowing for Main Phase 2 Efficacy Analysis to Proceed 

Nov 2, 2020 | Clinical Trial 

Related Post: Insights+: COVID-19 Healthcare News Monthly Updates – October 2020

The post Insights+: COVID-19 Healthcare News Monthly Updates – November 2020 first appeared on PharmaShots.

Prescient Announces Recent Appointments to its Senior Team

Prescient hires three new senior members to expand its expertise and keep pace with the company’s growth

LONDON, November 3, 2020 – Prescient, a biopharma product and portfolio strategy partner, announces the recent appointment of three new senior members: Gordon Gochenauer, Dr. Priya Kar and Dr. Cameron Mackenzie. They join the existing leadership team, which shapes the competitive strategies of Prescient’s clients through dynamic decision support.

Gordon joins Prescient with more than 15 years of dedicated oncology experience in market research and competitive intelligence. He has an MBA in market and strategy from Carnegie Mellon University and a BA in biochemistry from the University of Pennsylvania. Prior to joining Prescient, he led teams and projects at Kantar Health, AlphaImpactRx (now part of IQVIA) and Psyma International across the development timeline, including competitive intelligence, licensing and BD assessments, market landscapes, tracking studies, pricing and market access studies, and strategic workshops. At Prescient, Gordon is responsible for expanding our company’s presence in the Philadelphia and New Jersey areas and for supporting team professional development.

Priya joins Prescient with more than 15 years of healthcare experience, particularly in the realm of commercial and clinical insights and strategy development. She earned her PhD in molecular biology from the New Jersey Medical School and her MBA in pharmaceutical management and marketing from Rutgers Business School. Prior to joining Prescient, she served as a subject matter expert and trusted client advisor. Priya has co-authored several peer-reviewed scientific articles and industry-relevant white papers. At Prescient, Priya is responsible for driving growth within our Intelligence & Insight business, managing key business accounts and providing strategic leadership.

Cameron joins Prescient with 15 years of experience in the pharma and biotech industries. He spent his early career working in R&D and manufacturing at established companies before joining a start-up to lead the development, launch and global sales of a novel product. He holds a PhD in biophysical chemistry from the University of Glasgow, an MSc in chemistry from the University of Strathclyde and an MBA from Strathclyde Business School. At Prescient, Cameron is responsible for leading high-quality engagements with new and existing clients and applying his knowledge and experience to answer their strategic business questions.

“Clients partner with Prescient to understand the situation analysis, which impacts critical success factors underpinning their clinical and commercialization strategies, thus ensuring the product’s value proposition is differentiated and resonates with key market stakeholders,” says Dr. Rakesh Verma, Prescient’s President. “Gordon, Priya and Cameron bring extensive experience and deep-rooted expertise to support pharma cross-functional teams throughout the product life cycle in their decision making at critical inflection points.”

Biographies and contact information for the Prescient senior team can be found on www.PrescientHG.com.

The post Prescient Announces Recent Appointments to its Senior Team appeared first on .

Insights+: The US FDA New Drug Approvals in October 2020

The US FDA has approved 4 NDAs and 1 BLA in Oct 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 90 novel products so far in 2020, including 5 in Oct 2020. Additionally, last year in 2019, the US FDA has approved 48 novel products. We have compiled a list of a total of 5 new drugs approved by the US FDA in Oct 2020.

Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Received the US FDA’s Approval as the First Treatment for Ebola

Published: Oct 15, 2020 | Tags: Approval, Atoltivimab, Ebolavirus, Firs,t Inmazeb, Maftivimab, Odesivimab, Receives, Regeneron, Treatment, US FDA

  • The approval is based on the PALM trial assessing Inmazeb vs Zmapp and remdesivir in 681 adult and pediatric patients including newborns of mothers who have tested positive for the infection. The study demonstrated 1EPs of mortality @28days (33.5% vs 51.3%) and 2EPs of reduction in days until the virus was undetectable in the bloodstream
  • As per the agreement signed in Jul’2020, Regeneron will deliver a number of Inmazeb treatment doses for 6yrs. to the BARDA
  • Inmazeb is a triple antibody cocktail consisting of 3 mAbs (atoltivimab, maftivimab & odesivimab, 50 mg each /kg) that bind to different, non-overlapping epitopes on Zaire ebolavirus glycoprotein

Nevakar’s Ephedrine Sulfate Injection Received the US FDA’s Approval as Ready-To-Use Vials

Published: Oct 22, 2020 | Tags: Nevakar, Ephedrine Sulfate, Injection, Receives, US FDA, Approval, Ready to Use, Vials

  • Nevakar received US FDA’s approval to market Ephedrine Sulfate Injection (50mg/10 ml) in a ready to use vial presentation and it is the 1st approval under collaboration bw Nevakar and Endo for the development of sterile injectable product in the US and Canada
  • Nevakar to develop and obtain FDA approval for these products and Par Pharmaceuticals Sterile Products division will launch and distribute the products
  • The company is focused on developing and commercializing innovative products to address unmet medical needs, thereby improving patient care and quality of life

Gilead’s Veklury (remdesivir) Received the US FDA’s Approval as the First Treatment for COVID-19

Published: Oct 23, 2020 | Tags: COVID-19, Gilead, Receives, Remdesivir, US FDA, Approval, Veklury

  • The approval is based on three studies including P-lll ACTT-1 study assessing the efficacy and safety of a 10-day treatment course of Veklury vs PBO in 1063 hospitalized patients with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19 receiving the treatment with SOC. The other two studies include two P-II OLE studies (SIMPLE-Severe trial & SIMPLE-Moderate trial)
  • ACTT-1 trial results: improvement in time to recovery in overall study population & in patients who required oxygen (10 vs 15days & 11 vs 18days); reduction in disease progression in patients needing oxygen, reduction in new mechanical ventilation or ECMO (13% vs 23%)
  • Additionally, FDA also issued a new EUA for the use of Veklury to treat hospitalized pediatric patients aged <12yrs. weighing at least 3.5 kg or hospitalized pediatric patients weighing 3.5 kg to <40 kg with suspected or laboratory confirmed COVID-19 for whom use of an IV agent is clinically appropriate. Veklury is now the 1st and only approved COVID-19 treatment in the US

Kala Pharmaceuticals’ Eysuvis (loteprednol etabonate ophthalmic suspension) Received US FDA’s Approval for Dry Eye Disease

Published: Oct 27, 2020 | Tags: Kala Pharmaceuticals, Eysuvis, Loteprednol, Etabonate, Ophthalmic, Suspension, US FDA, Dry Eye Disease

  • The approval is based on results from four clinical trials, including three P-III trials and one P-II trial, that demonstrated significant improvements in both the signs and symptoms of dry eye disease
  • The approval has made Eysuvis, the 1st ocular corticosteroid for the treatment of dry eye disease and the 1st drug approved specifically for the short-term (up to 2 wks.) treatment of the signs and symptoms of dry eye disease
  • Eysuvis utilizes Kala’s Ampplify mucus-penetrating particle (MPP) drug delivery technology to enhance penetration of loteprednol etabonate into target tissue on the ocular surface. The company plans to launch Eysuvis in the US by the end of the year 2020

Chiesi’s Bronchitol (mannitol) Inhalation Powder Received US FDA’s Approval for Cystic Fibrosis

Published: Oct 30, 2020 | Tags: Chiesi, Bronchitol, Mannitol, Inhalation, Powder, Receives, US FDA, Approval, Cystic Fibrosis, Pulmonary

  • In the three large-scale global clinical trials assessing Bronchitol in 761 patients, sustained improvement in FEV1 (Forced Expiratory Volume) with Bronchitol use vs. control group was observed
  • Bronchitol is currently approved and marketed in Australia, Italy, Germany, Russia, and several other countries. Additionally, the company anticipates launching Bronchitol in the US in Mar 2021
  • Bronchitol (mannitol) inhalation powder is a sugar alcohol and also the 1st and only inhaled dry powder indicated as add-on maintenance therapy to improve pulmonary function in CF patients aged 18 yrs. of age and older

Related Post: Insights+: The US FDA New Drug Approvals in September 2020

The post Insights+: The US FDA New Drug Approvals in October 2020 first appeared on PharmaShots.

Insights+ Key Biosimilars Events of October 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference product to biologics” possessing similar therapeutic properties. During the month of October, Henlius signed two agreements for its biosimilar products and presented results of HLX03 (biosimilar, adalimumab) whereas Samsung Bioepis and Biogen announced EMA filing acceptance of SB11 (biosimilar, ranibizumab). Our team at PharmaShots has summarized 09 key events of the biosimilar space of Oct 2020.

1. Henlius Signed an Exclusive License Agreement with Accord for HLX02 (biosimilar, trastuzumab) in the US and Canada

Published: Oct 01, 2020

Product: HLX02 (biosimilar, trastuzumab)

  • Henlius to receives $27M up front, ~$13M regulatory milestones, $25M commercial milestones for every $500M of cumulative net sales and is eligible to receive royalty up to 50% profit of HLX02. If the cumulative net sales of HLX02 reaches $3B, Henlius to receive ~$150M as commercial milestones
  • Accord to get an exclusive license to develop and commercialize HLX02 in the US & Canada. The development process strictly followed the EMA and NMPA’s biosimilar guidelines
  • In 2018, the companies enter into a license agreement, under which Henlius granted Accord UK exclusive commercialization rights of HLX02 in the EU, the Middle East, North Africa, and the Commonwealth of Independent States. The therapy received EC’s and the NMPA approval sin July & Aug’2020, making it the first China-developed mAb biosimilar approved both in China and in the EU

2. Medicure Signed Agreement with Reliance Life Sciences for Marketing Rights of a Cardiovascular Biosimilar

Published: Oct 05, 2020

Product: Biosimilar

  • Medicure is responsible for the regulatory approval process for the product
  • The agreement grants an exclusive right to Medicure to market & sell the product in the US, Canada & the EU
  • The product fits well with Medicure’s mission of being a significant CV company focused on the US market

3. Samsung Bioepis and Biogen Announce EMA Filing Acceptance of SB11 (biosimilar, ranibizumab)

Published: Oct 07, 2020

Product: SB11 (biosimilar, ranibizumab)

  • EMA has accepted to review the MAA for SB11, a proposed biosimilar referencing Lucentis (ranibizumab). If approved, SB11 will join a growing number of biosimilars developed by Samsung Bioepis and commercialized by Biogen
  • In Nov 2019, Samsung Bioepis announced that it entered into a new commercialization agreement with Biogen for two ophthalmology biosimilar candidates: SB11 (ranibizumab) and SB15 (aflibercept) in the US, Canada, Europe, Japan, and Australia
  • Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness

4. Innovent and Lilly’s Halpryza (biosimilar, rituximab) Received NMPA’s Approval in China

Published: Oct 12, 2020

Product: Halpryza (biosimilar, rituximab)

  • NMPA has approved Halpryza for patients with DLBCL, FL, and CLL in China. The biosimilar is the fourth mAb approved in China following the approval of Tyvyt (biosimilar, sintilimab), Byvasda (biosimilar, bevacizumab) and Sulinno (biosimilar, adalimumab)
  • The clinical efficacy and safety of rituximab in CD20 +ve NHL have been confirmed in multiple large-scale clinical trials. Rituximab has received its FDA’s approval in 1997 for NHL, CLL, RA, GPA, MPA and PV
  • The approval of Halpryza will bring a new option to Chinese Lymphoma patients, help them to improve QoL & prolong their survival. Halprryza is rituximab injection and a recombinant human/murine chimeric mAb targeting CD20 antigen on the surface of B lymphocytes and mediates CDC and ADCC

5. Henlius Signed a License Agreement with Essex to Co-develop HLX04 (biosimilar, bevacizumab) for Ophthalmic Diseases

Published: Oct 19, 2020

Product: HLX04 (biosimilar, bevacizumab)

  • Henlius to receive upfront, regulatory, and commercial milestone payments of ~$43M, eligible to receive $30M for every $1B above the first $600M of the cumulative net sales along with 10% royalties on net sales of the therapy
  • Henlius will be responsible for the pre/ clinical development of HLX04, whereas Essex is responsible for regulatory filings and commercialization of HLX04 globally and will be responsible for 80% of all costs and expenses concerning the development of HLX04. Additionally, Essex has a right to grant a sublicense to third parties, for which Henlius will receive 20% of the related sublicensing revenue
  • Henlius is developing HLX04 for ophthalmic diseases, wAMD & DR. Henlius and Essex plan to conduct global clinical trials of HLX04 in China, Australia, EU & the US, & will apply MAA in different countries across the globe

6. NeuClone Reported Positive Results of NeuLara (biosimilar, ustekinumab) in P-l Study for Autoimmune Diseases

Published: Oct 21, 2020

Product: NeuLara (biosimilar, ustekinumab)

  • The P-I clinical trial involves assessing of a single dose of either NeuLara, US- or EU-sourced Stelara in ~200 healthy volunteers. NeuLara is NeuClone’s second biosimilar to have met all 1EPs & 2EPs in a three-arm P-I study
  • Result: the study met all co-primary PK endpoints for Cmax and AUC. For all PK 1EPs, CI (90%) of the GMR within the pre-specified (80%-125%) acceptance limits for all 3 pairwise comparisons. Additionally, the safety, immunogenicity and tolerability profiles were similar in all three treatment arms
  • NeuLara is a biosimilar referencing Stelara, being developed to treat patients with PsO, PsA, CD and UC. The biosimilar is being co-developed by NeuClone and its strategic manufacturing partner, Serum Institute of India

7. Samsung Bioepis Reported Results of Renflexis (biosimilar, infliximab) from Two Studies in IBD Patients

Published: Oct 27, 2020

Product: Renflexis (biosimilar, infliximab)

  • The company reported results from two real-world studies of Renflexis (infliximab-abda) in patients with IBD registered in the US Veteran Affairs Healthcare System database. Data were presented at ACG 2020
  • One study assesses the safety of switching from reference infliximab or infliximab-dyyb to Renflexis in patients with IBD identified from the VAHS database and demonstrated an 83% continuation rate over 1yr. with similar continuation rate in patients who underwent a single & double switch from reference infliximab
  • The second study focused on the real-world utilization pattern of infliximab products for IBD, within the context of VANF policy. The study found that Renflexis became the preferred infliximab product on VANF in Sept’2018 which was faster than the adoption of the previous biosimilar (infliximab-dyyb), listed on VANF in May’2017

8. SomaLogic Collaborated with the US FDA to Advance Biosimilar Development

Published: Oct 29, 2020

Product: Biosimilar

  • SomaLogic collaborate with the FDA to identify circulating pharmacodynamic biomarkers and analytical approaches that could be used to demonstrate bio-similarity of a biosimilar to a reference FDA-approved biologic drug
  • The collaboration will utilize the SomaLogic proteomic technology for the identification of circulating pharmacodynamic biomarkers for therapeutic biologics
  • SomaLogic’s SomaScan platform makes 5,000 protein measurements simultaneously in small samples of blood, to compare changes in circulating proteins following treatment with FDA-approved biologics and could reduce the need for costly and lengthy comparative clinical studies

9. Henlius Presented Results of HLX03 (biosimilar, adalimumab) in P-lll Study for Plaque Psoriasis at EADV 2020

Published: Oct 29, 2020

Product: HLX03 (biosimilar, adalimumab)

  • The P-III HLX03-Ps03 study involves comparing the efficacy, safety, and immunogenicity assessing of HLX03 (80mg, qd) with reference adalimumab in 262 Chinese patients in the ratio of (1:1) with moderate to severe plaque psoriasis
  • Result: On 1EPs % improvement of PASIwk16 (83.48% vs 82.02%), least-square mean difference (1.46%), no significant differences between the treatment groups in 2EPs that include PASI 75, PGA reaching clearance, and change in DLQI
  • HLX03 is an adalimumab biosimilar to be used for the treatment of autoimmune diseases including psoriasis, RA & AS

Related Post: Insights+ Key Biosimilars Events of September 2020

The post Insights+ Key Biosimilars Events of October 2020 first appeared on PharmaShots.

ViewPoints Interview: Eli Lilly’s Dr. Lotus Mallbris Shares Insights on Mirikizumab

In a recent interview with PharmaShots, Dr. Lotus Mallbris, the Vice President of Immunology Development at Eli Lilly shares her insights and highlights on Mirikizumab. 

Shots:

  • @52wks. ~60% achieved endoscopic responses (58.5% in IV dosing group and 58.7% in the SC group) while 45% + achieved PRO remission (46.3% in the IV group and 45.6% in the SC group)
  • If approved for IBD indications, mirikizumab – a biologic entity that blocks the activity of the IL-23 cytokine – could be one of the first IL-23s approved for ulcerative colitis, a disease state with fewer biologic treatment options, as well as one of the first of this class to be approved for Crohn’s disease
  • Lilly is currently investigating mirikizumab in P-III clinical trials. Lilly expects topline results for the P-III induction data in UC in the spring of 2021 and for the P-III Crohn’s data in 2022.

Tuba: How was your virtual experience at UEG week? Can we have a quick highlight on the data of mirikizumab presented at UEG Week?

Lotus: I was very pleased with my experience at UEG Week; although the format was different than previous years considering the meeting was entirely virtual, it was a great opportunity to learn about the latest innovation in the gastroenterology space. Lilly had the opportunity to present new efficacy and safety data from the Phase 2 SERENITY study evaluating mirikizumab in patients with moderately to severely active Crohn’s disease at this year’s virtual UEG Week. These are the first 52-week data for mirikizumab in Crohn’s disease (CD) and the results continue to build upon the data already presented in ulcerative colitis (UC). These results are an important part of the clinical development program for mirikizumab, and Lilly hopes these data can provide optimism for those living with Crohn’s disease.

At 52 weeks, patients who showed endoscopic improvement at 12 weeks and continued treatment with mirikizumab achieved the following results:

  • Endoscopic response: Nearly 60% of patients achieved endoscopic response (58.5% in the randomized IV dosing group and 58.7% in the SC group).
  • Patient-Reported Outcomes (PRO) remission: More than 45% of patients achieved PRO remission (46.3% in the IV group and 45.6% in the SC group).

Among the subset of patients who achieved an endoscopic response at Week 12, 69.6% and 66.7% in the IV (n=23) and SC (n=24) groups, respectively, also had endoscopic response at Week 52. Additionally, among those with endoscopic remission at Week 12, 50.0% and 64.3% in the IV (n=6) and SC (n=14) groups, respectively, also had endoscopic remission at Week 52. These Phase 2 data support and reinforce the potential for mirikizumab in the ongoing, pivotal VIVID Phase 3 program as a potential treatment for patients with Crohn’s disease.

Tuba: What are the other treatments across Lilly’s immunology portfolio for transforming the treatment experience of patients with autoimmune diseases?

Lotus: We recognize there are still significant unmet needs, as well as personal and societal costs, for people living with autoimmune diseases and our goal is to minimize the burden of disease and help patients find treatments that offer meaningful improvements. Our immunology portfolio includes first in class or first in disease molecules and we’re investing in leading-edge clinical approaches across our deep pipeline, which also includes early candidates currently in Phase 1 and Phase 2 development. Through these treatments, we hope to one day offer therapeutic options for patients across ten disease areas:

  • Mirikizumab is an investigational treatment that is being studied for the treatment of adults with Crohn’s disease, ulcerative colitis and moderate to severe plaque psoriasis.
  • Taltz® (ixekizumab) is approved for moderate to severe plaque psoriasis in adults and children, as well as active psoriatic arthritis, active non-radiographic axial and active ankylosing spondylitis in adults.
  • Olumiant® (baricitinib) is indicated for adults with moderately to severely active rheumatoid arthritis, and is being studied for moderate to severe atopic dermatitis (AD); systemic lupus erythematosus (SLE), which received Fast Track designation from the Food and Drug Administration (FDA); and alopecia areata (AA), which received Breakthrough Therapy designation from the FDA earlier this year.
  • Lilly recently announced a positive CHMP opinion by the European Medicines Agency’s (EMA) for Olumiant in AD, and if approved, Olumiant could become the first oral JAK inhibitor available in the EU.
  • Lebrikizumab is a novel, investigational, a monoclonal antibody in Phase 3 studies to evaluate its safety and efficacy in adolescent and adult patients with moderate-to-severe atopic dermatitis.

Mirikizumab is an investigational treatment that is being studied for the treatment of adults with Crohn’s disease, ulcerative colitis and moderate to severe plaque psoriasis.

Tuba: Are there any specific population or any group in which mirikizumab shows its higher and lower efficacy & safety?

Lotus: In addition to IBD, mirikizumab is also being studied in adults with moderate to severe psoriasis. Earlier this year, Lilly presented results from the Phase 3 OASIS-2 study, which showed mirikizumab met the primary and all key secondary endpoints versus placebo at Week 16 (superiority), as well as all key secondary endpoints versus Cosentyx® (secukinumab) at Week 16 (non-inferiority) and Week 52, including superiority in skin clearance at Week 52.

In the data presented at UEGW, mirikizumab demonstrated efficacy in adults with Crohn’s disease over 52 weeks of treatment. Additional studies in adults are ongoing, and Lilly expects Phase 3 Crohn’s data in 2022.

Tuba: As Lilly is evaluating mirikizumab in three different indications i.e. psoriasis, UC & CD. Can we have a quick review on the clinical data related to the targeted disease?

Lotus: Mirikizumab is being studied for the treatment of immune diseases, including psoriasis, ulcerative colitis and Crohn’s disease:

  • In psoriasis, Lilly presented results in July 2020 from the Phase 3 OASIS-2 study, which showed mirikizumab met the primary and all key secondary endpoints versus placebo at Week 16 and all key secondary endpoints versus Cosentyx® (secukinumab) at Week 16 and Week 52, including superiority in skin clearance at Week 52.
  • In addition to the data presented at UEGW this year, Lilly also expects topline results for Phase 3 Crohn’s data in 2022, following positive endpoints being met at 12 weeks in its Phase 2 trial.
  • Lilly expects topline results for the Phase 3 induction data in ulcerative colitis in the spring of 2021.
Source: Pinterest

Tuba: As the market is flooded with multiple biologics in IBD, what is Lilly’s strategy to position its therapy in CD?

Lotus: Inflammatory bowel disease (IBD), which included Crohn’s disease and ulcerative colitis, affects more than 10 million people worldwide. Crohn’s disease is a serious and difficult-to-treat condition, and there is a significant need for additional treatments that can address the challenging and painful symptoms of people living with Crohn’s disease experience. In the study presented at UEG Week, patients treated with mirikizumab showed a response in both symptom relief and endoscopic response and remission at 52 weeks. Based on these Phase 2 data, we’re optimistic Lilly is one step closer to providing relief for patients. 

Tuba: AbbVie’s Skyrizi, Johnson & Johnson’s Tremfya and Allergan’s Brazikumab, and Novartis’ Cosentyx are some competitors of mirikizumab.  What are other potential threats to the therapy?

Lotus: Lilly does not comment on competitors or data/trials conducted by other companies.

Tuba: What are your major steps in the digital world to transform inflammatory bowel disease (IBD) care?

Lotus: Through key partnerships, we are investigating several different approaches to enhance patient care, including the use of wearable sensors to collect biometric data and help us understand how patients respond to medications. We’re also leveraging artificial intelligence to better diagnose certain GI issues. Lastly, we’re conducting research to determine how digital disease management tools can provide a better understanding of one’s condition, so patients can have better discussions with their healthcare professional.

Tuba: As you select HealthVoyager as a winner of the digital health innovation challenge for inflammatory bowel disease. Can you highlight the specification of the digital tool you are working on and when can we expect its availability?

Lotus: HealthVoyager, an application developed by Boston Children’s Hospital and Klick Health, was named the winner of Lilly’s 2019 digital health open innovation challenge. The idea leverages a highly customizable software platform for doctors to create a personalized and immersive educational experience for patients living with inflammatory bowel disease (IBD). We are confident in the application’s success and support the team in their pursuit of its development, as Lilly focuses on other priorities for people living with inflammatory bowel disease. For additional updates about HealthVoyager, please contact Sheryl Steinberg at Klick Health ([email protected]).

Tuba: How do you think mirikizumab will raise the standard of Lilly in the field of immunology?

Lotus: If approved for IBD indications, mirikizumab – a biologic entity that blocks the activity of the interleukin 23 (IL-23) cytokine – could be one of the first IL-23s approved for ulcerative colitis, a disease state with fewer biologic treatment options, as well as one of the first of this class to be approved for Crohn’s disease.

We are excited about the data presented at UEG Week and are encouraged by these Phase 2 results. We look forwarding to continuing our clinical program for mirikizumab, and hope it, along with our already robust pipeline in immunology, will help raise the standard of care for those living with Crohn’s disease.

Tuba: What would be the pricing of the mirikizumab to compete with the emerging threats of lower-priced biosimilars in the space?

Lotus: Lilly does not comment on future pricing strategy.

Tuba: When can we expect the availability of mirikizumab in the US & EU?

Lotus: We are currently investigating mirikizumab in Phase 3 clinical trials. Lilly expects topline results for the Phase 3 induction data in ulcerative colitis in the spring of 2021 and for the Phase 3 Crohn’s data in 2022.

About Dr. Lotus Mallbris:

Lotus Mallbris, M.D., Ph.D., is the Vice President and Global Head of Immunology Product Development at Eli Lilly. She has joined Lilly in 2015 and leads the company’s global clinical development and global medical affairs teams across the dermatology, rheumatology, and gastroenterology fields.

Related Post: ViewPoints Interview: Eli Lilly’s Dr. Lotus Mallbris Shares Insights on Baricitinib

The post ViewPoints Interview: Eli Lilly’s Dr. Lotus Mallbris Shares Insights on Mirikizumab first appeared on PharmaShots.

Insights+: COVID-19 Healthcare News Monthly Updates – October 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected in Wuhan City, Hubei Province, China in Dec 2019. Life sciences companies are putting all of their efforts into finding a treatment or developing a vaccine for this disease. PharmaShots is keeping a track of all of the important updates in the Life-sciences sector, where we have covered news updates regarding collaborations, clinical trials, funding, and regulatory guidelines related to the COVID-19 from Jan to date.

Prenetics Acquires Oxsed, Oxford University Spin-out to Scale Rapid COVID-19 Test Globally. Rapid Airport Testing has begun in Heathrow with Trials in Hong Kong International Airport.

Oct 30, 2020 |

OncoSec Announces FDA Clearance of IND Application for Initiation of Phase 1 Clinical Trial of its CORVax12 Vaccine Candidate for COVID-19

Oct 29, 2020 |

Moleculin Announces Additional Collaboration on Drug Candidate Targeting COVID-19

Oct 29, 2020 |

Kintor Pharmaceutical’s COVID-19 Clinical Trials for Proxalutamide to expand Patient Enrolment

Oct 29, 2020 |

Data for Lilly’s bamlanivimab (LY-CoV555) in COVID-19 outpatients published in New England Journal of Medicine

Oct 28, 2020 |

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

Oct 28, 2020 |

COVID-19 Immune Response Study Could Lead to More Effective Treatments

Oct 28, 2020 |

JadiCell™ Stem Cells Licensed by Therapeutic Solutions International for Brain Injury Significantly Increased Survival of COVID-19 Patients in Double Blind FDA Clinical Trial

Oct 28, 2020 |

Daewoong Pharmaceutical’s COVID-19 Treatment Candidate Also Highly Effective against Influenza Virus

Oct 28, 2020 |

Qualigen Therapeutics Receives Positive Pre-IND Response from FDA for the Clinical Development of AS1411 as a Treatment for COVID-19

Oct 28, 2020 |

Ampio Begins Phase 1 Clinical Trial of Inhaled Ampion For COVID-19 Patients With Respiratory Distress

Oct 28, 2020 |

Companies could face difficulties registering cleaners and disinfectants with claims of “long-lasting” effectiveness against COVID-19, says TSG Consulting

Oct 27, 2020 |

Daewoong Pharmaceutical’s Long-Acting Niclosamide Shows High Promise Against Upcoming COVID-19 ‘Twindemic’

Oct 27, 2020 |

Quest Diagnostics and Catapult Health Provide Virtual Preventive Care Services for Employers During COVID-19 Pandemic and Beyond

Oct 27, 2020 |

Ampio Presents at Roth Capital Partners 2020 MedTech Innovation Forum Focusing on COVID-19 Clinical Trial Activities

Oct 26, 2020 |

Clinical Study Begins for the First Oral Systemic Nitric Oxide Based Therapeutic for African Americans with COVID-19

Oct 26, 2020 |

Truvian Sciences Announces Plans to Make Rapid Antibody Testing More Accessible with Easy Check COVID-19 IgM/IgG™ POC Antibody Test

Oct 26, 2020 |

Helix Receives Expanded Emergency Use Authorization for On-site Unsupervised Self-Collection and Asymptomatic Screening with the Helix® COVID-19 Test

Oct 26, 2020 |

SQI Diagnostics Updates Clinical Progress on Novel COVID-19 Tests Under Development for U.S. FDA Regulatory Submission

Oct 26, 2020 |

Biophytis Enrolls First Patient in Brazil in COVA, a Multinational Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure

Oct 26, 2020 |

Entos Pharmaceuticals Awarded funding to Conduct Phase I Clinical Trial of COVID-19 DNA Vaccine

Oct 23, 2020 |

FDA Approves First Treatment for COVID-19

Oct 22, 2020 |

Arizona Based Biotech Company Finds Preliminary Success Developing an Intranasal COVID-19 Vaccine Alternative

Oct 22, 2020 |

TrippBio Announces the Completion of Enrollment in a Proof of Concept Clinical Trial Evaluating the Efficacy of TD213 in Treating Patients with Confirmed COVID-19 Infections

Oct 22, 2020 |

Fresenius Medical Care North America Presents New Insights Related to COVID-19 and Dialysis Innovations at Kidney Week 2020

Oct 22, 2020 |

Alight and THINKMD Rapidly Adapt Established Medical Infrastructure in Fight Against COVID-19

Oct 22, 2020 |

Kedrion’s Partner, Kamada Ltd, Signs a Supply Agreement with the Israeli Health Authorities for the Investigational Anti-COVID-19 Plasma-Derived Therapy

Oct 22, 2020 |

Amyris and The Infectious Disease Research Institute Enter into Exclusive License for Novel RNA Vaccine Platform, Beginning with COVID-19 Vaccine

Oct 22, 2020 |

COVID-19 Respiratory Monitoring with MediPines AGM100® in Long-Term Care Facilities

Oct 22, 2020 |

Poseida Therapeutics and TScan Therapeutics Announce Research Collaboration and License Agreement to Explore Developing Allogeneic T Cell Receptor Therapies for the Treatment of COVID-19

Oct 21, 2020 |

Facilitating the ‘Vaccine Era’ of COVID-19 Response: ThermoGenesis to Receive U.S. Patent for Breakthrough Serological Test Reader Technology

Oct 20, 2020 |

CSL’s Broad Response to COVID-19 and Advancements across the Company’s Strategic Scientific Platforms are the Focus of Annual R&D Day

Oct 20, 2020 |

OPKO Health’s BioReference Laboratories Launches Multiplex COVID-19 and Influenza A/B Test

Oct 20, 2020 |

IncellDx to Study Maraviroc, a CCR5 antagonist, in a COVID-19 Phase 2 Clinical Trial

Oct 20, 2020 |

EIB Provides Immunic With up to €24.5 Million to Support Ongoing Development of a Potential COVID-19 Therapy

Oct 20, 2020 |

NHS Hospitals trial ground-breaking new decontamination technology to reduce COVID-19 transmission indoors

Oct 20, 2020 |

Open Orphan/hVIVO Signs Contract with UK Government for the Development of a COVID-19 Human Challenge Study Model

Oct 20, 2020 |

Aridis Pharmaceuticals Reports Positive Preclinical Efficacy Data of a Highly Effective Inhaled Treatment Supporting a Proposed Self-Administered Therapy for COVID-19 Patients

Oct 19, 2020 |

Thermo Fisher Scientific Increases Availability of COVID-19 Testing with Sample Collection Kit from Everlywell

Oct 19, 2020 |

DxTerity Announces a New At-Home COVID-19 Testing Solution

Oct 19, 2020 |

Aetion Statement on UCSF-Led Study to Inform Drug Development for COVID-19, Future Pandemics

Oct 15, 2020 |

Genalyte Obtains FDA Emergency Use Authorization for Rapid COVID-19 Antibody Test

Oct 15, 2020 |

Beckman Coulter receives BARDA funding to validate Monocyte Distribution Width in the rapid detection of Multisystem Inflammatory Syndrome (MIS-C), a severe COVID-19 complication in Children

Oct 15, 2020 |

Eiger BioPharmaceuticals Announces Positive Results of Investigator Sponsored Randomized Controlled Trial at University of Toronto with Peginterferon Lambda in Outpatients with Mild to Moderate COVID-19

Oct 15, 2020 | Clinical Trial

No Aborted Fetal Material in AVM Biotechnology’s COVID-19 Treatment Drug

Oct 14, 2020 |

New blood test predicts which Covid-19 patients will develop severe infection

Oct 14, 2020 |

Novellus Therapeutics Exclusively Licenses Induced Mesenchymal Stem Cells (iMSCs) to NoveCite for COVID-19 Related Acute Respiratory Distress Syndrome (ARDS) and Other Acute Respiratory Conditions

Oct 13, 2020 |

Medigen’s COVID-19 Vaccine Combined with Dynavax’s CpG 1018 Adjuvant Receives Taiwan Government Subsidy with First Participant Dosed in Early October

Oct 13, 2020 |

NeuroRx and Relief announce topline efficacy data from patients treated with RLF-100™ (aviptadil) under the U.S. FDA Expanded Access Protocol authorization for respiratory failure related to critical COVID-19

Oct 13, 2020 |

University of Milan Study Finds Self-Contained, Rapid ADEXUSDx® COVID-19 Antibody Test has 100% Specificity

Oct 12, 2020 |

Abbott Receives FDA Emergency Use Authorization for its COVID-19 IgM Antibody Blood Test

Oct 12, 2020 |

Review Article, Authored by ZyVersa Therapeutics’ Esteemed Scientific Advisors, Demonstrates the Role of Inflammasomes in the Exacerbated Immune Response Associated with COVID-19 Infection (Just Published in Frontiers in Immunology)

Oct 12, 2020 |

The Covid-19 pandemic is expected to further affect RhoVac’s clinical phase IIb study

Oct 12, 2020 | Clinical Trial

Rigel Announces First Patients Enrolled in NIH/NHLBI-Sponsored Trial of Fostamatinib in Hospitalized COVID-19 Patients in Collaboration with Inova

Oct 9, 2020 | Collaboration

Grifols’ anti-SARS-CoV-2 hyperimmune globulin begins clinical trial in patients with COVID-19

Oct 9, 2020 | Clinical Trial

Exogenesis Surgical Mask Reaches Primary Endpoints in COVID-19 Deactivation Challenge Trials

Oct 9, 2020 | Clinical Trial

First Patient Enrolled in NIH Phase 3 Trial to Evaluate Potential COVID-19 Hyperimmune Medicine

Oct 8, 2020 | Clinical Trial

Baricitinib has Significant Effect on Recovery Time, Most Impactful in COVID-19 Patients Requiring Oxygen

Oct 8, 2020 |

Johnson & Johnson Receives European Commission Approval of Agreement to Supply 200 Million Doses of Janssen’s COVID-19 Vaccine Candidate

Oct 8, 2020 | Collaboration

Prevea Health Selects Syntellis as Financial Planning Partner to Navigate COVID-19 Market Volatility

Oct 7, 2020 |

Abbott Reports Results of ID NOW™ COVID-19 Interim Clinical Study from 1,003 People to Provide the Facts on Clinical Performance and to Support Public Health

Oct 7, 2020 | Clinical Trial

Centaur Biopharmaceutical Signs Expansion Agreement with Vaxart of Manufacturing for COVID-19 and Other Vaccine Candidates

Oct 7, 2020 | Collaboration

Promising Research Showing New Way To Treat And Stop The Spread Of COVID-19 Using Gene Silencing And Reactivation Of “Innate” Immune System

Oct 6, 2020 |

Karyopharm Presents Results of Selinexor at the International Society for Influenza and Other Respiratory Virus Diseases Antiviral Group Virtual Conference on Therapeutics for COVID-19

Oct 6, 2020 | Clinical Trial

CLEAR Collaborates with Quest Diagnostics to Integrate COVID-19 Test Results with “Health Pass” for Safer Environments

Oct 5, 2020 | Collaborates

Hematogenix Unites With 19 Organizations from the Healthcare Community to Form COVID-19 Testing Industry Consortium

Oct 5, 2020 |

Intermountain Healthcare Researchers Develop New Diagnostic Tool to Identify & Treat Patients with COVID-19 at Risk of Severe Illness, Death Due to Inflammatory Disorder

Oct 1, 2020 |

GVN’s Top Virus Experts Meet Together To Identify Most Promising Advances To Battle COVID-19 & Strategies To Prepare For Future Pandemics

Sept 30, 2020 |

The post Insights+: COVID-19 Healthcare News Monthly Updates – October 2020 first appeared on PharmaShots.

PharmaShots’ Key Highlights of Third Quarter 2020

The third quarter of 2020 was flooded with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisitions, Gilead acquired Immunomedics for ~$21B, Illumina acquired GRAIL for ~$8B, J&J acquired Momenta Pharmaceuticals for $6.5B and Nestlé acquired Aimmune Therapeutics for $2.6B, Sanofi acquired Principia Biopharma for ~$3.68B  Apart from acquisitions, big alliances were the highlights of the quarter which include Biogen collaboration with Denali on LRRK2 program for Parkinson’s Disease worth ~$2.125B, Sanofi’s agreement with Kymera to advance novel protein degrader therapies, Roche & UCB’s collaboration to develop UCB0107 for AD, Merck’s $4.5B oncology deal with Seattle Genetics. The third quarter of the year also showcases multiple approvals of the therapies which include Roche’s FDA’s approval for the VENTANA HER2 Dual ISH test as CDx, Genentech’ Gavreto (pralsetinib) got the US FDA’s approval for metastatic RET fusion-positive NSCLC. Meanwhile, AstraZeneca, J&J, and Novavax initiated the P-III development of their COVID-19 vaccine candidates. Our team at PharmaShots has summarized and complied with the insights of Q3’20.

Novavax Initiated P-III Study of its COVID-19 Vaccine in the UK

Date – Sept 25, 2020

Product – NVX-CoV2373

  • Novavax has initiated P-III study assessing the efficacy, safety and immunogenicity of NVX-CoV2373 vs PBO in Matrix-M in up to 10,000 individuals aged 18-84yrs. with/out relevant comorbidities, over the next 4-6wks.
  • Half the participants will receive two IM injections of vaccine comprising 5µg of protein antigen with 50µg Matrix‑M adjuvant, administered 21 days apart, while half of the trial participants will receive PBO
  • The 1EPs & 2EPs is the first occurrence of PCR-confirmed symptomatic COVID-19 & PCR-confirmed symptomatic mod. to sev. COVID-19 with the onset at least 7 days after second study vaccination in volunteers prior not infected with SARS-CoV-2 respectively. Novavax has continued to scale-up its manufacturing capacity, currently up to 2B annually

J&J Initiated Global P-III Clinical Study of its COVID-19 Vaccine

Date- Sept 24, 2020

Product- JNJ-78436735

  • The initiation of the ENSEMBLE trial follows positive interim results of P-I/IIa study demonstrating the safety and immunogenicity of JNJ-78436735 following a single vaccination. The results have been submitted to medRxiv and expected to be published imminently
  • The P-III ENSEMBLE study is design to assess the safety & efficacy of a single vaccine dose vs PBO in up to 60,000 adults aged ≥18yrs., including those that are over age 60. The trial will include both with/ out comorbidities associated with an increased risk for progression to severe COVID-19
  • The company will continue to ramp up its manufacturing capacity to meet its goal of providing 1B doses/year. J&J anticipates the first batches of a COVID-19 vaccine to be available for EUS in early 2021, if proven to be safe and effective

Illumina Acquired GRAIL for ~$8B

Date – Sept 22, 2020

Deal Value – ~$8B

  • Illumina to acquire GRAIL in cash & stock transaction for $8B including ~$3.5B in cash and $4.5B in shares of Illumina common stock. Illumina founded GRAIL in 2016 and later spun out it to develop state-of-the-art data science, ML and create the atlas of cancer signals in the blood, enabling multi-cancer early detection tests
  • GRAIL to receive CVR and future payments representing a pro rata portion of certain GRAIL-related revenues/ year for 12yrs., reflecting a 2.5% payment right to the first $1B of revenue each year for 12yrs. and 9% CVR if revenue is above $1B. Additionally, GRAIL to get the option to receive additional cash and/or stock consideration, prior to closing, in lieu of the CVR
  • The acquisition will transform cancer care using genomics and NGS platform and accelerates commercialization and adoption of transformative multi-cancer screening test with potential to detect cancer. GRAIL expects to launch Galleri in 2021 which can detect 50+ cancer indications

Fitbit to Launch ECG App in the US and EU in October 2020

Date – Sept 15, 2020

Product – ECG App

  • Fitbit’s ECG app has received the US FDA’s 510 (k) clearance and EC’s CE marking to assess heart rhythm for atrial fibrillation (AFib). The Fitbit ECG app will be available in Oct’2020 to the users on Fitbit Sense smartwatch
  • The company has launched a multi-site clinical trial across the US, to detect AFib from normal sinus rhythm and to generate an ECG trace, recording of a heart’s electrical rhythm, that is qualitatively like Lead I ECG. The study demonstrated that algorithm has an ability to detect 98.7% of AFib cases (sensitivity) and is 100% accurate in identifying study participants with normal sinus rhythm (specificity)
  • Fitbit Sense smartwatch is available today for pre-order on Fitbit.com with WW availability starting later this month and is available for $329.95 in carbon/graphite stainless steel and lunar white/soft gold stainless steel

Novartis’ Beovu (brolucizumab) Received EMA’s Approval for its Safety Label Update to Treat Wet Age-Related Macular Degeneration

Date – Sept 15, 2020

Product – Beovu (brolucizumab)

  • The EU label update includes additional categorization of retinal vasculitis and/or retinal vascular occlusion, usually in the intraocular inflammation. The approval follows Novartis completion of safety review and initiation of update to the Beovu prescribing information globally
  • The label update is applicable to all 27 EU member states as well as UK, Iceland, Norway, and Liechtenstein. Beovu is now approved for wet AMD treatment in 40+ countries including in the US, EU, UK, Japan, Canada, and Australia
  • Beovu (brolucizumab) is the clinically advanced humanized single-chain Ab fragment (scFv) which enhances tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics. Novartis has established a multidisciplinary panel of internal experts collaborating with external advisors to examine the root cause, potential risk factors and mitigation of AEs

Gilead Acquired Immunomedics for ~$21B

Date – Sept 14, 2020

Deal Value – ~$21B

  • Gilead to acquire Immunomedics for $88.00/ share representing a 108% premium to Immunomedics’ closing price on Sept 11, 2020, making a total deal value $21B. The transaction is expected to be completed in Q4’20
  • The acquisition will add Immunomedic’s s Trodelvy to Gilead’s portfolio, expanding its oncology pipeline and accelerated its revenue and EPS growth. Additionally, the Trodelvy is being studied in an ongoing P-III study for 3L HR+/HER2- BC and a registrational P-II study in bladder cancer, NSCLC, and other solid tumors
  • Trodelvy (sacituzumab govitecan-hziy) is a Trop-2 directed ADC, received accelerated approved for mTNBC in the US while the company plans to submit the sBLA for the full approval of the therapy in Q4’20. Immunomedics is on track to file for regulatory approval in EU in the H1’21

Merck Signed Up to $4.5B Oncology Deal with Seattle Genetics

Date – Sept 14, 2020

Deal Value – ~$4.5B

  • Seattle Genetics to receive $600M up front, $1B as equity investment, 5M shares of Seattle Genetics common stock at a price of $200/ share, $2.6B as milestones including $850M development milestones and $1.75B as commercial milestones. The companies will equally share costs and profits on the global development of ladiratuzumab vedotin and other LIV-1-targeting ADCs
  • The companies will co-commercialize the therapy in the US and EU. Seattle Genetics will be responsible for approval in the US & Canada and will record sales in the US, Canada, and EU while Merck will be responsible for approval in EU & outside the US & Canada, and will record sales in countries outside the US, EU, and Canada
  • Additionally, companies enter exclusive license and co-development agreement to accelerate the global reach of Tukysa for HER2+ cancers in regions outside the US, EU & Canada. As per the agreement, Seattle Genetics to receive $125M as upfront and is eligible to receive up to $65M as progress-dependent milestones, $85M as research and development milestones, and royalties on sales of Tukysa in Merck’s territory

Novartis’ Kisqali (ribociclib) Received Highest Score on the ESMO Magnitude of Clinical Benefit Scale

Date – Sept 11, 2020

Product – Kisqali (ribociclib)

  • Novartis’ Kisqali + endocrine therapy has achieved 5 out of 5 score on ESMO-MCBS, confirming substantial benefit for premenopausal women with HR+/HER2- aBC, based on OS benefit and improved QoL in the P-III MONALEESA-7 study
  • Kisqali is also the only CDK4/6 inhibitor to receive a score of 4 out of 5 in combination with fulvestrant  for 1L postmenopausal women with HR+/HER2- aBC based on the OS benefit and maintained QoL observed in P-III MONALEESA-3. Additionally, Kisqali + fulvestrant receive a score of 4 out of 5 in 2L setting based on the MONALEEA-3 study
  • New data presented at ESMO 2020 add to the substantial body of evidence further differentiating Kisqali as the only CDK 4/6 inhibitor that improves OS in two P- III trials, with consistent results across patient subgroups, and with QoL benefits. Kisqali in patients with endocrine resistance led to a 30% & 41% reduction in the risk of death in the MONALEESA-3 & -7 studies over standard endocrine therapy respectively

AbbVie Licensed I-Mab’s Lemzoparlimab (TJC4) for ~$2B

Date – Sept 09, 2020

Deal Value – ~$2B

  • I-Mab to receive $180M upfront, $20M on P-I results and is eligible to receive $1.74B which include $840M as development & regulatory milestones while remaining as commercial milestones along with royalties on sales of the therapy outside China
  • AbbVie to get an exclusive global license (Ex-greater China) to develop and commercialize lemzoparlimab while I-Mab retain its right in China. Both the companies will conduct clinical trials to evaluate lemzoparlimab in multiple cancers while each partner have the potential to expand the collaboration to additional transformative therapies
  • The companies will have the opportunity to further licenses to explore each other’s related programs in their respective territories. Lemzoparlimab is an anti-CD47 mAb, designed to minimize inherent binding to normal RBCs while preserving its strong anti-tumor activity

Genentech’ Gavreto (pralsetinib) Received the US FDA’s Approval Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Date – Sept 07, 2020

Product – Gavreto (pralsetinib)

  • The approval is based on P-I/II ARROW study assessing Gavreto (400mg, qd) in RET fusion-positive NSCLC patients with or without prior therapy, and regardless of RET fusion partner or CNS involvement. The study also involves patients with RET-MTC, RET fusion-positive thyroid cancer and other RET-altered solid tumors
  • Results: ORR (57%) and CR rate (5.7%) in 87 NSCLC patients prior treated with Pt. based CT, m-DOR was not reached, in 27 treatment-naïve NSCLC patients, ORR (70%); CR rate (11%). Gavreto is now the 6th FDA-approved medicine in Genentech’s portfolio for lung cancer
  • Gavreto is an oral precision therapy targeting RET alterations, including fusions and mutations, regardless of the tissue of origin. Additionally, the US FDA has granted BT designation for RET fusion+ NSCLC and RET mutation+ MTC and PR for advanced or m-RET-mutant MTC and RET fusion+ thyroid cancer to the therapy with its anticipated PDUFA date as 28 Feb, 2021

AstraZeneca Expanded the Development of AZD1222 into P-III Study in the US Across All Adult Age Groups

Date- Sept 01, 2020

Product- AZD1222

  • AstraZeneca has expanded the development of AZD1222 into P-III D8110C00001 study to assess it safety, efficacy and immunogenicity. BARDA has funded the P-III study to accelerate the development of the vaccine
  • The P-III D8110C00001 study involves assessing of AZD1222 vs PBO for the prevention of COVID-19, in up to 30,000 participants aged ≥ 18yrs. in a ratio (2:1) across ~100 trial centers in and outside the US. Participants are being randomized to receive two doses of either AZD1222 or a saline control, 4wks. apart, with twice as many participants receiving the potential vaccine than the saline control
  • The company is evaluating the AZD1222 globally with late-stage clinical trials ongoing in the UK, Brazil, and South Africa, while the trials are planned to start in Japan and Russia

GSK and VIR Biotechnology Initiated P-II/III COMET-ICE Study of VIR-7831 Against COVID-19

Date- Sept 01, 2020

Product- VIR-7831

  • The first patient has been dosed last week in a P-II/III COMET-ICE study with VIR-7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalization
  • The study will enroll ~ 1,300 patients globally who have early symptomatic infection. The P-II/III study comprises of two parts: The Lead-In phase will assess the safety and tolerability of VIR-7831 (IV, 500mg) vs PBO over a 14-day period in non-hospitalized patients and aims to recruit 20 patients across the US
  • Following this initial safety assessment, the Expansion phase will assess the safety and efficacy VIR-7831 (IV) vs PBO in ~1,300 non-hospitalized participants globally. The company expects the results in Q1’21 and early access to the Ab treatment in H1’21

World’s First App-Based Nicotine Addiction Treatment Received the MHLW’s Approval in Japan

Date – Aug 31, 2020

Product – CureApp

  • On Aug 21, 2020, CureApp receive MHLW’s approval for the manufacturing and sale of Asia’s first therapeutics app, the “CureApp SC Nicotine Addiction Treatment App and CO Checker’’. The company plans to receive insurance reimbursement and release CureApp SC in FY2020
  • CureApp SC is a prescription medical device designed to aid patients receiving outpatient smoking cessation treatment and supports patients to quit smoking in a home setting. The product consists of three components – a patient app, a doctor app, and a portable CO Checker
  • The patient app can provide personalized guidance and is used in tandem with the portable CO Checker, allowing patients to accurately measure the concentration of CO in their breath at home. The patient’s condition obtained from the patient app and the CO Checker will be shared with doctors via the doctor app

GSK’s Blenrep (belantamab mafodotin) Received EC’s Approval for R/R Multiple Myeloma

Date – Aug 27, 2020

Product – Blenrep (belantamab mafodotin-blmf)

  • The EC’s approval is based on DREAMM-2 study assessing Blenrep (2.5/ 3.4 mg/kg, q3w) as monothx. in adult patients prior treated with 4 therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 mAb, and who have demonstrated disease progression on the last therapy
  • The data demonstrated that Blenrep (2.5 mg/kg dose, q3w) resulted in 32% ORR, mDoR (11mos.) & mOS (13.7mos.) while the safety and tolerability profile is consistent with previous data of the therapy
  • Blenrep is a BCMA mAb conjugated to the cytotoxic agent auristatin F via a non-cleavable linker and has received EMA’s PRIME designation in 2017

Novartis’ Kesimpta (ofatumumab) Received the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis

Date – Aug 21, 2020

Product – Kesimpta (ofatumumab)

  • The approval is based on P-III ASCLEPIOS I & II studies assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, qd) in 1,882 patients aged 18-55yrs. with RMS with an EDSS b/w 0 and 5.5 across 37 countries. Additionally, P-II APLIOS study determine the bioequivalence of subcutaneous delivery of Kesimpta via a prefilled syringe and a Sensoready pen in patients with RMS
  • ASCLEPIOS I & II studies results: reduction in ARR 51% & 59% (0.11 vs 0.22 & (0.10 vs 0.25), 34% reduction in 3mos CDP, reduction in number of Gd+ T1 (98% & 94%) and new/ enlarging T2 lesions (82% & 85%) respectively
  • In a post hoc analysis, Kesimpta may halt new disease activity in RMS with 47.0% & 7.8% of patients achieved (NEDA-3) within (0–12mos.) and (12–24 mos.) of treatment, respectively. The therapy is expected to be available in the US in early Sept’2020 along with its anticipated EU approval in Q2’21

Johnson & Johnson Acquired Momenta Pharmaceuticals for $6.5B

Date – Aug 19, 2020

Deal Value – ~$6.5B

  • J&J acquires Momenta in all cash transaction at a price of $52.50/ share, making a total deal value as $6.5B. The transaction is expected to be closed in H2’20
  • The acquisition allows J&J to expand its portfolio for autoimmune diseases with the addition of Momenta’s Nipocalimab (M281) to its pipeline. In addition to nipocalimab, Janssen will acquire Momenta’s pipeline of clinical and pre-clinical assets
  • Janssen plans to retain Momenta’s presence in Cambridge, Massachusetts which will increase J&J footprint and capabilities in key innovation hub. Nipocalimab provides an opportunity for Janssen to deliver transformative treatments in autoantibody-driven autoimmune diseases

Sanofi Acquired Principia Biopharma for ~$3.68B

Date – Aug 17, 2020

Deal Value – ~$3.6B

  • Sanofi to acquire Principia Biopharma in all stock transaction, at $100/share making total deal value ~$3.68B in cash. The transaction is expected to be completed in Q4’20
  • The focus of the acquisition is to strengthen its R&D areas of autoimmune and allergic diseases with the expansion of SAR442168 development program into CNS disorders. Additionally, the deal also adds rilzabrutinib to Sanofi’s portfolio of immunology and inflammation indications
  • The Principia’s BTK inhibitor ‘168 is developed using its Tailored Covalency platform and was evaluated in P-IIb study for MS leading reduction of 85% Gd-enhancing T1 hyperintense lesions vs PBO. In 2017, Sanofi signed exclusive WW license agreement with Principia to develop and commercialize BTK inhibitor ‘168 in MS and other CNS diseases

Zydus Launched Cheapest Version of Remdesivir at $37.41 per Vial in India

Date – Aug 13, 2020

Product – Remdesivir

  • The company has launched Remdec at a price of $37.41 (Rs. 2800) for a 100mg lyophilized injection. The generic version is the most economical Remdesivir brand in India
  • In Jun’2020, Zydus signed a non-exclusive agreement with Gilead to manufacture and commercialize Remdesivir for severe COVID-19 in India. The API of the therapy has been developed and manufactured at the group’s API manufacturing facilities in Gujarat
  • The drug will be made available across India via Zydus’ strong distribution chain reaching out to government and private hospitals treating COVID patients

Biogen Signed an Agreement with Denali on LRRK2 Program for Parkinson’s Disease Worth ~$2.125B

Date – Aug 07, 2020

Deal Value – ~$2.125B

  • Denali to receive $560M up front, $465M as equity investment at a price of $34.94/ share, representing 11.2% of Denali’s pro-forma outstanding stock along with $1.125B as milestones.
  • The two companies will codevelop Denali’ LRRK2 inhibitor for PD and co-commercialize it the US and China while Biogen have the right to commercialize the therapy in other territories and will pay royalties for the same. Biogen & Denali will share global development cost (60% & 40%) with equal share in profit and loss in the US and in China (60% & 40%) respectively
  • Denali’ LRRK2 inhibitor (DNL151) has been progressed into late stage clinical studies expected to commence in 2021. Additionally, Biogen to receive exclusive option rights to two programs for neurodegenerative diseases utilizing Denali’s TV technology platform, including for amyloid beta + right of first negotiation for two additional unnamed TV platform programs

Siemens Healthineers Acquired Varian for $16.4B

Date – Aug 04, 2020

Deal Value – ~$16.4B

  • Siemens Healthineers to acquire Varian in all-cash transaction, at a price of $177.50/ share with 42% to the 30-day volume weighted average closing price of Varian’s common stock as of July 31, 2020, making a total deal value ~$16.4B
  • The transaction is expected to be closed in H1’21. The combined company will offer an integrated platform of end-to-end oncology solutions to addressing the complete continuum of cancer care, from screening and diagnosis to care delivery and post-treatment survivorship
  • Varian and Siemens Healthineers will lead the digital transformation of oncology healthcare, enabling more efficient diagnosis, increased treatment quality and access, personalized precision cancer care, and improved outcomes for millions of patients worldwide

Sanofi and GSK Received $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine

Date – Aug 03, 2020

Value – $2.1B

  • The US government will provide ~$2.1B to support the development of the vaccine, including clinical trials with some amount to be used for ramping up the manufacturing and delivery of an initial 100M dose of the vaccine
  • The US government has an option to supply an additional 500M dose and helps the government’s Operation Warp Speed goals for providing millions of doses of a safe and effective COVID-19 vaccine
  • Additionally, the companies are in discussion with the EC for the supply of up to 300M doses of a COVID-19 vaccine. Both the companies are committed to making their COVID-19 vaccine affordable and available globally

Roche’s Actemra/RoActemra (tocilizumab) Failed to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Date – Jul 29, 2020

Product – Actemra/RoActemra (tocilizumab)

  • The P-III COVACTA study involves assessing of Actemra/RoActemra (IV) + SOC vs PBO + SOC in adult patients hospitalized with severe COVID-19 associated pneumonia. Patients will be followed for 60 days post randomization
  • The study did not meet its 1EPs i.e. improvement in clinical status and 2EPs i.e. difference in patient mortality @4wks. (19.7% vs 19.4%); median time to discharge (20 vs 28days); rate of infection (38.3% vs 40.6%); rates of serious infections (21.0% vs 25.9%)
  • Actemra/RoActemra was the first approved anti-IL-6 receptor biologic available in both in IV/ SC formulations for the treatment of adult patients with moderate-to-severe active RA. Roche will continue the clinical study of Actemra in other treatment settings including in combination with an antiviral

Roche and UCB Collaborated to Develop UCB0107 for Alzheimer’s Disease

Date- Jul 29, 2020

Deal Value- ~$2B+

  • UCB to receive $120M and is eligible to receive $2B as cost reimbursement, development and commercial milestones as well as royalties on sales of the therapies, if Roche proceed the clinical development. Roche to get an exclusive license to develop and commercialize UCB0107 for AD
  • UCB to fund and perform a POC study in AD and, upon availability of the results of that study while Roche has the right to progress with the development or return full rights back to UCB
  • UCB0107 is an IgG4 mAb targeting a central Tau epitope, being developed to block/reduce the spread of Tau pathology. UCB continues to develop UCB0107 in PSP, with anticipated initiation of P-III study in Q2’21

AstraZeneca Signed an Agreement with Daichii Sankyo to Develop and Commercialize DS-1062 Worth Up to $6B

Date – Jul 27, 2020

Deal Value – ~$6B

  • Daichii Sankyo to receive $1B as upfront of which $350M is due upon execution, $325M after 12mos. and $325M after 24 mos., ~$5B as contingent payment including $1B as regulatory milestones, and $4B as commercial milestones, making a total deal value up to ~6B
  • The companies will jointly develop and commercialize DS-1062 globally and share equal development & commercialization costs, except in Japan where Daiichi Sankyo will maintain exclusive rights and manufacture and supply DS-1062
  • Daiichi Sankyo is expected to book sales in US, certain EU countries, and other markets where the company has affiliates while AstraZeneca is expected to book sales in other markets globally, including China, Australia, Canada, and Russia. DS-1062 is a TROP2 directed DXd ADC, currently in P-I study for NSCLC and TNBC

Sanofi Signed an Agreement with Kymera to Advance Novel Protein Degrader Therapies Worth Up to $2.1B

Date – Jul 10, 2020

Deal Value – ~$2.1B

  • Kymera to receive $150M up front, $2B as development, regulatory and commercial milestones along with royalties on sales of therapies. Additionally, the company has an option to develop and commercialize the two programs in the US while retaining global rights to its IRAK4 program in oncology indications.
  • Sanofi will get a global right to develop and commercialize protein degrader therapies targeting IRAK4 in patients with immune-inflammatory diseases and a second undisclosed preclinical program
  • Kymera will advance the IRAK4 program through P-I study, afterwards Sanofi will be further responsible for its development and will lead all clinical development activities for the second program. IRAK4 is a key protein involved in inflammation mediated by the activation of TLRs and IL-1Rs

Bausch Health Spun off its Eye Health Business

Date – July 08, 2020

Product – N/A

  • Bausch Health spin off its leading eye health business into an independent publicly traded company under the name Bausch + Lomb. The spinoff is expected to be completed in H1’21
  • The spinoff will lead to the formation of two separate companies that include an eye-health company built on the iconic Bausch + Lomb brand and a diversified company with leading positions in gastroenterology, aesthetics/dermatology, neurology, and international pharmaceuticals
  • Bausch + Lomb will consist of Bausch Health’s global vision care, surgical, consumer and ophthalmic Rx businesses which had generated $3.7B revenue in 2019. The other company would comprise brands across the Salix, International Rx, neurology, and medical dermatology businesses that generated a revenue of ~$4.9B in 2019

Roche Signed a ~$1B Agreement with Blueprint Medicines for its Precision Therapy to Treat Patients with RET-Altered Cancer Indications

Date – Jul 07, 2020

Deal Value – ~$1B

  • Blueprint Medicine to receive $675M as up front, $100M as equity investment and is eligible to receive up to $927M as development, regulatory and commercial milestones along with royalties on sales of therapy outside the US
  • Roche to get an exclusive right to co-develop globally and commercialize pralsetinib outside the US, excluding Greater China. In the US, Roche will get co-commercialization rights to pralsetinib. The companies will share global development expenses based on pre-specified cost-sharing percentages and equally share profits and losses in the US
  • Pralsetinib (qd, PO) is precision therapy for the treatment of patients with RET-altered NSCLC, MTC and other types of thyroid cancer, and solid tumors and has demonstrated tumour-agnostic potential with its PDUFA date as Nov 23, 2020

Merck KGaA and Pfizer’s Bavencio (avelumab) Received the US FDA’s Approval as a 1L Treatment for Locally Advanced or Metastatic Urothelial Carcinoma

Date – Jul 01, 2020

Product – Bavencio (avelumab)

  • The approval is based on P-III JAVELIN Bladder 100 study assessing Bavencio (10 mg/kg, IV infusion, q2w) + BSC vs BSC as monothx. in 700 patients with LA/ m-UC whose disease had not progressed after 1L platinum-based induction CT as per RECIST v1.1
  • Results: median OS (7.1 vs 21.4mos.); improvement in OS represents a 31% reduction in the risk of death in the overall population, in PD-L1+ patients (44% reduction in risk of death), in an exploratory analysis of patients with PD L1 negative tumors, OS hazard ratio (0.85)
  • Priority review of the therapy was completed under FDA’s Real-Time Oncology Review (RTOR) pilot program, following the receipt of BT designation. In 2017, the US FDA approved the therapy under the accelerated approval program and now converted it to a full approval

The post PharmaShots’ Key Highlights of Third Quarter 2020 first appeared on PharmaShots.

ViewPoints Interview: Takeda’s Andrea Stancati Shares Insights on Entyvio (vedolizumab) SC Formulation

In a recent interview with PharmaShots, Andrea Stancati, Vice President, Head GI Global Medical Franchise shares his insights and highlights of Entyvio (vedolizumab)

Shots:

  • The ongoing P-IIIb VISIBLE OLE study involves assessing of Entyvio (SC) in adult patients with UC or CD, following enrolment and participation in the VISIBLE 1 (UC) or VISIBLE 2 (CD) studies. Patients who completed the maintenance period up to 52wks. (randomized completers) or who achieved clinical response @14wks. (non-randomized 14wks. responders) after a third IV infusion @6wks. received Entyvio (SC, 108mg, q2w)
  • Interim analysis from the VISIBLE OLE study showed long-term findings consistent with the known safety profile of vedolizumab with maintained rates of clinical remission and corticosteroid-free clinical remission
  • Entyvio is the first maintenance biological therapy approved across the EU in both IV and SC formulations to treat moderately to severely active UC or CD. VISIBLE OLE results presented at UEG Week Virtual 2020 congress

Tuba:  Can we have a brief summary of Takeda’s presentation at the UEG Week Virtual 2020 congress?

Andrea: During the UEG Week Virtual 2020 congress, we presented interim results from the VISIBLE open-label extension study on the long-term safety and efficacy of maintenance treatment with the subcutaneous formulation of Entyvio® (vedolizumab) in patients with moderately to severely active ulcerative colitis. Following two years of maintenance therapy with subcutaneous vedolizumab, long-term safety findings were consistent with the known safety profile of vedolizumab.

Additionally, patients continued to demonstrate clinical benefit from treatment, through the maintenance of clinical remission and corticosteroid-free clinical remission rates. These latest safety and effectiveness results are important as they provide further evidence that the benefits received from treatment with subcutaneous vedolizumab are sustained during long-term maintenance therapy.

Tuba :  Please tell us more about the mechanism of Entyvio (vedolizumab) and its uniqueness?

Andrea:  Entyvio is a gut-selective biologic which is approved in both intravenous and subcutaneous formulations.  It is a humanized monoclonal antibody designed to specifically antagonize the alpha4beta7 integrin on the cell surface of circulating T lymphocytes, inhibiting the binding of alpha4beta7 integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1) on the endothelial lining of capillaries. By blocking that interaction and inhibiting the alpha4beta7 integrin, Entyvio prevents T lymphocytes from going into the bowel wall and promoting and sustaining the cycle of inflammation that we see in patients with ulcerative colitis or Crohn’s disease.

Tuba: Is Takeda evaluating the safety & efficacy of Entyvio in pediatric patients with UC & CD?

Andrea:  Yes. While Entyvio is not currently approved for use in people under the age of 18, we have undertaken several phase 2 and 3 clinical studies to understand the potential use of Entyvio in pediatric patients.

Source: New York Presbyterian

Most recently, in May 2020, we completed a phase 2 study (NCT03138655) that evaluated the pharmacokinetics, safety, and tolerability of vedolizumab in patients aged 2-17 with moderately to severely active ulcerative colitis or Crohn’s disease. A phase 2b extension study (NCT03196427) is now in progress to determine the long-term safety profile of Entyvio, with results expected in 2021 and full completion in 2024. We recognize the considerable need to alleviate the debilitating symptoms experienced by children with inflammatory bowel disease and are working to optimize their care with new, targeted treatment solutions.

Tuba:  EU check, Canada check, Australia check, what are your plans for the geographic expansion of Entyvio (vedolizumab) SC formulation?

Andrea:  We intend to work with regulatory bodies globally to seek approval for the new subcutaneous formulation.

We are committed to providing physicians with treatment options that suit their patients’ individual needs and preferences, whether that is intravenous or subcutaneous for maintenance therapy. Some patients may prefer a subcutaneous formulation as it allows flexibility, while others may favor intravenous administration due to regular touchpoints with a healthcare professional in a medical setting.

Tuba:  Are there any new formulations of Entyvio that Takeda is experimenting with?

Andrea:  The recent approval of the subcutaneous formulation of Entyvio has been a significant step forward in advancing care, offering another treatment formulation to suit the individual medical needs, preferences, and different lifestyles of patients. The patient experience is very important to Takeda, and our next focus is on evolving patient care in inflammatory bowel disease with a needle-free Entyvio delivery device. We are working with Portal Instruments on the needle-free device, which is currently in development.

Entyvio is the only gut-selective biologic that addresses inflammation specifically in the gut, significantly differentiating from all other non-selective therapies

Tuba: How is Takeda’s Entyvio different from other competitors in this space?

Andrea:  Entyvio is the only gut-selective biologic that addresses inflammation specifically in the gut, significantly differentiating from all other non-selective therapies. It was the first maintenance biologic therapy approved across Europe in both intravenous and subcutaneous formulations to treat patients with moderately to severely active ulcerative colitis or Crohn’s disease. Entyvio is now approved in over 70 countries worldwide, with more than 510,000 patient-years of exposure to date, providing extensive knowledge on the treatment’s effectiveness and safety.

Tuba: As Takeda is committed to gastrointestinal innovation, what can we expect to see from Takeda to improve the QoL of patients with gastrointestinal diseases?

Andrea:  We’ve continued to demonstrate our patient-centric approach by further investigating and understanding the efficacy and safety profile of Entyvio. We have a number of important clinical studies still running, including in potential new patient populations, which will provide greater knowledge and enhance the body of evidence around the use of the therapy in inflammatory bowel disease. Furthermore, the newly approved subcutaneous formulation of Entyvio allows patients and healthcare professionals to better personalize care in line with which delivery method works best for the individual.

Longer-term, we are working with Portal Instruments on needle-free drug delivery options for patients who have problems with needles. These projects are a small part of our commitment to improving patient quality of life, aside from the research and development work we’re doing to bring new therapeutic options to patients.

Tuba: What is Takeda’s vision to restore the life of patients suffering from GI and liver diseases?

Andrea:  Patients are at the heart of our organization. At Takeda, we see no higher priority than closing the gap between the unmet needs and deserved solutions for those that battle these complicated conditions.

We believe that GI and liver diseases are not just life-disrupting conditions but diseases that can impact a patient’s quality of life. Routines are interrupted, symptom management takes precedence, and the emotional pain can be just as present as the physical. Beyond a fundamental need for effective treatment options, we understand that improving patients’ lives also depends on their needs being recognized. Our approach is a simple one: if there is a need, we will seek to meet it; if there is a patient, we will strive to find a viable treatment solution; if there are questions, we will search relentlessly for answers.

Tuba: Can we have a comment on your rich and diversified pipeline targeting gastrointestinal diseases?

Andrea:  We are committed to providing novel medicines for GI and liver diseases globally. Through specialized and strategic in-house development, external partnerships, in-licensing, and acquisitions, we currently have several promising early-stage assets in development. We remain committed to delivering innovative therapeutic options for patients with GI and liver diseases.

Our core research focus areas in gastroenterology are GI inflammation, GI motility, and advanced liver diseases. In particular, we are making significant strides toward closing the gap on new areas of unmet needs for patients who have celiac disease, eosinophilic esophagitis, alpha-1 antitrypsin-associated liver disease, Crohn’s disease, and acute pancreatitis, among others.

Our patient-centric philosophy begins with exploration as innovative as the treatments it leads to. To gain a greater understanding of the causes of GI and liver diseases, we collaborate with like-minded companies who are advancing the way patients are diagnosed and treated. One example of this is a new collaboration that has enabled us to obtain an intestine chip for research purposes that recreates the intestinal lining and maybe the “gateway” to new discoveries.

For more information on the Takeda pipeline, visit this link

Tuba: Is Takeda looking for any digital solutions for patients with IBD?

Andrea:  As part of our innovation in gastroenterology, we are exploring diverse ways to optimize the care and experiences of patients affected by inflammatory bowel disease. Our unique and holistic approach goes beyond providing patients with medicines by creating novel awareness campaigns and using medical education as a lever to empower patients. We believe that elevating gastrointestinal diseases starts with empathy. To make a real difference, we must understand how gastrointestinal diseases impact our patients’ everyday lives.

An example of this is the creation of Takeda’s digital disease awareness program called ‘In Their Shoes.’ This immersive, award-winning simulation is built around mobile technology. It has been highly successful at helping others, including healthcare professionals, gain more knowledge by experiencing what it’s like to live with inflammatory bowel disease and its complications. Over 2,000 participants from more than 30 countries worldwide have had the opportunity to simulate a patient’s daily life via mobile app challenges, experiencing first-hand the emotional and physical burden of living with inflammatory bowel disease.

About Andrea Stancati:

Andrea Stancati is the Vice President and the Head of GI Global Medical Franchise at Takeda. He has joined Takeda in June 2018 as VP & Global TA Head Gastroenterology Medical Affairs. He served multiple global companies in his career including UCB, Novo Nordisk, Novartis & Roche

Related Post: ViewPoints Interview: QIAGEN’s Kai te Kaat Shares Insights on QIAprep&amp Viral RNA UM Kit

The post ViewPoints Interview: Takeda’s Andrea Stancati Shares Insights on Entyvio (vedolizumab) SC Formulation first appeared on PharmaShots.

ViewPoints Interview: QIAGEN’s Kai te Kaat Shares Insights on QIAprep&amp Viral RNA UM Kit

In a recent interview with PharmaShots, Kai te Kaat, the Vice President, Head of Franchise Oncology, MDx at QIAGEN shares his insights and highlights on QIAprep&amp Viral RNA UM Kit.

Shots:

  • QIAGEN to launch the QIAprep&amp Viral RNA UM Kit, designed to simplify and accelerate PCR swab analysis and remove key testing bottlenecks for Covid-19 and other RNA viruses
  • The kit combines a liquid-based sample preparation step completed in the only 2min. with real-time PCR detection in a streamlined workflow that can be automated with standard lab equipment for any throughput, any assay and any reaction need from single to multiplex testing
  • The workflow takes ~1hr. to deliver a result, compared to ~3hrs. for standard extraction-based quantitative PCR processes and can handle~2,600 samples /8hrs. shift per cycler. The kit complements QIAGEN’s COVID-19 testing portfolio and accelerates PCR analysis for research applications

Tuba: Can we have a detailed discussion on QIAprep&amp Viral RNA UM Kit?

Or

Would you like to discuss the working of the novel kit and how it is accelerating the PCR analysis for research application?

Kai te Kaat: QIAprep&amp is an innovative ultrafast method that combines liquid-based sample preparation with real-time PCR detection for research purposes and/or epidemiological research debottlenecking the detection of SARS CoV2 and other RNA viruses. The end-to-end liquid-based workflow can be automated with standard lab equipment for any throughput, any assay and any reaction need from single to multiplex testing. It can be implemented on all open platforms, typically liquid handlers, and be used in conjunction with any RT PCR cycler such as Rotor-Gene Q, QIAquant, and others. The kit can also be used with a wide range of transport media from Universal Transport media (UTMTM), Viral Transport Media (VTM), or eSwabTM to Virocult®, physiological salt solution, or phosphate-buffered saline (PBS). Besides, it includes a control concept to increase the value of negative results consisting of a human sample control based on RNAse P and B2M genes to indicate the sufficiency of human material in the sample avoiding false negatives and an inhibition control based on artificial sequences to indicate the absence of inhibition by the sample matrix.

Image Source: QIAGEN

The QIAprep&amp workflow is simple, swift, and straightforward, consisting of only three steps: an aliquot is taken from a primary sample (nasopharyngeal, oropharyngeal, or nasal swab) in transport media (8 uL) and added to a sample preparation buffer (2 uL) that is optimized to prepare the viral RNA template without degradation. This is next combined with the RT-qPCR reaction mix (10 uL), which provides reliable and sensitive results for RNA viruses in transport media. The sample then undergoes a routine real-time PCR in a cycler using any assay for SARS-CoV2 RNA detection. The output is finally interpreted, delivering test results in under one hour from start to finish – including incubation and hands-on time – depending on the cycler used.

As the kit only uses three small pipette tips (10 uL and 50uL) per sample, the kit helps to keep consumption of plastic materials to a minimum, and thereby addresses the current major bottleneck of pipette tips at the market while providing significant cost savings by reducing reagent use and labor utilization. In addition, the QIAprep&amp kit can also be used manually with a multi-pipette in lower resources settings or to cover capacity peaks.

QIAprep&amp is a research-based kit and not a diagnostic test and hence cannot be compared to other typical COVID tests that are in the marketplace right now.

Tuba: As mentioned in a press release, QIAprep&amp complements QIAGEN’s efforts to build the broadest portfolio of COVID-19 solutions. Comment over the statement.

Kai te Kaat: Since the beginning of the coronavirus pandemic, we focus on building the most comprehensive portfolio of solutions for COVID-19 testing that addresses the varying needs for clinical and research applications in the fight against the pandemic. These include the production of viral RNA extraction for use on our QIAcube, QIAsymphony, and EZ1 platforms as well as third-party instruments; building up a range of PCR tests on the QIAstat-Dx and NeuMoDx systems that enable COVID-19 detection while analyzing samples at the same time for other respiratory infections and are developing novel easy-to-use solutions for antibody and antigen testing running on a portable device that provides highly accurate results in less than 15 minutes. We are also providing universal next-generation sequencing (NGS) solutions for research use with any sequencer, in particular gene panels integrated with bioinformatics for analysis of the SARS-CoV-2 virus, and are scaling up production capacity for reagents sold to other companies for use in their own COVID-19 tests. With the launch of QIAprep&amp that includes both sample extraction components and optimized PCR reagents for only one procedure we now complement our COVID-19 testing portfolio further removing key testing bottlenecks for SARS-CoV-2.

Image Source: QIAGEN

Tuba: How confidently you can pitch about its accuracy since it delivers results in under one hour?

Kai te Kaat: It is a research-based kit with which we achieve a detection limit of less than 8 viral copies/reaction and a high concordance to established extraction-based methods.

Tuba: What are your other targets except for COVID-19. Are you specifically working on something?

Kai te Kaat: The product is optimized for the mentioned transport media and detection of enveloped RNA viruses such as SARS-CoV2. We are further qualifying additional transport media for the workflow to increase its universal applicability. Further, we are looking into deploying the same workflow for other respiratory viruses.

Tuba: When can we expect QIAprep& Viral RNA UM Kit’s availability for research applications?

Kai te Kaat: The kit is available worldwide for research applications starting the week of October 19th. Since it is a fully liquid-based workflow, scalability in manufacturing is deep with the potential of more than 20 million reactions per month.

The kit is available worldwide for research applications starting the week of October 19th. Since it is a fully liquid-based workflow, scalability in manufacturing is deep with the potential of more than 20 million reactions per month.

Tuba: What do feel was the biggest roadblock in developing an accurate testing solution for COVID-19?

Kai te Kaat: General roadblocks for the development of accurate testing solutions for COVID-19 are the access to defined standard materials and controls as well as overall supply challenges in the industry, especially on plasticware.

Tuba: What all developments and can you count the name of QIAGEN in providing solutions for the COVID-19 to date?

Kai te Kaat: From the onset of the novel coronavirus outbreak, our teams have been working around the clock to ensure the availability of existing testing solutions and to develop new SARS-CoV-2 tests to address international testing needs. Today, we offer the most comprehensive portfolio of SARS-CoV-2 testing solutions on the market, covering the needs of clinical and research customers, from manual to automated sample processing, low to high throughput, single-plex to multi-plex, and from active infection testing to the detection of previous viral exposure. An overview of our global efforts in the fight against coronavirus can be found here; for background information on our coronavirus testing solutions please download our factsheet.

Tuba: Are you planning to further develop solutions for the COVID-19 testing portfolio?

Kai te Kaat: Based on the technology used in the novel QIAprep&amp kit we are currently developing IVD test kits for SARS-CoV2 RNA.

Tuba: Do you want to highlight anything else about QIAGEN for our subscribers?

Kai te Kaat: Today, we offer the most comprehensive portfolio of SARS-CoV-2 testing solutions on the market addressing the varying testing needs in the fight against the pandemic covering the needs of clinical and research applications, from manual to automated sample processing, low to high throughput, single-plex to multi-plex, and from active infection testing to the detection of previous viral exposure. Testing will continue to be a dominant factor in the fight against the pandemic: even when the vaccines will come to market, the immune status of the population will need to be assessed and monitored. Here, PCR will continue to remain the gold standard for the detection of SARS-CoV-2 and other RNA viruses, and with our QIAprep&amp technology, we made it even faster without compromising performance.

 About Kai te Kaat:

Kai te Kaat is the Vice President and the Head of QIAGEN’s Oncology Franchise in the Molecular Diagnostics Business Area.  He has joined QIAGEN in 2005 as the Global Business Director Proteins. He has been working for the last 11 years at QIAGEN

Related Post: ViewPoints Interview: Eli Lilly’s Dr. Lotus Mallbris Shares Insights on Baricitinib

The post ViewPoints Interview: QIAGEN’s Kai te Kaat Shares Insights on QIAprep&amp Viral RNA UM Kit first appeared on PharmaShots.

Insights+: The US FDA New Drug Approvals in September 2020

The US FDA has approved 6 NDAs in Sept 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 85 novel products so far in 2020, including 6 in Sept 2020. Additionally, last year in 2019, the US FDA has approved 48 novel products. We have compiled a list of a total of 6 new drugs approved by the US FDA in Sept 2020.

1. Athena Bioscience’s Qdolo (tramadol hydrochloride) Received the US FDA’s NDA Approval for Oral Solution

Published: Sept 01, 2020 | Tags: Athena Bioscience, QDOLO, tramadol hydrochloride, Receives, U.S. FDA, Approval, NDA, Oral, Solution

  • Athena Biosciences announced that the US FDA has approved Qdolo (tramadol hydrochloride) oral solution 5mg/1mL C-IV
  • The most common AE’s (≥15.0%) observed in patients were dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, and pruritus
  • Qdolo is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It will be available at the chain, independent, and specialty pharmacies

2. BMS’ Onureg (azacitidine) Received the US FDA’s Approval as Continued Treatment for Acute Myeloid Leukemia

Published: Sept 01, 2020 | Tags: Azacitidine, Acute Myeloid Leukemia, Approval, BMS, Continued Treatment, FDA, Onureg, US

  • The approval is based on P-III QUAZAR AML-001 study assessing Onureg (300 mg, PO) vs PBO  for 14 days of a 28-day cycle + BSC in a ratio (1:1) in 472 patients aged ≥55yrs. with AML and had achieved CR or Cri following intensive induction CT and cannot proceed with intensive curative therapy including HSCT
  • The P-III QUAZAR AML-001 study results: m-OS (24.7 vs 14.8mos.); m-DOR (12 vs 6 cycles). Additionally, the therapy has received the US FDA’s PR designation while EMA validates its MAA in May’2020
  • Onureg (CC-486) is an oral hypomethylating agent that incorporates into DNA and RNA and carries out hypomethylation of DNA, as well as direct cytotoxicity to abnormal hematopoietic cells in the bone marrow

3. RadioMedix and Curium Detectnet (copper Cu 64 dotatate injection) Received the US FDA’s Approval for Positive Neuroendocrine Tumors (NETs)

Published: Sept 03, 2020 | Tags: RadioMedix, Curium, Detectnet, copper Cu 64 dotatate injection, US FDA Approval, Positive Neuroendocrine Tumors (NETs)

  • The approval is based on P-lll study which involves the assessing of Detectnet (copper Cu 64 dotatate injection) in Neuroendocrine Tumors (NETs) patients. Curium expects to launch detectnet immediately with doses available through various nuclear pharmacies
  • The P-III results demonstrated that the clinical sensitivity and specificity provide a great aid to clinicians in develop accurate treatment approach for their NET patients. Additionally, the 12.7-hrs. half-life allows detectnet to be produced centrally and shipped to sites
  • Detectnet is a positron emission tomography (PET) agent indicated for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients

4. Genentech’ Gavreto (pralsetinib) Received the US FDA’s Approval Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Published: Sept 04, 2020 | Tags: Pralsetinib, Adults, Approval, FDA, Fusion-Positive, Gavreto, Genentech, Metastatic Non-Small Cell Lung Cancer, Rearranged, Transfection, US

  • The approval is based on P-I/II ARROW study assessing Gavreto (400mg, qd) in RET fusion-positive NSCLC patients with or without prior therapy, and regardless of RET fusion partner or CNS involvement. The study also involves patients with RET-MTC, RET fusion-positive thyroid cancer, and other RET-altered solid tumors
  • Results: ORR (57%) and CR rate (5.7%) in 87 NSCLC patients prior to treated with Pt. based CT, m-DOR was not reached, in 27 treatment-naïve NSCLC patients, ORR (70%); CR rate (11%). Gavreto is now the 6th FDA-approved medicine in Genentech’s portfolio for lung cancer and will co-commercialize by Genentech and Blueprint Medicines in the US
  • Gavreto is an oral precision therapy targeting RET alterations, including fusions and mutations, regardless of the tissue of origin. Additionally, the US FDA has granted BT designation for RET fusion+ NSCLC and RET mutation+ MTC and PR designation for advanced or m-RET-mutant MTC and RET fusion+ thyroid cancer to the therapy with its anticipated PDUFA date as Feb 28, 2021

5. Pfizer’s Xeljanz (tofacitinib) Received the US FDA’s Approval for Active Polyarticular Course Juvenile Idiopathic Arthritis

Published: Sept 28, 2020 | Tags: Active Polyarticular Course Juvenile Idiopathic Arthritis, Approval, FDA, Tofacitinib, US, Xeljanz

  • The approval is based on P-III study including 2 phases assessing tofacitinib (5mg or 1mg/mL oral solution, bid) for 44wks. The 2phases includes an 18 wks. open-label, run-in phase study of 225 patients and a 26wks. PBO controlled withdrawal study of 173 patients
  • Results: the study met its 1EP showing ACR30 response at the end of the run-in phase; the occurrence of disease flare in patients (31% vs 55%) @44wks. The approval makes Xeljanz the first and only JAK inhibitor approved in the US for pcJIA
  • The US FDA has approved the two formulations of Xeljanz (a tablet and an oral solution) and are dosed based on weight. The oral solution is expected to be available by the end of Q1’21 while the tablets (5mg) are available instantly

6. Eton Pharmaceutical’s Alkindi Sprinkle (hydrocortisone) Received the US FDA’s Approval as Replacement Therapy in Pediatric Patients

Published: Sept 29, 2020 | Tags: Eton Pharmaceuticals, Alkindi Sprinkle, hydrocortisone, US FDA Approval, Adrenocortical Insufficiency

  • The approval is based on 6 clinical studies, including the 1st and only interventional P-lll study which involves the assessing of Alkindi Sprinkle (hydrocortisone) for Pediatric AI in neonates to children under 8 yrs. of age
  • Eton expects Alkindi Sprinkle to be commercially available in the Q4’ 2020 and it will be available in four strengths: 0.5mg, 1mg, 2mg, and 5mg, to give greater dosing flexibility to clinicians
  • Alkindi Sprinkle is the 1st and only FDA-approved granular hydrocortisone formulation for the treatment of adrenocortical insufficiency specifically designed for use in children

Related Post: Insights+: The US FDA New Drug Approvals in August 2020

The post Insights+: The US FDA New Drug Approvals in September 2020 first appeared on PharmaShots.

Insights+ Key Biosimilars Events of September 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference product to biologics” possessing similar therapeutic properties. The month is flooded with biosimilar news where Henlius is on top as it unveils multiple news including NDA acceptance of HLX04 (biosimilar, bevacizumab), its presentation at CSCO, and an agreement with Accord for HLX02 (biosimilar, trastuzumab) in the US and Canada. Our team at PharmaShots has summarized 14 key events of the biosimilar space of Sept 2020.

Neuclone Disclosed Two Biosimilars Referencing Opdivo (nivolumab) and Keytruda (pembrolizumab)

Published: Sept 01, 2020

Products: Biosimilars

  • The company discloses two additional biosimilars in active development referencing Opdivo (nivolumab) and Keytruda (pembrolizumab). The biosimilars are in the advanced stages of pre-clinical development and are being co-developed by NeuClone and Serum Institute of India
  • The disclosure demonstrates NeuClone’s ability to develop multiple biosimilars simultaneously through its NeuMAX platform
  • Additionally, NeuClone and Serum Institute are developing eight other biosimilars including clinical-stage candidates referencing Stelara (ustekinumab) and Herceptin (trastuzumab)

Bio-Thera Initiated P-I Study of BAT2206 Proposed Biosimilar to Stelara (ustekinumab)

Published: Sept 04, 2020

Products: BAT2206

  • The first patient has been dosed in a P-I clinical study to compare the PK and safety of BAT2206, a proposed biosimilar to Stelara (ustekinumab) to US/EU-sourced reference product in healthy volunteers
  • The company is expected to enroll 270 healthy volunteers. BAT2206 represents the fifth biosimilar of Bio-Thera’s portfolio that has advanced into clinical development
  • BioThera is developing additional products, including QLETLI (biosimilar to Humira), which is approved in China, BAT1706 (biosimilar to Avastin), that has completed a P-III study with expected regulatory submission in Q4’20. The company is also pursuing biosimilar versions of Actemra, Cosentyx, and Simponi

Innovent’s Sulinno (biosimilar, adalimumab) Received NMPA’s Approval for Autoimmune Diseases

Published: Sept 04, 2020

Products: Sulinno (biosimilar, adalimumab)

  • The NMPA has approved Sulinno for the treatment of RA, AS, and psoriasis in China. The approval of the Sulinno marks the expansion of Innovent’s portfolio in the non-oncology field
  • Sulinno has similar clinical efficacy and safety to its reference product, Humira. The launch will provide Chinese patients with affordable adalimumab, bringing hope and opportunities to more patients
  • Sulinno is a biosimilar referencing Humira and is the third mAb approved by NMPA following the approval of Tyvyt (sintilimab) and Byvasda (bevacizumab)

Henlius Reported NMPA’s Acceptance of NDA for HLX04 (biosimilar, bevacizumab)

Published: Sept 11, 2020

Products: HLX04 (biosimilar, bevacizumab)

  • NMPA has accepted the NDA of HLX04, based on the series of study data, including comparative pharmaceutical quality studies, comparative non-clinical studies & clinical studies. The NDA acceptance makes HLX04 the fourth product of Henlius that has received NMPA’s NDA acceptance & can be potentially used for the treatment of advanced/ metastatic or recurrent NSCLC and metastatic colorectal cancer
  • The P-III study assessing the efficacy, safety, and immunogenicity of HLX04 or the reference bevacizumab + oxaliplatin and fluoropyrimidine-based CT (XELOX or mFOLFOX6) as a 1L treatment in Chinese patients with metastatic colorectal cancer
  • The study met its 1EPs of PFS @36wks.and has shown similarity to the reference product in terms of efficacy, safety, and immunogenicity. Additionally, Henlius is evaluating the HLX04 in combination with HLX10 for the treatment of solid tumors and is the first dual mAb combo therapy that has received IND approval

Merck’s Brenzys (biosimilar, etanercept) Received Health Canada Approval for Multiple Indications

Published: Sept 16, 2020

Products: Brenzys (etanercept, biosimilar)

  • Health Canada has approved Brenzys for new indications that include adults & pediatric patients (4-17yrs.) with PsO who are candidates for systemic therapy/ phototherapy, adult patients with PsA, and patients aged 4-17yrs. with JIA
  • The clinical efficacy and safety studies conducted in patients with RA demonstrate clinical comparability between Brenzys and the reference product. The extrapolation of these data supports the use of Brenzys in AS
  • Brenzys is a biosimilar referencing Enbrel, which is approved for use for PsO, PsA, and JIA in Canada. Brenzys received its first Health Canada approval in 2016 for the mod. to sev. RA in adults and AS and is administered via injection under the skin and should be used under the guidance and supervision of a physician

Henlius Present P-III Data of HLX02 (biosimilar, trastuzumab) at ESMO

Published: Sept 17, 2020

Products: HLX02 (biosimilar, trastuzumab)

  • The P-III HLX02-BC01 study involves assessing HLX02 vs EU-sourced trastuzumab in combination with docetaxel in a 3wks. cycle for up to 1yr. in patients in a ratio (1:1) with HER2-positive recurrent/ mBC, prior not treated with systemic treatment 
  • Results:  Per ITT set, ORRwk24 (71.3% vs 71.4%); Per PP set, ORRwk24 (74.2% vs 73.2%); All subgroup analyses showed no statistically significant differences in ORR between the treatment groups in all populations, demonstrating the equivalence in efficacy
  • No difference between the two treatment groups in 2EPs, including CBR, DCR, DoR, PFS, and OS

Samsung Bioepis Presented P-III Exploratory Analyses Results of Aybintio (biosimilar, bevacizumab) at ESMO 2020

Published: Sept 17, 2020

Products: Aybintio (biosimilar, bevacizumab)

  • The exploratory analyses of the P-III study evaluate the equivalent efficacy of Aybintio vs reference bevacizumab in combination with paclitaxel & carboplatin, q3w up to 6 cycles followed by Aybintio or reference bevacizumab as maintenance monothx. in 665 patients with metastatic/recurrent nsq. NSCLC
  • Results: previous analysis demonstrate ORR in PPS (50.1% vs 44.8%); expanded analysis showed the risk difference in best ORR by 11 & 17wks. (2.2% vs 2.4%); mean of maximum % change from baseline in tumor burden @24wks. (-27.8% vs -27.3%)
  • Aybintio is a biosimilar referencing Avastin and has received EC’s approval in Aug’2020 for mCRC, mBC, NSCLC, mRCC, epithelial ovarian, fallopian tube, primary peritoneal cancer and cervical cancer

Lotus Signed an Exclusive Commercialization Agreement with CKD for Biosimilar Darbepoetin Alfa

Published: Sept 18, 2020

Products: Biosimilar Darbepoetin Alfa

  • Lotus to get an exclusive commercialization right of biosimilar Darbepoetin alfa in Taiwan and Southeast Asian markets
  • The collaboration allows the Lotus to re-emphasize its focus on nephrology as a core therapy in key Asian markets by ensuring the access to quality medication and maintains growth momentum with another addition to its biosimilar pipeline
  • Darbepoetin alfa from CKD is the 5th biosimilar product Lotus has in the pipeline. Lotus has the rights to commercialize bevacizumab and adalimumab in multiple Asian countries and has submitted MAA for trastuzumab in Korea, and teriparatide in both Taiwan and Thailand

Henlius Presented P-III Data of HLX04 (biosimilar, bevacizumab) at CSCO 2020

Published: Sept 20, 2020

Products: HLX04 (biosimilar, bevacizumab)

  • The P-III HLX04-mCRC03 study involve assessing of HLX04 (7.5mg/kg, q3w, when combined with XELOX or 5mg/kg, q2w when combined with mFOLFOX6) vs reference bevacizumab + CT (XELOX or mFOLFOX6) as a 1L treatment in 675 patients in a ratio (1:1) with mCRC
  • Results: PFSR36wk (46.4% vs 50.7%); no difference in 2EPs including OS, PFS, ORR, TTR, and DoR
  • HLX04 is a bevacizumab biosimilar, indicated for advanced, metastatic, or recurrent NSCLC and metastatic colorectal cancer. Additionally, NMPA has accepted NDA of HLX04

Henlius Reported First Patient Dosing with HLX11 (biosimilar, pertuzumab) for HER2-Positive Metastatic Breast Cancer and Early Breast Cancer

Published: Sept 20, 2020

Products: HLX11 (biosimilar, pertuzumab)

  • The company has reported the first patient dosing in P-l study assessing the safety, tolerability, and immunogenicity of HLX11 vs US-, EU- and China-sourced reference pertuzumab in healthy Chinese male
  • The 1EPs of the study is to compare the PK b/w HLX11 and the three different sourced reference drugs head-to-head while the 2EPs is to evaluate the safety, tolerability, and immunogenicity of HLX11 and the reference drug, further describing the PK profile
  • HLX11 can be potentially used for the treatment of HER2-positive mBC & eBC. Additionally, the study demonstrated that combining pertuzumab with trastuzumab and CT can decrease the risk of recurrence or death for HER2+ BC

Alvotech and DKSH Extended their Collaboration to Commercialize Six Biosimilars in Asia  

Published: Sept 22, 2020

Products: AVT02 (biosimilar, adalimumab).

  • It is also an expansion of their strategic partnership to commercialize six new biosimilar product candidates for the Asian markets
  • In Mar’2020, the companies collaborated for AVT02 (biosimilar, adalimumab). The collaboration targets Taiwan, Korea, Hong Kong, Philippines, Vietnam, Thailand, Cambodia, Myanmar, Malaysia, Singapore, Indonesia, India, Bangladesh, and Pakistan
  • The expansion deepens the partnership b/w the two companies to accelerate the introduction of high quality biosimilar to patients in Asia

Accord Launched Zercepac (biosimilar, trastuzumab) in the UK

Published: Sept 25, 2020

Products: Zercepac (biosimilar, trastuzumab)

  • Accord launches Zercepac as s a biosimilar referencing Herceptin in the UK, following the EC’s approval in Jul’2020.
  • The EC’s approval is based on a series of robust studies including comparative quality studies, pre/ clinical studies. The results confirmed the Zercepac’s bio-similarity, demonstrating comparable efficacy and safety to the Herceptin
  • Zercepac is the first mAb and the fourth biosimilar launched in the EU and is indicated for patients with HER2+ eBC, HER2+ mBC and previously untreated HER2+ metastatic gastric cancer and will be available in a 150mg single-dose vial

Innovent Reported Results of Dual Regimen in P-III ORIENT-32 Study as 1L Therapy for Advanced HCC

Published: Sept 28, 2020

Products: Tyvyt (sintilimab) + Byvasda (biosimilar, bevacizumab)

  • The P-III ORIENT-32 involves assessing of Tyvyt (sintilimab) + Byvasda (bevacizumab, biosimilar) vs sorafenib in a ratio (2:1) for 1L treatment of patients with advanced HCC
  • The study resulted in meeting its 1EPs of PFS and OS, the safety profile is consistent with prior studies, and no new safety signals were identified. Following the IDMC recommendation, Innovent to review the results with NMPA’s CDE in China
  • Tyvyt is a type of IgG4 mAb, that binds to PD-1 molecules on the surface of T-cells, blocking the PD-1 pathway and reactivates T-cells to kill cancer cells. The company is evaluating Tyvyt in 20+ studies across multiple cancer indications globally

Henlius Signed an Exclusive License Agreement with Accord for HLX02 (biosimilar, trastuzumab) in the US and Canada

Published: Sept 30, 2020

Products: HLX02 (biosimilar, trastuzumab)

  • Henlius to receives $27M up front, ~$13M regulatory milestones, $25M commercial milestones for every $500M of cumulative net sales, and is eligible to receive royalty up to 50% profit of HLX02. If the cumulative net sales of HLX02 reaches $3B, Henlius to receive ~$150M as commercial milestones
  • Accord to get an exclusive license to develop and commercialize HLX02 in the US & Canada. The development process strictly followed the EMA and NMPA’s biosimilar guidelines
  • In 2018, the companies enter into a license agreement, under which Henlius granted Accord UK exclusive commercialization rights of HLX02 in the EU, the Middle East, North Africa, and the Commonwealth of Independent States. The therapy received EC’s and the NMPA approval sin July & Aug’2020, making it the first China-developed mAb biosimilar approved both in China and in the EU

Related News: Insights+ Key Biosimilars Events of August 2020

The post Insights+ Key Biosimilars Events of September 2020 first appeared on PharmaShots.

Insights+: The US FDA New Drug Approvals in July 2020

The US FDA has approved multiple NDAs and BLAs in July 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 59 novel products so far in 2020, including 8 in July 2020. Additionally, last year in 2019, the US FDA has approved 48 novel products. We have compiled a list of a total of 8 new drugs approved by the US FDA in July 2020.

1.Acacia Pharma’s Byfavo (remimazolam) Received the US FDA’s Approval for the Induction and Maintenance of Procedural Sedation

Published: Jul 02, 2020 | Tags: Acacia Pharma, Byfavo, remimazolam, Received, the US FDA, Approval, Induction, Maintenance, Procedural Sedation

  • The safety of Byfavo was evaluated in 969 patients assessing Byfavo for the induction and maintenance of procedural sedation
  • In Jan 2020, the company in-licensed the commercial rights to Byfavo and will pay $33.6M upfront generated by the approval, consisting of $16.8M in cash and $16.8M in ordinary shares of Acacia Pharma stock. Additionally, Acacia will get $11.2M net cash to launch the product in the US
  • Byfavo (remimazolam) is an injection rapid onset/offset IV benzodiazepine sedative for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less, with its expected launch in the US in H2’20

2. Osmotica’s Upneeq Received the US FDA’s Approval to Treat Blepharoptosis (Droopy Eyelid) in Adults

Published: Jul 09, 2020 | Tags: Osmotica, Upneeq, Received, the US FDA, Approval, Treat, Blepharoptosis, Droopy Eyelid, Adults

  • The approval was based on P-III trial assessing Upneeq vs PBO in a (2:1) ratio in 140 patients with acquired blepharoptosis split into two treatment groups for 42 days. Additionally, another second P-III clinical trial evaluated the safety and efficacy of Upneeq vs PBO in 35 patients to treat acquired blepharoptosis
  • The study resulted in well-tolerated results when administered once daily over a six-week period with no serious AEs and met its both 1EPs and 2EPs, mean change from baseline on the LPFT on Hour 6, Day 1 6.3 vs 2.1, Hour 2 Day 14 7.7 vs 2.4, improvement in MRD-1 at 5 and 15 minutes, and 2 and 6 hours post-dose on days 1 and 14
  • Upneeq (oxymetazoline hydrochloride ophthalmic solution) is a QD ophthalmic formulation of oxymetazoline and an alpha-adrenergic receptor agonist a novel pharmacologic treatment indicated for the treatment of acquired blepharoptosis

3. Otsuka Inqovi (decitabine and cedazuridine) Received the US FDA’s Approval to MDS and CMML

Published: Jul 20, 2020 | Tags: Otsuka, Inqovi, decitabine, cedazuridine, Received, the US FDA, Approval, MDS, CMML

  • The approval was based on P-III trial from the ASCERTAIN study supporting P-I and P-II clinical studies which evaluated the safety and efficacy including decitabine exposure equivalence in oral Inqovi vs intravenous decitabine
  • Otsuka a subsidiary of Astex Pharmaceuticals with its partner Taiho Pharmaceutical and North American reported the approval
  • Inqovi is a novel product orally administered hypomethylating agent approved by the US and Health Canada for the treatment of MDS and CMML

4. Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium, and sodium oxybates) Received the US FDA’s Approval for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy

Published: Jul 22, 2020 | Tags: Jazz Pharmaceuticals, Xywav, Calcium, magnesium, potassium, sodium oxybates, Received, the US FDA, Approval, Cataplexy, Excessive, Daytime, Sleepiness, Associated, Narcolepsy

  • The FDA approval was based on P-III study results assessing Xywav vs PBO in 201 patients to evaluate the safety and efficacy in the treatment of cataplexy and EDS in patients with narcolepsy 
  • The study resulted in statistically significant differences in the weekly number of cataplexy attack and Epworth Sleepiness Scale scores
  • Xywav, also known as JZP-258 is targeted for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy. Additionally, the USDEA (Drug Enforcement Administration) has designated Xywav as a Schedule III medicine also contains a boxed warning of as a central nervous system depressant

5. MC2 Therapeutics Wynzora Cream Received the US FDA’s Approval to Treat Plaque Psoriasis in Adults

Published: Jul 22, 2020 | Tags: MC2 Therapeutics, Wynzora Cream, Received, the US FDA, Approval, Treat, Plaque Psoriasis, Adults

  • The approval was based on P-III trial assessing Wynzora Cream vs Taclonex Topical Suspension in 794 patients for the treatment of plaque psoriasis in adults 18 years of age or older
  • The study resulted in a PGA treatment of 21.6% vs 14.6%, patients achieved at least a 4-point improvement in the peak pruritus NRS score at @4wks. 60.3% vs 21.4%
  • Wynzora is a novel topical solution offering high efficacy, favorable safety and excellent and is filled for MAA application in EU

6. AstraZeneca’s Breztri Aerosphere Received the US FDA’s Approval for the Maintenance Treatment of COPD

Published: Jul 24, 2020 | Tags: AstraZeneca, Breztri Aerosphere, Received, US, FDA, Approval, Maintenance Treatment, COPD

  • The approval was based on P-III ETHOS study assessing of Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) vs dual therapies [Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate)] with moderate to severe COPD and a history of exacerbation(s) in the previous year
  • The P-III ETHOS study demonstrated a reduction in the rate of moderate or severe exacerbations. Additionally, the P-III KRONOS study also support the approval of the therapy
  • Breztri Aerosphere is an approved therapy in Japan and China for patients with COPD and is under regulatory review in the EU. As per the agreement to acquire Pearl Therapeutics, AstraZeneca paid $150M as a milestone on US approval of the therapy for COPD

7. MorphoSys’ Monjuvi (tafasitamab-cxix) + Lenalidomide Received the US FDA’s Approval as 2L Treatment for Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma

Published: Jul 31, 2020 | Tags: MorphoSys, Monjuvi, tafasitamab-cxix, Lenalidomide, Received, US, FDA, Approval, 2L, Treatment, Patients, Relapsed, Refractory, Diffuse Large B-cell Lymphoma

  • The approval was based on P-II L-MIND study assessing Monjuvi in combination with lenalidomide as a treatment for adult patients with relapsed or refractory DLBCL
  • Results: ORR (55%); CR (37%); PR (18%); mDOR (21.7mos.). Additionally, the US FDA has granted BT designation for the combination therapy for r/r DLBCL
  • Monjuvi is a humanized Fc-modified cytolytic CD19 targeting mAb, has been approved under US FDA’s accelerated approval, and is expected to be commercially available in the US. MorphoSys and Incyte will co-commercialize Monjuvi in the US & has exclusive commercialization rights outside the territory

8. ViiV Healthcare’s Rukobia (fostemsavir) Received the US FDA’s Approval for HIV in Patients with Limited Treatment Options

Published: Jul 31, 2020 | Tags:  ViiV Healthcare, Rukobia, fostemsavir, Received, US, FDA, Approval, HIV, Patients, Limited Treatment Options

  • The approval was based on P-III BRIGHTE study assessing Rukobia (600mg, ER) + OBT in 371 HTE adults living with multidrug-resistant HIV. Participants were enrolled in either a randomized or nonrandomized cohort
  • In the randomized cohort, 60% adults achieved undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count @96wks., HIV-1 RNA <40 copies/mL @24 & 96wks. (53% & 60%); changes in CD4+ cell count (90 & 205 cells/mm3) respectively. In the nonrandomized cohort, 37% achieved HIV-1 RNA <40 copies/mL @24 & 96wks.; HIV-1 RNA <200 copies/mL (42% & 39%); mean changes in CD4+ cell count (41 & 119 cells/mm3) respectively
  • Fostemsavir is a first-in-class HIV-1 attachment inhibitor, currently under EMA’s review with additional submissions to regulatory authorities anticipated in 2020 & 2021

Investing in Drug Companies? Here are 6 Vital Non-Patent Factors to Consider

When drug patents expire, billions of dollars in revenues can disappear overnight as competitors enter the market. Accordingly, many investors focus on drug patents when evaluating drug companies. But, there…

The post Investing in Drug Companies? Here are 6 Vital Non-Patent Factors to Consider appeared first on DrugPatentWatch – Make Better Decisions.

Insights+ Key Biosimilars Events of July 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference product to biologics” possessing similar therapeutic properties. Mylan with its partner Kyowa Kirin received the US FDA’s approval for its adalimumab biosimilar, Hulio (adalimumab-fkjp). Cadila expanded its footprints in India with the launch of its two biosimilars Bevaro (bevacizumab, biosimilar) and Ritucad (rituximab, biosimilar). Our team at PharmaShots has summarized 9 key events of the biosimilar space of July 2020.

1. Samsung Bioepis Reported the Initiation of P-III Study for SB15 Proposed Biosimilar to Eylea (aflibercept)

Date: Jul 01, 2020  

Product: SB15 Biosimilar

  • The P-III study compared the efficacy, safety, PK, and immunogenicity between SB15 and Eylea in 446 patients with neovascular age-related macular degeneration
  • The company has two ophthalmology biosimilar candidates in clinical development, SB11 (ranibizumab) and SB15 (aflibercept). On May 18, 2020, Samsung Bioepis reported 24-week interim results from a P-III study of SB11 (proposed ranibizumab biosimilar)
  • SB15 is a proposed biosimilar referencing Regeneron’s Eylea, currently under preclinical treatment for diabetic macular edema, diabetic retinopathy, retinal edema, and retinal vein occlusion

2. Mylan and Fujifilm Kyowa Kirin Received the US FDA’s Approval for its Hulio (biosimilar, adalimumab)

Date: Jul 09, 2020

Product: Hulio (adalimumab-fkjp)

  • The US FDA has approved Hulio (adalimumab-fkjp), a biosimilar to AbbVie’s Humira (adalimumab) to treat RA, JIA (in patients aged ≥4yrs.), PsA, AS, adult CD,  UC, and PsO, in both prefilled syringe and auto-injector presentations
  • The approval was based on an analytical, pre/ clinical program. The P-III ARABESC study conducted by Fujifilm Kyowa Kirin, demonstrated no differences in terms of safety, efficacy, and immunogenicity compared to its reference product in patients with RA
  • In 2018, the companies collaborated to commercialize Hulio in the EU while expanded the agreement globally in 2019. As per the patent license agreement with AbbVie, Mylan will be able to launch Hulio in the US in Jul’2023

3. Bio-Thera Signed a License Agreement with Pharmapark for BAT2506 (golimumab, biosimilar)

Date: Jul 17, 2020  

Product: BAT2506 (golimumab, biosimilar)

  • Bio-Thera will take care of full development, and commercial supply of BAT2506 out of the manufacturing facilities in Guangzhou, China. Additionally, the agreement will utilize Pharmapark’s local presence, sales, and marketing capabilities in Russia and other CIS countries
  • Pharmapark to get exclusive rights to distribute and market the product in Russia and other CIS countries including its filing practices. In Q4’20, Bio-Thera to begin its global P-III trial in PsA patients and will include patients from China, Russia, and many other countries 
  • Bio-Thera’s BAT2506 is a mAb while the company plans for regulatory submission with NMPA, EMA and the US FDA in 2023

4. Cadila to Launch its Bevaro (bevacizumab, biosimilar) in India

Date: Jul 22, 2020  

Product: Bevaro (bevacizumab, biosimilar)

  • Cadila plans to launch multiple biosimilars including Bevaro in 2020 which are safe and efficacious compared to conventional treatment therapies
  • The company has also cleared he USFDA inspection in Feb’20 and holds approved 16 ANDAs plus currently filed 30 ANDAs  
  • Bevaro is a mAb will be available in two strengths of 100 and 400 mg targeted for Ovarian Cancer, Glioblastoma Multiforme (a type of Brain cancer), Colorectal Cancer, Breast Cancer, Lung Cancer, Cervical Cancer and Kidney Cancer in India

5. Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Received CHMP’s Positive Opinion for the Treatment of Multiple Cancer Indications

Date: Jul 27, 2020

Product: Equidacent (bevacizumab, biosimilar)

  • The EMA’s CHMP has adopted a positive opinion that recommended the MAA of Centus’ Equidacent (bevacizumab), a biosimilar to Roche’s Avastin to treat carcinoma of the colon or rectum, breast cancer, NSCLC, RCC, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix
  • Equidacent will be available as 25 mg/ml as the solution for infusion targeting VEGF and act by inhibiting the binding of VEGF to its receptors on endothelial cell
  • The company anticipates EC’s decision in ~60days. The clinical data demonstrated that Equidacent has comparable quality, safety, and efficacy to Avastin

6. NCCN Collaborated with Pfizer to Explore Adoption of Biosimilars in Oncology

Date: Jul 27, 2020

Products: Biosimilars

  • NCCN and Pfizer issued an open RFP that can develop and validate enduring approaches to improve the safe, effective, and efficient adoption of biosimilars in oncology
  • The RFP supports approaches to improve the processes related to biosimilar adoption in oncology. Letters of Intent are welcome from academic or community centres, patient advocacy groups, and HCPs organizations in the US and are due on Sept 09, 2020
  • The NCCN ORP will boost up the discovery that improves the lives of people with cancer and supports preclinical, translational, clinical research and quality improvement projects in oncology

7. Celltrion’s Remsima SC (infliximab, CT-P13) Received the EC’s MAA for Additional Five Indications

Date: Jul 27, 2020  

Product: Remsima SC (infliximab, CT-P13)

  • The approval followed the EMA’s CHMP positive opinion based on a study assessing Remsima SC (120 mg) vs IV formulations in patients with Crohn’s disease and ulcerative colitis, evaluating its PK, efficacy, and safety
  • The study resulted in high efficacy and safety comparable with IV formulation and the SC administration will also reduce the treatment time to approximately 2-5 minutes
  • Remsima is a world’s first mAb indicated to treat eight autoimmune diseases including RA & IBD and approved in the US & EU with Inflectra & Remsima respectively. Till now the product is approved in 94 countries including the US, Canada, Japan and throughout EU

8. Cadila to Launch its Ritucad (rituximab, biosimilar) in India

Date: Jul 27, 2020  

Product: Ritucad (rituximab, biosimilar)

  • Cadila to strengthen its biosimilar portfolio and oncology footprints in India with the launch of Ritucad and has cleared USFDA inspection in Feb’20
  • Additionally, the company has launched its Bevaro (bevasizumab, biosimilar) a mAb targeted for multiple cancer indications like Ovarian Cancer, Glioblastoma Multiforme, Colorectal Cancer, Breast Cancer, Lung Cancer, Cervical Cancer and Kidney Cancer in India
  • Ritucad is the second biosimilar in Cadila’s portfolio of biosimilars and will be available in a single-dose vial of two strengths, 100 mg & 500mg targeted to treat Non-Hodgkin’s lymphoma and RA

9. Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Received the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

Date: Jul 30, 2020

Product: Zercepac (trastuzumab, biosimilar)

  • The approval was based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy, and safety of Zercepac (HLX02) vs Herceptin
  • Zercepac is developed under NMPA and EMA biosimilar guidelines and has been evaluated with the reference trastuzumab including comparative quality studies, preclinical studies, a P-I clinical study and a global multi-centre P-III clinical study
  • Zercepac is a novel China-mAb approved in the EU for the treatment of HER2+ early breast cancer, HER2+ metastatic breast cancer, and HER2+ metastatic gastric cancer with an expected launch in China in 2020 while its manufacturing site has received EU GMP certificates

Related Post: Insights+ Key Biosimilars Events of June 2020




Insights+ KOL Articles: The New Normal and Covid-19 Vaccine Development

Since the virus outbreak in China, all eyes are on the most awaited Covid-19 vaccine offering a glimmer of hope. Abide by social distancing, wearing a mask, and frequent hand washing – until we have a vaccine. This new mantra amidst all misery has created hope in the hearts of many. We have to accept the “new normal” until we have a vaccine.

What is a Vaccine?

Vaccines, in a way, activate the immune system without the disease. Getting a particular vaccine is somewhat like having survived the disease once, without the health burden. Vaccines can be made with weakened viruses, inactivated viruses, and protein from a virus or even just the biological material (mRNA).

How Do Vaccines Provide Immunity?

Immunity is the body’s defense mechanism is to resist the effects of a microorganism. Immunity induced by a vaccine is weaker than that induced naturally after an infection. After you get a vaccine shot, your body will develop long-lasting antibodies that circulate in the blood. Such virus-specific antibodies will help to prevent severe disease. The vaccine will not prevent the entry of the virus into the body (infection), but it will prevent severe infection.

Vaccine Development

Scientists have gone from the discovery of the virus to more than 165 candidate vaccines in record time, with 27 vaccines already in clinical trials.

Challenges in Vaccine Development

  • Laboratory development & Preclinical testing
  • Large Clinical Trials
  • New technology for production
  • Availability: manufacturing millions of doses especially of a novel coronavirus
  • Developing an integrated and fair plan for vaccine distribution
  • Order of priority – health workers, elderly, and those with underlying conditions
  • Logistic –storage temperature
  • Resistance from the public – lack of awareness
  • Supply to rural areas
  • Multiple-dose may be needed

When Can We Expect A Vaccine And How Has Development Been Stepped Up?

Vaccine development normally takes years to complete, but the continuing crisis has prompted the multilateral system to accelerate the process. Regulatory approvals are up to speed but no important stages are skipped. This means that different tests of the vaccine are conducted in “parallel”.

The pandemic situation requires multiple activities and tests to be conducted at financial risk to stakeholders without knowing whether the vaccine candidate will be safe and effective.

Clinical Status of Vaccines Around the Globe

Research in India

The Indian government agency is working at lightning speed to test and approve an Indian origin COVID-19 vaccine. The government has permitted six Indian companies to develop vaccines against COVID-19. Recently, Bharat Biotech and Zydus Cadila were granted permission to start Phase I and II human clinical trials of their most advanced vaccines, named COVAXIN and ZyCoV-D respectively.

India Will Be The Manufacturer of The Covid-19 Vaccine

India is known for its mass manufacturing of pharmaceuticals. Leading international bodies like the World Health Organisation and the Bill and Melinda Gates Foundation to obtain their vaccines from India. Now is the time when India can definitely leverage its ability to mass-produce a Covid-19 vaccine whenever it is ready and also help reduce the price of these vaccines. Reasonable price provided by India`s mass production ability would be the only factor in assuring the Covid-19 vaccine’s access across the globe.

Serum Institute of India (SII) located in Pune has entered a manufacturing partnership with British pharmaceutical giant AstraZeneca to produce and supply 1 billion doses of the Covid-19 vaccine. These vaccines will be for India and middle- and low-income countries across the world (GAVI countries).

What Happens If You Choose Not To Get A Vaccine?

Firstly, you will not be protected from the deadly respiratory disease and may end up suffering from a severe infection. Secondly, refusal by many people might not get the country to herd immunity.

What Lies In The Future?

Even when a vaccine is introduced, we will have several months of significant infection or at least a risk of infection to take care of. This means that we may have to face more months under the threat of the novel coronavirus than we have already survived. If precautions are not taken and guidelines are not followed, there will continue to be more outbreaks, more deaths. The availability of the vaccine will be the slow start of the flattening of the curve. The total time taken to completely flatten the curve cannot be predicted, as it depends on awareness, accessibility, affordability, and adoption. With the world joining hands to find a vaccine for Covid-19, all eyes are on India, the powerhouse of vaccine manufacturing. It is a race between humans and the virus, rather than between countries or pharmaceutical companies.

Conclusion

Putting an end to this viral disaster with a vaccine has led to a global vaccine race to coherently extinguish Covid-19. Each week brings news on early success, low cost, fast track results, promising effects because of vaccine optimism. There is too much uncertainty that continues to be pondered upon. The vaccine won’t extinguish the disease itself but offer protection and immunity. It certainly will not immediately return life to “old normal”. The virus is too widespread but the vaccine could make Covid-19 easier to live with and prevent severe cases.

Finally, there seems to be a ray of hope amidst this tunnel of misery!

This image has an empty alt attribute; its file name is Picture2.png
Dr. Anish Desai

Dr. Anish Desai is a trained Clinical Pharmacologist and Pharmaceutical Physician with 3 decades of experience in Academia, Research, and Healthcare industry with proven leadership skills, strong business acumen, and a deep understanding of the Healthcare System, including Pharmaceutical, Nutraceutical & Medical device industry. He has been recognized for driving positive change, delivering solutions, developing talent, and nurturing strong relationships with external stakeholders. Holding Senior Management Position for the last 20 years and involved in strategic decision making. ‘IntelliMed Healthcare Solutions’ is a Healthcare startup launched by him with an intent to focus on strategic medical affairs for business growth, thereby infusing science into business. IntelliMed specializes in scientific, Clinical & medical support from conceptualization/Ideation to launch.

Sunaina Anand

Dr. Sunaina Anand, Pharm. D is a Clinical Pharmacist. She currently serves as Medical Affairs Executive in IntelliMed Healthcare Solutions. She previously interned in Tata Memorial Hospital and Columbia Asia Hospital, Bengaluru.

Related Post: Insights+ KOL Articles: Immunity & Pregnancy: Unique and Complex

Image Source: DNAIndia




Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected in Wuhan City, Hubei Province, China in Dec 2019. Life sciences companies are putting all of their efforts into finding a treatment or developing a vaccine for this disease. PharmaShots is keeping a track of all of the important updates in the Life-sciences sector, where we have covered news updates regarding collaborations, clinical trials, funding, and regulatory guidelines related to the COVID-19 from Jan to date.

75. Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Jul 30, 2020 | Clinical Trial

74. Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine

Jul 29, 2020 | Collaboration

73. UK’s Recovery Continues to Test Roche’s Tocilizumab in COVID-19

Jul 29, 2020 | Clinical Trial

72. Roche’s Actemra/RoActemra Fails in COVID-19 Trial

Jul 29, 2020 | Clinical Trial

71. Green Cross’ GC5131A Receives the Regulatory Approval for P-II Trial for COVID-19

Jul 29, 2020 | Regulatory

70. Relief’s RLF-100 (aviptadil) Receives the US FDA’s Expanded Access Protocol to Treat Respiratory Failure in COVID-19

Jul 29, 2020 | Regulatory

69. AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19  

Jul 28, 2020 | Regulatory

68. Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Jul 28, 2020 | Clinical Trial

67. Gilead’s Veklury (Remdesivir) Health Canada’s Marketing Authorization with Conditions (NOC/c) to Treat COVID-19 

Jul 28, 2020 | Regulatory

66. Three Pharma Companies Launch Favipiravir to Treat COVID-19 in India  

Jul 27, 2020 | Launch

65. Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies Targeting COVID-19 and Cancer  

Jul 27, 2020 | Collaboration

64. AI Therapeutics Reports Initiation of P-II Trial of LAM-002A (apilimod dimesylate) for COVID-19 Patients

Jul 27, 2020 | Clinical Trial

63. Zydus to Initiate Clinical Study of Desidustat in Patients with Chemotherapy-Induced Anemia (CIA)  

July 24, 2020 | Clinical Trial

62. Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19

Jul 27, 2020 | Clinical Trial

61. The UK Government to Launch AbC-19 Lateral Flow Free Finger-Prick Test for COVID-19  

Jul 27, 2020 | Launch

60. Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19 in India  

Jul 27, 2020 | Launch

59. Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

Jul 27, 2020 | Clinical Trial

58. AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19

Jul 27, 2020 | Clinical Trial

57. Quest Diagnostic Receives the US FDA’s First EUA for Sample Pooling in COVID-19  

Jul 20, 2020 | Diagnostic

56. Celltrion Initiates P-I Study of its COVID-19 Antibody Treatment in South Korea

Jul 20, 2020 | Clinical Trial

55. Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against COVID-19 in India  

Jul 16, 2020 | Clinical Trial

54. Novartis Launches Zero Profit Portfolio for Symptomatic Treatment of COVID-19

Jul 16, 2020 | Launch

53. AstraZeneca and the University of Oxford to Share Positive News on its COVID-19 Vaccine Imminently

Jul 15, 2020 | Collaboration

52. 3M Collaborates with MIT to Develop Paper-Based Diagnostic Test for COVID-19

Jul 13, 2020 | Collaboration

51. Moderna to Commence Late-stage COVID-19 Vaccine Trial on 27 July, 2020

Jul 13, 2020 | Clinical Trial

50. The International Fencing Federation (FIE) Reports the Global COVID-19 Support Plan

July 13, 2020 | Launch

49. Gilead’s Veklury (remdesivir) Receives the TGA’s Approval to Treat Adults and Adolescents with Severe COVID-19 Symptoms  

Jul 12, 2020 | Regulatory

48. The Zimbabwe Government to Launch US $10M COVID-19 Relief Package

Jul 11, 2020 | Launch

47. Gilead’s Veklury (remdesivir) Receives the TGA’s Approval to Treat Adults and Adolescents with Severe COVID-19 Symptoms

Jul 10, 2020 | Regulatory

46. AstraZeneca Collaborates with ProteinQure to Design Novel Peptide Therapeutics

Jul 10, 2020 | Collaboration

45. Cipla Launches Cipremi at $53.34 per Vial in India

Jul 10, 2020 | Launch

44. The Health Ministry of Kyrgyzstan Reports Supply of Avifavir an Antiviral Drug form Russia

Jul 09, 2020 | Regulatory

43. Regeneron Signs an Agreement with BARDA and the US Department of Defense for REGN-COV2 Worth $450M

Jul 08, 2020 | Clinical Trial

42. Angion Commences P-II Study of ANG-3777 in Patients with Acute Lung Injury Associated with COVID-19 Pneumonia in Brazil

Jul 08, 2020 | Clinical Trial

41. The European Commission Signs an Agreement with Roche and Merck to Supply their COVID-19 Therapies in EU

Jul 09, 2020 | Collaboration

40. GSK and Medicago to Initiate P-I Trial of Plant-Based COVID-19 Vaccine in July 2020

Jul 08, 2020 | Clinical Trial

39. Regeneron Signs an Agreement with BARDA and the US Department of Defense for REGN-COV2 Worth $450M

Jul 08, 2020 | Collaboration  

38. Innovation Pharmaceuticals Reports Results Brilacidin in COVID-19 Clinical Trial

 Jul 07, 2020 | Clinical Trial

37. Reven Reports Publication of Two COVID-19 Articles for RJX Platform

Jul 07, 2020 | Regulatory

36. Emergent Signs a Five-Year Manufacturing Services Agreement with Janssen for Ad26.COV2-S to Treat COVID-19  

Jul 07, 2020 | Collaboration   

35. Constant Therapeutics’ TXA127 will be Evaluated in P-II Trial for COVID-19 Patients

Jul 07, 2020 | Clinical Trial

34. Sinovac’s P-III COVID-19 Trial Receives the Brazilian Regulator Approval  

Jul 07, 2020 | Regulatory

33. Nasus Pharma Reports Results of TaffiX as a Intranasal Antiviral Protection Against SARS-CoV-2

Jul 07, 2020 | Clinical Trial

32. Mylan Receives EUA Approval for its Remdesivir to Treat COVID-19  

Jul 07, 2020 | Regulatory

31. Diffusion Pharmaceuticals Reports IND Submission for P-Ib/IIb COVID-19 Clinical Program with TSC to the US FDA

Jul 07, 2020 | Clinical Trial

30. Novavax to Receive $1.6B Funds from the US

Jul 07, 2020 | Grants

29. Aboundbio Signs an Agreement with SaudiVax for COVID-19

Jul 07, 2020 | Collaboration

28. Hepion Pharmaceuticals Reports Preclinical Results of CRV431 for Treating COVID-19

Jul 07, 2020 | Clinical Trial

27. Therapeutic Solution Reports Submission of Publication of Preclinical Data on StemVac for Supporting COVID-19 Indication

 Jul 07, 2020 | Clinical Trial

26. Regeneron with its Partner NIAID Report the Initiation of P-III Trial to Evaluate REGN-COV2 for Treatment and Prevention of COVID-19  

Jul 06, 2020 | Clinical Trial

25. Mylan’s Remdesivir Lyophilized Powder for Injection Receives the DCGI Accelerated Approval for Restricted Emergency Use in COVID-19 Patients in India    

Jul 06, 2020 | Regulatory

24. Zydus to Initiate Clinical Trials Evaluating ZyCoV-D Vaccine Against COVID-19 in July 2020

Jul 03, 2020 | Clinical Trial

23. Sanofi and Regeneron’s Kevzara (sarilumab) Fails in P-III Trial for Patients with COVID-19 in the US

Jul 03, 2020 | Clinical Trial

22. Moderna Reports the Enrollment of P-II Trial for its mRNA-1273 to Treat COVID-19  

Jul 03, 2020 | Clinical Trial

21. Sorrento Selects T-VIVA-19 as a Targeted Protein Vaccine Candidate Against COVID-19

Jul 02, 2020 | Clinical Trial

20. Dr. Reddy’s and GRA Collaborate with Fujifilm for Avigan (favipiravir) to Treat COVID-19 Outside Japan

Jul 02, 2020 | Collaboration

19. Pfizer and BioNTech Report Results of BNT162b1 mRNA-Based Vaccine in P-I/II Study Against COVID-19

Jul 02, 2020 | Clinical Trial

18. Zydus to Initiate Clinical Trials Evaluating ZyCoV-D Vaccine Against COVID-19 in July 2020

Jul 03, 2020 | Clinical Trial

17. Sanofi and Regeneron’s Kevzara (sarilumab) Fails in P-III Study for Patients with COVID-19 in the US

Jul 02, 2020 | Clinical Trial

16.  Phase II Study of MRx-4DP0004 in Patients Hospitalized with COVID-19 Open for Enrolment

Jul 02, 2020 | Clinical Trial

15.  Regulatory Authorities Step Up Cooperation in Connection with COVID-19

Jul 02, 2020 | Regulatory

14. Austria Donates €2M to CEPI to Support COVID-19 Vaccine Programmes

Jul 02, 2020 | Grant

13. Liminal BioSciences Joins CoVIg Plasma Alliance to Develop New COVID-19 Therapy

Jul 02, 2020 | Collaboration

12. Biophytis Receives FDA IND Clearance for COVA, a P-II/III Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure

Jul 02, 2020 | Clinical Trial

11.  EUSA Receives the US FDA Approval of P-III Clinical Trial for Siltuximab in Hospitalized Patients With COVID-19 Associated Acute Respiratory Distress Syndrome

Jul 02, 2020 | Clinical Trial

10.  Moderna Faces Delay in its COVID-19 Vaccine Trial

Jul 02, 2020 | Clinical Trial

9. Anivive Initiates Two Pre-Clinical Studies of GC376 for the Treatment of COVID-19

Jul 02, 2020 | Clinical Trial

8. MediciNova Announces Opening of IND for MN-166 (ibudilast) for Prevention of Acute Respiratory Distress Syndrome in Patients with COVID-19

Jul 01, 2020 | Clinical Trial

7. GoldenBiotech’s Antroquinonol Receives FDA Approval on COVID-19 P-II Trial in the US

Jul 01, 2020 | Regulatory

6. New Study Highlights Senhwa Biosciences Silmitasertib as Potential Treatment for COVID-19

Jul 01, 2020 | Clinical Trial

5. International Regulators Provide Guiding Principles for COVID-19 Clinical Trials

Jul 01, 2020 | Regulatory

4.  FibroGenesis Identifies Mechanism Responsible for Blocking COVID19-Like Lung Inflammation

Jul 01, 2020 | Clinical Trial

3. Inimmune Awarded $2M SBIR to Advance Vaccine Technologies

Jul 01, 2020 | Grant

2. UNION Receives Danish Medicines Agency’s Approval to Initiate Clinical Study With Niclosamide for Treatment of COVID-19

Jul 01, 2020 | Clinical Trial

1. FAMHP Facilitates and Supports the Development of COVID-19 Treatments and Vaccines

Jul 01, 2020 | Regulatory

Related Post : Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – June 2020




PharmaShots Celebrates Successful Accomplishment of Two Years

Shots:

  • PharmaShots started its journey in July 2018 as a concise news delivery service and is proud to announce the completion of two years, with many more to come. Till now, PharmaShots has published 3,057 posts delivered to our 3000+ subscribers
  • On the 2nd anniversary, PharmaShots announced “PharmaShots Bespoke” its new tailor-made, and targeted news alert services based on the client’s requirements. We are thankful to all our subscribers for their endless affection and trust towards PharmaShots
  • Pharmashots ensure to put our efforts in providing the latest news available to our valued subscribers and its new website experience is coming soon

Our current subscriber can avail “PharmaShots Bespoke” service at 50% discounted rate. Please contact [email protected]




Insights+ Exclusive: The US FDA New Drug Approvals in June 2020

 The US FDA has approved multiple NDAs and BLAs in Jun 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 51 novel products so far in 2020, including 8 in Jun 2020. Additionally, last year in 2019, the US FDA has approved 48 novel products. PharmaShots has compiled a list of 8 new drugs approved by the US FDA in Jun 2020.

1. Viela’s Uplizna (inebilizumab-cdon) Received the US FDA’s Approval to Treat Neuromyelitis Optica Spectrum Disorder (NMOSD)

Published: Jun 11, 2020 | Tags:  Viela, Uplizna, inebilizumab-cdon, Received, the US FDA, Approval, Treat, Neuromyelitis Optica Spectrum Disorder, NMOSD

  • The approval was based on N-MOmentum trial which involved assessing of Uplizna (300mg) vs placebo in 213 patients in the ratio (3:1) at day 1 to day 15 who are anti-AQP4 antibody-positive/negative   
  • The study resulted in anti-AQP4 antibody-positive group remained relapse-free (89% vs 58%) including reductions in NMOSD-related hospitalizations with safety and tolerability profile
  • Uplizna (inebilizumab-cdon) is a humanized CD19-directed mAb and is a novel B cell depleter approved for the treatment of NMOSD in adults who are anti-aquaporin-4 (AQP4) antibody positive

2. ViiV Healthcare’s Tivicay PD (dolutegravir) Received the US FDA’s Approval for Children Living with HIV

Published: Jun 12, 2020 | Tags: ViiV Healthcare, Tivicay PD, dolutegravir, Receives, the US FDA, Approval, Children, Living, HIV

  • The approval is based on ongoing P1093 (NCT03016533) and ODYSSEY (PENTA20, NCT02259127) studies in pediatric patients aged 4 weeks to 18 years, while the second study involves 2L pediatric patients aged four weeks to 18 years
  • The P1093 study was conducted by IMPAACT network in the USA, Brazil, Thailand, South Africa, Zimbabwe, Kenya and Tanzania and ODYSSEY by the PENTA network in Europe, South America, Thailand, Uganda, Zimbabwe, and South Africa
  • Tivicay and Tivicay PD are a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) used in combination with antiretroviral agents to treat HIV-1 infection in adults and in pediatric patients aged at least 4 weeks and weighing at least 3 kg

3. Pharma Mar’s Zepzelca (lurbinectedin) Received the US FDA’s Accelerated Approval for Adult Patients with Metastatic Small Cell Lung Cancer (SCLC)

Published: Jun 15, 2020 | Tags: Pharma Mar, Zepzelca, lurbinectedin, Received, the US FDA, Accelerated Approval, Adult, Patients, Metastatic Small Cell Lung Cancer, SCLC

  • The approval was based on P-II trial assessing Zepzelca in 105 adults Ultragenyx with SCLC at 26 hospitals in the US and EU
  • The study resulted in ORR was 35%, median response duration 5.3 mos., as per investigator assessment using RECIST 1.1 and as per independent review committee, ORR was 30%, median response duration 5.1 months. Project Orbis conducted the review which is an initiative of the FDA Oncology Center of Excellence
  • Zepzelca is an alkylating agent that binds to DNA and interferes with transcription factors and controls cancer cell growth. The product has also received the US FDA’s ODD for SCLC and priority review to this application

4. Ultragenyx’s Dojolvi (UX007/triheptanoin) Received the US FDA’s Approval to Treat Long-Chain Fatty Acid Oxidation Disorders

Published: Jun 15, 2020 | Tags: Ultragenyx, Dojolvi, UX007/triheptanoin, Receives, US FDA, Approval, Treat, Long-Chain, Fatty Acid, Oxidation Disorders

  • The FDA approved Dojolvi as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD)
  • The company expects its availability in the next 30 days while for its access the Ultragenyx’s UltraCare program will help patients and caregivers to understand insurance coverage and assist them in finding financial support for Ultragenyx medicines
  • Ultragenyx is a highly purified, pharmaceutical-grade, odd-carbon medium-chain triglyceride consisting of three 7-carbon fatty acids on a glycerol backbone created via a multi-step chemical process

5. Eli Lilly’s Lyumjev (insulin lispro-aabc injection) Received the US FDA’s Approval for Type 1 and Type 2 Diabetes

Published: Jun 15, 2020 | Tags: Eli Lilly, Lyumjev, insulin lispro-aabc injection, Receives, US, FDA, Approval, Type 1, Type 2, Diabetes

  • The approval is based on P-III PRONTO-T1D and PRONTO-T2D studies assessing Lyumjev (insulin lispro-aabc injection, 100 units/mL) and Humalog (insulin lispro injection, 100 units/mL), both in combination with either insulin glargine or insulin degludec in adults with T1D and T2D, respectively
  • Both the studies resulted in meeting its 1EPs of non-inferior A1C reduction @26wks., when both the therapies dosed at mealtime, Lyumjev demonstrated a superior reduction in blood glucose spikes at both 1hr. & 2hrs. after a test meal, safety & tolerability profile is similar for both
  • Lyumjev is a novel formulation of insulin lispro, developed to speed the absorption of insulin into the bloodstream and reduce A1C levels and is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin lispro or one of the excipients in Lyumjev

6. Evoke’s Gimoti (metoclopramide) Received the US FDA’s Approval to Relief Symptoms in Adults with Acute and Recurrent Diabetic Gastroparesis

Published: Jun 19, 2020 | Tags: Evoke, Gimoti, metoclopramide, Receives, the US FDA, Approval, Relief Symptoms, Adults, Acute, Recurrent Diabetic Gastroparesis

  • The US FDA’s approval allows Evoke to access its existing $5M line of credit from Eversana for manufacturing and commercialization of Gimoti
  • The approval will serve as a novel treatment for gastroparesis with expected commercialization in Q4’20
  • Gimoti nasal spray is the novel nasally administered product while Eversana will be responsible for its launch

7. Zogenix’s Fintepla (fenfluramine) Received the US FDA’s Approval for the Treatment of Seizures Associated with Dravet Syndrome

Published: Jun 26, 2020 | Tags: Zogenix, Fintepla, fenfluramine, Received, US, FDA, Approval, Treatment, Seizures, Associated, Dravet Syndrome

  • The US FDA’s approval was based on two P-III studies assessing Fintepla vs PBO in patients aged ≥2yrs. with Dravet syndrome and a safety data from an OLE trial in which many patients received Fintepla for up to 3yrs.
  • In addition to the existing treatment regimens, the therapy demonstrated a reduction in the frequency of monthly convulsive seizure in patients whose seizures were not controlled on one or more antiepileptic drugs
  • The company will launch the therapy through restricted distribution program, called the Fintepla REMS Program, and is expected to be available through Zogenix’s specialty pharmacy partner by July’20

8. Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin) Received the US FDA’s Approval for Early and Metastatic HER2-Positive Breast Cancer

Published: Jun 30, 2020 | Tags: Roche, Phesgo, fixed-dose combination, Perjeta, Herceptin, Received, US, FDA, Approval, Early, Metastatic, Her2-Positive Breast Cancer 

  • The approval was based on P-III FeDeriCa study which involved assessing of Phesgo (SC) + CT vs Perjeta (pertuzumab, IV) & Herceptin (trastuzumab, IV) + CT in 500 patients with HER2+ve early breast cancer treated in the neoadjuvant (before surgery) and adjuvant (after surgery) settings evaluated PK, efficacy, and safety
  • The study met its 1EPs showing non-inferior levels of Phesgo (SC) vs Perjeta (IV) in the blood plus no cardiac toxicity was demonstrated also the safety profile was comparable including no new safety signals. Additionally, in the P-II PHranceSCa study, 85% (136/160) patients preferred SC vs IV administration involving less time in the clinic with more comfort
  • Phesgo is an (FD, SC) formulation which involves a combination of pertuzumab + trastuzumab developed using Halozyme Therapeutics’ Enhanze drug delivery technology and administered within 8 mins for initial dosing and 5 mins for maintenance dosing

Related Post : Insights+ Exclusive: The US FDA New Drug Approvals in May 2020




Prescient Announces Recent Appointments to the Senior Advisory Team

Prescient hires two new senior members to support its fast-growing Advisory business

LONDON, July 20, 2020—Prescient, a biopharma product and portfolio strategy firm, announces the recent appointment of two new senior members, Peter Donachie and Dr. Haroon Khan, to its Advisory business. They join our specialist team focused on helping clients develop and commercialize assets and brands that resonate in the market and differentiate from the competition.

Peter joins as a Director in our London office supporting both the Advisory and Intelligence & Insight business units. After earning a degree in life sciences, he gained a first-class Master’s degree in business at Edinburgh Napier University and a postgraduate qualification in health economics at Aberdeen University. He brings experience in drug development and commercialization from his CRO and biopharmaceutical leadership roles at Charles River Laboratories, Kyowa Kirin and Ablynx NV. Peter’s advisory expertise includes commercial launch strategy, R&D portfolio and project management, pricing and market access, competitive strategy and opportunity assessment across various therapeutic areas.

Haroon joins as an Associate Director in our London office. He holds a doctorate in biochemical engineering from University College London, where he also gives guest lectures on the financial assessment and valuation of biotech start-ups. He brings experience in supporting value creation within global pharma and healthcare deals from his time in PwC’s M&A Advisory practice. He joined PwC from PharmaVentures, a corporate advisory firm focused on the life sciences sector, where he worked on a wide range of transactions covering different disease areas and product types. Haroon’s advisory expertise includes corporate strategy synthesis, product valuation and business development.

“As we continue to expand our presence and bring the best of product strategy advisory to biopharma clients, we are delighted to welcome Peter and Haroon to our rapidly growing team,” said Dr. Debasish Talukdar, Vice President and Head of Prescient Advisory. “Their combination of scientific expertise with commercial savviness and biopharma experience with core consultancy skills makes them an invaluable asset to the Advisory team as we bring expertise, experience and evidence together to partner with our clients to co-create winning strategies.”

The post Prescient Announces Recent Appointments to the Senior Advisory Team appeared first on .

Insights+ Interview: Paige’s CEO, Leo Grady Shares Insights on its Series B Funding and the FDA’s 510(k) Clearance for FullFocus Viewer

Paige is a global digital pathology founded in 2017 by Thomas Fuchs, Dr. Sc., and colleagues from Memorial Sloan Kettering Cancer Center. The company involves computational pathology products that are targeted for patients and their care teams for effective, more informed treatment decisions. Paige has developed a platform to deliver novel technology to pathologists to transform their workflow and increase diagnostic confidence and productivity.

On Jul 21, 2020 Paige received the US FDA’s 510(k) clearance for its FullFocus Viewer to use in digital pathology. Also in 2019, Paige received the FDA’s Breakthrough Designation for its artificial intelligence technology to diagnose cancer and started its AI diagnosis with Prostate Cancer. Leo mentioned the utilization of Series B funding of $95M to “Grow, the additional funding will help us continue our work to bring our computational pathology solutions to the market that requires growing our team, building additional biopharma partnerships, building a body of evidence to support our offering, and continuing to deliver our platform to clinical use.”

Prostate cancer is only the beginning of our work. We are also working on other cancers, including breast and bladder to name a few.”

Tuba: How has your journey been so far?  Can you talk about the growth of PAIGE since 2017?

Leo: “The journey so far has been both relentless and rewarding. We have come such a long way in such a short amount of time. Paige was born out of Memorial Sloan Kettering – the top cancer care center in the world—and spun out to commercialize the tech for a more widespread global impact. In doing so, we received approval to use MSK’s pathology slides to generate novel information from them. Right now, we have over 1.5M slides and add about 100,000 new slides per month. We are proud to say we are the first digital pathology company to receive a breakthrough device designation from the FDA, giving us the approval to expedite the development. We also received a CE mark for our computational diagnostic device in prostate cancer. We put some significant building blocks in place to bring our technology to market, where it will have the most impact.”

Tuba: Can you please briefly tell me about your tools? How will these be helpful to society?

Leo: Paige created a platform to give pathologists increased diagnostic confidence so they can arrive at accurate diagnoses for patients efficiently. It can also accelerate new biomarker discovery and generate new insights from the tissue. The applications are designed to relieve pathologists overburdened with the volume of cases, empower biopharma researchers searching for previously unidentified biomarkers, and help patients and care teams receive a quicker, accurate diagnosis that can help them better decide amongst their treatment options.”

Tuba: What does Paige plan to do with the new funding?

Leo: “Grow. The additional funding helps us continue our work to bring our computational pathology solutions to the market. That requires growing our team, building additional biopharma partnerships, building a body of evidence to support our offering, and continuing to deliver our platform to clinical use.

Tuba: What is Paige planning to do to push pathology into the digital era?

Leo: Paige is already pushing pathology into the next generation. We are taking a comprehensive approach to space. First, we are leveraging millions of images of tissue slides to give more information to pathologists within their diagnostic process and biopharma in their development endeavors. Second, to drive adoption, we are building our platform with an eye towards intuitive user experience and minimizing IT burden. Combined, our platform and our computational pathology offering stand to bring significant value to our customers.

Tuba: What are some of the pain points you’ve had to overcome in doing so?

Leo: I would not call them pain points, but as a new company in the space, we need to generate a body of evidence around our platform and our computational pathology solutions. We have partnered with top institutions around the world to do this and have recently published multiple papers at ASCO and in Modern Pathology, which have been very well received.”

Tuba: How does Paige’s technology work, and how does it benefit pathologists, Pharma, and cancer patients?

Leo: “We deliver advanced computational solutions for pathologists, oncologists, and the R&D community worldwide, while also working closely with biopharma companies to create custom biomarkers to improve patient care.  All of this is possible because of three key assets that Paige and our founders and collaborators at Memorial Sloan Kettering have built over the past decade. The first two are how we build our computational products: platinum-grade data and our proprietary Machine Learning development pipeline.

The foundation is our proprietary machine-learning techniques, which leverage the vast amounts of data and require no pixel-wise annotations to generate best-in-class performance. Then, once we have systems that understand cancer morphology, we can fine-tune them with far smaller datasets, like the data coming from clinical trials.

The third is the platform that I mentioned above. There is a big difference between building an algorithm and building a medical device that is easy to use and is valuable in-patient care. Our platform allows us to build products and workflows around our best-in-class computational pathology systems and deliver them globally to where they are needed most.
 
Tuba: As PAIGE received the FDA’s Breakthrough Designation in 2019 and started their AI diagnosis with Prostate Cancer, are you planning to expand the AI diagnosis in other indications also?

Leo: “Prostate cancer is only the beginning of our work. We are also working on other cancers, including breast and bladder to name a few.”

Tuba: What do you foresee your go-to-market strategy to be?

Leo: “Paige licenses diagnostic software to hospitals and clinical laboratories while providing custom services to the biopharma industry.”

“We work with the biopharma industry to build digital diagnostic solutions as well as tools that can be used in the many phases of drug development and clinical trials in which pathology plays a pivotal role. Revenue coming from these partnerships are bespoke, as each of these projects has different timelines and scope.”

On the clinical side, Paige offers state-of-the-art diagnostic software via software-as-a-service (SaaS) subscriptions. These subscriptions can be structured on a per-case or per-user bundle basis. The offering includes AI-powered digital diagnostics solutions, delivered via the Paige Platform (including the FDA cleared, CE-marked viewer).

Tuba: Do you have competition in this space? Who are they, and how does Paige’s product have the edge over them in your viewpoint?

Leo: “There are certainly other clinical and pharma focused competitors in digital pathology. Paige is uniquely positioned to bring computational pathology to scale across multiple cancers and biomarkers. Our diagnostic software is derived from millions of slides from one of the best cancer research hospitals in the world. This database is unparalleled. We also leverage a decade of research and development conducted at Memorial Sloan Kettering as well as an experienced leadership team with a proven track record in building and commercializing digital diagnostic technologies in other spaces.”

Tuba: When can we expect this to be available for commercial use?

Leo: “We are very committed to bringing our technology for commercial use so patients and their care teams can make faster, more informed treatment decisions. The first step has been getting our platform ready for prime time and cleared for primary diagnosis, which we have achieved in the US and Europe. Then, we got the first CE mark for a computational pathology product with Paige Prostate, which also earned FDA breakthrough designation and we are working on getting cleared in the US. Additional functionality and other cancer suites will follow shortly.”

Related Post: Paige Receives the US FDA’s 510(k) Clearance for its FullFocus Viewer to Use in Digital Pathology




Top 20 Prescription Drugs Based on 2019 Revenue

The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced for a wide range of medical sectors. It includes the lifesaving drugs or the major therapy area including immunology, cardiology, and neurology but are they not limited to only these indications and are rapidly increasing with the increasing medical needs. The drugs are developed targeting with the motive to cure, vaccinate, and alleviate the symptoms.

We have compiled a list of global top 20 drugs blockbuster prescription drugs based on their sales for last year i.e. 2019. The top position was maintained by AbbVie’s blockbuster drug Humira with $19.16B another drug grasped the second position headed by Merck’s Keytruda with $11.08B following the third was occupied by BMS’s Revlimid with $9.37B while ended at the low end by Gilead’s Truvada.

If you have any questions or see something we might have missed? Please reach out to Senior Editor, Shiwani Sharma by email.

Product – Truvada

First Approved – US (Aug 02, 2004), EU (Feb 20, 2005)

Indications Approved – HIV-1

Company – Gilead Sciences

Total Revenue – $2.81B

Truvada is a combination of tenofovir disiproxil fumarate (tenofovir DF) and emtricitabine used for HIV treatment and pre-exposure prophylaxis for PrEP (pre-exposure prophylaxis) that can help reduce the risk of getting HIV-1 through sex. On July 23, 2019, Gilead presented new findings on the profile of Descoy for potential use as HIV Pre-exposure Prophylaxis compared with Truvada. Descovy and Truvada are only 2 FDA-approved pills for PrEP.

Product Neulasta    

First Approved US (Jan 31, 2002), EU (Aug 22, 2002)

Indications Approved – Febrile Neutropenia

Company Amgen

Total Revenue $3.22B

Neulasta is a PEGylated form of the recombinant human granulocyte colony-stimulating factor analogue filgrastim. Neulasta has been steadily losing market share due to the launch of multiple biosimilars and the utilization of Neulasta’s OnPro on-body injector (the dominant player at > 55%) has been relatively steady.

Product Victoza                                                                                             Company Novo Nordisk

First Approved US (Jan 25, 2010), EU (Jun 30, 2009)                       Total Revenue $3.29B

Indications Approved – Glycemic control in type 2 diabetes mellitus patients, Reduce adverse cardiovascular events in adults with type 2 diabetes mellitus

Victoza or liraglutide belongs to a class of drugs called glucagon-like peptide-1 agonists (GLP-1). Recently Novo Nordisk’s patent on Victoza is been reviewed as Mylan has claimed that its invalid because it covers an obvious invention. Mylan has challenged the Victoza patent with an aim to launch the low-cost copy of the drug.

Product Lyrica                                                                                                Company Pfizer

First Approved US (Dec 30, 2004), EU (Jul 05, 2004)                       Total Revenue $3.32 B

Indications Approved – Neuropathic pain associated with diabetic peripheral neuropathy, Postherpetic neuralgia                

Lyrica is an anticonvulsant or an anti-seizure drug that can treat a range of conditions, including epilepsy, fibromyalgia, and nerve pain. The recent update on May 28, 2019, Pfizer announced that its epilepsy drug Lyrica (pregabalin), failed to meet the primary endpoint in P-III study, assessing it as adjunctive therapy in epilepsy patients (aged 5 to 65 years) with primary generalized tonic-clonic (“PGTC”) seizures.

Product Imbruvica                                                                                       Company Johnson & Johnson

First Approved US (Nov 13, 2013), EU (Nov 21, 2014)                    Total Revenue $3.41B

Indications Approved – Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia

Imbruvica is an oral therapy which inhibits Bruton’s tyrosine kinase (BTK) and has received its 10 FDA approval. In Apr 2020, US FDA approved Imbruvica (ibrutinib) plus Rituximab for the treatment of patients with Chronic Lymphocytic Leukemia (CLL) 

Product Genvoya                                                                                         Company – Gilead Sciences

First Approved – US (Nov 05, 2015), EU (Nov 19, 2015)                    Total Revenue $3.93 B

Indications Approved – HIV-1

Genvoya is a combination of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide targeting HIV. In Aug 2018, The CNDA approved Gilead’s Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for treating HIV Infection.

Product – Remicade                                                                                       Company – Johnson & Johnson

First Approved US (Aug 24, 1998), EU (Aug 13, 1999)                     Total Revenue $4.38B

Indications Approved – Crohn’s Disease, Rheumatoid Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Psoriatic Arthritis, Pediatric Ulcerative Colitis, Pediatric Crohn’s Disease

Remicade or infliximab is a tumour necrosis factor (TNF-alpha or TNF-α) blocker and a chimeric monoclonal IgG1 antibody. In June 2019, Janssen’s Remicade was issued a Civil Investigative Demand to Johnson & Johnson by FTC for investigating whether its contracting practices violate federal antitrust.

Product – Ibrance                                                                                            Company – Pfizer

First Approved US (Feb 03, 2015), EU (Nov 09, 2016)                    Total Revenue $4.96B

Indications Approved – HER2 Negative Advanced Breast Cancer

Ibrance PO is CDKs 4 and 6 inhibitors indicated for HR+, HER2- advance or mBC and has been prescribed up xto 160,000 patients with approval in 85 countries worldwide. On May 29, 2020, the Data Monitoring Committee (DMC) of the collaborative P-III early breast cancer PALbociclib CoLlaborative Adjuvant Study (PALLAS) determined that the trial failed in the primary endpoint of invasive disease-free survival (iDFS). Eli Lilly’s Verzenio has been chasing Ibrance in the metastatic setting since it hit the market and it now its ahead of Ibrance which recently took a big blow.

Product – Enbrel                                                                                              Company – Amgen

First Approved US (Nov 02, 1998), EU (Feb 02, 2000)                    Total Revenue $5.22B

Indications Approved – Rheumatoid Arthritis, Polyarticular-Course Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis

Enbrel is a TNF inhibitor drug that treats autoimmune diseases by interfering with tumour necrosis factor by acting as a TNF inhibitor. Enbrel was the drug of choice for multiple autoimmune indications. On Jul 01, 2020, the US Court of Appeals for the Federal Circuit held in Amgen’s favour on the validity of 2 patents that describe and claim Enbrel’s methods.

Product – Prevnar 13                                                                                       Company – Pfizer

First Approved US (Feb 24, 2010), EU (Dec 12, 2009)                     Total Revenue $5.84B

Indications Approved – S. Pneumoniae Infection

Prevnar 13 or Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein is a vaccine approved for adults 18 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumonia strains. In June 2020, Pfizer started four P-III clinical trials for investigational vaccines including Prevnar 13.

Product – Herceptin                                                                                       Company – Roche

First Approved – US (Sep 25, 1998), EU (Aug 28, 2000)                      Total Revenue – $6.23 B

Indications Approved – Metastatic Breast Cancer, Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma  

Herceptin or trastuzumab is a mAb that binds to HER2 receptors on the surface of HER2-positive tumor cells, blocking them from receiving growth signals and flagging them for destruction by the immune system. It is on the WHO’s List of Essential Medicines, the safest and most effective medicines needed in a health system. On 29 June 2020, Roche got the approval of Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin with hyaluronidase, administered by SC injection in combination with IV chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. This is the first time that Roche has combined two mAbs that can be administered by a single SC injection.

Product – Stelara                                                                                             Company – Johnson & Johnson

First Approved – US (Sep 25, 2009), EU (Jan 15, 2009)                       Total Revenue – $6.36B

Indications Approved – Plaque Psoriasis, Psoriatic Arthritis, Crohn’s Disease, Ulcerative Colitis

Stelara or ustekinumab is a mAb with a novel mechanism of action that targets the p40 subunit of cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23). In Apr 2020, Johnson & Johnson received NICE’s positive Final Appraisal Document (FAD) recommending Stelara (ustekinumab) for the treatment of ulcerative colitis.

Product – Rituxan                                                                                             Company – Roche

First Approved – US (Nov 26, 1997), EU (Jun 02, 1998)                      Total Revenue – $6.69B

Indications Approved – Non-Hodgkin’s lymphoma, Chronic Lymphocytic Leukemia, Rheumatoid Arthritis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Pemphigus Vulgaris

Rituxan or rituximab is a mAb used to target cancer cells with CD20 markers in patients. In Sep 2019, The US FDA approved Roche’s Rituxan (rituximab) in combination with glucocorticoids for treating granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) disorders.

Product – Opdivo                                                                                             Company – Bristol-Myers Squibb

First Approved – US (Dec 22, 2014), EU (Jun 19, 2015)                      Total Revenue – $7.20B

Indications Approved – Metastatic Melanoma, Non-Small Cell Lung Cancer,Melanoma, Small Cell Lung Cancer, Renal Cell Carcinoma, Hodgkin Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Urothelial Carcinoma, Mismatch Repair Deficient Metastatic Colorectal Cancer, Hepatocellular Carcinoma, Esophageal Squamous Cell Carcinoma

Opdivo or nivolumab is a PD-1 immune checkpoint inhibitor targeted for cancer cells and is approved in 65 countries including the US, EU, Japan & China. In Jun 2020, the US FDA granted approval for Opdivo (nivolumab) following the P-III ATTRACTION-3 study results evaluate it in comparison with taxane CT (docetaxel/paclitaxel) to treat patients with unresectable advanced, recurrent or ESCC, refractory/ intolerant to at least one prior fluoropyrimidine & platinum-based CT.

Product – Avastin                                                                                             Company – Roche

First Approved – US (Feb 26, 2004), EU (Jan 12, 2005)                       Total Revenue – $7.30B

Indications Approved Metastatic Carcinoma, Metastatic Colorectal Cancer, Non–Small Cell Lung Cancer, Glioblastoma, Metastatic Renal Cell Carcinoma, Metastatic Cervical Cancer, Primary Peritoneal Cancer, Hepatocellular Carcinoma

Avastin or bevacizumab is a tumour-starving (anti-angiogenic) therapy targeted for preventing tumour growth. In Jun 2020, Roche received the US FDA’s approval for a combination of Avastin (bevacizumab) + Tecentriq (atezolizumab) to treat patients with Unresectable Or Metastatic Hepatocellular Carcinoma (HCC) who have not received prior systemic therapy, which lead to a novel immunotherapy approval for the indication. The approval followed the P-III IMbrave150 study results assessing the combination.

Product – Eylea                                                                                                 Company – Regeneron Pharmaceuticals

First Approved – US (Nov 18, 2011), EU (Nov 21, 2012)                     Total Revenue – $7.54B

Indications Approved – Age-Related Macular Degeneration, Macular Edema, Diabetic Macular Edema, Diabetic Retinopathy

Eylea or aflibercept is one form of anti-VEGF therapy administered by injection into the eye. Recently, Bayer launched Eylea (aflibercept) pre-filled syringe in all 27 states of the EU including the UK, Iceland, Norway, and Liechtenstein in Apr 2020. In May 2019, Regeneron’s Eylea injection received the US FDA’s approval to treat all stages of Diabetic Retinopathy (DR) further reducing the risk of blindness.

Product – Eliquis                                                                                               Company – Bristol Myers Squibb  

First Approved – US (Dec 28, 2012), EU (May 18, 2011)                    Total Revenue – $7.92B

Indications Approved – Stroke, Systemic Embolism, Deep Vein Thrombosis, Pulmonary Embolism, Recurrence of DVT and PE

Eliquis or apixaban is an anticoagulant that reduces blood clotting. Eliquis stood on the fourth-highest selling product with $7.92B in 2019. In late 2019, the US FDA approved BMS’ Eliquis tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Product – Revlimid                                                                                          Company – Bristol-Myers Squibb

First Approved – US (Dec 27, 2005), EU (Jun 14, 2007)                      Total Revenue – $9.37B

Indications Approved – Anemia, Multiple Myeloma, Myelodysplastic Syndromes, Mantle Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma

Revlimid or lenalidomide is a thalidomide analogue candidate which reported WW sales of $9.37B. In Feb 2020, BMS’ Revlimid received the National Institute for Health and Care Excellence (NICE) approved it targeting to treat previously treated follicular lymphoma in combination with MabThera (rituximab).

Product – Keytruda                                                                                         Company – Merck & Co

First Approved – US (Sep 04, 2014), EU (Jul 17, 2015)                        Total Revenue – $11.08B

Indications Approved – Metastatic Melanoma, Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Head, and Neck Squamous Cell Cancer, Hodgkin Lymphoma, Mediastinal Large B-Cell Lymphoma, Urothelial Carcinoma, Deficient Cancer, Colorectal Cancer, Gastric Cancer, Esophageal Cancer, Cervical Cancer, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Renal Cell Carcinoma, Endometrial Carcinoma, Tumor Mutational Burden-High Cancer, Cutaneous Squamous Cell Carcinoma

Keytruda or pembrolizumab is a mAb serving as an anti-PD-1 therapy for the tumour cells blocking the interaction between PD-1 and its ligands, PD-L1, and PD-L2. It initially received FDA accelerated approval for refractory, advanced melanoma in September 2014. Subsequently, it has received approval for the treatment of many other oncologic conditions, and many more are currently in clinical development.

Keytruda acquired the second position in the WW sales list of 2019. In Jul 2020, the US FDA granted Priority Review to Merck’s Keytruda for its sBLA to treat patients with 2L+ Relapsed or Refractory Classical Hodgkin Lymphoma (cHL). The designation follows P-III KEYNOTE-204 study results and the expected PDUFA date as Oct 30, 2020. In Jun 2020, Merck’s Keytruda receives the US FDA’s approval to treat patients with 1L Unresectable or Metastatic MSI-H or dMMr Colorectal Cancer.

Product Name – Humira                                                                                Company Name – AbbVie

First Approved – US (Dec 31, 2002), EU (Aug 09, 2003)                     Total Revenue – $19.16B

Indications Approved – Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn’s Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis

Humira (adalimumab) is a mAb blocking TNF-a protein targeted for the inflammatory response of immune-mediated diseases. Humira has recorded the highest selling product sales with a generated revenue of $19.16B in 2019. Humira continues to be the leader of the commercial drug market and keeping its first position with the crown of the most lucrative drug in the history of the pharmaceutical market. In Jun 2020, AbbVie reported results of ABBV-3373, an ADC comprising novel glucocorticoid receptor modulator (GRM) vs Humira in patients with Moderate to Severe Rheumatoid Arthritis and resulted in similar profile with the original product.




Drug repurposing patent documents vs peer review: patent information comes more than 600 days earlier on average

This article was originally published by Hermann Mucke & Peter Mucke in Future Drug Discovery under a Attribution-NonCommercial-NoDerivatives 4.0 Unported License. https://doi.org/10.4155/fdd-2020-0001. Drug developers require access to scientific information in…

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The effect of patent expiration on sales of branded competitor drugs in a therapeutic class

DrugPatentWatch was used in a recent research study on branded drug sales following generic entry. In this paper, authors Jeffrey Fujimoto, Daniel M Tien, Sophie Snyder, Jeppe A Hertz, and…

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Customer Success: Will a generic version of a drug launch? And when?

DrugPatentWatch serves companies across the drug development-delivery sector. A common request among drug manufacturers, payers, and suppliers alike is anticipation of which branded drugs will face generic competition, and when…

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Customer Success: How do we identify generic entrants before they get FDA approval?

DrugPatentWatch can help identify generic entrants at the earliest stages Many clients come to DrugPatentWatch seeking to identify generic entrants well before they launch. CDMOs, equipment manufacturers, regulatory consultants, and…

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Why Follow-On Pharmaceutical Innovations Should Be Eligible For Patent Protection

This article was originally published by Christopher M. Holman* in Intellectual Property Watch under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Despite the important role of intellectual property rights in…

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