Category: Eli Lilly

South Korea’s Celltrion has announced encouraging top-line results for its potential antibody therapy for COVID-19, with the first part of a phase 2/3 trial showing it could cut recovery times and chances of progression from moderate to more severe disease.

Several other companies are also working on antibody therapies and Eli Lilly’s bamlanivimab gained an FDA Emergency Use Authorization in November last year, shortly after Regeneron’s cocktail of casirivimab and imdevimab.

There are doubts over efficacy of Lilly’s antibody, which failed to produce benefits in hospitalised patients in a phase 3 trial last month.

AstraZeneca is developing an antibody therapy and so is its UK rival GlaxoSmithKline, which this week announced a deal with VIR Biotechnology to trial VIR-7832 in mild to moderate COVID-19 patients.

Until COVID-19 hit Celltrion was best known for producing biosimilars, which are near-copies of biologic drugs that have been shown to be as safe and effective in rigorous trials and tests.

But the company is using its expertise to develop an antibody therapy, CT-P59, to help the effort against the pandemic.

Celltrion filed the therapy with the Korean regulator at the end of December and plans to submit data to regulators in Europe and the US in the coming months.

A spokesperson said in an email that company is “working closely with the regulatory agencies to accelerate the regulatory procedures”.

Part I of the trial enrolled 327 patients with mild-to-moderate symptoms of COVID-19 across three treatment groups (40mg/kg, 80mg/kg and placebo), in which approximately 60% of patients with moderate symptoms suffered from COVID-19 related pneumonia.

This data analysis has demonstrated that at day 28, CT-P59 treated patients presented with a significantly reduced risk of COVID-19 related hospitalisation and oxygenation without mortality.

When compared to placebo, CT-P59 treated patients reported reduced progression rates to severe COVID-19 by 54% for mild-to-moderate patients and 68% for moderate patients aged 50 years and over.

CT-P59 treatment groups also reported with significantly shortened time to clinical recovery ranging from 3.4 to 6.4 days quicker compared to placebo.

Patients treated with CT-P59 recovered 3.4 days earlier than those in a placebo group, while patients with pneumonia reported that their recovery time was 5.1 days shorter compared with placebo.

A group of patients with moderate disease aged 50 years and over treated with CR-P59 reported that their recovery time was 6.4 days shorter than placebo, the company said.

CT-P59 treated patients rapidly and significantly reduced viral load through Day 7 compared to placebo. Top-line results from the trial shows CT-P59 to have a positive safety profile, comparable to that of the placebo group, with no serious adverse advents reported.

Infusion related reactions were mild and transient, with the CT-P59 treatment group having reported 0.5%, compared to 1.8% reported with placebo.

Feature image courtesy of Rocky Mountain Laboratories/NIH

 

 

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When Eli Lilly reported results for donanemab in Alzheimer’s disease earlier this week it was hailed as a rare win for the amyloid hypothesis, although there’s no shortage of candidates that have failed despite positive mid-stage trial results.

Some analysts have intimated that given the small size of the study at just over 270 patients, rival amyloid drug developers Biogen and Eisai could claim the biggest benefit from the data in positive sentiment ahead of an FDA decision later this year.

Goldman Sachs analyst Terence Flynn said the result was a “positive surprise” after Lilly revealed top-line data from the TRAILBLAZER-ALZ study showing that donanemab slowed cognitive decline by a third in people with early Alzheimer’s and completely resolved the amyloid beta plaques that are a hallmark of the disease.

Flynn also said the data was an “incremental positive” for Biogen, whose Eisai-partnered aducanumab is already filed for approval and awaiting an FDA decision by 7 March, as it lends further weight to the amyloid beta hypothesis of Alzheimer’s.

Biogen is nearest to market with aducanumab but a positive verdict from the US regulator is far from assured. In November, an FDA advisory committee voted ten to one against approval, saying the clinical data backing the drug was inconclusive, but that came on the back of a positive assessment by the FDA’s own reviewer.

Wolfe analyst Tim Anderson said in a research note issued ahead of the donanemab readout that the FDA could be influenced by the donanemab data and – if positive – that would raise the chances of a greenlight for aducanumab.

There’s an alternative view however that donanemab’s data might actually harm aducanumab’s prospects. Analysts at Jefferies told Barron’s this week that the FDA may have been minded to approve Biogen and Eisai’s drug because there were no other late-stage candidates in play, but Lilly’s drug could change that perception.

Donanemab is unlike most other amyloid-targeting drugs – including aducanumab – because it targets a pyroglutamated form of amyloid beta called N3pG that is found only in amyloid plaques and according to some research can stimulate misfolding of proteins.

Lilly’s hypothesis – as yet unproven – is that clearing those plaques has a direct association with cognitive benefits.

Lilly says TRAILBLAZER-ALZ met its primary endpoint, slowing decline on the Integrated Alzheimer’s Disease Rating Scale in the donanemab group by 32% compared to placebo, with trends towards improvement on secondary endpoints that didn’t hit statistical significance.

On safety, around 27% of the treatment arm showed ARIA-E – an inflammatory reactions also seen with other amyloid-targeting antibodies – but there’s little other data available yet.

Lilly started a 500-patient phase 2 trial called TRAILBLAZER-ALZ-2 last June that it suggests could serve as a confirmatory pivotal study and potentially support regulatory filings – dramatically shortening the development timeline for the drug. That’s due to read out in next year or later.

The post Could Lilly’s donanemab readout in Alzheimer’s boost Biogen’s prospects? appeared first on .

Boehringer and Eli Lilly have moved closer to a heart failure indication for their SGLT2 inhibitor Jardiance, as the FDA starts a fast-track review of the drug in its first use beyond diabetes.

The US regulator is looking at data from the EMPEROR-Reduced trial of Jardiance (empagliflozin), which found that the drug achieved a 25% reduction in the combined primary endpoint of cardiovascular death or hospitalisation compared to placebo.

Lilly and Boehringer claim almost 60% market share for Jardiance among SGLT2 drugs used to treat type 2 diabetes, driving blockbuster sales for the brand.

It was the top-selling drug in the SGLT2 inhibitor class in 2019, with sales of almost $3 billion, helped by side-effect problems that have afflicted first-to-market rival Invokana (canagliflozin) from Johnson & Johnson.

However its rivals – which also include AstraZeneca’s Farxiga (dapagliflozin)  – have moved more swiftly into areas like heart failure and chronic kidney disease (CKD) which have made large numbers of new patients eligible for treatment with the class.

The new FDA review – covering Jardiance as a treatment for adults with heart failure with reduced ejection fraction (HFrEF) in patients with and without diabetes – is Lilly and Boehringer’s first chance to fight back.

Farxiga won FDA approval for adults with HFrEF in May 2020, which helped to drive its third-quarter sales up by a third to $525 million. AZ picked up EU approval for the same indication the following November.

Lilly and Boehringer will be hoping for a swift FDA review so that Jardiance will not fall too far behind its competitor in the heart failure category, and that looks likely as the benefit in HFrEF increasingly appears to be an SGLT2 class effect.

GlobalData has said that heart failure could add billions to the sales of the two SGLT2 inhibitors, particularly if they also claim approvals in heart failure with preserved ejection fraction (HFpEF), a larger patient population.

It says Farxiga will reach peak sales of $9 billion in 2028, with Jardiance forecast to reach $4.6 billion, assuming a launch for HFrEF this year. The bulk of those sales will come from HFpEF, however,  as in this form of heart failure there is a huge unmet need and no approved therapies.

Boehringer and Lilly are waiting for the results of the EMPEROR-Preserved later in 2021, while AZ should also Farxiga in the DELIVER trial in HFpEF, with additional data on both HFrEF and HFpEF due from the DETERMINE study, before year-end.

Meanwhile, EMPEROR-Reduced also showed a slowdown in the rate of decline in kidney function among patients with HFrEF, an effect that Lilly and Boehringer are exploring in the CKD patient population in the EMPA-KIDNEY trial due to generate results in 2022.

Invokana was the first mover among the SGLT2 drugs in the kidney area, winning FDA approval towards the end of 2019 for diabetic kidney disease. After a couple of years of declining sales due to concern about a risk of lower limb amputation, Invokana managed a 25% gain to $224 million in third-quarter 2020.

Farxiga meanwhile has already been filed for CKD on the back of the DAPA-CKD trial, with a verdict due in the second quarter.

The post Boehringer, Lilly’s Jardiance ties to match AZ’s Farxiga with heart failure label appeared first on .

• Biopharma merger and acquisition activity in 2020 was mainly filled with late-stage, bolt-on acquisitions, which were orders of magnitude smaller than the mega M&A deals of prior years.
• AstraZeneca holds the top rank by acquiring Alexion Pharmaceuticals among the top 20 acquisitions with a total deal value of $39B at a 1-day premium of 45% strengthening its capabilities in immunology, neurology, metabolic cardiovascular, nephrology, and rare disease.
• This article is based on the 2020 deals data as provided by the DealForma database. Our team at PharmaShots compiled a list of the top 20 acquisitions of 2020 based on total deal value.

Deal Date: Dec 17, 2020

Deal Value: $0.77B 

Novartis acquired Cadent Therapeutics. The acquisition strengthens Novartis’ neuroscience portfolio with the addition of Cadent’s NMDAr program, including CAD-9303, an NMDAr positive allosteric modulator in Phase I for schizophrenia, and MIJ-821, an NMDAr negative allosteric modulator in Phase I for treatment-resistant depression. CAD-9303 and MIJ-821 were licensed to Novartis in 2015. Additionally, Novartis will gain full rights to CAD-1883, a clinical-stage SK channel positive allosteric modulator for movement disorders. Cadent Therapeutics received $210M up front and is eligible for up to $560M in milestones.

Deal Date: Aug 11, 2020

Deal Value: $0.87B

Bayer acquired KaNDy Therapeutics with its Phase IIb compound, NT-814, a small molecule for menopause and vasomotor symptoms. The acquisition strengthens Bayer’s drug development portfolio in women’s healthcare. KaNDy Therapeutics received $425M up front and is eligible for up to $450M in R&D milestones and additional undisclosed sales-based milestones.

Deal Date: Aug 25, 2020

Deal Value: $0.93B

ACADIA Pharmaceuticals acquired CerSci Therapeutics with its lead candidate, ACP-044, a Phase I small molecule for acute & chronic pain. The acquisition strengthens ACADIA’s non-opioid pain therapies portfolio. CerSci shareholders received $52.5M up front and are eligible for up to $887M in development and sales-based milestones.

Deal Date: Dec 15, 2020

Deal Value: $1.04B

Eli Lilly acquired Prevail Therapeutics. The acquisition strengthens Eli Lilly’s gene therapies portfolio with Prevail’s clinical and preclinical disease-modifying AAV9 gene therapy assets in neuroscience. Prevail’s pipeline includes PR001 in Phase I/II for Parkinson’s disease and in preclinical studies for neuronopathic Gaucher disease, and PR006 in Phase I/II for frontotemporal dementia with GRN mutations. Prevail shareholders received $880M up front at a purchase price of $22.50 per share which represents a premium of approximately 117% plus 1 non-tradable CVR worth up to $4.00 per share in cash (or an aggregate of approximately $160M), for a deal total of up to $26.50 per share in cash, approximately $1.04B. The CVR is payable upon the first regulatory approval for the commercial sale of a Prevail product in one of the countries, including the US, Japan, UK, Germany, France, Italy, or Spain.

Deal Date: Jan 10, 2020

Deal Value: $1.1B     

Eli Lilly acquired Dermira with its IL-13 inhibitor antibody lebrikizumab, which is in Phase III for moderate-to-severe atopic dermatitis, and its marketed QBREXZA (glycopyrronium) medicated cloth for the topical treatment of primary axillary hyperhidrosis (uncontrolled excessive underarm sweating). Dermira licensed lebrikizumab from Genentech/Roche, which acquired the compound when it acquired Tanox, the originator. Dermira shareholders received $18.75 per share in cash at a 1-day premium of 2.2% for approximately $1.1B.

Deal Date: Oct 15, 2020

Deal Value: $1.3B

Lilly acquired Disarm Therapeutics. The acquisition strengthens Lilly’s neurology portfolio with the addition of preclinical SARM1 inhibitors, a small molecule for peripheral neuropathy and other neurological diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis. Disarm shareholders received $135M up front and are eligible for up to $1.225B in development, regulatory, and commercial milestones if Lilly develops and commercializes new medicines based on Disarm’s approach.

Deal Date: May 5, 2020

Deal Value: $1.3B     

Alexion Pharmaceuticals acquired Portola Pharmaceuticals including its balance sheet and debt of approximately $215M. The acquisition expands Alexion’s hematology, neurology, and critical care portfolio. Portola shareholders received $18 per share in cash at a premium of 130% for a total of $1.38B.

Deal Date: Dec 10, 2020

Deal Value: $1.4B     

Boehringer Ingelheim acquired NBE-Therapeutics. The acquisition strengthens Boehringer Ingelheim’s oncology pipeline with NBE-002, Phase I immunoconjugates for TNBC, lung, and ovarian cancers. NBE-Therapeutics is eligible to receive up to EUR 1.18B ($1.428B).

Deal Date: Dec 10, 2020

Deal Value: $1.7B

Gilead Sciences acquired MYR. The acquisition strengthens Gilead’s infectious disease and liver disease portfolio with the addition of hepcludex, a lipoprotein approved for Hepatitis D in Europe and in Phase III for Hepatitis D, in Phase II for Hepatitis B, in Phase I for dyslipidemia, and in preclinical studies for NASH and primary biliary cholangitis. MYR shareholders received EUR 1.15B ($1.39B) up front and are eligible for up to EUR 300M ($363.7M) in milestones.

Deal Date: Nov 6, 2020

Deal Value: $1.8B     

Novo Nordisk acquired Emisphere Technologies for $1.8B. The acquisition strengthens Novo Nordisk’s biologics segment with the addition of Eligen SNAC drug delivery technology. Additionally, Novo Nordisk will buy out its Eligen SNAC royalty stream obligations with MHR Fund Management, Emisphere’s largest shareholder. Novo Nordisk partnered with Emisphere in 2007 to develop oral biologics by applying Eligen SNAC. Emisphere shareholders received $7.82 per share in cash representing a 15% 1-day premium at approximately $1.35B. Additionally, Novo Nordisk will pay $450M to MHR Fund in connection with its royalty stream obligations.

Deal Date: June 11, 2020

Deal Value: $2.1B

Novo Nordisk acquired Corvidia Therapeutics. The acquisition strengthens Novo Nordisk’s cardiovascular disease portfolio with Phase II ziltivekimab, an antibody for inflammatory cardiovascular risk in CKD patients. Corvidia received $725M up front and is eligible for up to $1.375B in regulatory and sales-based milestones.

Deal Date: Aug 31, 2020

Deal Value: $2.6B

Nestle acquired Aimmune Therapeutics. The acquisition strengthens Nestle’s food allergy portfolio with Palforzia, an approved protein for peanut allergy. Aimmune Therapeutics received $2.6B at $34.50 per share at a 1-day premium of 174%. Nestle previously acquired 25% of the company starting with their 2016 partnership.

Deal Date: Nov 5, 2020

Deal Value: $2.7B     

Merck acquired VelosBio. The acquisition strengthens Merck’s oncology pipeline with the addition of Phase II VLS-101 antibody-drug conjugate targeting ROR1 for hematologic malignancies and solid tumors plus preclinical ADCs and bispecific antibodies. VelosBio shareholders will receive $2.75B.

Deal Date: Aug 17, 2020

Deal Value: $3.6B     

Sanofi acquired Principia Biopharma. The acquisition strengthens Sanofi’s autoimmune and allergic diseases portfolio with tolebrutinib (SAR442168), a small molecule in Phase III for multiple sclerosis and in Phase II for CNS disorders. Principia Biopharma received $3.6B at a purchase price of $100 per share at a premium of 10%. In 2017, Sanofi and Principia partnered on the development and commercialization of SAR442168, which was in Phase IIb for multiple sclerosis. Principia’s lead compound was rilzabrutinib, which was in Phase III for pemphigus.

Deal Date: Oct 26, 2020

Deal Value: $4B

Bayer acquired Asklepios BioPharmaceutical for $4B. The acquisition strengthens Bayer’s cell and gene therapy portfolio with the addition of AskBio’s AAV technology platform, CDMO facilities, and preclinical and clinical compounds for neuromuscular, CNS, cardiovascular, and metabolic diseases. Its leading gene therapy is in Phase I/II for Pompe disease. This also complements Bayer’s 2019 acquisition of BlueRock Therapeutics. Asklepios is eligible to receive 75% of the milestone payments in the next five years.

Deal Date: Mar 2, 2020

Deal Value: $4.9B

Gilead acquired Forty-Seven with its lead product magrolimab, a monoclonal antibody targeting CD47 in Phase Ib for acute myeloid leukemia (AML). The company is also studying myelodysplastic syndrome (MDS) and diffuse large B-cell lymphoma (DLBCL). The acquisition strengthens Gilead’s oncology portfolio. Forty-Seven received $4.9B at $95.50 per share at a premium of 65%.

Deal Date: Aug 19, 2020

Deal Value: $6.5B     

Johnson & Johnson acquired Momenta Pharmaceuticals for $6.5B at $52.50 per share at a premium of 79%. The acquisition strengthens Johnson & Johnson’s portfolio of autoimmune disease therapies with Phase III nipocalimab (M281), an anti-FcRn antibody for warm autoimmune hemolytic anemia, which is also in Phase II for myasthenia gravis among other indications. Momenta’s potential pipeline may have indications in maternal-fetal disorders, neuro-inflammatory disorders, rheumatology, dermatology, and autoimmune hematology. Nipocalimab recently received a rare pediatric disease designation.

Deal Date: Oct 05, 2020

Deal Value: $13.1B 

Bristol Myers Squibb acquired MyoKardia for $13.1B at $225 per share at a 1-day premium of 61%. MyoKardia’s mavacamten, a small molecule in Phase III for obstructive hypertrophic cardiomyopathy (HCM), has an NDA submission expected in Q1 2021 and is in Phase II for Non-obstructive Hypertrophic Cardiomyopathy. MyoKardia also has 2 clinical compounds, danicamtiv (MYK-491) in Phase II for genetic dilated cardiomyopathy, systolic dysfunction, and atrial fibrillation, and MYK-224, a Phase I small molecule for hypertrophic cardiomyopathy.

Deal Date: Sep 13, 2020

Deal Value: $21B

Gilead acquired Immunomedics for $21B at $88.00 per share at a premium of 108%. The acquisition gives Gilead trodelvy, an antibody-drug conjugate approved for mTNBC. Trodelvy (sacituzumab govitecan-hziy) is a Trop-2 directed ADC, which received accelerated approval for mTNBC in the US. Trodelvy is also being studied in Phase III for 3L HR+/HER2- breast cancer and Phase II for bladder cancer, NSCLC, and other solid tumors.

Deal Date: Dec 12, 2020

Deal Value: $39B     

AstraZeneca acquired Alexion for $39B including its drugs Soliris, Ultomiris, and 11 pipeline molecules in 20 different clinical programs. Soliris is an anti-complement component 5 mAb approved for paroxysmal nocturnal haemoglobinuria, atypical haemolytic uremic syndrome, generalized myasthenia gravis, and neuromyelitis optica spectrum disorder and is in Phase III for Guillain-Barre syndrome. Ultomiris is an approved antibody for Paroxysmal nocturnal hemoglobinuria and Hemolytic uremic syndrome and is in Phase III for generalized Myasthenia gravis, neuromyelitis optica spectrum disorder (NOSMD), hematopoietic stem cell transplant-associated thrombotic microangiopathy, Amyotrophic lateral sclerosis, complement-mediated thrombotic microangiopathy, severe pneumonia or acute respiratory distress syndrome in COVID-19. Alexion’s expertise in the complement cascade beyond C5 and additional modalities, including the pathway of the complement system, will strengthen AstraZeneca’s portfolio including immunology, neurology, metabolic cardiovascular, nephrology, and rare disease. Alexion shareholders received $60 per share in cash and 2.1243 ADS shares of AstraZeneca valued at $175 per share at a premium of 45%, or approximately $39B. Upon completion, Alexion will own 15% of the combined company.

The post Top 20 Biopharma M&A of 2020 by Total Deal Value first appeared on PharmaShots.

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.

The lawsuit follows action by at least a half-dozen drug companies to rein in what they see as waste and abuse in the program, overseen by the Department of Health and Human Services. Meanwhile, the Hospital plaintiffs have a potentially powerful ally in the person picked to head the department under the incoming Biden administration.

Eli Lilly has acquired Prevail, a biotech focusing on gene therapies for neurodegenerative diseases including Parkinson’s, in a deal potentially worth more than $1 billion.

The big US pharma is to pay up to $1.04 billion to buy Prevail, paying $22.5 per share up front plus a $4 contingent value right (CVR) to sweeten the deal.

The CVR pays out if one of Prevail’s gene therapies is approved in one of several developed countries before December 31, 2024.

Prevail is working on gene therapies based on adeno-associated virus 9 (AAV9) technology, which must be approved in any of the group of countries comprising the US, Japan, UK, Germany, France, Italy, or Spain.

Lilly pointed out that there can be no assurance of payouts from the CVR – something that shareholders in other companies have found out the hard way.

Sanofi last year settled with holders of a CVR dating back to the French pharma’s acquisition of Genzyme that was contingent on MS drug Lemtrada achieving several goals – cash that never materialised.

And former Celgene shareholders are currently sweating over a CVR relating to three cancer drugs that looks increasingly unlikely to pay out because of delays with FDA reviews.

The acquisition is set to close in the first quarter of 2021 and will see several gene therapies added to the company’s pipeline.

Top of the list is PR001, a potentially disease-modifying single-dose gene therapy for Parkinson’s disease with GBA1 mutations (PD-GBA) and the rare condition neuronopathic Gaucher disease (nGD) that is injected into a gap at the base of the brain stem.

The phase 1/2 PROPEL clinical trial in PD-GBA is ongoing and the phase 1/2 PROVIDE trial in nGD has been granted Fast Track Designation in these indications.

Also in the pipeline is PR006 for patients with frontotemporal dementia with GRN mutations (FTD-GRN), also delivered by an injection in the same place.

This is being tested in the phase 1/2 PROCLAIM trial, where the first patient was dosed earlier this month.

Prevail is also developing PR004 for neurodegenerative diseases associated by the abnormal accumulation of alpha-synuclein protein in neurons, nerve fibres or glial cells.

It is also working on therapies for Alzheimer’s and amyotrophic lateral sclerosis (ALS).

Lilly’s CEO David Ricks is pursuing a policy of “bolt-on” acquisitions to add to the company’s pipeline, and scooped up dermatology specialist Dermira in a similar-sized deal at the beginning of the year.

The post Lilly pays up to $1.04bn for neurology gene therapy biotech Prevail appeared first on .

Eli Lilly’s decision to throw large amounts of research dollars at its next-generation diabetes drug tirzepatide could be vindicated, according to its first phase 3 trial readout.

Results from the phase 3 SURPASS trial showed tirzepatide led to a reduction in both blood sugar and body weight in adults with type 2 disease, compared with placebo.

Shares in the big US pharma were up nearly 6% following the announcement, although the pharma stocks in general were buoyed by optimism over BioNTech/Pfizer’s COVID-19 vaccine.

Lilly said that the highest dose of tirzepatide monotherapy led to a blood sugar reduction, measured by A1C, 2.07% and reduced body weight by 9.5kg (11%) after 40 weeks of treatment.

More than half (51.7%) of participants in the treatment arm achieved an A1C less than 5.7% – the level seen in people without diabetes.

Lilly said the overall safety profile of tirzepatide was similar to the well-established GLP-1 receptor agonist class, with gastrointestinal side effects being the most commonly reported adverse events.

Treatment discontinuation rates due to adverse events were less than 7% in each tirzepatide treatment arm.

Results are significant because Lilly is looking for a successor to its blockbuster diabetes Trulicity (dulaglutide), which holds a significant share of the hotly-contested GLP-1 class market niche.

Novo Nordisk’s semaglutide, available both as a weekly injection and as a daily pill, is its main competitor and Lilly needs to find a follow-up before the Trulicity’s patent expires in 2027.

Tirzepatide is also taken weekly, cutting the number of injections needed to control blood sugar.

It has a dual action as an agonist of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors.

GIP is a hormone that may complement the effects of stimulating GLP-1, decreasing food intake and increasing energy expenditure.

Until this year the FDA required cardiovascular outcomes trials to ensure diabetes drugs do not damage patients’ hearts – but pharma companies have begun to use these to try and demonstrate their drugs actually cut risks of events such as heart attacks in diabetes patients.

Lilly is going to run a hugely expensive cardiovascular outcome trial for tirzepatide involving 12,500 patients, the largest so far in a bid to find data to give it an edge over the competition from other players in diabetes such as Novo and AstraZeneca.

As well as being in phase 3 development for blood glucose management in adults with type 2 diabetes and chronic weight management, tirzepatide is also being studied as a potential treatment for non-alcoholic steatohepatitis (NASH).

The post Lilly surges on positive phase 3 readout from diabetes contender appeared first on .

Eli Lilly’s buyout of Loxo Oncology last year has already yielded one approved drug, and it now has a path to market for a second after BTK inhibitor LOXO-305 after reporting promising data at the American Society of Haematology (ASH) meeting.

Updated results from the phase 1/2 BRUIN trial suggest that LOXO-305 could become a go-to therapy in B-cell non-Hodgkin’s lymphoma (NHL) patients whose cancer progresses despite earlier treatment with older BTK drugs.

Lilly’s drug is a non-covalent inhibitor, while already-approved BTK inhibitors like Johnson & Johnson and AbbVie’s Imbruvica (ibrutinib), AstraZeneca’s Calquence (acalabrutinib), and BeiGene’s Brukinsa (zanubrutinib) are covalent inhibitors.

According to its developers, that means it has efficacy in NHL that has developed resistance to first-line BTK drugs, mainly because it binds to its target reversibly. That means it can return to the circulation and continue to bind to BTK, without stimulating the resistance escape mechanism.

Imbruvica has become a mainstay of first-line treatment for NHL and other blood cancers like chronic lymphocytic leukaemia, driving it to sales of more than $6 billion collectively for J&J and AbbVie last year, but resistance can make its benefits short-lived.

It’s estimated that resistance can cause treatment failure of more than 40% of patients treated with first-line Imbruvica after five years, and more than 50% when the drug is used second-line for relapsed or refractory disease.

In BRUIN, LOXO-305 was tested in various types of NHL, including 61 patients with mantle cell lymphoma (MCL) and 19 with Waldenström’s macroglobulinemia (WM) who had previously been treated with a covalent BTK inhibitor.

In MCL, the drug had an overall response rate (ORR) of 52%, even though patients had received on average three prior lines of therapy, with around half of them seeing a complete response to the drug.

Most patients had been treated with a BTK drug, anti-CD20 antibody therapy with rituximab, and/or chemotherapy, with some also receiving Bristol-Myers Squibb/Celgene’s Revlimid (lenalidomide), a bone marrow transplant or CAR-T cell therapies.

Four out of five (83%) of the MCL patients were still responding to LOXO-305 at the data cutoff, after a median of six months of treatment.

For the WM group there was an ORR of 68%, with 13 of 19 patients responding including nine partial responses and four minor responses.

Ten of the 13 are still on the drug and responding after a median of 4.6 months, and there were also encouraging response data with other forms of NHL including follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), and marginal zone lymphoma (MZL).

Armed with the new data, Lilly has embarked on a bold strategy for LOXO-305 that will try to position it quickly as an alternative to the established drugs, rather than an option after they have failed.

The drugmaker is planning to start a head-to-head phase 3 trial of LOXO-305 versus the investigator’s choice of covalent BTK inhibitor in relapsed-refractory MCL in the first quarter of next year, gambling that its drug will show best-in-class efficacy.

If it eventually does get approved, LOXO-305 would join Lilly’s RET inhibitor Retevmo (selpercatinib, formerly LOXO-292) on the market, becoming the second product from Lilly’s $8 billion acquisition of Loxo in January 2019.

Analysts think LOXO-305 has greater sales potential than Retevmo, given the size of its target market and the fact that the RET inhibitor is in a marketing battle with rival drug Gavreto (pralsetinib) from Roche and Blueprint Medicine.

The post ASH: Lilly builds case for its BTK drug LOXO-305 in lymphoma appeared first on .

Merck Collaborates with Siemens for the Digitalization of Production

Published: Nov 26, 2020 | Tags: Agreement, Collaborative, Digitalization, Merck, Siemens, Sign

CoSara Receives CDSCO’s Approval for its Saragene COVID-19 2-Gene Multiplex Test

Published: Nov 26, 2020 | Tags: approval, CDSCO, Co-Diagnostics JV CoSara, COVID-19 2-gene multiplex RT-PCR, India, Manufacture, receives, Saragene, Sell, Test

PostEra Collaborates with NeuroLucent to Identify Therapies for Alzheimer’s Disease

Published: Nov 25, 2020 | Tags: Agreement, Alzheimer Disease, Collaborative, Develop, NeuroLucent, Novel, PostEra, Sign, Treatment

BASE10 Collaborates with DNA Link to Support Authorization of COVID-19 IgG Antibody Test at the Point of Care

Published: Nov 26, 2020 | Tags: BASE10, Collaborates, DNA, Link, Support, Authorization, COVID-19, IgG Antibody, Test, Point, Care

Egle Identifies First Novel Regulatory T-cell Targets Under its Collaboration with Takeda

Published: Nov 26, 2020 | Tags: Agreement, Alliance, Egle, First, Identifies, Novel, Regulatory, Research, T-cell, Takeda, Targets, therapeutics

Merck KGaA Reports EMA’s Validation of MAA for Tepotinib to Treat Advanced NSCLC with METex14 Skipping Alterations

Published: Nov 26, 2020 | Tags: Advanced NSCLCs, EMA’s Validation, MAA, Merck, reports, Tepotinib, Treat

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

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

CorticoMetrics’s THINQ Receives the US FDA’s 510(k) Clearance for MRI Brain Volumetric Reporting

Published: Nov 24, 2020 | Tags: 510(k), Brain, Clearance, CorticoMetrics, MRI, receives, Reporting, THINQ, Us FDA, Volumetric

BioNTech and Fosun Pharma Initiate P-ll Study of BNT162b2 Against COVID-19 in China

Published: Nov 25, 2020 | Tags: BioNTech, BNT162b2, China, Clinical Trial, Covid-19 Vaccine, Fosun Pharma, Lead mRNA, P-ll, Resumes

Urovant’s Vibegron Fails to Meet its Primary Endpoint in P-IIa Study for IBS Pain

Published: Nov 24, 2020 | Tags: Irritable Bowel Syndrome, P-IIa, reports, results, Sciences, study, Treatment, Urovant, Vibegron

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

Published: Nov 25, 2020 | Tags: Avastin, BAT1706 Proposed Biosimilar, Bio-Thera Solutions, Cancer, EMA, Marketing Authorization Application, Submits

Janssen’s Tremfya (guselkumab) Receives EC’s Approval as a First in Class Treatment for Active Psoriatic Arthritis

Published: Nov 25, 2020 | Tags: Active Psoriatic Arthritis (PsA), EC’s Approval, First in Class, guselkumab, Janssen’s, receives, Treatment, Tremfya

Bausch Health Initiates Second P-III Study for NOV03 (perfluorohexyloctane) to Treat DED Associated With MGD

Published: Nov 24, 2020 | Tags: Associated, Bausch Health, Disease, Dry Eye, Initiates, Investigational, MGD, NOV03, P-III, Second, study, Treatment

Evotec Collaborates with Rappta Therapeutics to Focus on Oncology Target

Published: Nov 24, 2020 | Tags: Agreement, Development, Discovery, Evotec, Focused, Oncology, Rappta, Signs, Target, therapeutics

Russia’s Sputnik V Demonstrates 91.4% Efficacy Against COVID-19

Published: Nov 24, 2020 | Tags: COVID-19, Gamaleya Center, P-lll Study, RDIF, reports, results, Second Interim Analysis, Sputnik V

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

Published: Nov 24, 2020 | Tags: Alvotech, CCHT, China, Eight Biosimilar Medicines, Exclusive Commercialization Agreement, Sign, Yangtze River

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

Published: Nov 24, 2020 | Tags: Adult, Alnylam, approval, Hyperoxaluria, Lumasiran, OXLUMO, patients, Pediatric, Primary, receives, Treatment, Type 1, Us FDA

BMS’ Opdivo (nivolumab) Receives EC’s Approval as 2L Treatment for Unresectable Advanced and Metastatic Esophageal Squamous Cell Carcinoma

Published: Nov 24, 2020 | Tags: 2L Treatment, Bristol Myers Squibb, EC’s Approval, Metastatic Esophageal Squamous Cell Carcinoma (ESCC), Nivolumab, Opdivo, receives, Unresectable Advanced

Selvita to Acquire Fidelta from Galapagos for ~$37M

Published: Nov 23, 2020 | Tags: $37.08M, Acquire, Fidelta, Galapagos, Selvita

Targovax Reports Results of ONCOS-102 in P-l/ll Study as 1L and 2L Treatment for Malignant Pleural Mesothelioma

Published: Nov 24, 2020 | Tags: (SoC), 1L and 2L Treatment, Malignant Pleural Mesothelioma (MPM), ONCOS-102, P-l/ll Study, reports, results, SITC Annual Meeting, Standard of Care, Targovax

Roche’s Xofluza (baloxavir marboxil) Receives 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

Baxter’s Homechoice Claria APD System Receives the US FDA’s 510 (k) Clearance for Kidney Failure

Published: Nov 23, 2020 | Tags: Baxter’s, Claria Automated Peritoneal Dialysis (APD) System, Clearance, Homechoice, Kidney Failure, receives, US, US FDA’s 510 (k)

Schrödinger Signs a $2.7B Agreement with BMS to Develop and Commercialize Therapies in Multiple Disease Areas

Published: Nov 23, 2020 | Tags: Agreement, Areas, BMS, Commercialize, Develop, Discover, Disease, Multiple, Schrödinger, Signs, therapeutics

Merck to Acquire OncoImmune for $425M

Published: Nov 23, 2020 | Tags: Acquire, CD24Fc program, Merck, OncoImmune

AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19

Published: Nov 23, 2020 | Tags: AstraZeneca, AZD1222, COV002, COV003, COVID-19, P-II/III, P-III, Positive, Preventing, reports, results, Trial, vaccine

Eli Lilly Signs an Exclusive Agreement with Precision BioSciences on Genome Editing Research

Published: Nov 20, 2020 | Tags: Develop of Potential, Genetic Disorders, License Agreement, Lilly, Precision, Research, Research Collaboration, Signs, Vivo Therapies

Eiger’s Zokinvy (lonafarnib) Receives 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

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

Published: Nov 22, 2020 | Tags: 1L treatment, Advanced Hepatocellular Carcinoma (HCC), Byvasda, ESMO ASIA Virtual Congress 2020, Innovent, ORIENT-32 Study, P-lll, reports, results, Tyvyt

Lilly’s Bamlanivimab (LY-CoV555) Receives Health Canada’s Interim Authorization as a Treatment for COVID-19

Published: Nov 20, 2020 | Tags: Authorization, Bamlanivimab, canada, COVID-19, health, Interim, Lilly, LY-CoV555, receives, Treatment

Regeneron’s Casirivimab and Imdevimab Receive the US FDA’s EUA as the First Combination Therapy for COVID-19

Published: Nov 21, 2020 | Tags: Casirivimab, COVID-19, EUA, Imdevimab, patients, receives, Regeneron, US FDA’s

Related Post: PharmaShots Weekly Snapshot (Nov 16-20, 2020)

The post PharmaShots Weekly Snapshot (Nov 23 – 27, 2020) first appeared on PharmaShots.

Regeneron’s antibody cocktail is the latest COVID-19 drug to receive Emergency Use Authorization in the US, becoming the first therapy of this kind to become available.

The cocktail of casirivimab and imdevimab is still being investigated in trials but the FDA has enough data to grant a temporary licence while the pandemic continues.

Formerly known as REGN-COV2 or REGEN-COV2, the cocktail can be used for mild to moderate COVID-19 in adults and children at least 12 years of age and weighing at least 40 kg.

Doctors now have another option to choose from to combat the disease, following EUAs for drugs such as Eli Lilly’s baricitinib and Gilead’s Veklury (remdesivir).

To be eligible for Regeneron’s combination, patients must have received positive results of direct SARS-CoV-2 viral testing and be considered at high risk for progressing to severe COVID-19 and/or hospitalisation.

Clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

As part of the Operation Warp Speed project to rapidly develop therapies and vaccines against the disease, the US government and Regeneron a supply agreement for the cocktail, which was famously used to treat president Donald Trump after he became infected.

Regeneron will coordinate with state authorities to allocate the cocktail on a weekly basis, based on prevalence of the disease in each state.

The first 300 doses will be provided at no cost to patients, although hospitals and clinics may add their own fees.

AmerisourceBergen will be the first national distributor to begin delivering the therapy.

Earlier this month, Regeneron had to modify a trial protocol for the therapy after independent safety experts said it should not be given to high-risk patients after an undisclosed safety issue emerged in testing.

In late October, Eli Lilly said it wouldn’t resume a trial of its rival antibody therapy in hospitalised patients after National Institutes of Health researchers said it wouldn’t help.

AstraZeneca is developing a long-acting antibody therapy combination in the US and other countries to prevent infection happening and as a therapy for those already infected.

Regeneron’s antibodies were designed to combat SARS-CoV-02 using the company’s proprietary genetically modified mice, which have been engineered to have a human immune system.

The antibodies bind non-competitively to the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population.

The post Regeneron’s COVID-19 antibody cocktail gets US emergency licence appeared first on .

Doctors in the US are to get another option to treat COVID-19 after the FDA granted an Emergency Use Authorization (EUA) for Eli Lilly’s baricitinib.

Baricitinib is the active ingredient in Lilly’s rheumatoid arthritis drug Olumiant and is the latest example of a drug being repurposed to combat COVID-19.

Most of the drugs attempt to tackle the inflammation that can cause complications in patients with severe disease.

While not all the attempts to get existing drugs to work in COVID-19 have been successful, the FDA said there is enough evidence to justify the emergency use for baricitinib in adults and children aged over two who are hospitalised with the disease and require oxygen therapy or invasive mechanical ventilation.

This temporary authorisation, which only applies during the COVID-19 crisis, is based on data from the Adaptive COVID-19 Treatment Trial (ACTT-2) conducted by the National Institute of Allergy and Infectious Diseases, part of the government funded National Institutes of Health.

Patients treated with baricitinib in combination with Gilead’s remdesivir had a significant reduction in median time to recovery from eight to seven days (12.5% improvement) compared to remdesivir.

The FDA’s decision came as the World Health Organization has advised against using Gilead’s Veklury (remdesivir) to treat hospitalised patients with COVID-19, no matter how severe their illness, after saying new evidence no longer supports its use.

The update is in contrast to the FDA, which has approved remdesivir to treat patients hospitalised with COVID-19 last month, after it was granted and Emergency Use Authorization earlier in the year.

But in the new guidance published in the BMJ, the WHO’s experts recommend against using remdesivir in non-severe, severe, or critical patients, citing weak evidence.

However the panel said there is strong evidence in favour of using corticosteroids in patients with severe or critical disease.

The latest guidance was produced using a systematic review of latest evidence.

According to the panel of experts who drew up the guideline, the evidence suggests that remdesivir has no important effect on mortality, need for mechanical intervention, time to clinical improvement and other outcomes.

The guidance was triggered by findings of the WHO’s SOLIDARITY trial last month, which reported results treating hospitalised COVID-19 patients with remdesivir, the steroid hydroxychloroquine, and the antiviral combination lopinavir-ritonavir.

Findings of SOLIDARITY diverged from evidence gathered in the US – last month data from the National Institutes of Health-backed ACTT-1 trial study showed Veklury resulted in five days’ faster recovery in patients hospitalised with COVID-19.

There was a non-statistically significant trend towards a reduction in mortality, with the effect being more pronounced in patients who were on low-flow oxygen at baseline.

In a statement, Gilead noted that Veklury has been included in guidelines from the NIH and Infectious Diseases Society of America, as well as in national guidelines in Japan, the UK, and Germany.

Gilead added: “These recommendations are based on the robust evidence from multiple randomised, controlled studies published in peer-reviewed journals that demonstrate the clinical benefits of Veklury, such as significantly faster recovery, which can free up limited hospital resources.

“We are disappointed the WHO guidelines appear to ignore this evidence at a time when cases are dramatically increasing around the world and doctors are relying on Veklury as the first and only approved antiviral treatment for patients with COVID-19 in approximately 50 countries.”

 

The post Lilly’s baricitinib granted US emergency use in COVID-19 appeared first on .

Shots:

• The EUA is based on ACCT-2 study assessing baricitinib (4mg, qd for 14 days or until hospital discharge) in combination with remdesivir vs PBO with remdesivir in hospitalized patients with/ out oxygen requirements
• Result: Median time to recovery from 8-7days (12.5% improvement), patients who progressed to ventilation (23% vs 28%), patients who died @day29 (4.7% vs 7.1%) with a relative reduction of 35%; better clinical status @day15
• This marks the second Lilly therapy to be granted a EUA, in addition to neutralizing Ab EUA for high-risk non-hospitalized patients, increasing the number of treatment options for COVID-19 patients at different stages of the disease

Click here ­to­ read full press release/ article | Ref: Eli Lilly | Image: CNBC

The post Eli Lilly and Incyte Receive FDA’s EUA for Baricitinib + Remdesivir to Treat Hospitalized Patients with COVID-19 first appeared on PharmaShots.

UK cost-effectiveness agency NICE has said that Eli Lilly’s Emgality can be made available through the NHS for migraine prevention, the second drug in the CGRP inhibitor class to achieve that milestone.

The decision means that with two CGRP antibodies now cleared for migraine prevention, the first drug in the class to be approved in Europe – Novartis’ Aimovig (erenumab) – has fallen further behind its rivals in getting access to the UK market.

NICE has backed Emgality (galcanezumab) as a once-monthly injection to prevent migraine attacks in people with episodic or chronic migraine who suffer at least four days with a migraine headache per month, and who have tried at least three prior preventative medicines.

That puts Emgality ahead of Teva’s Ajovy (fremanezumab), which picked up a positive opinion from NICE earlier this year but is only recommended for use in chronic migraine sufferers who have 15 or more headache days a month for more than three months, with at least eight of those having features of migraine.

It also puts Lilly’s drug ahead of Aimovig, which has been rejected twice by NICE although the agency has agreed to take another look at the application after an appeals panel ruled that its technology appraisal committee had failed to consider all of the evidence about the cost-effectiveness for the drug.

NICE said Ajovy was an option for around 10,000 people in the UK in guidance issued in June, but Lilly says many more patients are eligible for its drug – around 144,000 people with episodic migraine and 59,000 people with chronic migraine.

The decision is based on trials comparing Emgality with placebo which showed that the antibody halved the number of monthly migraine headache days for up to 40% of adults with migraine who had previously tried three or more prior medicines, such as Allergan’s Botox (botulinum toxin type A) or topiramate.

Gemma Jolly of medical charity the Migraine Trust said NICE’s recommendation is “wonderful news for people living with this very painful and debilitating neurological condition [as] both chronic and episodic migraine patients across England and Wales will be able to access an effective drug on the NHS.”

The CGRP inhibitors have performed well in clinical trials, but so far commercial success has been limited, despite blockbuster sales predictions ahead of their approval.

First-to-market Aimovig generated sales of $108 million in the first nine months of 2020 for Novartis, which records ex-US sales, while Amgen booked $274 million from the drug in the US in the same period.

Aimovig is said to be the most prescribed anti-CGRP drug worldwide with more than 480,000 patients prescribed the drug worldwide. In the same period, Lilly reported sales of $253 million for Emgality, and Teva made $98 million from Ajovy.

Novartis is hoping for a bounce to Aimovig sales from the HER-MES trial reported earlier this month, which showed it was more effective than topiramate – a go-to oral therapy for people with chronic migraine – in a head-to-head trial.

There’s more competition jostling for position however, following the approval of Lundbeck’s Vyepti (eptinezumab), an intravenous drug that only needs to be administered four times a year.

Lilly has a real opportunity to build momentum behind Emgality in England and Wales, but will have to wait until next year before it hears from NICE’s counterpart in Scotland, the Scottish Medicines Consortium (SMC). Aimovig was cleared for use by NHS Scotland last year, with Ajovy given a green light in January 2020.

The post NICE backs Lilly’s Emgality for migraine, adding pressure on Novartis rival appeared first on .

Shots:

• Seed Therapeutics to receive $10M upfront, $10M equity investment, ~$780M as pre/clinical development, regulatory & commercial milestones along with royalties on net sales of products that emerges from the collaboration
• Seed utilizes molecular glue protein degradation technology to develop potential new therapies
• The agreement allows Seed to advance its platform to deliver new molecules targeting proteins that cause human diseases

Click here ­to­ read full press release/ article | Ref: Globe Newswire | Image: Medium

The post Eli Lilly Signs a License Agreement with Seed Therapeutics for Protein Degradation-Based Therapies first appeared on PharmaShots.

Eli Lilly has said it will start shipping supplies of its COVID-19 drug bamlanivimab immediately, after claiming emergency-use authorisation (EUA) for the antibody.

The AbCellera-partnered drug, previously known as LY-CoV555 or LY3819253, can be used to treat mild-to-moderate COVID-19 in patients 12 years and older, who are at high risk for progressing to severe disease that might require hospitalisation.

President Trump has previously pledged to make antibody drugs available for free to anyone who needs them, and his administration has already signed a $375 million contract with Lilly to supply 300,000 doses of the drug within two weeks of the EUA.

The US has also taken an option on another 650,000 doses of the drug between now and the end of June 2021.

Lilly chief executive David Ricks has also said that patients should have no out-of-pocket costs for the drug, although healthcare facilities may charge a fee for the antibody’s intravenous administration.

The EUA as well as the US government contract came despite the results of the ACTIV-3 trial run by the National Institute of Allergy and Infectious Diseases (NIAID), which halted enrolment in the bamlanivimab arm because data to date suggested the drug was unlikely to be effective in hospitalised patients.

The FDA approved a 700mg single IV dose of the drug based on the phase 2 BLAZE-1 trial, which showed a reduced rate of hospitalisation in patients at high risk of COVID-19 progression who were treated with the antibody in the outpatient setting.

The NIAID is also running another study of Lilly’s antibody, ACTIV-2, which involves outpatients with mild-to-moderate COVID-19 symptoms.

Lilly says it will ship supplies of the drug to AmerisourceBergen, which will handle distribution once a week in accordance with the US government’s allocation plans. Where the drug is distributed will depend on confirmed COVID-19 cases across the US over the prior seven days.

Bamlanivimab – an antibody that neutralises the SARS-CoV-2 coronavirus – joins Gilead’s antiviral Veklury (remdesivir) on the list of drugs with EUAs for COVID-19, but is the first to be cleared for use outside hospitals.

Veklury’s EUA and subsequent full approval by the FDA covers the treatment of patients with COVID-19 who already require hospitalisation. The FDA has also issued EUAs for convalescent plasma for hospitalised patients, as well as for certain drugs that don’t target the virus directly but are used to support patients whilst in acute care.

Lilly notes that bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.

The company says it hopes to be able to produce up to one million doses of bamlanivimab 700mg by the end of 2020, “for use around the world through early next year.”

The FDA is meanwhile reviewing an EUA for Regeneron’s COVID-19 antibody therapy REGN-COV2, focusing on patients with mild to moderate disease who are at risk of progressing, and a decision on that could be made shortly.

REGN-COV2 also seems at risk of falling short in hospitalised patients, after a safety concern led to the pause of enrolment in a clinical trial in this setting earlier this month.

The post Lilly to ship COVID-19 drug straight away after FDA green light appeared first on .

Eli Lilly’s chief information and digital officer (CIDO) Aarti Shah is leaving the company next year after 27 years at the company.

Shah is retiring from a role that only became part of the drugmaker’s executive committee in 2017, reflecting the relatively late acknowledgement of the strategic value of information technology in the pharma industry. A search is now underway for her successor.

She has been CIDO at Lilly since 2016, charged with leading the “digital transformation” of the company and merging a diverse portfolio spanning IT, information security, digital health, and data analytics.

Shah’s appointment came at the beginning of a proliferation of senior pharma data specialists becoming elevated to the C-suite, and being able to influence company-wide strategy and make IT more central to corporate decision-making.

Even now, having a CIDO or chief digital officer on the board isn’t ubiquitous among big pharma companies, despite the encroachment of big tech firms like Amazon, Google and Apple into the healthcare space.

Lilly is one of a select but growing group of pharma companies – along with Pfizer, Bayer, GlaxoSmithKline, Novartis, Merck & Co, Sanofi and others – who have made CIDO/CDO appointments in the last few years.

Companies are looking to thread digital capabilities throughout their operations, from drug discovery to production and delivery to patients, in order to boost productivity and make processes more efficient.

At the same time, the industry is looking to develop digital medicines that improve patient outcomes.

Shah has been at Lilly since 1994, joining the company as a senior statistician, rising to become vice president for biometrics in 2009. That was followed by a stint in 2013 as global brand development leader in Lilly’s biomedicines business unit – leading up to the approval of Taltz (ixekizumab) for psoriasis – before making the step up to CIDO three years later.

“Aarti has been an invaluable member of our executive committee,” said Lilly’s chairman and CEO David Ricks.

“Her deep experience in drug development enabled her to connect our information technology organisation to all aspects of our business from drug discovery and development, to manufacturing, to our commercial capabilities,” he added.

The post Lilly’s chief digital officer Aarti Shah announces retirement appeared first on .

Regeneron’s coronavirus antibody cocktail therapy against COVID-19, famously used to treat president Donald Trump, has hit a safety issue after independent safety experts recommended it should not be given to high-risk patients in a late-stage clinical trial.

It’s the latest blow for antibody therapies against COVID-19 after Eli Lilly last week announced it won’t resume a trial in hospitalised patients, after National Institutes of Health researchers concluded it wouldn’t help.

Regeneron said an Independent Data Monitoring Committee (IDMC) from the REGN-COV2 trial said that based on an unspecified safety signal and an “unfavourable risk benefit profile” the committee recommends a modification to the trial protocol.

The IDMC recommends further enrolment of patients requiring high-flow oxygen or mechanical ventilation be placed on hold pending collection and analysis of further data from those already on the trial.

Regeneron remains blinded to the data and is implementing the recommendations.

The company has also informed the FDA, which is reviewing REGN-COV2 data for a potential Emergency Use Authorization in patients with mild-to-moderate outpatients at high risk for poor outcomes.

The data is also being shared with the independent committee monitoring the RECOVERY trial in the UK, which is testing the drug cocktail in hospitalised patients.

REGN-COV2 is split into four cohorts – patients on low-flow oxygen, patients not requiring oxygen, patients on high-flow oxygen and patients on mechanical ventilation.

The spotlight has been on antibody therapies for COVID-19 after it emerged early last month that Trump was treated with the Regeneron combination.

Regeneron’s therapy is based on two antibodies the company has developed to neutralise the virus.

The rationale is that by having a double therapy, the chances of the virus developing resistance to both parts of the drug are reduced.

AstraZeneca is to begin phase 3 trials of a long-acting antibody therapy combination in the US and other countries in the coming weeks, to prevent infection happening and as therapy for those already infected.

The post Regeneron’s COVID-19 antibody cocktail therapy hits safety problem appeared first on .

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.

The US government said it will buy 300,000 doses of Eli Lilly’s COVID-19 therapy bamlanivimab for $375 million if the drug gets Emergency Use Authorisation (EUA) – despite the fact its effectiveness has been called into question.

The initial agreement is for delivery over the two months following an EUA, and provides the option for the government to purchase up to an additional 650,000 vials through 30 June 2021.

Lilly filed for emergency use authorisation (EUA) of bamlanivimab for the treatment of recently diagnosed mild to moderate COVID-19 illness in high-risk patients in early October.

The US has said that patients will have no out-of-pocket costs for the medicine – echoing a promise by Lilly CEO Dave Ricks – although healthcare facilities may charge a fee for the product’s administration. 

The federal government, in partnership with state health departments, is developing a government allocation program for bamlanivimab.

Ricks has said that the company “must work with global health systems to ensure equitable access to our medicine at a fair price”.

“Our goal is to ensure that Lilly antibody treatments are available to patients who need them, no matter where they live.

“As long as supply of neutralising antibodies is constrained, we believe the only way to ensure equitable access is for Lilly to contract directly with governments and pan-national philanthropic organisations. These institutions are best positioned to direct our antibody treatments to the patients who need them most.”

He added that treatment allocation will be based on unmet medical needs globally and that  equitable government pricing will be tiered based on a country’s ability to pay.

But the news might be dampened somewhat by this week’s announcement that no more patients will be treated with bamlanivimab in a trial run by the National Institute of Allergy and Infectious Diseases (NIAID), as results to date suggest it is unlikely to be effective.

The ACTIV-3 study was comparing bamlanivimab (also known as LY-CoV555 or LY3819253) and placebo when added to therapy with Gilead Sciences’ Veklury (remdesivir), which is already approved to treat COVID-19 requiring hospitalisation.

According to Lilly, the NIAID took its decision on the strength of trial data  which indicated that bamlanivimab – an antibody that neutralises the SARS-CoV-2 coronavirus – was unlikely to help hospitalised patients recover from advanced-stage COVID-19.

The drugmaker stressed however that other trials of its drug in COVID-19 are still continuing, and it pointed out that the earlier BLAZE-1 study of bamlanivimab showed a reduced rate of hospitalisation in patients treated with the antibody in the outpatient setting.

It also said it “remains confident…that bamlanivimab monotherapy may prevent progression of disease for those earlier in the course of COVID-19.

ACTIV-3 is a substudy of a larger, 10,000-patient trial that is putting a series of COVID-19 drugs through their paces, and Lilly’s drug is the only arm to include an antibody targeting SARS-CoV-2. In each case, 300 patients are enrolled initially before a decision is taken whether to expand the trial to 1,000 subjects.

In a statement, the NIAID said enrolment of patients into the bamlanivimab was paused on 13 October after 326 had been recruited, “out of an abundance of caution”, and terminated on 26 October.

There were no safety issues – the decision was “driven by lack of clinical benefit for LY-CoV555,” according to the agency – and the patients will continue to be followed for 90 days’ follow-up.

The NIAID is also running another study of Lilly’s antibody, ACTIV-2, which involves outpatients with mild-to-moderate COVID-19 symptoms, and that is continuing as planned.

BLAZE-1 is also continuing – looking at bamlanivimab alone and in combination with etesevimab (LY-CoV016) another Lilly antibody targeting SARS-CoV-2 – and the company is also running the BLAZE-2 trial of bamlanivimab as prophylaxis against COVID-19 in nursing home residents and staff.

The post US buys Lilly COVID antibody, as effectiveness questions remain appeared first on .

Eli Lilly says no more patients will be treated with its COVID-19 therapy bamlanivimab in a trial run by the US National Institute of Allergy and Infectious Diseases (NIAID), as results to date suggest it is unlikely to  be effective.

The ACTIV-3 study was comparing bamlanivimab (also known as LY-CoV555 or LY3819253) and placebo when added to therapy with Gilead Sciences’ Veklury (remdesivir), which is already approved to treat COVID-19 requiring hospitalisation.

According to Lilly, the NIAID took its decision on the strength of trial data  which indicated that bamlanivimab – an antibody that neutralises the SARS-CoV-2 coronavirus – was unlikely to help hospitalised patients recover from advanced-stage COVID-19.

The drugmaker stressed however that other trials of its drug in COVID-19 are still continuing, and it pointed out that the earlier BLAZE-1 study of bamlanivimab showed a reduced rate of hospitalisation in patients treated with the antibody in the outpatient setting.

It also said it “remains confident…that bamlanivimab monotherapy may prevent progression of disease for those earlier in the course of COVID-19.

Lilly filed for emergency use authorisation (EUA) of bamlanivimab for the treatment of recently diagnosed mild to moderate COVID-19 illness in high-risk patients.

ACTIV-3 is a substudy of a larger, 10,000-patient trial that is putting a series of COVID-19 drugs through their paces, and Lilly’s drug is the only arm to include an antibody targeting SARS-CoV-2. In each case, 300 patients are enrolled initially before a decision is taken whether to expand the trial to 1,000 subjects.

In a statement, the NIAID said enrolment of patients into the bamlanivimab was paused on 13 October after 326 had been recruited, “out of an abundance of caution”, and terminated on 26 October.

There were no safety issues – the decision was “driven by lack of clinical benefit for LY-CoV555,” according to the agency – and the patients will continue to be followed for 90 days’ follow-up.

The NIAID is also running another study of Lilly’s antibody, ACTIV-2, which involves outpatients with mild-to-moderate COVID-19 symptoms, and that is continuing as planned.

BLAZE-1 is also continuing – looking at bamlanivimab alone and in combination with etesevimab (LY-CoV016) another Lilly antibody targeting SARS-CoV-2 – and the company is also running the BLAZE-2 trial of bamlanivimab as prophylaxis against COVID-19 in nursing home residents and staff.

The post NIAID drops Lilly antibody from ACTIV-3 COVID-19 trial appeared first on .

Shots:

• The companies present the findings from a new exploratory sub-analysis of the P-III EMPEROR-Reduced study demonstrating that Jardiance (empagliflozin) reduced the risk of adverse CV by 25% and kidney events by 50% in adults with HFrEF with/out diabetes regardless of CKD status at ASN Week 2020
• In all patient cohorts participating in the EMPEROR-Reduced trial, the safety profile was like the well-established safety profile of Jardiance. In Mar’2020, the US FDA granted FT designation to the therapy for CKD based on its ongoing EMPA-KIDNEY study with its expected results in 2022
• In 2019, the US FDA granted FT designation to Jardiance for the reduction of the risk of CV death and hospitalization for heart failure in people with HF based on its EMPEROR program, which consists of two P-III studies EMPEROR-Reduced & EMPEROR-Preserved

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Dialysis Patient Citizens Education Center

The post Boehringer Ingelheim and Eli Lilly Report Results of Jardiance in Adults with HFrEF Regardless of Chronic Kidney Disease Status first appeared on PharmaShots.

Immunology is an important branch of science which deals with the study of the immune system. The immune system is a highly regulated and balanced system and when the balance is disturbed, the disease can result. A lot of this work has importance in the development of new therapies and treatments that can handle or heal the condition by modifying the way the immune system is working or, in the case of vaccines, instructing the immune system and enhancing the immune reaction to specific pathogens. In the top 20 ledgers, AbbVie again ensured the top position with total revenue of $19.57B with its blockbuster drug, Humira (adalimumab) from its immunological segment. Our team at PharmaShots has compiled a list of the top 20 immunology companies based on their 2019 immunology revenue

Antares Pharma is an American pharmaceutical company focus on developing and commercializing therapies for rheumatology, urology, endocrinology, and neurology. Antares has reported a total sale of $0.01B from its immunology segment in 2019

Horizon Therapeutics is an Ireland based biopharmaceutical company focused on developing and commercializing therapies for the treatment of gout, rheumatoid arthritis, and rare diseases. Horizon has generated the sale of $0.24B from its four approved immunology products including Tepezza, Rayos, Duexis and Vimovo. Horizon’s Tepezza was selected for “2020 R&D World R&D 100 Award”

3SBio is a fully integrated Chinese biotechnology company with market-leading biopharmaceutical franchises in oncology, auto-immune diseases, nephrology, metabolic diseases, and dermatology. There are three approved drugs in its immunology portfolio including Yisaipu, Tpiao and Xenopax. 3SBio’s Tpiao used to treat chemotherapy-induced thrombopenia (approved in 2005) and immune thrombocytopenia has generated global sales of $0.33B in 2019.

Biogen is a global biopharma company focused on neurology, hematologic, and autoimmune diseases. Biogen has a total of six products in its immunology segment with four approved drugs including Tysabri, IMRALDI, FLIXABI, BENEPALI. Biogen’s lead drug Tysabri recorded a revenue of $1.89B. Biogen revealed the positive result of BIIB059 in the Phase 2 LILAC study for cutaneous lupus erythematosus and systemic lupus erythematosus.

GlaxoSmithKline (GSK) is a global healthcare company serving the world with drugs, vaccines & consumer healthcare products. With only approved products, Benlysta, GSK has generated a revenue of $0.81B in 2019. In Jul 2019, GSK initiated the phase 3 study of otilimab for rheumatoid arthritis. In Sep’19, EMA granted a positive CHMP opinion for intravenous Benlysta in children with lupus and was approved in Oct 2019.

Mitsubishi Tanabe is a Japanese pharma company focused on autoimmune diseases, diabetes and kidney diseases, neurological disorders, and vaccines. Mitsubishi has reported a total sale of $1.11B from its immunology segment in 2019.

Merck & Co. is a global health care company delivering innovative health care products with its Prescription medicines, Oncology drugs, Vaccines, Biologic therapies, and Animal Health care products. Merck has recorded the sale of $1.24B in 2019 from its five approved drugs in its immunology portfolio including Simponi, Remicade, Renflexis, Brenzys, Hadlima. Simponi and Remicade was co-commercialized by Merck and Johnson & Johnson and Simponi recorded the revenue of $0.83B in 2019.

Incyte Corp is a global biopharmaceutical firm focused on developing therapies in two categories Oncology and Inflammation & Autoimmune. Incyte has generated a revenue of $1.68B from its immunological segment. In Jan’19, Incyte reports results of Itacitinib in GRAVITAS-301 P-III study for patients with treatment-naive acute graft-versus-host disease.

Astellas Pharma is a Japanese multinational pharmaceutical company focused on the therapeutic fields of urology, immunology including transplantation and infectious diseases, oncology, neuroscience and DM complications, and metabolic diseases. Astellas has four drugs in its immunology portfolio including two approved drugs Smyraf And Prograf and has recorded the sale of $1.79B in 2019. In Jul’19, Astellas Pharma launched Smyraf 50 mg and 100 mg tablets for rheumatoid arthritis.

Eli Lilly and Company is a global pharmaceutical firm focused on delivering therapies in two divisions Human Pharmaceutical Products and Animal Health products. The pharmaceutical portfolio offers products for Cardiovascular, Endocrinology, Immunology, Neuroscience, and Oncology. Eli Lilly has two approved drugs including Taltz and Olumiant. Lilly’s Taltz, an approved drug for plaque psoriasis or psoriatic arthritis has generated a revenue of $1.6B in 2019. In Apr’19, Eli Lilly signs research and licensing agreement with avidity biosciences to develop therapies in immunology.

UCB is a global biopharmaceutical company focused on neurology, inflammatory, gastrointestinal and autoimmune disorders. UCB has recorded the sale of $1.92B in 2019 from its immunology segment with its only approved drug, Cimzia indicated for psoriatic arthritis (PsA). In Jul’19, Cimzia was approved by China’s NMPA.

Sanofi is a global healthcare leader in vaccines providing healthcare solutions in 170+ countries around the world. Sanofi is ranked third in the global market and first in EU and Latin America. Sanofi has four drugs in its immunology portfolio including one approved drug Kevzara, developed in partnership with Regeneron. In Dec’19, Sanofi presented the positive result from its pivoted phase 3 study of sutimlimab for cold agglutinin disease. Additionally, Sanofi restructured its agreement with Regeneron to obtain worldwide rights for Kevzara.

Bristol-Myers Squibb is an American pharmaceutical company focused on Oncology, Cardiovascular, Immuno-Science, and Fibrosis. BMS has two approved drugs Orencia and Nulojix. BMS’ Orencia is a protein indicated to treat adult rheumatoid arthritis, juvenile idiopathic arthritis, and adult psoriatic arthritis has generated the highest revenue of $2.97B in 2019. The acquisition of Celgene in 2019, has boosted up BMS’ Immunology pipeline.

Takeda is a global biopharma company focused on Oncology, Gastroenterology (GI), Neuroscience, Immunology, and Rare Diseases. With three approved drugs including Immunoglobulin, Albumin, and Entyvio, Takeda has generated a $3.66B sale in 2019. In Apr’19, EMA accepted the application for a subcutaneous formulation of Entyvio in Crohn’s disease, and in Oct 2019, Takeda acquired CNP-101 from COUR Pharmaceuticals. In Feb’20, Takeda acquired PvP Biologics to strengthen its immunology pipeline. Additionally, Takeda got approval for Entyvio from China’s NMPA for Crohn’s disease in Mar 2020.

Novartis is a multinational group of companies specializing in research, development, manufacturing, and marketing with a broad range of healthcare solutions including generic and ophthalmic therapies. The company is focused on Immunology, Hepatology, Dermatology, Oncology, Neurology, and Ophthalmology. Novartis has the uppermost number of immunology drugs with eight approved products including ACZ885/Ilaris, AIN457/Cosentyx, Myfortic (Renal transplant), Neoral, Simulect, and Zortress. Novartis’ Cosentyx (secukinumab) used to treat Psoriasis, ankylosing spondylitis and psoriatic arthritis have generated global sales of $3.55B in 2019. In Apr’19 Novartis acquired IFM Tre to enhance its immunologic portfolio with its NLRP3 inhibitors for $1.5B.

Pfizer is a research-based, global biopharmaceutical company having a vast portfolio including Oncology, Medicines, vaccines, and other health care products for the prevention & treatment of untreated diseases. With 3 approved drugs including Xeljanz, Enbrel (outside the US and Canada), and Inflectra (Biosimilar), Pfizer has generated $4.73B sale from its immunology portfolio indicated for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, Behcet’s disease, and ulcerative colitis. Pfizer’s Xeljanz has generated revenue of $2.24B in 2019. In Jan’2019, CytoReason signed a research partnership with Pfizer to develop drugs using CytoReason’s cell-centered models of the immune system.

Amgen is one of the leading biotechnology company developing novel therapies focused on cardiology, oncology, neurology, nephrology, and inflammatory diseases. Amgen has generated a total sale of $5.39B in 2019 with its drugs Otezla, Avsola, Enbrel, Nplate, and Prolia. Amgen’s Otezla used to treat certain types of psoriasis and psoriatic arthritis has generated sales of $1.6B.

Roche Holding AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. The immunology department focus on rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, and giant cell arteritis including severe persistent allergic asthma (AA), chronic idiopathic urticaria (CIU), and idiopathic pulmonary fibrosis (IPF) with 3 approved drugs including Actemra, CellCept and Mabthera and has generated the sale of $8.97B in 2019. In Dec’2019, Roche signed an exclusive global option and license agreement with Rheos Medicines to develop and commercialize therapies for immune metabolism.

Johnson & Johnson (J&J) is an American multinational healthcare company focused on the development and commercialization of pharmaceutical, medical device, and consumer packaged products. The pharmaceutical portfolio offers products for Cardiovascular, Endocrinology, Immunology, Neuroscience, and Oncology. J&J has generated $13.95B from its Immunology portfolio with 5 approved products including Remicade, Simponi, Stelara, Tremfya, Simponi Aria. Remicade was jointly marketed by J&J and Merck and has generated a revenue of $4.38B in 2019. In Nov 2019, J&J’s Tremfya meets the primary endpoint in the phase 3 study for Psoriatic Arthritis. Additionally, J&J submit two applications with the USFDA for Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis. FDA approved Tremfya for Psoriatic Arthritis and Simponi Aria for polyarticular juvenile idiopathic arthritis and active psoriatic arthritis for patients 2 years of age and older in Jul 2020.

AbbVie is a global, research and development-based biopharmaceutical company focused on developing innovative advanced therapies. The company is focused on developing products in immunology, oncology, virology, and neuroscience, dermatology. AbbVie has generated the sale of $19.57B in 2019 from its immunological segment with 3 approved drugs including RINVOQ, SKYRIZI, HUMIRA. AbbVie’s blockbuster drug HUMIRA recorded a revenue of $19.16B. In Apr’2019, AbbVie received EMA approval of SKYRIZI for Plaque Psoriasis. Its RA drug RINVOQ received FDA approval in Aug 2019 and EMA approval in Dec 2019. Additionally, RINVOQ achieved positive results in primary and key secondary endpoints for Psoriatic Arthritis and subsequently submitted the regulatory applications with the FDA and EMA.

Related Post: Top 20 Immunology Companies Based on 2018 Immunology Segment Revenue

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Eli Lilly is to buy the private biotech Disarm Therapeutics, which is working on a new class of disease-modifying drugs for neurological diseases, in a deal worth up to $1.36 billion.

Massachusetts-based Disarm is focused on treatments for diseases caused by axonal degeneration, such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis.

Disarm has discovered novel, potent SARM1 inhibitors and is advancing them into preclinical development for diseases including peripheral neuropathy as well as ALS and MS.

Axonal degeneration is a common yet unaddressed occurrence in a range of neurological diseases and is known to cause severe sensory, motor and cognitive symptoms.

Disarm’s scientific founders, Dr Jeffrey Milbrandt and Dr Aaron DiAntonio of Washington University School of Medicine in St Louis, discovered that the SARM1 protein is a central driver of axonal degeneration. Disarm’s SARM1 inhibitors are designed to directly prevent the loss of axons.

Lilly will pay $135m million up front for Disarm and shareholders may be eligible for up to $1.225 in further payments if certain goals are met if the big pharma develops and markets medicines resulting from the acquisition.

There will be no change to Lilly’s earnings per share guidance as a result of the deal.

While there are limited treatment options for ALS, the market for MS drugs is increasingly crowded with a range of different options including oral and injected medicines.

Roche has demonstrated the commercial potential for MS drugs after its Ocrevus (ocrelizumab) became a blockbuster after just a year on the market following its launch in 2017.

Migraine drug gets NHS funding

Lilly has also made some progress with its already-marketed neurology drug Emgality (galcanezumab), after NICE okayed NHS funding in final draft guidance applying to England and Wales.

NICE has already recommended Teva’s rival Ajovy (fremanezumab) this year, although it has rejected Novartis’ Aimovig (erenumab) despite an appeal from the manufacturer.

All the drugs come from the calcitonin gene-related peptide (CGRP) class of drugs, which patients inject to reduce the likelihood of attacks occurring.

NICE’s latest guidance recommends Emgality for preventing migraine in adults who have at least four migraine days each month and where at least three previous preventive treatments have failed.

This is the same point in the treatment pathway as Ajovy, but patients will have to experience at least 15 migraine days each month to be eligible for Teva’s drug.

 

The post Lilly to buy private biotech Disarm Therapeutics for up to $1.36bn appeared first on .

Shots: 

• The independent DSMB recommended pausing the enrollment of the ACTIV-3 clinical trial. The trial is evaluating Lilly’s bamlanivimab (LY-CoV555, 7000mg) + remdesivir as a treatment for COVID-19 in hospitalized patients, and is sponsored by the NIAID
• Lilly trusts the judgment & supports independent DSMB decisions to exercise caution in ensuring the safety of the patients participating in the study. DSMB also considered the impact of the ACTIV-3 study pause on ACTIV-2 and did not recommend any changes to that study’s design or enrollment
• Lilly is testing both single Ab therapy, as well as combinations of Abs as potential therapeutics for COVID-19, across two different patient populations in P-II BLAZE-1, P-III BLAZE-2, and ACTIV-2 study. These trials are not affected by the enrollment pause in the ACTIV-3 clinical trial

Click here ­to­ read full press release/ article | Ref: Eli Lilly | Image: Eli Lilly

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Eli Lilly’s Olumiant (baricitinib) has a significant effect on recovery from COVID-19 when combined with Gilead Veklury (remdesivir), according to a large trial backed by funding from the US government.

The findings came from additional safety and efficacy data harvested from the US National Institute of Allergy and Infectious Diseases’ (NIAID) ACCT-2 trial.

Results in hospitalised adults with COVID-19 infection also showed a numerical decrease in death – 35% – in patients treated with the combination therapy, which was more pronounced in patients receiving oxygen.

Lilly said that mortality rate seen on the combination was 5.1%, compared with 7.8% in patients treated with remdesivir alone.

In patients receiving oxygen the combination reduced mortality rate by 60% at day 29, was 43% in certain subgroups.

No new safety signals were observed for patients treated with Olumiant and results will be peer reviewed soon, the company added.

Lilly is continuing talks with the FDA around the potential for an Emergency Use Authorisation for Olumiant, which has been approved since 2018 in the US to treat rheumatoid arthritis.

However because of the well-known side effects associated with Olumiant, which may increase the risk of blood clots that can cause deep vein thrombosis and pulmonary embolism, it’s likely that the drug will be reserved for use in only very sick COVID-19 patients.

The drug works by inhibiting janus kinase (JAK1 and JAK2), which has the effect of reducing the activity of the immune system.

This is important because the more extreme symptoms seen in serious cases of COVID-19 are caused when the virus causes the body’s immune system to over-react.

Several drugs have been trialled to counter the inflammation and damage to organs that this can cause, such as dexamethasone, a cheap steroid that was found to work against COVID-19 in the UK’s large RECOVERY trial.

Feature image courtesy of Rocky Mountain Laboratories/NIH

The post Eli Lilly and Gilead’s combination cuts COVID-19 recovery time appeared first on .

Eli Lilly has asked the FDA for an Emergency Use Authorization for its COVID-19 antibody therapy, after announcing new efficacy data from an ongoing trial.

It’s been a big week for this class of therapies – Regeneron’s antibody cocktail was famously used to treat president Donald Trump’s illness and GlaxoSmithKline is expanding research into its rival.

The big US pharma is asking for an emergency approval of the monotherapy version of its antibody therapy codenamed LY-CoV555.

The Emergency Use Authorization (EUA) will be for use in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19.

This is expected to be followed by an EUA in November for the combination therapy, if more patients enrol on trials, further data on safety is available and enough stock has been manufactured.

Lilly announced data from an interim analysis of the BLAZE-1 clinical trial that showed the combination of two of Lilly’s virus-neutralising antibodies reduced viral load, symptoms, COVID-related hospitalisation, and emergency room visits.

The randomised, double-blind, placebo-controlled phase 2 study tested LY-CoV555 and LY-CoV016, which bind complementary regions of the SARS-CoV-2 spike protein, for the treatment of symptomatic COVID-19 in the outpatient setting.

The combination cohort enrolled recently diagnosed patients with mild-to-moderate COVID-19, with 112 patients receiving 2800 mg of each antibody, with 156 receiving placebo.

The combination therapy significantly reduced viral load at day 11, meeting the primary endpoint of the study.

An exploratory analysis showed that the proportion of patients with persistent high viral load at day seven for combination therapy was 3% versus 20.8% on placebo – a highly statistically significant finding.

So far no resistant viral strains have emerged in patients treated with the combination therapy, the company added.

Other endpoints met included improvements in symptom score, and this was observed as early as three days after dosing and was similar in magnitude to monotherapy with LY-CoV555.

The post Lilly asks FDA for emergency clearance for COVID-19 antibody therapy appeared first on .

Shots:

• Eli Lilly reports additional data on its SARS-CoV-2 neutralizing Ab programs including interim data on combination therapy in diagnosed patients with mild-to-mod. COVID-19 and plans to make therapies available to patients
• The new analysis P-II BLAZE-1 study assessing LY-CoV555 (2800mg) + LY-CoV016 (2800mg) vs PBO demonstrated reduced viral [email protected] meeting its 1EPs, reduction in symptoms and COVID-related hospitalization and ER visits
• Based on the combination regimen data, along with the previous findings for LY-CoV555, Lilly has submitted the initial EUA for LY-CoV555 monothx. and plans to initiate a large open-label pragmatic study in COVID-19 outpatients in Oct’2020. Additionally, Lilly anticipates the data supporting BLA submission for dual regimen as early as Q2’21

Click here ­to­ read full press release/ article | Ref: Eli Lilly | Image: GMP News

The post Eli Lilly Seeks the US FDA’s EUA for its COVID-19 Antibody Treatment first appeared on PharmaShots.

Eli Lilly has doubled down on its partnership with Chia’s Innovent with a licensing deal for ex-China rights to Tyvyt, their PD-1 inhibitor, which some analysts think may be launched at a discount to its rivals.

Lilly and Innovent co-developed Tyvyt (sintilimab) in China and launched the drug there together last year as a third-line treatment for Hodgkin’s lymphoma. It was the first PD-1 inhibitor to get reimbursement approval from the Chinese authorities.

Now, Lilly clearly thinks there’s still room to grow a new PD-1 inhibitor outside China – despite six drugs from the PD-1/PD-L1 class already on the market.

The US drugmaker has agreed to pay $200 million to secure rights to the drug in the US and other ex-China markets, including Europe, with another $825 million earmarked for Innovent if development and commercial objectives are met.

Along with Hodgkin’s lymphoma, Lilly and Innovent are also developing Tyvyt non-squamous non-small cell lung cancer (NSCLC) and other solid tumours and blood cancers, but will face stiff competition in both lead indications from Merck & Co’s top-selling checkpoint inhibitor Keytruda (pembrolizumab).

There has been speculation that latter entrants into the PD-1/PD-L1 inhibitor may start to compete on price in indications where they are trying to displace a dominant player, such as Keytruda in first-line NSCLC.

Commenting on the latest deal on Twitter, biotech investor Brad Loncar asked whether Lilly will seek a price for Tyvyt in line with its US rivals, given the drug is so much cheaper in China.

With Lilly and other companies like Novartis and GlaxoSmithKline still back in the PD-1/PD-L1 queue with candidates in late-stage development – and increasingly multiple drugs available in individual cancer types – it may not be long before prices for checkpoint inhibitors start to fall.

NSCLC looks like the indication that Lilly will be going after first in the US, as it recently reported results from the phase 3 Orient-11 trial, showing Tyvyt outperformed placebo when added to  treatment with Lilly’s big-selling chemotherapy Alimta (pemetrexed) and platinum drugs in patients with previously-untreated non-squamous NSCLC without EGFR or ALK mutations.

Tyvyt significantly extended the time to tumour progression or death compared to placebo, with progression-free survival of 8.9 months compared to 5 months with placebo, and the data has already been used to file a marketing application for Tyvyt in China.

The data was pretty much in line with the Keynote-189 study that underpinned approval of Keytruda in first-line NSCLC, but as it was conducted in China may not be enough on its own to secure US approval.

Keytruda’s dominance in first-line NSCLC and oncologists’ familiarity with the drug, built up over several years, may make it tough to displace without a sizeable discount on price.

Meanwhile, Lilly and Innovent are running upwards of 20 studies as they play catch-up with other PD-1/PD-L1 drugs testing the drug in other indications, including kidney, liver, colorectal, gastroesophageal and small cell lung cancers, as well as diffuse large B-cell lymphoma (DLBCL).

The post Latecomer Lilly throws cash at Innovent PD-1 partnership appeared first on .

1. Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children

Published: Aug 10, 2020 | Tags: Roche, Evrysdi, risdiplam, Receives, US, FDA, Approval, SMA, Adults, Children

2.  The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer

Published: Aug 07, 2020 | Tags: Guardant Health, Guardant360 CDx, Receives, US, FDA, Approval, First, Liquid Biopsy, NGS, Assay, Identify, EGFR, Mutations, Non-Small Cell Lung Cancer

 3. Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis

Published: Aug 10, 2020 | Tags: Roche, Report, Mixed Results, Etrolizumab, P-III, Studies, Patients, Moderately, Severely, Active, Ulcerative Colitis

4. Boehringer Ingelheim Acquires GST to Boost its Stem Cell Capabilities in Animal Health

Published: Aug 10, 2020 | Tags: Boehringer Ingelheim, Acquires, GST, Boost, Stem Cell Capabilities, Animal Health

5. Gilead Reports NDA Submission to the US FDA for Veklury (Remdesivir) to Treat COVID-19

Published: Aug 11, 2020 | Tags: Gilead, Reports, NDA, Submission, US, FDA, Veklury, Remdesivir, Treat, COVID-19

6. Samsung Bioepis Launches Ontruzant (trastuzumab, biosimilar) for Early and Metastatic HER2-Overexpressing Breast Cancer in Brazil

Published: Aug 11, 2020 | Tags: Samsung Bioepis, Launches, Ontruzant, trastuzumab, biosimilar, Early, Metastatic, HER2-Overexpressing, Breast Cancer, Brazil

7. Olympus to Acquire Arc Medical Design for Expanding its Product Portfolio

Published: Aug 10, 2020 | Tags: Olympus, Acquire, Arc Medical Design, Expand, Portfolio

8.  Bayer to Acquire KaNDy Therapeutics for Augmenting its Women’s Healthcare Portfolio

Published: Aug 11, 2020 | Tags: Bayer, Acquire, KaNDy Therapeutics, Augment, Women’s Healthcare, Portfolio

9.  Ligand to Acquire Pfenex for $516M

Published: Aug 11, 2020 | Tags: Ligand, Acquire, Pfenex, $516M

10. Medtronic to Acquire Companion Medical for Adding Smart Insulin Pen to its Diabetes Unit

Published: Aug 11, 2020 | Tags: Medtronic, Acquire, Companion Medical, Smart Insulin Pen, Diabetes Unit

11. BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) + CT Receive Health Canada Approval for Metastatic Non-Small Cell Lung Cancer

Published: Aug 11, 2020 | Tags: BMS, Opdivo, nivolumab, Yervoy, ipilimumab, CT, Receive, Health Canada, Approval, Metastatic, Non-Small Cell Lung Cancer

12. Sarepta Therapeutics Collaborates with University of Florida to Accelerate the Development of Therapies for Rare Genetic Diseases

Published: Aug 12, 2020 | Tags: Sarepta Therapeutics, Collaborates, University of Florida, Accelerate, Development, Therapies, Rare Genetic Diseases

13.  Innovent and Eli Lilly Report sNDA Acceptance of Tyvyt (sintilimab) Combination Regimen as 1L Therapy in Squamous Non-Small Cell Lung Cancer in China

Published: Aug 12, 2020 | Tags: Innovent, Eli Lilly, Report, sNDA, Acceptance, Tyvyt, sintilimab, Combination Regimen, 1L Therapy, in Squamous, Non-Small Cell Lung Cancer, China

14. Roche Collaborates with Celleron Therapeutics for Emactuzumab to Treat Patients with Tenosynovial Giant Cell Tumor

Published: Aug 12, 2020 | Tags: Roche, Collaborates, Celleron Therapeutics, Emactuzumab, Patients with Tenosynovial Giant Cell Tumor

15. Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH

Published: Aug 13, 2020 | Tags: Regeneron, Reports, US, FDA, Acceptance, Evinacumab, BLA, Priority Review, Treatment, Patients, HoFH

16.  Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

Published: Aug 13, 2020 | Tags: Roche, Reports, US, FDA, Acceptance, sBLA,  Xolair, (omalizumab), Prefilled Syringe, Self-Administration, Across, All, Indications

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

Published: Aug 13, 2020 | Tags:  Zydus, Launches, Remdac, (remdesivir), $37.41, Vial, India

18.   Novo Nordisk Resumes P-III Study of Concizumab for Patients with Hemophilia A and B

Published: Aug 13, 2020 | Tags: Novo Nordisk, Resumes, P-III, Study, Concizumab, Patients, Hemophilia A and B

19.  Alphabet’s Verily Establishes CLIA-Certified Lab Focusing on COVID-19 Testing

Published: Aug 11, 2020 | Tags: Alphabet, Verily, Establishes, CLIA-Certified, Lab, Focusing, COVID-19, Testing

20.   Strata Oncology Collaborates with Mirati Therapeutics to Broaden Enrollment Clinical Trial of MRTX849 for Patients with Advanced Solid Tumors

Published: Aug 13, 2020 | Tags: Strata Oncology, Collaborates, Mirati Therapeutics, Broaden, Enrollment, Clinical Trial, MRTX849, Patients,  Advanced Solid Tumors

21.  AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021

Published: Aug 13, 2020 | Tags:  AstraZeneca, Initiate, Production, COVID-19, Vaccine, Early, 2021

22. EC Concludes Exploratory Talks with J&J to Supply 200M Doses of COVID-19 Vaccine

Published: Aug 13, 2020 | Tags: Johnson & Johnson, EC, Supply, 200M, Doses, COVID-19, Vaccine

23.  SK bioscience Collaborate with Novavax to Supply Antigen for COVID-19 Vaccine

Published: Aug 14, 2020 | Tags: Novavax, SK bioscience, Collaborate, NVX-CoV2373, Treat, COVID-19

24. Novavax Collaborates with UK Government to Supply 60M Doses of NVX-CoV2373 to Combat COVID-19

Published: Aug 14, 2020 | Tags: Novavax, Collaborates, UK Government, Supply, 60M, Doses,  NVX-CoV2373, Combat, COVID-19

25. Solasia Signs a License Agreement with Isofol to Develop and Commercialize Arfolitixorin for mCRC in Japan

Published: Aug 13, 2020 | Tags: Solasia, Signs, License Agreement, Isofol, Develop, Commercialize, Arfolitixorin, mCRC, Japan

Related Post: PharmaShots Weekly Snapshot (Aug 03- 07, 2020)

Shots:

• The NMPA has accepted the sNDA for Tyvyt (sintilimab) in combination with Gemzar (gemcitabine) and platinum as 1L therapy in sq. NSCLC
• The sNDA is based on P-III ORIENT-12 study assessing sintilimab (200mg) vs PBO in combination with Gemzar and Pt (q3w for up to 4 or 6 cycles), followed by either sintilimab or PBO maintenance therapy in 327 patients in a ratio (1:1). The study demonstrated improvement in PFS with no new safety signals
• Additionally, the therapy in combination with CT has met its 1EPs in ORIENT-11 study in 1L non-squamous NSCLC patients. Today’s acceptance marks the second sNDA of Tyvyt for 1L NSCLC indication

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: PharmaShots

US biotech Pieris Pharmaceuticals has begun a collaboration and supply agreement with Eli Lilly, trialling its cancer drug PRS-343 in combination with the big pharma’s Cyramza (ramucirumab).

PRS-343 is a bispecific drug targeting the 4-1BB and HER2 receptors, which the companies hope will work well with Cyramza, a VEGFR2 antagonist already approved in several types of solid tumours.

The companies are looking to add a bispecific to Cyramza and the chemotherapy paclitaxel to create a more potent combination therapy in second-line HER2 positive gastric cancer.

Pieris is working towards beginning a phase 2 single-arm combination study later this year.

Lilly will supply Pieris with ramucirumab for the study as well as collaborate on data from the trial.

Stephen Yoder, president and CEO of Pieris, said: “We have seen impressive single-agent activity in the phase 1 trial of PRS-343, including a complete response and many patients experiencing a clinical benefit, and believe there is a compelling biology and clinical rationale to adding PRS-343 to the current standard of care regimen for advanced or metastatic gastric cancer in the second line, ramucirumab and paclitaxel.”

The company says PRS-343 has demonstrated activity both as a single agent and in combination with checkpoint inhibitors in heavily pre-treated patients with HER2-positive tumours.

Pieris is already working with several other big pharma companies, focusing on oncology and respiratory diseases.

In March Servier decided to continue with a collaboration focusing on Pieris’ anticalin technology that began in 2017.

The French pharma decided to focus on the two most advanced drugs in the collaboration while discontinuing two earlier-stage drugs in the tie-up.

In 2017, AstraZeneca signed a deal worth up to $2 billion to develop respiratory drugs and a potential successor to its Fasenra (benralizumab), which is approved in asthma but has failed to produce convincing results in chronic obstructive pulmonary disease (COPD).

The lead drug from that project, an IL-4 receptor alpha antagonist, reduced exhaled nitric oxide in mild asthmatics in a phase 1 study, and a phase 2a study is slated to begin later this year.

The post Pieris begins gastric cancer combination trial with Lilly’s Cyramza appeared first on .

Denmark’s Novo Nordisk has beaten profit forecasts in the second quarter after overcoming tough conditions in the diabetes market by improving its productivity.

Novo said that COVID-19 has begun to affect sales, with fewer new starts as a result of social distancing measures.

The company’s diabetes care products saw an increase in sales during the second quarter, although this was offset by lower sales of insulin.

But net profit for the three months to 30 June increased to 10.63 billion Danish kroner ($1.69bn), up from 9.6 billion DKK ($1.53 billion) in the same period last year.

This was on sales that were flat at 30 billion DKK ($4.77 billion), slightly below analysts’ expectations.

Sales growth is expected to be between 3% and 6% at constant exchange rates while reported sales growth is expected to be slightly lower.

The company said in its results statement: “The increased gross margin reflects productivity improvements, mainly within insulin and GLP-1, a positive product mix driven by increased GLP-1 sales and a positive currency impact of 0.2% percentage points.”

For years Sanofi has been Novo’s major rival, but the French company is turning its back on diabetes after it failed to find a successor to its big-selling insulin Lantus.

That leaves Novo to slug it out with Eli Lilly, which has a cheaper biosimilar of Lantus and a big-selling GLP-1 class drug.

Insulins are still important for Novo Nordisk, bringing in sales of 29.5 billion in the first half, but this figure was down by a reported 3% compared with last year’s H1 total.

But sales of the company’s GLP-1 drugs are increasing, and were up 30% in the first half to 19.4 billion DKK ($3.1 billion).

This is down to the popularity of Novo’s weekly injected GLP-1 drug Ozempic (semaglutide), which increased sales by a reported 156% to 9.6 billion DKK ($1.53bn), although sales of Novo’s older daily injection Victoza are falling.

Novo’s daily semaglutide pill Rybelsus is also beginning to contribute, bringing in sales of 584 million DKK (around $93 million) in the first half after US approval in September last year.

The post Novo Nordisk beats Q2 profit forecasts by cutting costs appeared first on .

Shots:

• Eli Lilly initiates P-III BLAZE-2 study assessing LY-CoV555 to prevent SARS-CoV-2 infection and COVID-19 in residents and staff at long-term care facilities in the US (skilled nursing facilities, commonly referred to as nursing homes, and assisted living facilities)
• The company will enroll up to ~2400 patients and test whether a single dose of LY-CoV555 reduces the rate of SARS-CoV-2 infection @4wks. as well as complications of COVID-19 @8wks.
• LY-CoV555 is a potent, neutralizing IgG1 mAb, directed against the spike protein of SARS-CoV-2. The therapy emerges from the collaboration b/w Lilly and AbCellera to create Ab therapies for the prevention & treatment of COVID-19

Click here ­to­ read full press release/ article | Ref: Eli Lilly | Image: Fierce Pharma

While the world waits an effective coronavirus vaccine, Eli Lilly has started late-stage human testing an antibody drug as an alternative way to prevent viral transmission in high-risk locations.

The US drugmaker is testing the antibody – called LY-CoV555 and developed in collaboration with Canadian biotech AbCellera – in a phase 3 trial to see if it can prevent the spread of the coronavirus among residents and staff in US nursing homes.

More than 40% of coronavirus deaths in the US have occurred in people who live or work in long-term care facilities, so if effective in the study the antibody could have a significant impact on the pandemic, according to Lilly. Results are due before the end of the year.

The US has been affected by the coronavirus crisis more than any other country around the world, with the number of confirmed cases heading towards 5 million, and almost 160,000 deaths at last count.

It’s a challenging study to run, so Lilly has set up customised mobile research units, including a retrofitted recreational vehicle (RV) to provide mobile lab support and clinical trial material preparation and a trailer truck to deliver the supplies needed to create an on-site infusion clinic.

The fleet will be sent out in response to outbreaks of the virus at long-term care units. Staff will also be deployed to minimise the impact of the trial on facilities that don’t normally run clinical trials.

The decision to advance LY-CoV555 into phase 3 comes just a couple of months after Lilly and AbCellera started testing the drug in clinical trials. It was identified from a blood sample taken from one of the first US patients who recovered from COVID-19.

AbCellera screened over five million immune cells looking for lines that produced functional antibodies that could neutralise SARS-CoV-2, the virus that causes the disease.

The company then identified over 500 unique fully human antibody sequences –  which it says is the largest panel of antiSARS-CoV-2 antibodies ever reported – before screening those antibodies to find the ones most effective in neutralising the virus.

Lilly and AbCellera intend to test the drug both for prophylaxis against the coronavirus and as a treatment for confirmed infections.

The phase 3 study – which Lilly says is the first of its kind – is called BLAZE-2 and will enrol around 2,400 subjects at care homes that have had confirmed, recent cases of COVID-19 and so have a high risk of coronavirus transmission.

It is being conducted in collaboration with the National Institute of Allergy and Infectious Disease (NIAID), part of the US National Institutes of Health, and will test a single dose of LY-CoV555 to see if it can protect against viral transmission over four weeks’ follow-up.

A secondary aspect of the study will be to see if the antibody can reduce complications of COVID-19 through eight weeks among patients who succumb to infection.

The post Lilly’s antibody for COVID-19 protection starts nursing home trial appeared first on .

The FDA’s approval of AstraZeneca’s SGLT2 inhibitor Farxiga in heart failure was a first for the class, but Boehringer Ingelheim and Eli Lilly are closing the gap with a positive pivotal trial for their rival drug Jardiance.

Top-line data from the phase 3 EMPEROR-Reduced study have shown that Jardiance (empagliflozin) beat out placebo on the primary objective of reducing death and hospitalisation rates in heart failure patients with and without diabetes.

The study was carried out in heart failure patients with reduced ejection fraction (HFrEF), the same group for which AZ claimed an FDA approval for Farxiga (dapagliflozin) in May.

Boehringer and Lilly now plan to present the data from EMPEROR-Reduced at the European Society of Cardiology (ESC) congress next month, and start filing for approval of Jardiance for HFrEF before the end of the year.

Jardiance was the top-selling drug in the SGLT2 inhibitor class with sales of almost $3 billion last year helped by side-effect problems that have afflicted Johnson & Johnson’s first-to-market Invokana (canagliflozin).

Farxiga has been gaining ground quickly however, with sales topping $1.5 billion in 2019 and growing another 20% in the first half of 2020, despite the impact of the coronavirus pandemic.

“The results of the EMPEROR-Reduced trial indicate that SGLT2 inhibitors have the potential to become a new standard of care for this disease, which will be a meaningful addition to currently established treatments,” said lead investigator Milton Packer of Baylor University Medical Center in Dallas.

Analysts at GlobalData have suggested that heart failure could add billions to the sales of the two SGLT2 inhibitors, particularly if they also claim approvals in heart failure with preserved ejection fraction (HFpEF), a larger patient population.

GlobalData has predicted that Farxiga will reach peak sales of $9 billion in 2028, while Jardiance is forecast to reach $4.6 billion, assuming a launch for HFrEF in 2021.

The bulk of those sales will come from HFpEF, which has “a huge unmet need and no specific standard of care,” it says.

AZ will however start losing patent protection for its drug in the coming years, depending on the outcome of patent litigation, so the launch of generics could rein in the SGLT2 market.

There have been numerous trial failures in HFpEF in recent years, including Novartis’ big selling heart failure therapy Entresto (sacubitril/valsartan), and Farxiga, Jardiance, and Merck & Co/Bayer’s vericiguat are the only drugs with positive data in this form of heart failure.

Boehringer and Lilly are waiting for the results of the EMPEROR-Preserved next year, while AZ is testing Farxiga in the DELIVER trial in HFpEF, with additional data on both HFrEF and HFpEF due from the DETERMINE study. Both of those Farxiga trials are also due to read out in 2021.

The post Study puts Jardiance in hot pursuit of AZ’s Farxiga in heart failure appeared first on .

Shots:

• The P-III EMPEROR Trial involves assessing of Jardiance (10 mg) vs PBO in two studies EMPEROR-Reduced [NCT03057977, N=3,730] & EMPEROR-Preserved [NCT03057951, N=5,990] in patients with HFrEF & HFpEF respectively
• The EMPEROR-Reduced study meets its 1EPs in reducing the risk for the composite of cardiovascular death or hospitalization due to heart failure while the overall safety profile was similar. Additionally, the full data of the stay will be presented at ESC 2020 on Aug 29, 2020, with expected regulatory submissions are planned in 2020
• Jardiance is a prescribed drug administered along with diet and exercise to lower blood sugar in and helps in reduction of CV death in adults with T2D

Click here to read full press release/ article | Ref: Eli Lilly | Image: Pharma World

Shots:

• The study involved 1402 patients across 3 cohorts: a) 81 patients in Arizona (34 with AD and 47 without), b) 699 in Sweden (301 with no cognitive impairment, 178 with mild cognitive impairment, 121 with AD dementia and 99 with other neurodegenerative diseases) and c) 622 in Colombia (365 with E280A mutations and 257 noncarriers)
• Results:  P-tau217 accurately identified AD from other neurodegenerative diseases in both 1&2 cohort while in 3rd cohort P-tau217 was elevated in mutation carriers’ blood for 20yrs.before anticipated symptom onset and was associated with memory performance, published in JAMA
• P-tau217 is better than blood-based biomarkers or MRI but did not perform significantly better than cerebrospinal fluid- or PET-based tau biomarkers. Moreover, the test has the potential together with digital tools for checking memory performance like smartphone apps, to improve the diagnosis of AD

Click here to­ read full press release/ article | Ref: Eli Lilly | Image: PharmaShots

Shots:

• Chi-Med to receive 70%-80% of Elunate sales in the form of royalties, manufacturing costs and service payments with no upfront regarding this amendment. Lilly will maintain the exclusive commercialization rights and will continue to consolidate the sales of Elunate in China while Chi-Med retains all rights to fruquintinib outside of China
• The agreement allows the company to deploy full resources of both companies to maximize the potential of the Elunate in China. From Oct 01, 2020, Chi-Med will be responsible to develop and execute all medical detailing, promotion, and marketing activities for the product in China
• Fruquintinib is a highly selective and potent oral VEGFR 1/2/3 inhibitor, acts by minimizing off-target toxicities, improve tolerability and provide more consistent target coverage

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: StraitTimes

 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

Eli Lilly is a latecomer in the new generation of biologic therapies for psoriasis with its mirikizumab candidate, but a win in a head-to-head trial against Novartis’ big-selling Cosentyx could help close the gap.

The pivotal trial with anti-IL-23 antibody mirikizumab – OASIS-2 – delivered a significant improvement over placebo at 16 weeks, achieving its primary objective, but while that would help secure marketing approval it would not be enough to give Lilly a return on its investment.

More importantly, 12-month data from the trial showed that mirikizumab outperformed Novartis’ IL-17-targeting antibody Cosentyx (secukinumab), which brought in $3.6 billion in sales last year in psoriasis as well as other indications like psoriatic arthritis and ankylosing spondylitis.

The results mean Lilly can now submit mirikizumab to regulatory authorities around the world armed with data showing it works better than Cosentyx, which could help it grow more quickly in the crowded psoriasis market if it is eventually approved.

In OASIS-2, 74% of patients had a 90% improvement in psoriasis symptoms (PASI 90) at 16 weeks with mirikizumab – roughly the same proportion as those on Cosentyx, which compared to 6% of the placebo group.

At the 12-month timepoint there was no placebo assessment, with a monthly 300 mg dose of Cosentyx compared to 250 mg of mirikizumab given every four or eight weeks. For Lilly’s drug, PASI 90 scores were seen in upwards of 81% of patients, while for Cosentyx they had dipped below 70%.

A similar pattern was seen in patients who had complete clearance of their skin lesions (PASI 100), at around 37% for the two active drugs versus 1.8% for placebo at four months. After a year, that outcome was seen in 43% of the Cosentyx group, and 54% and 59% for the four- and eight-week mirikizumab doses.

“We look forward to bringing mirikizumab to market to provide patients with an additional treatment option that has the potential to provide near complete or complete skin clearance as measured by PASI 90 and PASI 100, with sustained results at 52 weeks,” commented Patrik Jonsson, president of Lilly Bio-Medicines.

Mindful of its latecomer status, Lilly is investing heavily to catch up with Cosentyx and other new psoriasis antibodies, including IL-23-targeting drugs like AbbVie’s Skyrizi (risankizumab) – which also trumped Cosentyx in a head-to-head trial – as well as Johnson & Johnson’s Tremfya (guselkumab) and Sun Pharma’s Ilumya (tildrakizumab).

Lilly is also running large-scale phase 3 trials of mirikizumab in ulcerative colitis and Crohn’s disease to expand the potential uses of the antibody in an attempt to build a franchise quickly.

Skyrizi is thought by some analysts to be the key rival in psoriasis. AbbVie’s only launched last year but is already on track for blockbuster sales with a turnover of $300 million in the first quarter of 2020, notwithstanding the possible brake on sales caused by coronavirus lockdowns.

The post Lilly’s mirikizumab tops Novartis’ blockbuster Cosentyx in psoriasis appeared first on .

Shots:

• The P-III OASIS-2 study involves assessing mirikizumab vs PBO & Cosentyx (secukinumab) in 1,465 patients with mod. to sev. PsO. The patients were randomized in a (4:4:4:1) ratio to one of the following induction and maintenance period treatments: mirikizumab (250mg) @ 0, 4, 8, 12wks. followed by 250 & 125mg, q8w starting @16wks; 300mg secukinumab @ 0, 1, 2, 3, 4wks. followed by 300mg, q4w starting @4wks.; PBO @ 0, 4, 8, 12 wks. followed by 250mg mirikizumab q4w starting @16wks. through 32wks. followed by q8w thereafter
• Results: @16wks. sPGA(0,1) (79.7% vs 6.3% & 76.3%), PASI 90 (74.4% vs 6.3% & 72.8%); PASI 100 (37.7% vs 1.8% & 36.6%). In general, the study resulted in meeting its 1EPs and all key 2EPs vs PBO @16wks. and all key 2EPs vs Cosentyx (secukinumab) @16wks. (non-inferiority) and @52wks. (superiority)
• Mirikizumab is an IgG4 mAb binding p19 subunit of IL-23 and being evaluated for immune diseases, including psoriasis, UC and CD

Click here to read full press release/ article | Ref: Eli Lilly | Image: Glassdoor

Shots:

• The second P-III LIBRETTO-531 involves assessing of selpercatinib vs physician’s choice of cabozantinib or vandetanib in 400 patients in ratio (2:1) with advanced or metastatic RET-mutant MTC who have received no prior systemic therapy for metastatic disease
• The study will have efficacy endpoints as progression-free survival (PFS), treatment failure-free survival (TFFS), overall survival (OS), overall response rate (ORR), and duration of response (DoR)
• LOXO-292 is an oral investigational new medicine targeted to inhibit native RET signaling as well as anticipated acquired resistance mechanisms and has also received Breakthrough Therapy designation in RET fusion-positive NSCLC, RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancers

Click here to read full press release/ article | Ref: PRNewswire | Image: Twitter