Astellas Reports Results of Fezolinetant in Two P-III Studies for the Nonhormonal Treatment of VMS in Postmenopausal Women

Shots:

  • The P-III studies SKYLIGHT 1 & 2 involves assessing fezolinetant (30 & 45mg, qd) vs PBO in women with mod. to sev. vasomotor symptoms (VMS) for the first 12wks. followed by 40wks. active treatment extension periods
  • Both the trials met all four co-1EPs demonstrating a significant reduction from baseline in the frequency and severity of moderate to severe VMS to week 4 and week 12
  • Fezolinetant is an NK3R antagonist targeting NKB binding on the KNDy neuron to moderate neuronal activity in the brain to treat VMS associated with menopause

Click here ­to­ read full press release/ article | Ref: Astellas | Image: Nasdaq

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PharmaShots Weekly Snapshots (Feb 15- 19, 2021)

RedHill Signs a Manufacturing Agreement with Cosmo for Movantik and RHB-204 

Published: Feb 19, 2021 | Tags: RedHill, Signs, Manufacturing, Agreement, Cosmo, Movantik, RHB-204

Astellas and Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

Published: Feb 19, 2021 | Tags: Astellas, Seagen, Reports, Submission, Two, BLA, US, FDA, Padcev (enfortumab vedotin), Locally, Advanced, Metastatic, Urothelial Cancer

The US FDA Approves Patient Specific Talus Spacer to Treat AVN of Ankle Joint as a Humanitarian Use Device

Published: Feb 19, 2021 | Tags: US, FDA, Approves, Patient, Specific, Talus Spacer, Treat, AVN, Ankle Joint, Humanitarian, Use, Device

Dermavant Report Results of Tapinarof Cream in P-III PSOARING 3 Study with Durable and Remittive Benefits for Plaque Psoriasis

Published: Feb 19, 2021 | Tags: Dermavant, Report, Results, Tapinarof Cream, P-III, PSOARING 3, Study, Durable, Remittive Benefits, Plaque Psoriasis

Fresenius Kabi Launches Idacio (biosimilar, adalimumab) for Multiple Chronic Inflammatory Conditions in Canada

Published: Feb 19, 2021 | Tags: Fresenius Kabi, Launches, Idacio (biosimilar, adalimumab), Multiple Chronic Inflammatory, Conditions, Canada

Lilly Collaborates with Rigel to Develop RIPK1 Inhibitors for Immunological and Neurodegenerative Diseases

Published: Feb 19, 2021 | Tags: Lilly, Collaborates, Rigel, Develop, RIPK1 Inhibitors, Immunological ,Neurodegenerative Diseases

BeiGene Reports the US FDA’s Acceptance of sNDA for Brukinsa (zanubrutinib) in Waldenström’s Macroglobulinemia

Published: Feb 18, 2021 | Tags: BeiGene, Reports, US, FDA, Acceptance, sNDA, Brukinsa (zanubrutinib), Waldenström’s Macroglobulinemia


Myovant and Pfizer Publish the Results of Relugolix Combination Regimen in P-III LIBERTY Studies in NEJM

Published: Feb 18, 2021 | Tags: Myovant, Pfizer, Publish, Results, Relugolix, Combination, Regimen ,P-III, LIBERTY, Studies, NEJM

GSK Expand its 2020 Collaboration with Vir to Advance New Therapies for Influenza and Other Respiratory Viruses

Published: Feb 18, 2021 | Tags: GSK, Expand, 2020, Collaboration, Vir, Advance, New, Therapies,  Influenza, Other, Respiratory, Viruses

Novartis Collaborates with Bill & Melinda Gates Foundation to Discover and Develop Gene Therapy for Sickle Cell Disease

Published: Feb 18, 2021 | Tags: Novartis, Collaborates, Bill & Melinda, Gates Foundation, Discover ,Develop, Gene Therapy, Sickle Cell Disease

Lilly Reports Results of Tirzepatide in P-lll SURPASS-3 and 5 Trials for Type-2 Diabetes

Published: Feb 18, 2021 | Tags: Lilly, Reports, Results, Tirzepatide, P-lll, SURPASS-3 and 5, Trials, Type-2 Diabetes

Coherus Reports the US FDA’s Acceptance of BLA for CHS-1420 (biosimilar, adalimumab)

Published: Feb 18, 2021 | Tags: Coherus, Reports, US, FDA, Acceptance, BLA, CHS-1420 (biosimilar, adalimumab)

Boehringer Ingelheim Animal Health Establishes Pawru for its PetPro Portfolio

Published: Feb 17, 2021 | Tags: Boehringer Ingelheim, Animal Health, Establishes, Pawru,  PetPro Portfolio

Novartis’s Entresto Receives US FDA’s Approval for Chronic Heart Failure

Published: Feb 17, 2021 | Tags: Novartis, Entresto, Receives, US, FDA, Approval, Chronic Heart Failure

GSK Initiates P-III study for RSV Candidate Vaccine Programme for Older Adults

Published: Feb 17, 2021 | Tags: GSK, Initiates, P-III study, RSV, Candidate, Vaccine, Programme, Older, Adults

Novartis Report Results of Kesimpta (ofatumumab) Sensoready Autoinjector Pen for Multiple Sclerosis

Published: Feb 17, 2021 | Tags: Novartis, Report, Results, Kesimpta (ofatumumab), Sensoready, Autoinjector Pen, Multiple Sclerosis

BMS and Acceleron’s Reblozyl (Luspatercept) Receives Health Canada Approval for Adult Patients With Myelodysplastic Syndromes

Published: Feb 17, 2021 | Tags: BMS and Acceleron, Reblozyl (Luspatercept), Receives, Health Canada, Approval, Adult Patients, Myelodysplastic Syndromes

Guardant Health Launches Guardant Reveal Liquid Biopsy Test for Early-Stage Colorectal Cancer

Published: Feb 17, 2021 | Tags: Guardant Health, Launches, Guardant Reveal, Liquid, Biopsy Test, Early Stage, Colorectal Cancer

Onward Signs a Worldwide Exclusive License and Co-Development Agreement with Biomunex for Immuno-Oncology

Published: Feb 16, 2021 | Tags: Onward, Signs, Worldwide, Exclusive, License, Co-Development ,Agreement, Biomunex, Immuno-Oncology

Aker BioMarine Collaborate with Université de Sherbrooke Department of Medicine for Alzheimer’s Disease

Published: Feb 16, 2021 | Tags: Aker BioMarine, Collaborate, Université de Sherbrooke, Department, Medicine, Alzheimer’s Disease

AstraZeneca and Serum Institute of India’s COVID-19 Vaccine Receive WHO’s EUA to Prevent COVID-19

Published: Feb 16, 2021 | Tags: AstraZeneca and Serum Institute of India, COVID-19 Vaccine, Receive ,WHO, EUA, Prevent, COVID-19

Targovax Receives US FDA’s Fast Track Designation for ONCOS-102 for Malignant Pleural Mesothelioma

Published: Feb 16, 2021 | Tags: Targovax, Receives, US, FDA, Fast Track Designation, ONCOS-102,  Malignant Pleural Mesothelioma

Celltrion Receives EC’s Approval for Yuflyma (biosimilar, adalimumab) for the Treatment of Multiple Chronic Inflammatory Diseases

Published: Feb 16, 2021 | Tags: Celltrion, Receives, EC, Approval, Yuflyma (biosimilar, adalimumab), Treatment, Multiple Chronic Inflammatory,, Diseases

Exelixis Report Results of Cabometyx (cabozantinib) in P-II PAPMET Study for Patients with Metastatic Papillary Renal Cell Carcinoma

Published: Feb 16, 2021 | Tags: Exelixis, Report, Results, Cabometyx (cabozantinib), P-II, PAPMET Study, Patients, Metastatic, Papillary, Renal Cell Carcinoma

Roche’s Receives the US FDA’s Clearance for Urine Sample Type for BK Virus Quantitative Test

Published: Feb 15, 2021 | Tags: Roche, Receives, US, FDA, Clearance, Urine Sample, Type, BK Virus, Quantitative Test

Biocon Biologics and Viatris Receive EC’s Approval for Kixelle (biosimilar, insulin aspart) for Diabetes Mellitus

Published: Feb 15, 2021 | Tags: Biocon Biologics and Viatris, Receive, EC, Approval, Kixelle (biosimilar, insulin aspart), Diabetes Mellitus

Merck Report Result of Keytruda (pembrolizumab) + Lenvima (lenvatinib) as 1L Treatment for Advanced Renal Cell Carcinoma

Published: Feb 15, 2021 | Tags: Merck, Report, Result, Keytruda (pembrolizumab) + Lenvima (lenvatinib), 1L, Treatment, Advanced Renal Cell Carcinoma

Pfizer’s Panzyga Receives the US FDA’s Approval of sBLA for Chronic Inflammatory Demyelinating Polyneuropathy

Published: Feb 15, 2021 | Tags: Pfizer, Panzyga, Receives, US, FDA, Approval, sBLA, Chronic Inflammatory, Demyelinating, Polyneuropathy

Takeda Report Results of TAK-620 (maribavir) in P-III SOLCTICE Trial for the Treatment of Post-Transplant Patients with Cytomegalovirus Infection

Published: Feb 15, 2021 | Tags: Takeda, Report, Results, TAK-620 (maribavir), P-III, SOLCTICE Trial, Treatment, Post Transplant, Patients, Cytomegalovirus Infection

G1 Therapeutics’ Cosela (trilaciclib) Receives US FDA’s Approval as the First Myeloprotection Therapy for Extensive-Stage Small Cell Lung Cancer

Published: Feb 15, 2021 | Tags: G1 Therapeutics, Cosela (trilaciclib), Receives, US, FDA, Approval, First, Myeloprotection, Therapy, Extensive Stage, Small Cell, Lung Cancer

Related post: PharmaShots Weekly Snapshots (Feb 08 – 12, 2021)

The post PharmaShots Weekly Snapshots (Feb 15- 19, 2021) first appeared on PharmaShots.

Astellas/Seagen prepare full US filing of bladder cancer drug Padcev

Astellas and Seagen have the data they need for a full licence for their bladder cancer drug Padcev in the US, based on trial results announced over the weekend.

To recap, Padcev (enfortumab vedotin) was quickly okayed by the FDA in December 2019 in advanced urothelial cancer on the basis of phase 2 response data that made it a rising star at that year’s American Society of Clinical Oncology (ASCO) conference.

But although the response rate data was eye-catching, the FDA could only grant a faster accelerated approval that needed to be confirmed with further data.

That is now available from the trial data announced at this year’s ASCO genitourinary cancer specialist conference (ASCO GU), from a second cohort from the phase 2 EV-201 trial.

The first cohort formed the basis for the accelerated approval and the second cohort from the single-arm trial showed an objective response of 52% and a median duration of response was 10.9 months.

In Seagen’s Q4 results statement, the company said that the new EV-201 data will support a filing for a full licence in the US.

Meanwhile the data from the phase 3 EV-301 data will support filings with regulators outside of the US, Seagen said.

The late stage data showed Padcev significantly improved overall survival compared with chemotherapy in a group of patients previously treated with platinum chemo and and a PD-1/L1 inhibitor.

An interim analysis from EV-301 showed a median overall survival of 12.9 months in patients treated with Padcev compared with nine months in those treated with chemotherapy.

For patients in the Padcev arm of the trial, maculopapular rash, fatigue and decreased neutrophil count were the most frequent Grade 3 or greater treatment-related adverse events (TRAEs) occurring in more than 5% of patients.

Median progression-free survival was 5.6 months in the Padcev group compared with 3.7 months in the chemotherapy group.

Overall response rate, the percentage of patients with either complete or partial response, was 40.6% vs. 17.9% of patients in the chemotherapy arm.

Disease control rate – the percentage of patients who have achieved complete response, partial response or had stable disease, was 71.9% for Padcev and 53.4% for chemotherapy.

In an interview with pharmaphorum, Andy Krivoshik, senior vice president and Oncology Therapeutic Area head at Astellas, said the data could be used to confirm a full US licence as well as negotiations with payers.

In the UK, cost-effectiveness body NICE requires overall survival data for regular NHS reimbursement and Krivoshik said the overall survival data could help with discussions with other reimbursement authorities.

He said that the endpoints are “meaningful for payer systems”, because of the implications they have for patients.

Moving forward, Astellas and Seagen will be looking to develop the drug for other cancers with high expression of NECTIN-4, including triple-negative breast cancer, non-small cell lung cancer, head and neck and certain types of gastro-oesophageal cancer.

The post Astellas/Seagen prepare full US filing of bladder cancer drug Padcev appeared first on .

Top 20 Biopharma Deal Terminations of 2020 Based on Total Deal Value

  • The biopharma industry saw numerous deal terminations in 2020. Clinical and regulatory results, change in control limitations, and strategic reprioritizations were among the most common reasons for deal termination.
  • Sanofi and Hanmi’s agreement in 2015 ranked first under which Hanmi regained WW rights to its protein/peptide discovery technology, lapscovery. The second position goes to the Merck KGaA termination of its development and commercialization deal with Pfizer  
  • This article is based on the 2020 biopharma deals data provided by Chris Dokomajilar of DealForma. PharmaShots has compiled a list of the top 20 terminations of 2020 based on total deal value

Sanofi Terminated its 2015 Agreement with Hanmi

In Nov. 2015, Hanmi granted Sanofi exclusive, worldwide rights to its protein/peptide discovery technology, lapscovery to develop and commercialize a late-stage GLP1-RA agonist, efpeglenatide weekly insulin, and a fixed-dose weekly GLP-1-RA/insulin drug combination for the treatment of diabetes. Additionally, Hanmi had an exclusive option to co-commercialize the products in Korea and China. Hanmi received $434.7M up front and was eligible for up to $3.8B in development, regulatory, and sales-based milestones, plus double-digit royalties. In May 2020, Sanofi terminated the agreement and Hanmi regained worldwide rights. 

Merck KGaA Terminated its Development and Commercialization Deal with Pfizer

Merck KGaA partnered with Pfizer to jointly develop & commercialize MSB0010718C for multiple types of cancer. The companies would develop the Ab as a single agent and in combination with Pfizer’s and Merck KGaA’s portfolio of approved and investigational oncology therapies. Both companies would collaborate on up to 20 immuno-oncology clinical development programs expected to commence in 2015, including up to 6 trials in P-II or P-III. Pfizer and Merck KGaA also partnered separately to co-promote Pfizer’s Xalkori in the US and other markets. Merck KGaA received $850M up front and was eligible to receive up to $2B in regulatory and sales milestones. Both companies would jointly fund all development and commercialization costs and split profits. On Mar. 19, 2019, Merck & Pfizer discontinued the P-III trial (JAVELIN Ovarian PARP 100) due to clinical trial results to develop avelumab in combination with CT followed by maintenance therapy of avelumab in combination with PARP inhibitor (talazoparib) for LA or metastatic ovarian cancer (Stage III or Stage IV). On Mar. 13, 2020, the companies terminated their P-III JAVELIN Head and Neck 100 trial of Bavencio (avelumab) with CRT for LA SCCHN as it failed to hit its 1Eps.

AbbVie (Allergan) Terminated its Development and Commercialization Deal with Assembly Biosciences

In Jan. 2017, Assembly Biosciences granted Allergan exclusive, worldwide rights to co-develop and commercialize ABI-M201 and ABI-M301 for the treatment of ulcerative colitis and Crohn’s disease, plus an additional two drugs for the treatment of Irritable Bowel Syndrome with Diarrhoea, with Constipation (IBS-C), or Mixed (IBS-M). Allergan and Assembly shared development costs until proof-of-concept studies. Assembly received $50M up front and was eligible for up to $2.77B in milestones, plus royalties. In May 2020, AbbVie acquired Allergan and on Jun. 18, 2020, AbbVie, terminated the agreement with Assembly Biosciences.

Eli Lilly Terminated its 2017 Agreement with CureVac

In Oct. 2017, CureVac granted Eli Lilly rights to develop and commercialize its 5 mRNA cancer vaccines using CureVac’s RNActive technology for up to 5 cancer vaccines that target neoantigens across multiple tumor types. Lilly was responsible for target identification, clinical development, and commercialization. CureVac was responsible for mRNA design, formulation, and manufacturing of clinical supplies. CureVac had the option to co-promote vaccines in Germany. CureVac received $50M up front, an equity investment of $51M (€45M), and CureVac would be eligible to receive more than $1.7B in development and sales milestones if all 5 vaccines are successfully developed, plus tiered royalties. In Jun. 2020, Eli Lilly terminated the agreement.

Voyager Terminated its Option and License Deal with AbbVie

In Feb. 2019, Voyager granted AbbVie options to license exclusive, worldwide rights to vectorized antibody-based gene therapies for Parkinson’s and other neurodegenerative diseases. Voyager would perform preclinical development to vectorize antibodies directed against alpha-synuclein designated by AbbVie. AbbVie would select one or more vectorized antibodies to advance into IND-enabling studies and clinical development. Voyager would be responsible for research, IND-enabling, and P-I clinical activities and costs. After completing P-I, AbbVie had an option to license the vectorized alpha-synuclein antibody program for further clinical development and global commercialization for Parkinson’s disease and other synucleinopathies. Voyager received $65M up front and was eligible for up to $245M in preclinical and P-I option payments, up to an additional $728M in development and regulatory milestones for each alpha-synuclein vectorized antibody compound, and up to $500M in total sales milestones, plus tiered royalties. On Aug. 3, 2020, Voyager Therapeutics terminated the agreement with AbbVie.

AstraZeneca Terminated its Development and Commercialization Deal with Allergan

In Oct. 2016, AstraZeneca’s global biologics research and development arm, MedImmune, granted Allergan exclusive, worldwide rights to develop and commercialize MEDI2070. The IL-23 monoclonal antibody was being developed for the treatment of Crohn’s disease and ulcerative colitis and was developed in partnership with Amgen Inc. under a 2012 deal. AstraZeneca received $250M up front and was eligible for up to $1.27B in milestones, plus royalties. AstraZeneca would share one-third of all payments and royalties with Amgen Inc. Amgen would also receive a single-digit inventory royalty on MEDI2070. On Jan. 27, 2020, AstraZeneca and Allergan mutually terminated the agreement, Allergan funded the ongoing study of brazikumab in CD and UC including CDx.

Eli Lilly Terminated its Research Partnership and Option to License Agreement with NextCure

In Nov. 2018, Lilly signed a research partnership with NextCure with an option to license immuno-oncology therapies using NextCure’s FIND-IO platform. Lilly had the exclusive option to license the antibodies resulting from the study. NextCure received $25M up front and Lilly invested $15M in NextCure. If Lilly exercised its option to license the drug, NextCure would be eligible to receive up to $1.4B in milestones, plus royalties. On Jan. 10, 2020, Eli Lilly terminated the agreement with NextCure effective Mar. 3, 2020.

Bridge Biotherapeutics and Boehringer Ingelheim Mutually Terminated their Development and Commercialization Deal

In Jul. 2019, Bridge granted Boehringer exclusive, worldwide rights to develop and commercialize BBT-877 for the treatment of fibrosing interstitial lung diseases such as idiopathic pulmonary fibrosis (IPF). The Bridge received $50.48M up front and was eligible for up to $1.23B in milestones, plus royalties. On Nov. 9, 2020, Bridge Biotherapeutics and Boehringer mutually terminated the agreement.

Voyager Terminated its License Option Deal with AbbVie

In Nov. 2018, Voyager granted AbbVie an option to license the development and commercialization of its vectorized antibodies targeting tau by combining AbbVie’s monoclonal antibody expertise and Voyager’s gene therapy platform and expertise to generate AAV vectors for the treatment of neurodegenerative diseases, including Alzheimer’s disease. Both companies planned to identify 5 antibodies based on Voyager’s gene therapy platform and select 3 antibodies for development. AbbVie had an option to license up to 2 antibodies following the completion of P-I and would be fully responsible for development costs. Voyager received $69M up front, and was eligible for up to $155M in preclinical and P-I option payments, and was eligible for up to $895M in development and regulatory milestones, plus royalties. On Aug. 3, 2020, Voyager terminated the agreement with AbbVie.

Amgen Terminated its 2006 Research Partnership with Cytokinetics

In Dec. 2006, Cytokinetics signed a research partnership with Amgen to develop CK-1827452 for the treatment of heart failure. Amgen had an exclusive option to license the drug candidate worldwide excluding Japan before the completion of a P-IIa study. Cytokinetics was responsible for initial development. Upon exercising its option, Amgen was responsible for all further development costs. Also, the partners developed cardiac myosin as a backup compound. Cytokinetics received $75M up front, including $33M in its common stock at a premium of $6.9M. Upon option exercise, Cytokinetics received a $50M option exercise fee and was eligible for up to $600M in development, regulatory, and sales milestones, plus escalating royalties. Cytokinetics had the option to co-fund the P-III study in exchange for additional royalties. If Cytokinetics decided to co-fund the study, it could co-promote the drug in North America. In 2013, Amgen licensed Japan rights, and in 2016 Amgen sublicensed the rights for Europe and the Commonwealth of Independent States to Servier. On Nov. 23, 2020, Amgen terminated the agreement and Cytokinetics regained worldwide rights for omecamtiv mecarbil and backup compound AMG 594. The termination was effective May 20, 2021. The sublicense agreement between Amgen and Servier would remain effective post-termination.

Roivant Terminated its Development and Commercialization Deal with Poxel

In Feb. 2018, Poxel granted Roivant Sciences and its subsidiary Metavant rights to develop and commercialize its oral therapy, Imeglimin, for T2 Diabetes. Poxel received $35M up front and was eligible for up to $600M in milestones, plus royalties. Roivant invested $15M in Poxel’s common stock by purchasing 1,431,399 ordinary shares at €8.5 per share. Roivant was responsible for worldwide development and commercialization. Poxel planned to contribute $25M to the development and had an option to co-promote the product. In Nov. 2020, Metavant terminated the agreement with Poxel for the development of Imeglimin following a strategic analysis.

Alexion Terminated its Development and Commercialization Deal with Affibody

In Mar. 2019, Affibody granted Alexion rights to develop and commercialize ABY-039 for IgG-mediated autoimmune diseases. Affibody received $25M up front and was eligible for up to $625M in development and sales-based milestones, plus tiered low double-digit royalties. Additionally, Affibody had an option to co-promote the bivalent antibody-mimetic targeting the neonatal Fc receptor (FcRn) in the US. In Feb. 2020, Alexion terminated the agreement following unfavourable early-stage data.

Boehringer Ingelheim Terminated its Development and Commercialization Deal with Zealand

In Jun. 2011, Zealand granted Boehringer Ingelheim exclusive, worldwide rights to develop and commercialize glucagon/GLP-1 dual agonists, including ZP2929, for the treatment of type-2 diabetes and obesity. Zealand received $52.4M up front, including reimbursements cost and $5.6M in research funding, and was eligible for up to $532.2M in development and commercial milestones, plus double-digit royalties. In Mar. 2020, Boehringer Ingelheim terminated the agreement and Zealand regained worldwide rights.

BMS (Celgene) Terminated its Development and Commercialization Deal with Jounce

In Jul. 2019, Jounce granted Celgene exclusive, worldwide rights to develop and commercialize JTX-8064 targeting the LILRB2 receptor on macrophages. Jounce received $50M up front and was eligible for up to $480M in milestones, plus royalties. In Jun. 2020, Bristol Myers Squibb terminated the agreement.

Cytokinetics Terminated its Development and Commercialization Deal with Astellas

In Jun. 2013, Cytokinetics granted Astellas exclusive, worldwide rights to co-develop and commercialize CK-2127107 for skeletal muscle weakness. Cytokinetics had the option to co-promote products in the US and Canada. Cytokinetics received $16M up front, $24M in R&D reimbursement, and was eligible for over $250M in development and sales milestones for collaboration products, including up to $112M for CK-2127107 and up to $200M in sales milestones, plus undisclosed royalties. On Dec. 22, 2014, Cytokinetics restated the agreement and granted Astellas exclusive, worldwide rights to co-develop & commercialize CK-2127107 and other products for SMA and other neuromuscular indications. Cytokinetics was responsible for P-II in patients with SMA and other neuromuscular diseases. Both companies would co-develop and co-commercialize CK-2127107 and other skeletal troponin activators in neuromuscular indications. Cytokinetics had the option to co-fund certain development costs, co-promote & conduct commercial activities for CK-2127107 in non-neuromuscular and neuromuscular indications in the US, Canada, and EU. On Jul. 27, 2016, Cytokinetics extended the agreement and granted Astellas additional rights to develop and commercialize tirasemtiv and CK-2127107 for ALS. Cytokinetics received a $100M option exercise fees and was eligible for additional milestones, plus royalties based on sales of tirasemtiv in Astellas’ countries. Also, Astellas was eligible for royalties based on Cytokinetics’ sales of tirasemtiv in its territory. On Apr. 23, 2020, the companies mutually terminated the agreement, Astellas contributed one-third of the development cost, or ~$12M, in an exchange of royalties in the US, Canada, and the EU for 10 years or reduced royalties until 2034. Also, Astellas returned all inventory and IP related to FRSA compounds and agreed not to engage in any research and development activities on FSRA compounds for 4 years.

Calithera Terminated its Development and Commercialization Deal with Incyte

In Jan. 2017, Calithera granted Incyte worldwide rights to develop and commercialize its arginase inhibitor, CB-1158, for the treatment of hematology and oncology indications. Incyte would fund 70% of the development cost while Calithera would fund 30%. Incyte and Calithera would share profits and losses, with Incyte at 60% and Calithera at 40%, based on U.S. sales. Incyte and Calithera planned to co-detail the drug in the U.S. and Calithera was eligible for up to $483M, including upfront and milestones, plus royalties ex-U.S. In Sep. 2020, Calithera terminated the agreement and regained worldwide rights.

Idorsia Terminated its Option and License Deal with Santhera for Vamorolon

In Nov. 2018, Idorsia granted Santhera an option to sublicense the development and commercialization of vamorolone for the treatment of DMD worldwide, excluding Japan and South Korea. Idorsia received 1M new registered shares of Santhera and an upfront cash payment of $20M. Idorsia became the largest shareholder in Santhera with a 13.3% equity position. The option was exercisable upon receipt of data from the P-IIb VISION-DMD study (VBP15-004). If exercised, Idorsia would receive a one-time payment of $30M and was eligible for regulatory & commercial milestones of up to $80M for the DMD indication and four one-time sales milestone payments of up to $130M in total. Idorsia was also eligible for regulatory milestone payments of up to $205M for three additional indications. On Sep. 2, 2020, Santhera exercised its option to license vamorolone for all indications including DMD, and revised the terms of the agreement. Vamorolone was originally developed by ReveraGen, and Actelion had the option rights. In Jun. 2017, Actelion spun off Idorsia as a separate entity along with vamorolone rights before its merger with Johnson & Johnson. According to the revised terms of the agreement, Idorsia received 366,667 shares in Santhera’s common stock and CHF10M in the form of convertible notes, up to 65% was converted in the form of Santhera common stock and transfer the control rights to its original developer ReveraGen BioPharma. Santhera had replaced Idorsia as party to the ReveraGen agreement.

AMAG Terminated its Development and Commercialization Deal with Palatin Technologies

In Jan. 2017, Palatin Technologies granted AMAG Pharmaceuticals rights to develop and commercialize Rekynda (bremelanotide) for the treatment of female sexual disorders in North America. Palatin received $60M up front, up to $380M in milestones, and $25M in reimbursement payments, plus royalties. In Jul. 2020, AMAG terminated the agreement and Palatin Technologies regained the rights plus $16.3M in termination fees.

Gilead Terminated its Development and Commercialization Deal with Precision BioSciences

In Sep. 2018, Precision granted Gilead rights to develop and commercialize therapies for Hepatitis B Virus targeting HBV cccDNA and integrated HBV DNA present in human hepatocytes using Precision’s ARCUS platform. Precision would focus on the development, formulation, and preclinical studies. Gilead was responsible for clinical studies and commercialization. Precision received research funding and was eligible for up to $445M in milestone payments and royalties. In Sep. 2020, Gilead terminated its agreement with Precision BioSciences.

ReveraGen Terminated its Option and License Deal with Actelion (Idorsia after the spin-off from Actelion)

In Nov. 2016, Actelion signed a research partnership with ReveraGen BioPharma with an option to license vamorolone for the treatment of DMD and other indications. Actelion would co-develop the compound for the next 28 months and would contribute $1M annually. ReveraGen received $10M up front, up to $165M in dev. and reg. milestones for DMD, and up to $190M for an additional three indications, plus tiered double-digit royalties. On Jun. 16, 2017, Actelion was acquired by Johnson & Johnson. Actelion spun off Idorsia as a new company. In 2018, Idorsia maintained the option rights for vamorolone and restructured the agreement. It agreed to contribute the research for an additional year (until mid-2020). ReveraGen initially received $15M to maintain the agreement, a $20M option fee, and would be eligible for up to $75M in milestones for the DMD indication, and three additional sales milestones of up to $120M. Royalties and milestone payments for other indications remain unchanged. In Nov. 2018, Idorsia granted Santhera an option to sublicense the development and commercialization of vamorolone for DMD worldwide, excluding Japan and South Korea. On Sep. 2, 2020, Santhera exercised its option to license vamorolone for all indications including DMD with the control rights transferred to ReveraGen BioPharma.

Related Post: Top Biopharma Deal Terminations of 2018-2019 by Total Value Received

The post Top 20 Biopharma Deal Terminations of 2020 Based on Total Deal Value first appeared on PharmaShots.

PharmaShots Weekly Snapshot (Feb 01-05, 2021)

Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis

Published: Feb 5, 2020 | Tags: Reiston, Report, Result, SHR0302, P-II, Study, Treat, Ulcerative Colitis

Enzene Receives Marketing Authorization for Teriparatide (biosimilar) in India

Published: Feb 5, 2020 | Tags: Enzene, Receives, Marketing Authorization, Teriparatide (biosimilar), India

Johnson & Johnson Reports EUA Submission to US FDA’s for its Single Shot COVID-19 Vaccine Candidate

Published: Feb 5, 2020 | Tags: Johnson & Johnson, Reports, EUA, Submission, US, FDA, Single Shot, COVID-19, Vaccine, Candidate

23andMe Going Public Via Virgin Group SPAC Merger

Published: Feb 5, 2020 | Tags: 23andMe, Going, Public, Virgin Group, SPAC, Merger

Biocon Biologics Signs an Agreement with CHAI to Expand Access to its Oncology Biosimilars in 30 Countries

Published: Feb 5, 2020 | Tags: Biocon Biologics, Signs, Agreement, CHAI, Expand, Access, Oncology, Biosimilars, 30 Countries

AstraZeneca’s Forxiga (dapagliflozin) Receives NMPA’s Approval for Chronic Heart Failure

Published: Feb 5, 2020 | Tags: AstraZeneca, Forxiga (dapagliflozin), Receives, NMPA, Approval, Chronic, Heart Failure

Astellas’ Xospata (gilteritinib) Receives NMPA’s Conditional Approval for R/R AML with a FLT3 Mutation

Published: Feb 4, 2020 | Tags: Astellas, Xospata (gilteritinib), Receives, NMPA, Conditional, Approval, R/R AML, FLT3 Mutation

Daiichi Sankyo Initiates P-II Study of Patritumab Deruxtecan in Patients with EGFR-Mutated NSCLC

Published: Feb 4, 2020 | Tags: Daiichi Sankyo, Initiates, P-II, Study, Patritumab Deruxtecan, Patients, EGFR-Mutated NSCLC

Thermo Fisher Collaborates with JW Therapeutics for CAR-T Therapies in China

Published: Feb 4, 2020 | Tags: Thermo Fisher, Collaborates, JW Therapeutics, CAR-T Therapies, China

Pfizer Signs a License and Research Agreement with Imcyse to Develop Imotopes for Rheumatoid Arthritis

Published: Feb 4, 2020 | Tags: Pfizer, Signs, License, Research Agreement, Imcyse, Develop, Imotopes, Rheumatoid Arthritis

Merck KGaA’s Tepmetko (tepotinib) Receives the US FDA’s Approval for Patients with Metastatic NSCLC with METex14 Skipping Alterations

Published: Feb 4, 2020 | Tags: Merck KGaA, Tepmetko (tepotinib), Receives, US, FDA, Approval, Patients, Metastatic NSCLC, METex14, Skipping, Alterations

Jazz to Acquire GW Pharmaceuticals for $7.2B

Published: Feb 4, 2020 | Tags: Jazz, Acquire, GW Pharmaceuticals, $7.2B

Covaxx Initiates P-II Trial of UB-612 Against COVID-19 in Taiwan

Published: Feb 3, 2020 | Tags: Covaxx, Initiates, P-II, Trial, UB-612, Against, COVID-19, Taiwan

Russia’s Sputnik V Demonstrates 92% Efficacy Against COVID-19

Published: Feb 3, 2020 | Tags: Russia, Sputnik V, Demonstrates, 92%, Efficacy, Against, COVID-19

GSK Collaborate with CureVac to Develop Next Generation mRNA COVID-19 Vaccines

Published: Feb 3, 2020 | Tags: GSK, Collaborate, CureVac, Develop, Next, Generation, mRNA COVID-19, Vaccines

Innovent’s Tyvyt (sintilimab) + Pemetrexed and Platinum CT Receives NMPA’s Approval as 1L Therapy with Non-squamous Non-Small Cell Lung Cancer

Published: Feb 3, 2020 | Tags: Innovent, Tyvyt (sintilimab), Pemetrexed, Platinum CT, Receives, NMPA, Approval, 1L, Therapy, Non-squamous Non-Small Cell Lung Cancer

Genentech Signs an Exclusive License Agreement with X-Chem to Discover Oncology Targets

Published: Feb 3, 2020 | Tags: Genentech, Signs, Exclusive, License, Agreement, X-Chem, Discover Oncology, Targets

BMS’ Deucravacitinib Demonstrate Superiority Over Otezla (apremilast) in P-III POETYK PSO-2 Study for Plaque Psoriasis

Published: Feb 3, 2020 | Tags: BMS, Deucravacitinib, Demonstrate, Superiority, Otezla (apremilast), P-III, POETYK PSO-2, Study, Plaque Psoriasis

Celltrion Receives Health Canada’s Approval for Remsima SC (biosimilar, infliximab) for Rheumatoid Arthritis

Published: Feb 2, 2020 | Tags: Celltrion, Receives, Health, Canada, Approval, Remsima SC (biosimilar, infliximab), Rheumatoid Arthritis

Clover and Dynavax Plan to Initiate P-II/III Trial for Adjuvanted COVID-19 Vaccine Candidate

Published: Feb 2, 2020 | Tags: Clover, Dynavax, Plan, Initiate, P-II/III, Trial, Adjuvanted, COVID-19 Vaccine, Candidate

Medtronic Receives the US FDA’s Approval for DiamondTemp Ablation System to Treat Atrial Fibrillation

Published: Feb 2, 2020 | Tags: Medtronic, Receives, US, FDA, Approval, DiamondTemp, Ablation System, Treat, Atrial Fibrillation

Janssen Reports CHMP’s Acceptance for Accelerated Assessment of Cilta-cel’s MAA to Treat Patients with Heavily Pretreated Multiple Myeloma

Published: Feb 2, 2020 | Tags: Janssen, Reports, CHMP, Acceptance, Accelerated, Assessment, Cilta-cel, MAA, Treat, Patients, Heavily, Pretreated, Multiple Myeloma

Gilead Signs an Option and License Agreement with Gritstone for HIV Vaccine

Published: Feb 2, 2020 | Tags: Gilead, Signs, Option, License Agreement, Gritstone, HIV Vaccine

Horizon Therapeutics to Acquire Viela Bio for ~ $3.05B

Published: Feb 2, 2020 | Tags: Horizon, Therapeutics, Acquire, Viela Bio, ~ $3.05B

Incyte Receive Positive CHMP’s Opinion for Pemigatinib

Published: Feb 1, 2020 | Tags: Incyte, Receive, Positive, CHMP, Opinion, Pemigatinib

Gan & Lee Receives the US FDA’s Fast Track Designation for GLR2007 for the Treatment of Patients with Glioblastoma

Published: Feb 1, 2020 | Tags: Gan & Lee, Receives, US, FDA, Fast Track Designation, GLR2007  Treatment, Patients, Glioblastoma

Johnson & Johnson Report Results from P-III ENSEMBLE Trial for COVID-19 Vaccine

Published: Feb 1, 2020 | Tags: Johnson & Johnson, Report, Results, P-III, ENSEMBLE Trial, COVID-19 Vaccine

Amgen’s Sotorasib Receives NMPA’s Breakthrough Therapy Designation in China for the Treatment of Advanced NSCLC With KRAS G12C Mutation

Published: Feb 1, 2020 | Tags: Amgen, Sotorasib, Receives, NMPA, Breakthrough Therapy Designation, China, Treatment, Advanced, NSCLC, KRAS G12C Mutation

Novo Nordisk Receives the CHMP’s Positive Opinion for Sogroya (somapacitan)

Published: Feb 1, 2020 | Tags: Novo Nordisk, Receives, CHMP, Positive Opinion, Sogroya (somapacitan)

Merck’s Report Results of Keytruda (pembrolizumab) in Combination With Ipilimumab vs Keytruda Monotherapy in P-III KEYNOTE-598 for Metastatic Non-Small Cell Lung Cancer Patients

Published: Feb 1, 2020 | Tags: Merck, Report, Results, Keytruda (pembrolizumab), Combination, Ipilimumab, Keytruda Monotherapy, P-III, KEYNOTE-598, Metastatic, Non-Small Cell Lung Cancer Patients

Related Post: PharmaShots Weekly Snapshots (Jan 25- 29, 2021)

The post PharmaShots Weekly Snapshot (Feb 01-05, 2021) first appeared on PharmaShots.

Astellas’ Xospata (gilteritinib) Receives NMPA’s Conditional Approval for R/R AML with a FLT3 Mutation

Shots:

  • The approval was based on P-III ADMIRAL assessing gilteritinib (120mg, qd) vs CT in 319 patients with relapsed or refractory AML. The study showed patients had significantly longer overall survival OS, mOS (9.3 vs 5.6mos.)
  • Additionally, Chinese patient PK data from the ongoing P-III COMMODORE trial were also reviewed. The accelerated approval follows PR designation granted in Jul’2020 and its inclusion in overseas new drugs urgently needed in clinical settings
  • Xospata is the 1st FLT3 inhibitor approved by the NMPA for patients with r/r AML

Click here ­to­ read full press release/ article | Ref: Astellas | Image: Behance

The post Astellas’ Xospata (gilteritinib) Receives NMPA’s Conditional Approval for R/R AML with a FLT3 Mutation first appeared on PharmaShots.

PharmaShots Weekly Snapshot (Jan 4-8, 2020)

Almirall and Tyris Collaborate to Develop Next Generation Gene Therapies

Published: Jan 7, 2020 | Tags: Almirall, Tyris, Collaborate, Develop, Next Generation, Gene Therapies

Sarepta Reports Mixed Results of SRP-9001 (rAAVrh74.MHCK7.micro-dystrophin) in Part 1 of Study 102 for DMD   

Published: Jan 7, 2020 | Tags: Sarepta, Reports, Mixed Results, SRP-9001, (rAAVrh74.MHCK7.micro-dystrophin), Part 1, Study 102, DMD

PerkinElmer to Acquire Oxford Immunotec for ~$591M

Published: Jan 7, 2020 | Tags: PerkinElmer, Acquire, Oxford Immunotec, ~$591M

Pfizer Reports the First Patients Dosing of PF-06939926 in P-III CIFFREO Study for DMD

Published: Jan 7, 2020 | Tags: Pfizer, Reports, First, Patients, Dosing, of PF-06939926 in P-III CIFFREO Study for DMD

Alnylam Reports Results of Vutrisiran in P-III HELIOS-A Study for Patients with hATTR Amyloidosis with Polyneuropathy

Published: Jan 7, 2020 | Tags: Alnylam, Reports, Results, Vutrisiran, P-III, HELIOS-A, Study, Patients, hATTR Amyloidosis, Polyneuropathy

Bayer Collaborates with CureVac for CVnCoV Against COVID-19

Published: Jan 7, 2020 | Tags: Bayer, Collaborates, CureVac, CVnCoV, Against, COVID-19

Hologic to Acquire Biotheranostics for ~$230M

Published: Jan 7, 2020 | Tags: Hologic, Acquire, Biotheranostics, ~$230M

Pfizer Signs a License and Supply Agreement with ImaginAb for CD8 ImmunoPET Technology

Published: Jan 6, 2020 | Tags: Pfizer, Signs, License, Supply, Agreement, ImaginAb, CD8 ImmunoPET Technology

Merck KGaA Acquires AmpTec to Strengthen its mRNA Capabilities for Vaccines, Treatments and Diagnostics

Published: Jan 6, 2020 | Tags: Merck KGaA, Acquires, AmpTec, Strengthen, mRNA, Capabilities,  Vaccines, Treatments, Diagnostics

Genentech Signs ~$1B Pact with Ribometrix to Develop RNA-Targeted Small Molecule Therapies

Published: Jan 6, 2020 | Tags: Genentech, Signs, ~$1B, Pact, Ribometrix, Develop, RNA-Targeted, Small Molecule Therapies

Astellas Reports the US FDA’s Acceptance of Priority Review for its NDO Therapy

Published: Jan 6, 2020 | Tags: Astellas, Reports, US, FDA, Acceptance, Priority Review, NDO Therapy, Myrbetriq, mirabegron, tablets, oral suspension

Pfizer Collaborates with Dewpoint to Develop Therapies for Rare Form of Muscular Dystrophy

Published: Jan 6, 2020 | Tags: Pfizer, Collaborates, Dewpoint, Develop, Therapies, Rare Form of Muscular Dystrophy

 Nirmidas Receives the US FDA’s EUA for its COVID-19 Rapid Antibody Fingerstick Test    

Published: Jan 6, 2020 | Tags: Nirmidas, Receives, US, FDA, EUA, COVID-19, Rapid, Antibody, Fingerstick Test

AstraZeneca’s Farxiga (dapagliflozin) Receives the US FDA’s Priority Review for Chronic Kidney Disease

Published: Jan 6, 2020 | Tags: AstraZeneca, Farxiga, (dapagliflozin), Receives, US, FDA, Priority Review, Chronic Kidney Disease

AbbVie Reports Results of Skyrizi (Risankizumab) in P-III Studies for Active Psoriatic Arthritis

Published: Jan 5, 2020 | Tags: AbbVie, Reports, Results, Skyrizi, (Risankizumab), P-III, Studies, Active Psoriatic Arthritis

Regenxbio Reports the Initiation of First Pivotal Program for RGX-314 to Treat Wet AMD

Published: Jan 5, 2020 | Tags: Regenxbio, Provide, Update, RGX-314, Treat, Wet AMD, RGX-202

Evotec Receives Milestones in its Neurodegeneration Collaboration with BMS

Published: Jan 5, 2020 | Tags: Evotec, Bristol Myers Squibb, $6M, Milestones

Stryker Acquires OrthoSensor and its Knee Surgery Sensor Technology

Published: Jan 5, 2020 | Tags: Stryker, Acquires, OrthoSensor, Knee Surgery Sensor Technology

Biogen Signs a License Agreement with ViGeneron for Ophthalmic Gene Therapy Development

Published: Jan 4, 2020 | Tags: ViGeneron, Signs, Global License Agreement, Biogen, Ophthalmic Gene Therapy, Development

 Y-Biologics Signs a License Agreement with 3D Medicines for YBL-013 in the Territory of Greater China

Published: Jan 4, 2020 | Tags: Y-Biologics, signed, License Agreement, 3D Medicines, Develop, Manufacture, Commercialize, YBL-013

aTyr Reports Results of ATYR1923 in P-ll Study for COVID-19 Patients with Severe Respiratory Complications

Published: Jan 4, 2020 | Tags: aTyr Pharma, Report, Positive Results, ATYR1923, P-ll Study, COVID-19

Genentech’s Tiragolumab + Tecentriq Receive the US FDA’s Breakthrough Therapy Designation for PD-L1-High Non-Small Cell Lung Cancer

Published: Jan 5, 2020 | Tags: Genentech, Tiragolumab + Tecentriq, Receives, US FDA’s, Breakthrough Therapy Designation, PD-L1-High Non-Small Cell Lung Cancer

Pfizer and OPKO Reports the US FDA’s Acceptance of BLA for Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency

Published: Jan 4, 2020 | Tags: Pfizer, OPKO, Reports, US FDA, Acceptance, BLA, Somatrogon, Treat, Growth Hormone Deficiency (GHD)

 Hologic to Acquire Somatex for ~$64 M   

Published: Jan 4, 2020 | Tags: Hologic, Acquire, Somatex, $64 M

Provention Bio Reports Submission of BLA and Priority Review to the US FDA for Teplizumab to Prevent T1D  

Published: Jan 3, 2020 | Tags: Provention Bio, Reports, Submission, BLA, Priority Review, US, FDA, Teplizumab, Prevent, T1D

Oura Ring Monitors Body Temperature and Identify Early COVID-19 Symptoms

Published: Jan 2, 2020 | Tags: Oura Ring Monitors, Body Temperature, Identify, Early, COVID-19, Symptoms

Tiziana Completes Clinical Trial of Nasally Administered Foralumab for COVID-19 in Brazil

Published: Jan 3, 2020 | Tags: Tiziana, Completes, Clinical Trial, Nasally, Administered, Foralumab, COVID-19, Brazil

 Antengene Reports NDA Submission for ATG-010 (Selinexor) to Treat RRMM and RR DLBCL in South Korea     

Published: Jan 3, 2020 | Tags: Antengene, Reports, NDA, Submission, ATG-010, (Selinexor), RRMM, RR DLBCL, South Korea

AstraZeneca’s COVISHIELD Receives EUA in India for COVID-19

Published: Jan 4, 2020 | Tags: AstraZeneca, COVISHIELD, Receives, EUA in India

RedHill Reports Results of Yeliva (opaganib) in P-II Study for COVID-19

Published: Jan 3, 2020| Tags: RedHill, Reports, Results, Yeliva, (opaganib), P-II, Study, COVID-19

Related Post: PharmaShots Weekly Snapshots (Dec 28- 31, 2020)

The post PharmaShots Weekly Snapshot (Jan 4-8, 2020) first appeared on PharmaShots.

Astellas Reports the US FDA’s Acceptance of Priority Review for its NDO Therapy

Shots:

  • The US FDA has accepted the PR for NDA of mirabegron (oral suspension) and sNDA for Myrbetriq (mirabegron, tablets) for neurogenic detrusor overactivity (NDO) in pediatric patients aged ≥ 3yrs. with anticipated PDUFA date as Mar 28, 2021
  • The NDA & sNDA is based on P-III study assessing efficacy, safety, tolerability and PK of mirabegron in children and adolescents aged 3-<18yrs. with NDO and using clean intermittent catheterization
  • In 2012, Myrbetriq tablets were initially approved in the US for adults with overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency

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

The post Astellas Reports the US FDA’s Acceptance of Priority Review for its NDO Therapy first appeared on PharmaShots.

PharmaShots Weekly Snapshots (Dec 7-11, 2020)

Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing

Published: Dec 11, 2020 | Tags: Antigen, COVID-19, High, Laboratory, Launch, patients, Roche, SARS-CoV-2, Support, Suspected, Test, Testing, Volume

Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan

Published: Dec 10, 2020 | Tags: Casirivimab, Chugai, Commercialization, COVID-19, Development, Imdevimab, In-License Agreement, Japan, Roche, Sign

Roche Presents Results of Tecentriq (atezolizumab) in P-III IMvigor010 Study for MIUC at ESMO 2020

Published: Dec 10, 2020 | Tags: (atezolizumab), ESMO Virtual Congress 2020, IMvigor010 Study, Muscle-Invasive Urothelial Cancer (MIUC), P-III, reports, results, Roche, Tecentriq

Biogen Reports NDA Submission of Aducanumab (BIIB037) to the MHLW for Alzheimer’s Disease

Published: Dec 9, 2020 | Tags: (BIIB037) US FDA, aducanumab, Alzheimer Disease, Biogen, J-NDA Submission, reports

Gilead to Acquire MYR for ~$1.4B

Published: Dec 10, 2020 | Tags: ~$1.4B, Acquire, Gilead Sciences, MYR GmbH

Boehringer Ingelheim to Acquires NBE-Therapeutics ~ $1.5B

Published: Dec 10, 2020 | Tags: Acquires, Boehringer Ingelheim, NBE-Therapeutics

Pfizer and BioNTech ‘s BNT162b2 Receive Health Canada Authorization to Combat COVID-19

Published: Dec 9, 2020 | Tags: (BNT162b2), BioNTech, COVID-19, Health Canada Authorization, Interim Order, patients, Pfizer, receives

Google Launches Health Research App Focusing on Respiratory Illnesses

Published: Dec 9, 2020 | Tags: App, COVID-19, Flu, Google, Launches, Virtual Medical Research

Novartis Reports Results of Kisqali in P-III MONALEESA-7 Trial to Treat HR+/HER2- Metastatic Breast Cancer

Published: Dec 9, 2020 | Tags: HR+/HER2- Metastatic Breast Cancer, Kisqali, MONALEESA-7 Trial, Novartis, P-III, reports, results

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials

Published: Dec 9, 2020 | Tags: Collaborates, COVID-19, Moderna, Roche, SARS-CoV-2 Ab Test, Vaccine Trials

Lilly Reports Results of Tirzepatide in P-lll SURPASS-1 Monotherapy Trial for Type-2 Diabetes

Published: Dec 9, 2020 | Tags: Lilly, Monotherapy Trial, P-lll, reports, results, SURPASS-1, Tirzepatide, Type-2 diabetes

Boehringer Ingelheim to Acquires Labor Dr. Merk & Kollegen for Boosting its Next Generation Cancer Immunology Program

Published: Dec 9, 2020 | Tags: Acquires, Boehringer, Cancer Immunology Program, Kollegen, Labor Dr. Merk, Next Generation, Strength

Elsevier Acquires Shadow Health

Published: Dec 9, 2020 | Tags: Acquires, Elsevier, Extensive Portfolio, Shadow Health

Roche Highlights its Bispecific Antibody Portfolio Across a Range of Blood Cancers at ASH 2020

Published: Dec 8, 2020 | Tags: 62, Across, ALL, Annual, antibody, ASH, Bispecific, Blood, cancers, Data, From, Meeting, Portfolio, Presents, Range, Roche, Virtual

Amgen’s Sotorasib Receives the US FDA’s Breakthrough Therapy Designation for Advanced or Metastatic NSCLC with KRAS G12C Mutation

Published: Dec 8, 2020 | Tags: Advanced or Metastatic Non-Small Cell Lung Cancer, Amgen, Breakthrough Therapy Designation, KRAS G12C, Mutation, receives, Sotorasib, US FDA’s

Medtronic Launches Carpediem as the First Pediatric and Neonatal Acute Dialysis Machine in the US

Published: Dec 8, 2020 | Tags: Acute, Carpediem, Dialysis, First, Launch, Machine, Medtronic, neonatal, Only, Pediatric, System, US

AstraZeneca Reports Results of AZD1222 in Interim Analysis of P-lll Program for COVID-19

Published: Dec 8, 2020 | Tags: AstraZenca, AZD1222, Clinical Trials, COVID-19, Four, Interim Analysis, P-lll, reports, results

Novartis’ Asciminib (ABL001) Demonstrate Superiority Over Pfizer’s Bosulif in Chronic Myeloid Leukemia Trial

Published: Dec 8, 2020 | Tags: (ABL001), ASCEMBL Study, Asciminib, Chronic, Chronic Myeloid Leukemia, Novartis, P-lll, Philadelphia Chromosome, reports, results

RetinAI Collaborates with Novartis to Provide AI Solutions in Ophthalmology

Published: Dec 8, 2020 | Tags: Artificial Intelligence, Multi-Year Collaboration, Novartis, Ophthalmology, Provide, RetinAI, Signs, Solutions

Astellas Collaborates with KaliVir to Develop and Commercialize VET2-L2

Published: Dec 7, 2020 | Tags: Agreement, Astellas, Commercialization, Development, KaliVir Immunotherapeutics, Novel, Oncolytic, Signs, VET2-L2, Virus

Qiagen Launches QuantiFERON SARS-CoV-2 RUO Solution for COVID-19

Published: Dec 7, 2020 | Tags: COVID-19, Launches, Qiagen, QuantiFERON, SARS-CoV-2 RUO, Solution

Bayer Signs an Exclusive Worldwide License Agreement with Atara for Mesothelin-Targeted CAR T-cell Therapies to Treat Solid Tumors

Published: Dec 6, 2020 | Tags: Agreement, Atara, Bayer, Exclusive, License, Mesothelin-Targeted CAR T-cell Therapies, Signs, Solid Tumors, Worldwide

Nektar Therapeutics Presents Preclinical Data of NKTR-255 in P-Ib/II Study at ASH 2020

Published: Dec 7, 2020 | Tags: 2020, 62nd, Annual, ASH, Meeting, Nektar Therapeutics, NKTR-255, P-Ib/II, preclinical, Presents, results, study

AbbVie Reports Results of Imbruvica (ibrutinib) in Two P-III Studies as 1L Treatment for Chronic Lymphocytic Leukemia

Published: Dec 6, 2020 | Tags: (ibrutinib), 1L treatment, AbbVie, CLL, ILLUMINATE Study, Imbruvica, Integrated Analysis, Long-Term, P-lll, reports, RESONATE-2

Roche Reports of Polivy + Bendamustine and MabThera / Rituxan in P-lb/ll GO29365 Study for R/R Diffuse Large B-Cell Lymphoma

Published: Dec 7, 2020 | Tags: (polatuzumab vedotin), (R/R) Diffuse Large B-Cell Lymphoma, Bendamustine, GO29365 Study, MabThera / Rituxan (rituximab), P-lb/ll, Polivy, reports, Result, Roche

Roche Presents Results of Hemlibra Reinforcing the Long-Term Benefits for Hemophilia A at ASH 2020

Published: Dec 7, 2020 | Tags: 62nd, Annual, ASH, Haemophilia A, HAVEN, Hemlibra, I-IV, Meeting, P-III, People, Presents, results, Roche, Studies, Virtual

AstraZeneca Reports Long-Term Efficacy and Tolerability of Calquence (acalabrutinib) in P-ll ACE-LY-004 Study for MCL

Published: Dec 7, 2020 | Tags: (acalabrutinib) in P-ll ACE-LY-004 Study for Relapsed or Refractory Mantle Cell Lymphoma, AstraZenca, Calquence, Long-Term Efficacy, reports, Tolerability

Roche Reports Long-Term Benefits of Venclexta/Venclyxto Based Combination for R/R Chronic Lymphocytic Leukemia

Published: Dec 5, 2020 | Tags: Based, CLL14, combination, MURANO, P-III, People, R/R CLL, reports, results, Roche, Studies, Venclexta, Venclyxto

Kite Reports Results of Yescarta in P-II ZUMA-5 Study for Adult Patients with R/R Indolent Non-Hodgkin Lymphoma

Published: Dec 5, 2020 | Tags: Adult, iNHL, Kite, P-II, patients, Refractory, Relapsed, reports, results, study, Yescarta, ZUMA-5

Janssen Reports Long-Term Benefits of Imbruvica (ibrutinib) as 1L Treatment for High-Risk Chronic Lymphocytic Leukemia

Published: Dec 6, 2020 | Tags: (ibrutinib), 1L treatment, High-Risk Chronic Lymphocytic Leukaemia, ILLUMINATE Study, Imbruvica, Janssen, P-lll, reports, RESONATE-2, results

Related Post: PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

The post PharmaShots Weekly Snapshots (Dec 7-11, 2020) first appeared on PharmaShots.

Astellas Collaborates with KaliVir to Develop and Commercialize VET2-L2

Shots:

  • KaliVir to receive $56M as upfront & other payments supporting the research & preclinical activities of VET2-L2 & is eligible to receive $307M & $271M as development, regulatory & commercialization for VET2-L2 & second product, respectively along with royalties on sales of each licensed product
  • The alliance integrates KaliVir’s expertise in the development of oncolytic viruses with Astellas’ capabilities in advanced drug development & its global business experience, enabling both parties to develop new immuno-oncology therapies
  • VET2-L2 (IV) is an oncolytic vaccinia virus that destroys cancer cells & activates anti-cancer immunity through the expression of therapeutic transgenes

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

The post Astellas Collaborates with KaliVir to Develop and Commercialize VET2-L2 first appeared on PharmaShots.

$200M investment to advance clinical programs for Ambrx

The San Diego-based biopharma firm has several oncology therapies in development and has partnered in the past with the likes of Astellas, BeiGene and Bristol-Myers Squibb.

Top 20 Immunology Companies Based 2019 Immunology Segment Revenue

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

Immunology Segment Revenue: $0.01B

Founded Year: 1979

Market Cap: ~ $0.49B

Total Employees: ~178

Headquarter: New Jersey, United States

Stock Exchange: NASDAQ

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

Immunology Segment Revenue: $0.24B

Founded Year: 2008

Market Cap: ~$15.70B

Total Employees: ~1,200

Headquarter: Dublin, Ireland

Stock Exchange: NASDAQ

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”

Immunology Segment Revenue: $0.49B

Founded Year: 1993

Market Cap: ~$2.57B

Total Employees: ~5,047

Headquarter: Shenyang, China

Stock Exchange: HKD

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.

Immunology Segment Revenue: $0.73B

Founded Year: 1978

Market Cap: ~$42.57B

Total Employees: ~7,400

Headquarter: Massachusetts, United States

Stock Exchange: NASDAQ

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.

Immunology Segment Revenue: $0.81B

Founded Year: 2000

Market Cap: ~$88.14

Total Employees: ~99,000

Headquarter: Brentford, United Kingdom

Stock Exchange: LON

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.

Immunology Segment Revenue: $1.11B

Founded Year: 2007

Market Cap: ~$34.6B

Total Employees: ~7,228

Headquarter: Osaka, Japan

Stock Exchange: TYO

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.

Immunology Segment Revenue: $1.24B

Founded Year: 1891

Market Cap: ~$197.46B

Total Employees: ~71,000

Headquarter: New Jersey, United States

Stock Exchange: NYSE

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.

Immunology Segment Revenue: $1.68B

Founded Year: 1991

Market Cap: ~$19.38B

Total Employees: ~1,300

Headquarter: Delaware, United States

Stock Exchange: NASDAQ

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.

Immunology Segment Revenue: $1.79B

Founded Year: 2005

Market Cap: ~ $26.49B

Total Employees: ~15,883

Headquarter: Tokyo, Japan

Stock Exchange: TYO

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.

Immunology Segment Revenue: $1.79B

Founded Year: 1901

Market Cap: ~$135.16B

Total Employees: ~33,625

Headquarter: Indiana, United States

Stock Exchange: NYSE

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.

Immunology Segment Revenue: $1.92B

Founded Year: 1928

Market Cap: ~$20.49

Total Employees: ~7,600

Headquarter: Brussels, Belgium

Stock Exchange: EBR

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.

Immunology Segment Revenue: $2.53B

Founded Year: 1973

Market Cap: ~$122.35B

Total Employees: ~100,000

Headquarter: Paris, France

Stock Exchange: EPA

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.

Immunology Segment Revenue: $2.97B

Founded Year: 1887

Market Cap: ~$135.30B

Total Employees: ~30,000

Headquarter: New York, United States

Stock Exchange: NYSE

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.

Immunology Segment Revenue: $3.66B

Founded Year: 1925

Market Cap: ~$52.60B

Total Employees: ~49,578

Headquarter: Osaka, Japan

Stock Exchange: TYO

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.

Immunology Segment Revenue: $4.22B

Founded Year: 1996

Market Cap: ~$205.93B

Total Employees: ~109,000

Headquarter: Basel, Switzerland

Stock Exchange: SIX Swiss Exchange, NYSE

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.

Immunology Segment Revenue: $4.73B

Founded Year: 1849

Market Cap: ~$206.05B

Total Employees: ~83,000

Headquarter: New York, United States

Stock Exchange: NYSE

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.

Immunology Segment Revenue: $5.39B

Founded Year: 1980

Market Cap: ~$134.11B

Total Employees: ~23,400

Headquarter: California, United States

Stock Exchange: NASDAQ

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.

Immunology Segment Revenue: $8.79B

Founded Year: 1896

Market Cap: ~ $281.59B

Total Employees: ~98,000

Headquarter: Basel, Switzerland

Stock Exchange: SWX

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.

Immunology Segment Revenue: $13.95B

Founded Year: 1887

Market Cap: ~$378.94B

Total Employees: ~132,100

Headquarter: New Jersey, United States

Stock Exchange: NYSE

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.

Immunology Segment Revenue: $19.57B

Founded Year: 2012

Market Cap: ~$146.29B

Total Employees: ~30,000

Headquarter: Illinois, United States

Stock Exchange: NYSE

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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Astellas doubles down on partnership and buys bioelectronics firm iota

Astellas Pharma is to buy bioelectronic medical devices firm iota Biosciences in a deal worth up to $429m, building on a previous research partnership.

In August last year the companies began a joint research and development agreement based around iota’s bioelectronic devices in several indications.

Bioelectronics is a field that has been investigated by Google’s life sciences division Verily, which co-founded Galvani Bioelectronics with GlaxoSmithKline in 2016.

The partnership focused on harnessing the body’s electrical signals to treat chronic diseases such as asthma, arthritis and gastrointestinal diseases.

Companies including AliveCor and Apple use bioelectronics to measure the heart rate and predict atrial fibrillation.

iota’s technology uses ultrasound as a power source and means of communication. Together with Astellas the pair will develop technology based around tiny millimetre-sized implantable medical devices, the companies said.

Astellas will pay $127.5 million up front to buy the remainder of the iota shares that it does not already own – the Japan-based pharma already has a stake after a US subsidiary invested in iota’s Series A stock offering.

Shareholders in iota could also receive additional payments of up to $176.5 million if pre-determined milestones are met before certain deadlines.

Upon completion iota will become a wholly-owned subsidiary of Astellas, which said it is also committing to spend a total of $125 million over the next five years to fuel iota’s “aggressive expansion”.

iota is a start-up founded in 2017 by Michel Maharbiz and Jose Carmena, who are both experts in the field of bioelectronics.

The company’s technology uses ultrasound to power miniature devices and enable wireless communication, allowing ultra-small, battery-free, wireless implantable medical devices.

Conventional implantable medical devices require batteries for power supply and wires or large electronic circuits to enable communications.

This has made size reduction difficult and has often resulted in highly invasive implant procedures.

iota’s bioelectronic devices can be implanted through a less invasive operative procedure and promise improved effectiveness and reduced physical burden for the patients during and after surgery.

Since striking up the research partnership last year the companies have begun several projects, and clinical trials based on the technology are expected to begin in the next few years.

Astellas said it is still reviewing the financial impacts of the transaction for the fiscal year ending 31st March 2021.

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NICE backs NHS use for Astellas’ Xospata after rethink

NICE has recommended regular NHS funding for Astellas’ Xospata (gilteritinib) monotherapy for certain adult patients with acute myeloid leukaemia. 

In final draft guidance NICE said that the drug is recommended for relapse or refractory FLT3 mutation-positive AML, giving patients an alternative to chemotherapy and its unpleasant side effects. 

However because of considerable uncertainty about long-term survival after stem cell transplant, NICE said the drug should not be funded as maintenance therapy after a haematopoietic stem cell transplant. 

The decision follows first draft guidance in January where NICE rejected Xospatabut has had a rethink after Astellas submitted additional data and cost-effectiveness estimates. 

Guidance applies to England and Wales, meaning that around 443 patients will benefit from the drug each year now that final guidance has been issued. 

The list price for Xospata is £14,188 per 28-day pack however, the company has made the drug available to the NHS at a confidential discount. 

AML is an aggressive and fast-growing blood cancer with a poor prognosis and is often diagnosed after emergency admission to hospital. 

Only 16% of women and 15% of men in England survive more than five years with the disease, and those with the FLT3 mutations are more likely to relapse. 

Treatment for AML is limited and is managed with salvage chemotherapy, often requiring inpatient care. 

But chemotherapy side effects are unpleasant and NICE acknowledged that alternative treatment options that improve survival and quality of life would be welcomed by patients. 

Xospata is the first oral monotherapy to be approved in the UK that targets relapsed or refractory FLT3 positive AML.  

This means that medication can be taken at home rather than in hospital. Gilteritinib also improves overall survival when compared with chemotherapy. In one study, gilteritinib increased median overall survival from 5.6 months to 9.3 months. 

Xospata was approved in this indication by the European Commission in October last year, and by the FDA in 2018. 

Daiichi Sankyo has tried to produce a rival FLT3 inhibitor, quizartinib, but this has been rejected by regulators in the US and EU. 

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