Target $80
Thursday, April 1, 2021
AbCellera, Gilead in New Multi-Year, Multi-Target Antibody Discovery Collaboration
Expanded collaboration includes an eight-target discovery partnership leveraging AbCellera’s entire technology stack, including the Trianni Mouse® and the OrthoMabTM bispecific platforms
AbCellera (Nasdaq: ABCL) today announced agreements to expand its collaboration with Gilead Sciences, Inc. (Gilead) including a multi-year, multi-target antibody discovery collaboration and access to AbCellera’s humanized mouse technology, the Trianni Mouse®. Under the financial terms of the agreements, AbCellera will receive an upfront payment and is eligible for milestone payments and royalties based on the development and commercialization of antibodies generated by AbCellera under this collaboration.
Building on the successful completion of the first collaboration together, under the new agreement AbCellera will generate panels of antibodies for up to eight new targets, across multiple indications, selected by Gilead. The expanded collaboration will leverage the full breadth of AbCellera’s technology stack, including the recently added capabilities for sourcing diverse, fully-humanized antibodies using the Trianni Mouse® platform and combining any two antibodies to create native bispecifics using the OrthoMabTM protein engineering platform.
https://finance.yahoo.com/news/abcellera-gilead-sciences-announce-multi-130000943.html
CVS Expands Covid-19 Vaccinations To Pharmacies In 44 States
CVS Health (NYSE: CVS) has surpassed 10 million COVID-19 vaccine doses administered through its participation in the Pharmacy Partnership for Long-Term Care Program and Federal Retail Pharmacy Program. The company is now administering vaccines in nearly 2,000 stores across 44 states, Puerto Rico, and Washington, D.C., with the pace of vaccinations expected to rapidly accelerate as more supply becomes available. CVS Pharmacy has the capacity to administer up to 25 million shots per month.
https://finance.yahoo.com/news/cvs-health-surpasses-10-million-120000682.html
Agios Agrees to Repurchase 10% Stake from Bristol-Myers Squibb for $344.5M
Agios Pharmaceuticals, Inc.. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat genetically defined diseases, today announced the closing of the sale of its commercial, clinical and research-stage oncology portfolio to Servier Pharmaceuticals, LLC, an independent global pharmaceutical company. The transaction was approved by Agios shareholders on March 25, 2021.
In consideration for its oncology portfolio, Agios received from Servier $1.8 billion in upfront cash and is eligible to receive an additional $200 million in a potential future milestone payment for vorasidenib, as well as 5% royalties on U.S. net sales of TIBSOVO® (ivosidenib tablets) from sales after the closing through loss of exclusivity and 15% royalties on U.S. net sales of vorasidenib from the first commercial sale through loss of exclusivity.
In addition, Agios today announced that it has entered into a definitive agreement with Bristol-Myers Squibb Company (BMS) to repurchase 7,121,658 shares of Agios common stock held by BMS and its affiliates for an aggregate purchase price of $344.5 million, or $48.3785 per share, using the proceeds from the sale of the oncology business. As previously disclosed, the Agios board of directors authorized the company to repurchase up to $1.2 billion of its outstanding shares, using the proceeds from the sale of the oncology business. Following completion of the repurchase of shares from BMS, Agios expects to conduct the remaining $855.5 million of share repurchases over the next 12-18 months, including executing a meaningful portion of the planned repurchases by year-end through a combination of 10b5-1 plans and open market purchases.
With a singular focus on growing the company’s genetically defined disease clinical and research pipeline, Agios anticipates significant key milestones in 2021, including filing for regulatory approval for mitapivat in adults with PK deficiency in both the U.S. and EU; initiating two Phase 3 studies of mitapivat in transfusion dependent and non-transfusion dependent thalassemia; initiating a Phase 2/3 study of mitapivat in sickle cell disease; presenting the first data from the healthy volunteer study of AG-946, the next generation PKR activator; and prioritizing new indications for PKR and pyruvate kinase M2 (PKM2) activator clinical development. In addition, Agios will explore all options to maximize the patient impact and value of mitapivat globally, including strategic transactions.
Aytu BioPharma Divests U.S. Rights to Natesto(R) to Acerus Pharma
Aytu BioPharma, Inc. (NASDAQ:AYTU) a specialty pharmaceutical company focused on commercializing novel therapeutics and consumer healthcare products, today announced the signing of an agreement with Acerus Pharmaceuticals Corporation (ASP)(ASPCF) whereby Acerus will acquire all remaining rights to Natesto in the United States from Aytu. In consideration, Aytu will receive $7.5M in cash from Acerus, which is payable in $250,000 monthly payments over 30 months. Additionally, Acerus will assume all product responsibilities associated with Natesto following the April 1, 2021 effective date. Aytu will provide transition support to Acerus over a 120-day transition period.
https://finance.yahoo.com/news/aytu-biopharma-divests-u-rights-113000202.html
United Therapeutics: FDA OKs Tyvaso® for Pulmonary Hypertension
First and only approved therapy in the United States for patients with PH-ILD, a serious, life-threatening disease with potentially more than 30,000 patients in need
FDA approval based on data from the INCREASE clinical trial
PH-ILD is the second FDA-approved indication for Tyvaso, which was initially approved for the treatment of pulmonary arterial hypertension
Pfizer COVID-19 vax continues to be over 90% effective at least 6 months
Six months after getting a second dose of the Pfizer-BioNTech vaccine as part of a 46,000-person clinical trial, volunteers remained more than 90% protected against symptomatic COVID-19 and even better protected against severe disease, a new company study found.
Out of 927 trial participants who fell ill with COVID-19 more than a week after their second dose, only 77 had received the active vaccine, compared with 850 who got a placebo.
There were no serious safety concerns seen among the 12,000 volunteers who are least least six months past their second dose, according to the newly released findings. Many, however, did have typical, short-term side effects like fatigue and sore arms.
The new data is likely sufficient for the vaccine to meet the criteria set by the U.S. Food and Drug Administration for full approval.
All three COVID-19 vaccines authorized so far – from Pfizer-BioNTech, Moderna and Johnson & Johnson – are being distributed under Emergency Use Authorizations rather than full FDA Biologics Licenses, because they did not have long-term safety and effectiveness data.
The FDA allowed the companies to present only two months of data so they could get the COVID-19 shots to the public faster during a global emergency. The agency has said it would consider issuing a full license once a vaccine has a track record of at least six months – the same requirement as for vaccines that prevent other infectious diseases.
Pfizer and its German collaborator BioNTech, whose vaccine has been administered to nearly 77 million Americans, are expected to submit their application for full licensure to the FDA some time this month.
"These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. FDA,” Pfizer CEO Albert Bourla said in a prepared statement.
Others said the data suggests the vaccine deserves full approval. "It seems pretty safe" to assume that the agency will fully license the vaccine, said Luciana Borio, a biotech executive and former FDA chief scientist.
"It's really wonderful news that these vaccines continue to progress very rapidly toward licensure," she said.
Full licensure, she said, would be "one less reason for the skeptics to decline vaccination."
But the general public will notice very little difference, said Jacob Sherkow, a law professor at the University of Illinois College of Law.
The main advantage of licensure, he said, is to provide security to the company that its authorization won't expire. A Biologics License usually provides a company 12 years of exclusivity for its product.
Emergency Use Authorizations, by contrast, are temporary, Sherkow said. "If the FDA grants an EUA, it can yank it any time it wants for any reason or no reason." It would also expire when the "emergency" is over.
"I think (licensure) will give the company some solace that they're not going to be victims of their own success," he said. "If you have a very effective vaccine and the vaccine ends the pandemic, then you've ended the emergency that authorized the EUA and you're not authorized anymore. The BLA guarantees that you get to stay on the market indefinitely."
The FDA will likely move quickly to consider full licensure, Borio said, but noted that staffers are busy with other requests, too.
Pfizer and BioNTech said Wednesday they would ask the FDA for permission to provide their vaccine to adolescents ages 12-15. The vaccine is already authorized for use in older adolescents, and new data suggests it's just as safe and totally protective in younger ones.
The agency is also expected to be asked within the next few days to review an application for authorization from AstraZeneca and Oxford University for the vaccine they've co-developed.
In their latest study Pfizer and BioNTech also showed that their vaccine is effective against a virus variant called B.1.351, first identified in South Africa.
About 800 of the trial participants were from South Africa and nine of them developed COVID-19, all in the placebo group. The companies sequenced the genes of all nine of those infected and found that six belonged to the B.1.351 variant.
“These data also provide the first clinical results that a vaccine can effectively protect against currently circulating variants, a critical factor to reach herd immunity and end this pandemic for the global population,” Ugur Sahin, CEO and co-founder of BioNTech, said in a prepared statement.
The vaccine also appeared to be extremely effective against nearly all cases of severe disease across all trial participants.
The FDA and Centers for Disease Control and Prevention have slightly different definitions for "severe disease." Under the FDA's definition, there were 21 cases of severe disease, 20 of whom received a placebo. Under CDC's definition, 32 trial participants developed severe disease, all of them in the placebo group, according to the study.
Pfizer and BioNTech plan to submit the new data to a peer-reviewed journal for review and publication.
They will continue to follow trial participants for two years to ensure continued safety and effectiveness and to begin to answer one of the last major outstanding questions about COVID-19 vaccines: how long they will remain effective.
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