AstraZeneca will have enough COVID-19 vaccine for 200M doses this year

 AstraZeneca will have enough of its candidate vaccine for 200 million doses by the end of 2020, with drug substance for 700 million doses by the end of the first quarter of 2021 globally, operations executive Pam Cheng said on Monday.

Cheng told a briefing that the company would keep the “active” drug substance in stock while it awaited regulatory approval around the world.

She said there would be enough vaccine for 20 million doses in Britain by the end of the year, with enough “active” drug substance for 70 million doses for the UK by the end of Q1 2021.

She said she expected that to translate into 4 million finished vaccine doses by the end of 2020, and 40 million finished doses by the end of Q1 next year.

Those calculations were based on using two full doses, she said, although trial data suggests higher efficacy when the initial shot is a half dose.

“If we go with a half dose you can imagine for the initial dose, we will be able to double the number of vaccinations here,” she said.

She said the figures referred to the vaccine doses being manufactured by AstraZeneca, and not those being made by manufacturing partners.

https://www.reuters.com/article/us-health-coronavirus-astrazeneca-cheng/astrazeneca-will-have-enough-covid-19-vaccine-for-200-million-doses-this-year-idUSKBN2830XV

Oxford COVID-19 vaccine efficacy would look higher if trial tested for severe virus

 

The experimental COVID-19 vaccine developed by AstraZeneca and Oxford University would have a higher efficacy rate if trials were only measuring whether the shot prevents hospitalisation and severe disease, Oxford's vaccine chief said on Monday.

Speaking in a briefing, Andrew Pollard, director of the Oxford Vaccine Group, said it is hard to explain the different efficacy rates between the AstraZeneca/Oxford shot and the other vaccines developed by Pfizer and BioNTech and one by Moderna.

Pfizer-BioNTech and Moderna late-stage studies showed efficacy of more than 90%, while the British shot was on average 70% effective after testing its efficacy for all levels of the disease from severe to mild.

One reason may be that the companies are measuring for different things, Pollard said.

There may also be real differences between all the vaccines, he said.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/Oxford-COVID-19-vaccine-efficacy-would-look-higher-if-trial-tested-for-severe-virus-31846376/

Kiniksa: FDA Accepts Supplemental Application for Rilonacept for Pericarditis

 Kiniksa Pharmaceuticals Ltd. said Monday the U.S. Food and Drug Administration accepted the supplemental biologics license application for rilonacept in recurrent pericarditis.

The biopharmaceutical company said the FDA granted priority review to the application and assigned a Prescription Drug User Fee Act goal date of March 21. Rilonacept is a weekly, subcutaneously injected, recombinant dimeric fusion protein that blocks interleukin-1 alpha and interleukin-1 beta signaling.

The FDA granted breakthrough therapy designation to rilonacept for the treatment of recurrent pericarditis in 2019 and orphan drug designation to rilonacept for the treatment of pericarditis in 2020.

Rilonacept was discovered and developed by Regeneron Pharmaceuticals Inc. and is approved by the FDA for the treatment of cryopyrin-associated periodic syndromes. Kiniksa licensed rilonacept from Regeneron in 2017. If approved by the FDA for recurrent pericarditis, Kiniksa would take responsibility for sales and distribution of rilonacept for all the approved indications in the U.S. and evenly split profits with Regeneron.

Kiniksa is obligated to pay regulatory milestones to Regeneron of up to $27.5 million through the time of a potential approval of rilonacept in recurrent pericarditis, of which $7.5 million is expected to be paid in the fourth quarter of 2020.

https://www.marketscreener.com/quote/stock/KINIKSA-PHARMACEUTICALS-43459706/news/Kiniksa-Pharmaceuticals-FDA-Accepts-Supplemental-Application-for-Rilonacept-for-Pericarditis-31848499/

Sell-side pans AstraZeneca COVID-19 results; AZN slips, Pfizer, BioNTech, Moderna gain

 

• On just the headline numbers alone, the AstraZeneca (NASDAQ:AZN)/Oxford Covid-19 vaccine trial numbers (on average preventing 70% of infections) didn't match the 90%+ results from the Pfizer/BioNTech (PFE, BNTX) and Moderna (NASDAQ:MRNA) studies.
• SVB Leerink's Geoff Porges throws a bit more shade on things, calling AZN's efficacy results "embellished," and raising questions after safety data disclosures. Porges believes the vaccine will never be licensed for U.S. use.
• For now, AstraZeneca awaits data from its U.S. trial (this morning's results were from trials in the U.K. and Brazil). In the meantime, the company is readying applications for conditional approval from other global regulators, including an emergency use listing from the WHO.
• Premarket action: AZN -1.65%, PFE +1%, BNTX +5.1%, MRNA +4%
• https://seekingalpha.com/news/3638661-least-one-sell-sider-not-impressed-astrazeneca-covidminus-19-results-azn-slips-while-pfizer

Eiger Bio rises on sale of priority review voucher for $95M

 

• Eiger BioPharmaceuticals (NASDAQ:EIGR) jumps 8% premarket after entering into an agreement to sell its Priority Review Voucher (PRV) for a lump sum payment of $95M.
• Eiger will retain 50% of the proceeds, or $47.5M, under the terms of the Collaboration and Supply Agreement with The Progeria Research Foundation (PRF).
• The PRV was granted in conjunction with the recent approval by the FDA of Zokinvy (lonafarnib) for treatment of Progeria and processing-deficient Progeroid Laminopathies.
• "The sale of the PRV provides Eiger with an important source of non-dilutive capital and further strengthens our balance sheet," said David Cory, President and CEO of Eiger.
• Eiger licensed worldwide rights to lonafarnib from Merck.  Merck will not receive any milestone payments for the development of lonafarnib, and has waived royalty obligations from Eiger for a specified quantity of lonafarnib.
• https://seekingalpha.com/news/3638658-eiger-bio-rises-8-on-sale-of-priority-review-voucher-for-95m

Merck files for licensure of V114 in U.S. and Europe

 

• Merck (NYSE:MRK) has submitted applications to the FDA and EMA for licensure of V114, its investigational 15-valent pneumococcal conjugate vaccine, for use in adults 18 years of age and older for prevention of pneumococcal disease.
• The company awaits acceptance by the U.S. and European regulatory authorities.
• An overview of the late-stage development program for V114 is available here.
• V114 has previously secured accelerated review status in U.S. for the prevention of invasive pneumococcal disease in pediatric patients 6 weeks to 18 years of age and adults 18 years of age and older.
• https://seekingalpha.com/news/3638590-merck-files-for-licensure-of-v114-in-u-s-and-europe

Schrödinger inks multi-target drug discovery deal with Bristol-Myers

 

• Schrödinger (NASDAQ:SDGR) jumps 7% premarket on collaboration with Bristol-Myers Squibb (NYSE:BMY) to discover, develop, and commercialize therapeutics in multiple disease areas.
• The collaboration includes two of Schrödinger’s early-stage programs and additional undisclosed targets.
• Under the terms of the agreement, Bristol-Myers will pay $55M upfront, and Schrödinger will also be eligible to receive up to $2.7B in milestone payments plus royalties.
• Schrödinger will be responsible for the discovery of development candidates and has agreed to grant BMY exclusive worldwide rights to develop and commercialize the development candidates generated by the collaboration.
• https://seekingalpha.com/news/3638576-schrodinger-inks-multi-target-drug-discovery-deal-bristol-myers-squibb