Pharma giants granted coronavirus approvals but doubts remain on manufacturing a global vaccine
- On Sunday, Roche's Covid-19 antibody test received FDA Emergency Use Authorization.
- After weeks of speculation and mixed messages from prematurely released data, Gilead's experimental drug remdesivir was granted emergency use authorization by the U.S. Food and Drug Administration.
- Moderna announced a 10-year manufacturing agreement with Lonza that could result in the production of 1 billion doses per year.
There were several major developments over the last week with the medical community marking progress in all three critical areas: testing, treatments and vaccines.
Experts have welcomed positive data on potential treatments and progress on testing, but warn that vaccine timelines look ambitious and argue more thought is needed on manufacturing.
Testing
On Sunday, Roche's Covid-19 antibody test received FDA Emergency Use Authorization. The test is designed to help determine if a patient has been exposed to the virus and has developed antibodies against it. Roche will provide high double-digit millions of tests from this month.
Roche CEO Severin Schwan told CNBC on April 22 that, "Unlike with molecular tests which directly measure the virus, with antibody tests, the scaling is much easier from a technical point of view plus there is an enormous base of installed instruments and platforms out there."
Treatments
After weeks of speculation and mixed messages from prematurely released data, Gilead's experimental drug remdesivir was granted emergency use authorization by the U.S. Food and Drug Administration for Covid-19 on Friday. This will enable broader use of remdesivir to treat hospitalized patients with severe Covid-19 in the United States.
On April 30, the European Medicines Agency announced a "rolling" review of remdesivir, which enables the agency to assess data on the drug as it becomes available, speeding up the evaluation process and potentially paving the way for faster approval.
Separately, initial data on Kevzara, a rheumatoid arthritis drug co-developed by Regeneron and Sanofi seen as a potential treatment, delivered mixed results. It showed promise for treating the sickest patients but no benefit for less severe cases. As a result, the companies decided to stop testing the drug with those patients and are instead proceeding with a larger trial only in critical patients. Results are due in June.
JPMorgan's U.S. biotechnology equity research team commented on Kevzara in a published note on Friday: "Although this might come as a relative disappointment to some — especially given the heightened sensitivities around Covid-19 — we continue to believe Regeneron may have a better shot treating this pandemic with its antibody cocktail."
Vaccines
On the vaccine front, more manufacturing partnerships were announced last week, underlining the importance of discovering a vaccine that works but also ensuring there is enough to go around.
President Donald Trump said on Sunday that he was confident there will be a coronavirus vaccine by the end of the year.
However, Severin Schwan, CEO of pharmaceutical giant Roche, expressed some skepticism over the president's proposed time frame on Monday, saying the end of the year was "certainly an ambitious goal."
"I have no doubt that as so many companies are working on a vaccine in parallel, and as we see such great collaboration with regulators including the FDA, we can actually speed up the approval of vaccines," he told CNBC's "Squawk Box Europe."
"But still, typically it would take years to develop a new medicine. So most experts agree that it will take at least 12 to 18 months until we see a vaccine which is available in the necessary quantities for patients."
Bank of America's U.S. biopharmaceuticals equity research team hosted a biotech policy landscape call for clients last week which concluded that there needs to be some very serious thought on manufacturing.
Moderna announced a 10-year manufacturing agreement with Lonza that could result in the production of 1 billion doses per year. Goldman Sachs equity research said in a research note published May 1 that "based on Moderna's vaccine portfolio data to date, we remain optimistic into the initial Covid-19 vaccine results, and view the Lonza collaboration as further supporting Moderna's continued efforts to produce a Covid-19 vaccine to meet global demand." The company says a phase three trial could begin as soon as the fall of 2020.
AstraZeneca and the University of Oxford announced last week an agreement on the global development and distribution of the university's potential vaccine. The plan is to produce up to 100 million doses by the end of the year. The Oxford team is aiming to have the vaccine available by September.
Pascal Soriot, the chief executive officer of AstraZeneca, said in a press release: "This collaboration brings together the University of Oxford's world-class expertise in vaccinology and AstraZeneca's global development, manufacturing and distribution capabilities."
Prior to that announcement, India's Serum Institute, the world's biggest vaccine manufacturer, said it plans to produce up to 60 million doses of the potential vaccine by the end of the year.
The UBS health-care equity research team hosted a client call with an American infectious disease epidemiologist last week and said in a published note that the expert thinks highly of the scientific group at Oxford University. However, the expert was doubtful on the proposed timeline, considering the amount of data and follow-up time required to establish safety and efficacy of a vaccine.
Furthermore, the expert warned that even if a vaccine demonstrates safety and efficacy, there are significant additional challenges with manufacturing and distributing doses for the global population of nearly 8 billion.
Several other partnerships have already been announced including between Pfizer and BioNTech, and Sanofi and GlaxoSmithKline.
There are currently at least 102 vaccines for the coronavirus in development globally, according to the WHO. Experts have predicted that it will take between 12 and 18 months for a vaccine to be deemed safe for distribution to the market.