- Drugmakers Gilead and Merck & Co. are taking steps to expand access in India to their antiviral medicines for coronavirus infections as COVID-19 cases and deaths in the country surge to new heights.
- Gilead, which previously licensed its drug Veklury to several generic drugmakers in India, said Monday it will donate at least 450,000 vials of the treatment, which is approved there for restricted emergency use. The California biotech also plans to increase technical support for the Indian manufacturers and donate raw materials.
- Merck, meanwhile, announced Tuesday non-exclusive license agreements allowing five generic drugmakers to make molnupiravir, an experimental, oral coronavirus antiviral it's developing with Ridgeback Biotherapeutics. The partners are planning Phase 3 trials to test molnupiravir both as a preventive treatment and for COVID-19 patients who haven't yet been hospitalized.
After months of apparent progress, India's COVID-19 epidemic has rapidly worsened, with new infections soaring past 300,000 a day. By comparison, daily new cases are averaging between 50,000 and 60,000 in the U.S. and Brazil, the next two hardest hit countries globally.
More than 2,000 people are dying each day and experts believe those figures are likely an undercount.
Multinational companies and governments are beginning to respond, although their planned aid may not come fast enough. Earlier this week, the Biden administration said it would send tens of millions of doses of AstraZeneca's vaccine, which is not yet authorized in the U.S., to India, as well as supplies the country's manufacturers need to produce their own shots.
The planned shipments of vaccine doses, however, won't occur until the Food and Drug Administration ensures the supplies meet its standards for product quality. One factory that was making doses of vaccines from AstraZeneca and Johnson & Johnson was forced to shut down production after a manufacturing mix-up that health officials are still investigating. Already produced doses are being tested for contamination.
Should the FDA give an all clear, there are about 10 million doses already made that the U.S. could send, a senior administration official said Monday. Fifty million more are in "various stages of production" and could be ready to ship by May or June, according to the official.
Gilead and Merck, meanwhile, could help India with supplies of antiviral drugs, although both companies' pledges may not do much to alleviate India's immediate crisis.
Gilead's donation of 450,000 Veklury vials equates to a full treatment course for about 75,000 patients hospitalized with COVID-19. Typically, patients are given a double "loading" dose on the first day of treatment, which usually spans five days in total and therefore requires six vials.
Results from a U.S. government-run clinical trial last year showed Veklury treatment could speed patients' recovery, but the data did not show a clear-cut reduction in the risk of death. The drug is only proven to help patients who are already hospitalized with COVID-19, further limiting the drug's impact.
Gilead's assistance to generic drugmakers could have a larger impact on supply in India, but expanding production will take time. Gilead has licensed Veklury to seven India-based manufacturers, which the company says have all ramped up production.
Merck's newly announced agreements, meanwhile, mirror Gilead's initial licensing deals from May of last year. The pharma provided non-exclusive licenses for its drug molnupiravir to Cipla, Dr. Reddy's, Emcure Pharmaceuticals, Hetero Labs and Sun Pharmaceutical. Merck is also discussing additional licenses with the Medicines Patent Pool.
Molnupiravir is currently unproven, with Merck just beginning a Phase 3 trial of the antiviral drug. The company recently adjusted its development plans, choosing to focus on outpatient treatment after reviewing mid-stage study results for hospitalized patients. Data from the Phase 3 trial could come in September or October, Merck said earlier this month. The company also plans to study the drug as a preventive treatment for people exposed to infection.
Though results are still months away, molnupiravir could eventually play an important role if proven to work. Initial testing showed the drug appeared to help patients early on in their disease course clear the virus more quickly. And as a pill that can be easily manufactured and distributed, it's far less complex to make and administer quickly than COVID-19 antibody drugs or even Veklury, which are typically infused in healthcare settings.