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US bets $1.2B on Merck’s last hope for a COVID-19 drug

Dive Brief:

  • The U.S. government has agreed to pay Merck & Co. $1.2 billion for roughly 1.7 million courses of an experimental COVID-19 drug should the treatment, currently in late-stage testing, win emergency authorization.

 

  • The drug, known as molnupiravir, is an antiviral pill being tested in COVID-19 patients who haven’t yet been hospitalized. In addition to the U.S. deal, Merck, which is developing the treatment as part of a partnership with biotech Ridgeback Biotherapeutics, is also discussing advanced purchase agreements with other governments. The pharma has alliances with generic manufacturers to provide access to the drug in low- and middle-income countries.

 

  • If successful in clinical testing, molnupiravir has the chance to become the first oral COVID-19 treatment, an improvement over the injectable and infused medicines used now. The drug is also the only remaining piece of Merck’s once-sprawling effort to develop multiple COVID-19 treatments and vaccines. Results from an ongoing Phase 3 trial are expected later this year.

 

Dive Insight:

One of the world’s top infectious disease drug developers, Merck has watched as Pfizer, Moderna, Regeneron and others successfully developed coronavirus vaccines and antibody drugs, earning billions of dollars in government deals along the way. The pharma, by contrast, scrapped two vaccine programs and one drug, significantly scaling back what were once expansive plans.

Those setbacks have relegated Merck to a supporting role, with its largest contribution to the COVID-19 response a deal to help make Johnson & Johnson’s coronavirus vaccine. But that could change if molnupiravir succeeds in clinical testing.

The drug is a pill Ridgeback licensed from Emory University. Merck and Ridgeback agreed to co-develop it last year. Since then, the antiviral has shown the potential to help patients, particularly those early in their disease course, clear the coronavirus more quickly than they would otherwise. One Phase 3 trial in mild-to-moderate COVID-19 patients is underway. Another, in people exposed to potential infection, should start in the second half of 2021.

Ideally, molnupiravir would protect COVID-19 patients from severe disease, much like marketed synthetic antibody drugs from Regeneron, Eli Lilly, and most recently Vir Biotechnology do. But an effective oral antiviral would have significant advantages given its convenience and the ease with which it can be manufactured and distributed. Antibodies are complex to make and typically infused in healthcare settings, making it more difficult to get the right patients treated at the right time. (Regeneron was recently cleared to begin selling a version of its drug administered through a subcutaneous injection as well.)

What’s more, due to differences in how the two types of drugs work, antivirals could be better equipped to handle virus variants. That could be important as variants trigger outbreaks among unvaccinated or partially vaccinated groups and blunt the effectiveness of some antibody drugs. Roughly 48% of the U.S. population isn’t fully vaccinated yet, while a more infectious and evasive variant known as Delta is growing in prevalence.

The spread of variants already led the Food and Drug Administration to revoke the authorization for one of Eli Lilly’s antibodies upon the drugmaker’s request. The U.S. stopped distributing Lilly’s other drug in multiple states for the same reason. Regeneron and Vir’s antibodies appear potent against the variants that have spread so far, but the drugs have been underutilized due to logistical challenges.

Pending positive results, Merck expects to seek emergency of clearance of molnupiravir later this year and have 10 million courses ready for use by the end of 2021.

Other companies are working on antivirals, too. Pfizer, Atea Pharmaceuticals and partner Roche, as well as an alliance between Molecular Partners and Novartis, are developing small molecule drugs.