- Merck & Co. made clear Tuesday it hopes to play a major role in developing medicines for COVID-19, announcing a slate of deals to gain access to two vaccine candidates and one antiviral drug for the disease caused by the new coronavirus.
- The two experimental vaccines come by way of Themis, an Austrian biotech Merck is acquiring, and the nonprofit IAVI, with which Merck will collaborate. Clinical trials of the two candidates will begin later this year, Merck said. The pharma also bought rights to an oral antiviral drug from privately held Ridgeback Biotherapeutics.
- The announcements mark the entry of one of the world's leading infectious disease drugmakers to a worldwide race to develop therapies for COVID-19. Merck is a relative latecomer, making its plans public well after large pharma company peers Johnson & Johnson, Sanofi, Pfizer and AstraZeneca.
For months, Merck, one of the top four producers of vaccines and anti-infective medicines, was strangely quiet about how it might approach solving the world's most urgent infectious threat.
The silence stood in contrast to early declarations from Johnson & Johnson, which first announced its vaccine development plans in January; Sanofi, which got involved in coronavirus vaccine research several weeks later; and Pfizer, which partnered with Germany's BioNTech in mid-March.
More recently, GlaxoSmithKline agreed to join forces with Sanofi in an unusual big pharma collaboration, and AstraZeneca licensed a coronavirus vaccine from the University of Oxford.
Before Tuesday, Merck's public pronouncements were sparse, revealing only the company's participation in a National Institutes of Health-led collaboration and research into coronavirus infection biomarkers. But there were hints the company was working behind the scenes on a larger research program. In early May, NIH director Francis Collins told Bloomberg that Merck "may not be as much of a non-player as you might think," and last week Reuters reported the company would be involved in the U.S. government's "Operation Warp Speed."
While Merck may be getting a later start — at least publicly — its announcements Tuesday show it plans to test several treatment approaches in parallel.
In its collaboration with IAVI, Merck will develop a coronavirus vaccine that relies on the same recombinant technology which underpinned Ervebo, Merck's Ebola virus vaccine which was approved by the Food and Drug Administration in December.
Currently in preclinical stages of testing, Merck and IAVI's coronavirus candidate is supported by $38 million in funding from the Biomedical Advanced Research and Development Authority, which has already put money behind vaccines from Moderna, J&J, AstraZeneca and Sanofi. Human trials of the vaccine should start later this year, seemingly on a similar timeline as Sanofi's and J&J's projects but behind a list of frontrunners that includes Moderna, AstraZeneca and Pfizer.
Merck's also investing in a second vaccine technology by acquiring privately held Themis, which had been collaborating with the pharma under an earlier partnership. In March, Themis teamed up with France's Institut Pasteur and the University of Pittsburgh to develop a COVID-19 vaccine, receiving backing from the Coalition for Epidemic Preparedness Innovations.
Themis' vaccine candidate uses a modified measles virus to deliver into the body an antigen capable of triggering a protective immune response. Clinical tests will start this year as well, Merck said.
In backing two vaccine technologies, Merck joins Sanofi in hedging its bets that one approach might not pan out or work as well as expected. The French drugmaker is advancing a protein-based vaccine together with GlaxoSmithKline, but is also developing an RNA-based candidate with Translate Bio.
Merck also has plans to develop an oral antiviral drug, choosing to license EIDD-2801 from Ridgeback. The candidate wasn't originally designed for treating the new coronavirus, but preclinical tests have shown it to be active against SARS-CoV-2, Merck said.
An oral antiviral, if successful, could have a significant advantage over Gilead's remdesivir. The drug, one of just two therapies cleared for emergency use against covid-19, has to be infused over multiple days at a hospital and is thus only an option for more advanced cases. A pill would open up the option of earlier treatment outside of hospitals, wrote ISI Evercore analyst Umer Raffat.
The Ridgeback drug, which was invented at Emory University, comes with some controversy. In a whisteblower complaint made public earlier this month, Rick Bright, the ousted former director of BARDA, claimed he was pushed by his superiors to fund the drug's development despite his concerns about its safety.
Bright also alleged EIDD-2801's developers circumvented BARDA's normal funding process, a claim the drug's inventor and Ridgeback's co-founder denied to Science.