• The Medicines Patent Pool (MPP) issues a press release to announce that it has entered into a voluntary license agreement with Merck Sharpe Dohme for molnupiravir, the company’s experimental oral antiviral COVID-19 medicine, to increase access in low- and middle- income countries. Merck and its development partners Ridgeback and Emory University will only receive royalties for molnupiravir after COVID-19 is no longer classified as a Public Health Emergency of International Concern by WHO.
Dr Philippe Duneton, Executive Director, Unitaid and co-lead of the ACT-A Therapeutics Pillar said: “Effective, easy to administer, oral treatments that can help to reduce the risk for progression to severe illness may be an important tool to help get the pandemic under control. We encourage further efforts in voluntary licencing to ensure that people in low- and middle-income countries can access COVID-19 treatments once authorized by WHO or a stringent regulatory authority.”
An application for emergency use authorization for molnupiravir has been submitted to the US FDA and additional regulatory agencies worldwide; the EMA has initiated a rolling review for molnupiravir for the treatment of COVID-19 in adults. Source
• The Médecins Sans Frontières Access Campaign issues a statement announcing its disappointment with the Medicines Patent Pool/Merck Sharpe Dohme voluntary license for molunpiravir, noting it “…excludes nearly half of the world’s population, including important upper-middle-income countries (where there have already bee 30 million cases of COVID-19 during the first half of 2021)…” adding that it contains a harmful provision that “…could stifle the production and supply of more affordable and available generic molnupiravir. This new voluntary license continues pharma’s ‘business as usual’.” Source
• The UK reports its highest rates of hospitalization and death from COVID-19 since March. Source
• GSK is halting development of an experimental monoclonal antibody, otilimab, as a potential treatment for COVID-19, which is also being studied for rheumatoid arthritis.The company noted that their approved monoclonal antibody Xevudy “…plays an important role as a treatment for mild-to-moderate COVID-19 in high-risk adult and pediatric patients,” according to a company statement. Source
• Novavax issues a press release to announce that it has completed its rolling regulatory submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for authorization of NVX-CoV2373, its experimental protein-based COVID-19 vaccine candidate. Source