Merck & Co. signed a deal with Thermo Fisher Scientific to manufacture its oral treatment for COVID-19, molnupiravir, in Canada as part of its effort to make the investigational treatment more widely available across the globe.
Production will be conducted at Thermo Fisher’s facility in Ontario, Canada, with distribution upon approval slated for Canada and the U.K. as well as other markets in the EU, the Asia-Pacific region and Latin America, the companies said in an announcement. The Ontario plant is one of only three production sites for the therapy in the world.
Last week, Merck announced that it had reached a supply agreement with the Canadian government to provide 500,000 molnupiravir courses with an option for another 500,000 in 2022.
Merck, which is known outside the U.S. and Canada as MSD, is developing the treatment with Ridgeback Biotherapeutics. Financial terms of the agreement (PDF) with Thermo Fisher weren’t disclosed.
The oral treatment recently hit some bumps in the road. A recent report by the two companies indicated the antiviral molnupiravir isn’t as effective as was first thought. After interim results showed an impressive 50% decrease in risk of hospitalization and death, final results based on all patients enrolled in the trial found a 30% relative risk reduction.
Then, in late November, an FDA advisory panel voted by only a narrow margin of 13-10 to endorse the oral treatment, although there were a number of concerns related to efficacy and safety. Committee members said at the time they would support revoking their endorsement if another oral treatment was approved and showed a superior efficacy and safety profile.
U.S. approval of the treatment is now in the hands of the FDA and the Centers for Disease Control and Prevention for use in patients.