MSD Pharmaceuticals, the wholly owned subsidiary of Merck Sharp Dohme, known as Merck & Co in the US, announced that it has decided to enter into non-exclusive voluntary licensing agreements for COVID-19 antiviral drug molnupiravir with five established Indian generic manufacturers.
The US drugmaker has signed licensing agreements with Cipla, Dr Reddy's, Emcure Pharmaceuticals, Hetero Labs and Sun Pharmaceutical Industries – five generic manufacturers with World Health Organization (WHO) Pre-Qualified Manufacturing facilities and experience as major suppliers to global and key low and middle-income country (LMIC) procurers.
Under the agreements, MSD will provide licences to these manufacturers to supply molnupiravir to India and more than 100 LMICs. MSD is also in talks with the Medicines Patent Pool to explore the potential for additional licences.
Molnupiravir is an investigational oral antiviral agent currently being studied in a Phase-3 trial for the treatment of non-hospitalised patients with confirmed COVID-19. MSD is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.
MSD has entered into these agreements to accelerate the availability of molnupiravir in India and in other LMICs following approvals or emergency authorisation by local regulatory agencies.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
“The scale of human suffering in India at this moment is devastating, and it is clear that more must be done to help alleviate it. These agreements, toward which we have been working as we have been studying molnupiravir, will help to accelerate access to molnupiravir in India and around the world,” said Kenneth C. Frazier, chairman and CEO, Merck & Co.
“We remain committed to aiding in the global response that will bring relief to the people of India and, ultimately, bring an end to the pandemic,” Frazier said.
“Through partnerships with established Indian generic manufacturers, we are reinforcing our commitment towards expanding access to molnupiravir in India,” said Rehan A Khan, Managing Director, MSD-India Region.
“We look forward to collaborating with these partners and supporting them in advancing our mission of improving lives. We are in talks with the government and other key stakeholders as we remain committed to expanding equitable access to medicines and bringing innovative treatments to the country,” Khan added.
Separately, MSD will also donate more than $5 million worth of oxygen-production equipment, masks, hand sanitisers and financial aid to support relief efforts in India.