Discussions with Medicines Patent Pool for additional licenses in India.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, has entered into non-exclusive voluntary licensing agreements for molnupiravir with five established Indian generics manufacturers. Merck is also in discussions with the Medicines Patent Pool to explore the potential for additional licenses.
Molnupiravir is an investigational oral antiviral agent currently being studied in a Phase 3 trial for the treatment of non-hospitalized patients with confirmed COVID-19.
Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics. Merck has entered into these agreements to accelerate availability of molnupiravir in India and in other low- and middle-income countries (LMICs) following approvals or emergency authorization by local regulatory agencies.
“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 said in a release on 27 Apr 2021 from Kenliworth.
“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,” said Frazier.
The agreements have been signed with Cipla Limited, Dr. Reddy’s Laboratories Limited, Emcure Pharmaceuticals Limited, Hetero Labs Limited and Sun Pharmaceutical Industries Limited – five generics manufacturers with World Health Organization (WHO) Pre-Qualified Manufacturing facilities and experience as major suppliers to global and key LMIC procurers.
Under the agreements, Merck will provide licenses to these manufacturers to supply molnupiravir to India and more than 100 LMICs. Merck is also in discussions with the Medicines Patent Pool to explore the potential for additional licenses.
Separately, Merck will also donate more than US$5 million worth of oxygen-production equipment, masks, hand sanitizer and financial aid to support relief efforts in India.
Molnupiravir (EIDD-2801/MK-4482) is an investigational, orally bioavailable form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19.
Molnupiravir has been shown to be active in several models of SARS-CoV-2, including for prophylaxis, treatment and prevention of transmission, as well as SARS-CoV-1 and MERS. EIDD-2801 was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University. Since licensed by Ridgeback, all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman and Merck.
For 130 years, Merck has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of its mission to save and improve lives. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. #health #manufacturing #COVID-19 /fiinews.com
