MSD in talks to give additional licences for molnupiravir

Merck Sharp & Dohme (MSD) is in talks with several Indian drug manufacturers to give voluntary licences for its investigational covid-19 treatment molnupiravir and also aims to participate in United Nations-backed Medicines Patents Pool (MPP) through which it can increase access to the drug, MSD India managing director Rehan A. Khan said.

“The company has had discussions with a number of established Indian generics manufacturers and is in discussion with the Medicines Patent Pool to explore the potential for additional licences in India, as well licences with manufacturers outside of India to broaden the geographic footprint of MSD’s generic partners,” Khan told Mint in an email interview.

US-based MSD, known as Merck and Co. in its home country and Canada, has so far signed pacts with eight generic drug manufacturers in India, including Aurobindo Pharma, Cipla, Dr Reddy’s Laboratories, Emcure Pharmaceuticals, Hetero Labs, Sun Pharmaceutical Industries, Torrent Pharmaceuticals, and Viatris, for manufacturing the drug, which is in phase 3 trial in the US. Viatris is the merged entity of Mylan and Pfizer arm Upjohn.

The drug manufactured by these firms will be supplied to about 100 low-and-middle-income countries. It is aimed at treating non-hospitalized patients with mild-to-moderate covid-19 and as part of the agreement with MSD, the authorized partners will conduct clinical trials in India.

“They have already been engaging with the regulatory authority on the design of the phase 3 clinical trials and will base these trials on learnings from MSD’s global phase 2 trials, for Indian patients to have access to Molnupiravir as soon as possible,” Khan said. They will seek expedited approvals for faster access to molnupiravir in India, he said.

MSD expects to make a submission for an emergency use authorization with the US Food and Drug Administration in the second half of 2021, after which it would seek authorization from others.

There is “a nominal royalty, standard to voluntary licensing agreements, shared between the company and its development partners”, but the company is not entering into these agreements for financial gain, Khan said. However, he refused to divulge the details on royalty, as they are confidential.

MSD also plans to make its drug part of the MPP to help improve access. MPP was formed by Unitaid in 2010 and is aimed at improving access to affordable treatments in low and middle income countries via non-exclusive voluntary licensing. Its mandate initially was for drugs that treated HIV, hepatitis C, and tuberculosis, but it was last year expanded to include covid-19 as well.