Merck’s promising results fuel expectations for Indian partners

About a dozen companies in India are in the race to make molnupiravir, Merck's oral drug, which recently showed promising results in reducing Covid-19-linked hospitalizations and halving people's deaths. at risk.

Interim findings from Merck (known as MSD outside of the United States and Canada) and Ridgeback Biotherapeutics led them to announce late last week that they would approach the US Food and Drug Administration for authorization from emergency use (US), as well as submitting marketing requests to other global regulatory authorities.

Merck Sharpe Dohme (MSD) has alliances with eight local generic drug manufacturers and the recent global announcement fueled the expectation that similar measures could be in place to speed up regulatory approvals in India as well.

In response to Line of business, an MSD spokesperson reiterated that the parent company should submit a US application to the USFDA "as soon as possible." In addition, the spokesperson added: "We will also assist our voluntary licensing partners with the necessary data from MSD to support their requests for regulatory approval in India."

In India, there are non-exclusive voluntary license agreements for molnupiravir between MSD and eight companies: Aurobindo Pharma, Cipla, Dr Reddy's Labs (DRL), Emcure Pharmaceuticals, Hetero Labs, Sun Pharmaceuticals, Torrent Pharmaceuticals, and Viatris (formerly Mylan). This would allow them to manufacture and sell in India and 100 other low- and middle-income countries.

Joint clinical trial

And for the first time, five Indian drugmakers are conducting a joint clinical trial on the drug, anchored in a sense by DRL. In June, DRL, Emcure, Sun Pharmaceutical, Cipla, and Torrent said they would collaborate on the clinical trial of the investigational oral antiviral drug Molnupiravir for the treatment of mild Covid-19 in an outpatient setting in India.

While the five were to jointly sponsor, oversee and monitor the clinical trial in India, they then said: "Dr. Reddy's will conduct the clinical trial using his product, and the other four pharmaceutical companies will need to demonstrate the equivalence of their products by product used by Dr. Reddy's in his clinical trial. "

Once joint testing is complete, each company would independently approach the Indian regulator to get the go-ahead for its version of the drug.

The trials would take place between June and September this year, with the recruitment of 1,200 patients. Line of business reached out to some of these companies involved in the trials, but they did not comment on the progress the trial had made since then.

Interestingly, also in the fray for the manufacture of molnupiravir, or the active ingredient to make the final drug, are companies such as MSN Laboratories, Optimus Pharma and Divi's Laboratories. One indicator of the future outlook for pharmaceutical companies was reflected, for example, in the rise in Divi's share price on Monday, closing more than 8 percent at ₹ 5,220.85.