Merck’s promising results fuel expectations for Indian partners

PT Jyothi Datta Mumbai | Updated on October 05, 2021

Drug-maker approaching USFDA for emergency approval “as soon as possible”

Close to a dozen companies in India are in the race to make anti-viral drug molnupiravir, the oral drug from Merck, that recently showed promising results in reducing Covid-19 linked hospitalisations and halving deaths in those at risk.

The interim findings from Merck (known as MSD outside 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 an emergency use authorisation (EUA), besides submitting marketing applications to other global regulatory authorities.

Merck Sharpe Dohme (MSD) has alliances with eight local generic drug-makers and the recent global announcement fuelled expectation that similar moves could be afoot to speed up regulatory approvals in India as well.

In a response to BusinessLine, a spokesperson for MSD reiterated that the parent company was to submit an EUA application to the USFDA “as soon as possible”. Further, the spokesperson added, “We will also assist our voluntary license partners with necessary data from MSD to support their filings for regulatory approval in India.”

In India, non-exclusive voluntary licensing agreements are in place 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 (erstwhile Mylan). This would allow them to make and sell in India and 100 other low- and middle-income countries.

Joint clinical trial

And in a first time of sorts, five Indian drug-makers are undertaking 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 for the clinical trial of the investigational oral anti-viral drug Molnupiravir for the treatment of mild Covid-19 in an outpatient setting in India.

While the five of them were to jointly sponsor, supervise and monitor the clinical trial in India, they had then said, “Dr Reddy’s will conduct the clinical trial using its product, and the other four pharma companies will be required to demonstrate equivalence of their product to the product used by Dr Reddy’s in its clinical trial.”

Once the joint trials are completed, each company would independently approach the Indian regulator for a go-ahead on its version of the drug.

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

Interestingly, also in the fray making molnupiravir, or the active ingredient to make the final drug, are companies like MSN Laboratories, Optimus Pharma and Divi’s Laboratories. An indicator of the prospects ahead for the drug companies was reflected, for example, in the surge in Divi’s stock price on Monday, closing up over 8 percent at ₹5,220.85.

Published on October 04, 2021

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