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Merck’s oral COVD-19 drug on the anvil; Indian partners will price drug post-approval, says MSD India’s Rehan Khan

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Merck's oral antiviral molnupiravir could reduce the chances of death from the virus by 50 percent. It could also significantly reduce chances of hospitalisation for patients with mild or moderate COVID-19.

Pharmaceutical major Merck's oral antiviral COVID-19 drug molnupiravir could reduce the chances of death from the virus by 50 percent. It could also significantly reduce chances of hospitalisation for patients with mild or moderate COVID-19.
These results have emerged from an interim analysis done by the company on 775 patients who were given the pill twice a day for five days. Of them, only 7.3 percent patients have been hospitalised and there were no deaths. The company will now be seeking approval in the US.
If the approval comes through, this will be the most effective oral COVID-19 drug in the market.
CNBC-TV18 spoke with Dr Saumya Swaminathan, Chief Scientist, the World Health Organization (WHO), about this and COVID-19 numbers. She said the data from Merck on this new drug is encouraging. If there’s enough evidence of the benefits of the oral drug, guidelines for it will be developed by WHO, she said, adding that there's encouraging news on the COVID-19 numbers front.
According to Dr Swaminathan, the number of global cases has been declining now for five straight weeks; only some regions continue to see a high caseload and Africa continues to see deaths.
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To discuss the developments at Merck and the timeline for the drug's approval and pricing in India, CNBC-TV18 spoke with Rehan Khan, MD, Merck Sharp & Dohme (MSD) India.
Khan said, “For the very first time, prior to the drug getting regulatory approval, we have entered into non-exclusive voluntary licence agreements with eight different manufacturers. These include Aurobindo, Cipla, Dr Reddys, Emcure, Hetero Labs, Sun Pharma, Torrent, and Viatris. Our goal is to help them facilitate availability of the generic molnupiravir here in India, and over 100 low- and middle-income countries, following approvals by local regulatory agencies.”
“As part of these agreements, our authorised partners in India have been engaged in local clinical trials to expedite access to molnupiravir,” she said. When asked for details, she said,  “For an update on the trials and the timings by our real partners in India, you'll have to contact these companies. I can't comment on that, but it is very exciting and we're hopeful that this goes forward positively.”
Hetero has done the trial or is the process of submitting the data. When asked if each of these eight partners has to go through the same process, Khan said some of the partners have banded together to conduct these trials, and they can then go ahead and file these trials with the Drugs Controller General of India (DCGI).
Talking about the post-regulatory process, Khan said once these products are approved locally in India and in other markets, the partners can go ahead and launch in these markets. They will be responsible for pricing these products, including for India. “We are supporting them in the best way possible, but we're not responsible for anything else beyond the upfront support,” she said.
On the pricing of the product in India, he said, Merck is committed to providing timely access to molnupiravir. If the product is authorised or approved, the company plans to implement a tiered pricing approach based on World Bank data that recognises the country's relative ability to finance their health response to the pandemic.
For the entire discussion, watch the accompanying video