Hyderabad Firm Seeks Approval To Produce Generic Merck Covid Pill

The bulk drugs manufacturer Optimus Pharma is seeking domestic regulatory approval to produce a generic version of Merck & Co's oral COVID-19 treatment molnupiravir, the company's top executive told Reuters on Thursday.

If granted emergency use approval, the company could scale up production to 80 million capsules a month and is targeting a price of 40 cents per capsule, said D. Srinivasa Reddy, managing director at the Hyderabad-based company.

A treatment course for a patient comprises some 40 capsules, which means the total cost would be around $16. In comparison, Merck has a contract with the U.S. government to supply 1.7 million courses of the drug at a price of $700 per course.

Optimus in May received approval from the Drugs Controller General of India (DCGI) to conduct a late-stage trial with molnupiravir in patients with mild COVID-19.

In a statement on Thursday, the company said it has completed the trial which showed that on day five, about 78% of patients in the molnupiravir treatment group tested negative for the coronavirus compared to about 48% in the placebo group.

"We independently applied for the trial. We don't have a voluntary licensing (agreement) with Merck," said Reddy.

"There is no granted patent for molnupiravir's drug substance. There is only a composition patent filed by Merck," said Mr Reddy, adding Optimus has developed its own composition and is also manufacturing the active pharmaceutical ingredient (API) in-house.

Once Optimus receives approval, it can produce 10 million capsules in two weeks and up to 40 million capsules in four to six weeks. It will need three months to install more machinery to get up to 80 million capsules a month, said Mr Reddy.

To turn India into a manufacturing hub for molnupiravir, Merck has separately entered into voluntary licensing agreements for the treatment with eight domestic companies that have yet to disclose their production plans.

Mr Reddy said the company is also doing regulatory groundwork to enable it to market the drug in nations like Vietnam, Egypt, Indonesia, the Philippines and Lebanon.

Optimus' price of 40 cents per capsule is in line with market competition, said Reddy.

"(The) price could also come down when we do the commercial launch," Mr Reddy said. "This is the advantage with India because all the materials are available in India, so we need not depend on outside."

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