Molnupiravir, the COVID drug that everyone wants to launch

Indian drug makers are gearing up to play a key role in the global scale-up of the oral covid-19 drug molnupiravir, touted to be the first antiviral to treat the disease.

Last week, US drugmaker Merck announced that the experimental drug reduced the risk of hospitalization or death by 50% in an interim trial. Following the results from the study, Merck decided to stop trials and seek emergency approval from the US drug regulator.

Next month, at least three Indian drugmakers will seek approval from the drug regulator following the completion of their own clinical trials for the drug in India. An approval from the Indian drug regulator will help in the global scale-up of the drug, especially in low- and middle-income countries.

In India, there are 12 companies that are running clinical trials for this drug, according to details filed with the clinical trial registry of India. Hetero, Natco Pharma, Optimus Pharma and Dr Reddy’s are the front-runners with their studies. Dr Reddy’s is leading the trial on behalf of a consortium of five Indian generic companies—others being Cipla, Sun Pharma, Emcure and Hetero—who have received a voluntary licence to distribute the drug in over 100 countries. The remaining 11 trials are being run by firms that are non-licence holders of the drug. Natco,

Optimus and Hetero are expected to submit their data to the Indian regulator by this month, company officials aware of the development said.

“We are in the process of cleaning up data from our clinical trials and are hoping to submit our application for approval by the end of October”, said D. Srinivasa Reddy, managing director of Optimus Pharma. A senior official from Natco who did not want to be named confirmed that the company would be seeking approval by October.

Merck is expected to price the five-day oral therapy at $700 for a full course of treatment in the US and other established markets. In India, companies are looking to price the drug at ₹880- 1,000 (each tablet costing ₹22) for a full course. With nearly a dozen Indian companies in the fray to launch the drug in India and in other low- and middle-income countries, the price of the drug is expected to drop further.

India holds the key to the global distribution of molnupiravir: besides Merck offering voluntary licences to the companies mentioned above, the other generic makers are looking to launch this drug with their own brand names, considering there is no patent on the main drug substance.

Companies such as Optimus have already sent a few thousand batches of the drug to the Vietnam government for use as an experimental therapy in the government’s covid-19 management. The company supplied 10 million doses to the Vietnam government. “Unlike a vaccine, there is really no limitation to scale up the manufacturing of this drug as the chemical process to produce it is simple”, Reddy of Optimus said.

“We are also in discussions with not-for-profit organizations such as UNITAID, UNICEF for a possible supply agreement”, said a senior company official of a Hyderabad-based pharma company that is waiting to finish the clinical trial of the drug. Mint