Firms gearing up to launch successful covid drug

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

Next month, at least three Indian drugmakers will seek approval from the drug regulator after the completion of their own clinical trials for the drug in India. The approval from the Indian drug regulator will help the drug grow globally, especially in low- and middle-income countries.

As per the details filed with the Clinical Trials Registry in India, there are 12 companies in India that are running clinical trials for this drug. Hetero, Natco Pharma, Optimus Pharma and Dr Reddy’s are at the forefront of their studies. Dr Reddy’s is leading the trial on behalf of a consortium of five Indian generic companies – Cipla, Sun Pharma, Emcure and Hetero – which have received voluntary licenses to distribute the drug in over 100 countries. The remaining 11 trials are being run by firms that are non-license holders of the drug. natco,

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

“We are in the process of clearing the data from our clinical trials and look forward to submitting our application for approval by the end of October,” said D. Srinivas Reddy, managing director, Optimus Pharma. A senior Natco official, who wants to confirm the name, said the company will seek approval by October.

Merck expects five-day oral therapy to cost $700 for the full course of treatment in the US and other established markets. In India, companies are considering drug pricing ₹880- 1,000 (Each tablet cost .) ₹22) For a full course. With about a dozen Indian companies in the fray to launch the drug in India and other low- and middle-income countries, the price of the drug is expected to fall further.

India holds the key to global distribution of Molnupiravir: In addition to Merck granting voluntary licenses to the companies mentioned above, other generic manufacturers are looking to launch this drug with their own brand names, given that the main drug on the substance There is no patent.

Companies like Optimus have already shipped a few thousand batches of the drug to the Vietnamese government for use as an experimental therapy in the government’s COVID-19 management. The company supplied 10 million doses to the Vietnamese government. “Unlike the vaccine, there is no limit to increase the formulation of this drug as the chemical process to make it is simple,” said Reddy of Optimus.

“We are also in discussion with non-profit organizations like United, UNICEF for a possible supply agreement,” said a senior company official of a Hyderabad-based pharma company.