Hyderabad-based Optimus Pharma has claimed to have completed the Phase-III clinical trials of Molnupiravir—an investigational Covid-19 drug developed by U.S. pharmaceutical major Merck and Ridgeback Biotherapeutics.
Optimus is not among the list of Indian firms that have entered into a voluntary licensing agreement with Merck to develop and sell the drug in the country. However, it is expecting a voluntary licence from United Nations-backed Medicines Patent Pool with whom Merck has an agreement to provide such licences to manufacture and sell low-cost versions of Molnupiravir.
D. Srinivas Reddy, MD, Optimus Pharma, says the company has not infringed intellectual property rights as Molnupiravir does not have patent protection in India. The company already manufactures and exports key raw materials that are needed to produce Molnupiravir. Once it gets regulatory approval to market the final product in India, the company will thus be able to produce the entire value chain within the country.
The company said the results of its Phase-III trials are promising. According to the company, on day 5, 78.4% patients in the treatment group were recorded RT-PCR negative as compared to 48.2% in the placebo group. On Day 10, 91.5% of patients in the treatment group were recorded RT-PCR negative as compared to 43% in the placebo group. Conducted at 29 clinical trial sites across India covering roughly 96% of the nation’s demographic capital, the trial was meant to prove the superiority of Molnupiravir over the standard Covid-19 treatment options across India’s gene pool diversity.
On May 18, 2021, Optimus had received approval from the Drugs Controller General of India to conduct the trial as per the recommendations of the Subject Expert Committee of the Central Drugs Standard Control Organisation.