Pharma Cos Rush To Develop Drugs For Covid-19 Patients

Mumbai: Glenmark Pharma may have received a regulatory nod to initiate clinical trials of anti-retroviral drug Favipiravir on Covid-19 patients. But other Mumbai-based firms, including BDR Pharma and API (active pharmaceutical ingredient) manufacturer Lasa Supergenerics, are also readying plans to make the product to cater to the sudden spike in demand.

Favipiravir is an anti-viral drug approved in Japan for treating influenza, including those that are oseltamivir-resistant, and has recently shown promise as a potential treatment for coronavirus, creating a spike in its demand in India and globally. Anti-malarial drug hydroxychloroquine, or anti-retrovirals/anti-virals like Favipiravir and Lopinavir, are increasingly being used worldwide for Covid treatment, while doubts have recently risen on Gilead’s anti-viral medicine Remdesivir, as it did not report encouraging results in initial clinical trials.

Glenmark has received approval from the country’s Drugs Controller General to start clinical trials in May on 150 mild-to-moderate patients of Covid-19, the first such company, sources say. The trials will be conducted in hospitals across Gujarat, Maharashtra and Madhya Pradesh — which are Covid hotspots — with a 14-day dosing period, while the study period is 28 days. The first dose is given twice a day (1800mg twice) on day 1, and then from day 2 to 14, it is 800mg twice a day, a company official confirmed to TOI.

Another company BDR Pharma has developed the API and formulation for two anti-retrovirals Favipiravir and Remdesivir, according to its CMD Dharmesh Shah. “We started work on this very early, and were awaiting clarity on the regulatory process. Now we will submit our application on Favipiravir to the regulator for trials on around 100 subjects. Even though initial data regarding Remdesivir is not positive, we will continue our efforts and wait for full-blown trials, as it’s a promising molecule,” he stated.

Gilead has a patent on the drug in India. So, for a generic version, the option of seeking a licence will need to be explored.

Lasa Supergenerics chairman Omkar Herlekar said an API of Favipiravir being developed with technical know-how from the Institute of Chemical Technology is in the final stages, and commercial production is expected by May-end. “We have a capacity of 12 metric tonne-per-annum and are flooded with global orders and requests from MNCs here for the API,” he added.

Earlier, Cipla promoter Dr Y K Hamied had told TOI in an interview that the company is initiating development of raw materials of promising anti-viral compounds — Favipiravir, Remdesivir and Bolaxavir — with the help of government laboratories.-Times Of India