Glenmark to conduct trials for potential COVID-19 drug, first company in India to receive DCGI approval; shares jump 9%

Glenmark Pharmaceuticals on Thursday said it has become the first company in India to receive approval from Drug Controller General of India (DCGI) to conduct clinical trials of Favipiravir antiviral tablets for the treatment of COVID-19 patients.

Having internally developed the active pharmaceutical ingredients (API)  and the formulations for the product, Glenmark filed the product for clinical trials with the DCGI and has received approval for conducting the trial on mild to moderate patients, said a BSE filing.

Shares of Glenmark Pharmaceuticals Ltd rose almost 9 percent.

Last week, sources told CNBC-TV18 that the company may become the first Indian company to develop API for the anti-viral drug. Since then the stock has rallied 13 percent.

Glenmark receives approval from the Indian regulator (DCGI) to conduct Clinical Trials in India on Favipiravir Antiviral tablets for COVID-19 patients pic.twitter.com/wHJRXL0Fw9

— CNBC-TV18 (@CNBCTV18Live) April 30, 2020

As per the clinical trial protocol approved, 150 subjects with mild to moderate COVID-19 will be randomised in the study in a 1:1 ratio to Favipiravir with standard supportive care or standalone standard supportive care. Treatment duration is a maximum of 14 days and the total study duration will be maximum for 28 days from randomization, the filing further informed.

Favipiravir is a generic version of Avigan of Fujifilm Toyama Chemical, Japan, a subsidiary of Fujifilm Corporation.

“Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections. Recently in the past few months, post the outbreak of COVID-19, multiple clinical trials have been initiated on COVID-19 patients in China, Japan and in the US,” the company said in a BSE filing.

The treatment duration is a maximum of 14 days and the total study duration will be a maximum for 28 days from randomisation, it added.

In the past few months, following the outbreak of COVID-19, multiple clinical trials have been initiated on such patients in China, Japan and in the US.

Glenmark Pharmaceuticals Executive Vice President- Global R&D- Sushrut Kulkarni said the company is all geared to immediately begin clinical trials on Favipiravir on COVID-19 patients in India.

“The clinical trial will let us know the efficacy of this molecule on COVID-19 patients. If the clinical trials are successful, Favipiravir could become a potential treatment for COVID-19 patients,” Kulkarni said.