Glenmark Pharma gets DCGI nod for Favipiravir trials on COVID-19 patients

BENGALURU - Glenmark Pharmaceuticals Ltd (GLEN.NS) said on Thursday it will start clinical trials in India of antiviral drug favipiravir, seen as a potential treatment for COVID-19, sending its shares up as much as 9% The trials come after a Chinese official told reporters last month that an active ingredient of the drug had been effective, with no obvious side effects, in helping coronavirus patients recover.

Favipiravir is manufactured under the brand name Avigan by a unit of Japan’s Fujifilm Holdings Corp (4901.T) and approved for use as an anti-flu drug in the country in 2014.

Mumbai-based Glemark said the approval made it the first pharmaceutical company in India to be given the go-ahead to start trials on COVID-19 patients in the country, which recorded its 1,000th coronavirus-related death on Wednesday.

"After having successfully developed the API (active pharmaceutical ingredient) and the formulations ... Glenmark is all geared to immediately begin clinical trials on favipiravir on COVID-19 patients in India," Sushrut Kulkarni, executive vice-president for global R&D, Glenmark Pharmaceuticals, said in a statement reut.rs/2VNF43h.

Drugmakers across the world have been rushing to develop a treatment or vaccine for the fast-spreading coronavirus that has killed over 220,000 people and ravaged financial markets.Early clinical trial results on Wednesday from Gilead Sciences Inc’s (GILD.O) experimental antiviral drug remdesivir showed it helped patients recover more quickly from the illness caused by the coronavirus.

Glenmark will initially enroll 150 patients with mild-to-moderate COVID-19 in a randomized trial that will compare favipiravir with standard supportive care. The trial will last for a maximum of 28 days, it said.

The Drug Controller General of India, which approved the trials, declined to provide more detailed information.

Another Indian pharmaceutical company, Strides Pharma Science Ltd (SRID.NS), said on Wednesday it had developed and commercialized favipiravir antiviral tablets, and had applied to the authorities to start trials.

Shares of Glenmark Pharmaceuticals pared some gains and were trading up 4.8% at 0540 GMT.