Shares of Glenmark surge after USFDA approval

Glenmark Pharma gained more than two percent intraday on Monday after getting approval from the US health regulator for anti-migraine drug.

The pharmaceutical company in its filling reported full and final approval by the United States Food and Drug Administration (USFDA) for Frovatriptan Succinate tablets, 2.5 mg.

Frovatriptan Succinate is therapeutic equivalent to listed drug product, Frova tablets of Endo Pharmaceuticals Inc. According to IMS Health sales data for 12-month period ended January 2016, Frova market achieved annual sales of approximately USD 87.8 million.

Glenmark's current portfolio consists of 108 products authorised for distribution in the US and 61 ANDA's pending approval with the USFDA.

However, according to Nomura, Glenmark (along with Alkem, Ipca, Abbott and Pfizer) is likely to be impacted after India's Ministry of Health and Family Welfare banned sale of around 350 fixed-dose combinations (FDCs) in India with immediate effect.

Based on AIOCD AWACS estimates, overall annual sales impact of ban on India's pharma market will be around Rs. 3,000-3,500 crore.

In terms of therapy areas, respiratory (mainly cough and cold), pain/analgesics and antidiabetes are the most affected and account for more than one-third of the overall impact. Cough syrups, triple-combination anti-diabetes drugs and combination pain killers are some of the categories most affected due to this ban, the brokerage explains.