Glenmark Pharma gains after getting USFDA nod to sell Rufinamide

Glenmark Pharmaceuticals rose 1.74% to Rs 864.70 at 9:32 IST on BSE after the company said it received final approval by the US health regulator to sell Rufinamide, which is used to treat seizures caused by Lennox-Gastaut syndrome.

The announcement was made before trading hours today, 19 May 2016.

Meanwhile, the BSE Sensex was down 127.03 points, or 0.49%, to 25,577.58.

On BSE, so far 1,998 shares were traded in the counter, compared with an average volume of 41,689 shares in the past one quarter. The stock hit a high of Rs 866 and a low of Rs 855 so far during the day. The stock hit a 52-week high of Rs 1,261.95 on 21 August 2015. The stock hit a 52-week low of Rs 671.50 on 12 February 2016. The stock had outperformed the market over the past one month till 18 May 2016, rising 7.56% compared with 0.43% decline in the Sensex. The scrip had also outperformed the market in past one quarter, rising 16.57% as against Sensex's 8.69% rise.

The large-cap company has an equity capital of Rs 28.22 crore. Face value per share is Re 1.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for its Rufinamide Tablets USP, 200 milligram (mg) and 400 mg, a therapeutic equivalent of Banzel Tablets, 200 mg and 400 mg of Eisai, Inc. With respect to 180-day generic drug exclusivity, Glenmark was one of the first ANDA applicants to submit a substantially complete ANDA for Rufinamide Tablets USP, 200 mg and 400 mg, with a paragraph IV certification. Therefore, with this approval, Glenmark is eligible for 180 days of shared generic drug exclusivity for Rufinamide Tablets USP, 200 mg and 400 mg.

According to IMS Health sales data for the 12 month period ending March 2016, the Banzel markets achieved annual sales of approximately $155.1 million in the US market.

Glenmark's current portfolio consists of 113 products authorized for distribution in the US marketplace and 63 ANDA's pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

On a consolidated basis, Glenmark Pharmaceuticals' net profit rose 1516.31% to Rs 171.49 crore on 23.96% rise in net sales to Rs 2174.02 crore in Q4 March 2016 over Q4 March 2015.

Glenmark Pharmaceuticals is a research-driven, global, integrated pharmaceutical organization headquartered at Mumbai, India. Glenmark has several molecules in various stages of clinical development and is primarily focused in the areas of Inflammation (asthma/COPD, rheumatoid arthritis etc.) and pain (neuropathic pain and inflammatory pain).

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