Glenmark Pharma gains after receiving USFDA approval for Kenalog generic

Glenmark Pharmaceuticals rose 0.71% to Rs 848.85 at 9:30 IST on BSE after the company said it received final approval for Triamcinolone Acetonide cream.

The announcement was made before trading hours today, 8 August 2016.

Meanwhile, the BSE Sensex was up 135.86 points, or 0.48%, to 28,214.21.

On BSE, so far 1,993 shares were traded in the counter, compared with average daily volume of 40,431 shares in the past one quarter. The stock hit a high of Rs 852.30 and a low of Rs 846.30 so far during the day. The stock hit a record 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 underperformed the market over the past 30 days till 5 August 2016, rising 2.80% compared with 3.22% rise in the Sensex. The scrip had also underperformed the market in past one quarter, rising 2.90% as against Sensex's 11.30% rise.

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

Glenmark Pharmaceuticals said that its US-based subsidiary, Glenmark Pharmaceuticals Inc., USA, has been granted final approval by the United States Food & Drug Administration (USFDA) for Triamcinolone Acetonide cream USP, 0.1%, the generic version of Kenalog cream, 0.1% of Delcor Asset Corporation (Which is no longer being marketed in the US).

Triamcinolone acetonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

According to IMS Health sales data for the 12-month period ending June 2016, the Kenalog Cream, 0.1% market achieved annual sales of approximately $43.6 million in the US market.

Glenmark said that its current portfolio consists of 108 products authorized for distribution in the US marketplace and 61 Abbreviated New Drug Application (ANDA) 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 ofits 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. The company will declare Q1 results on 12 August 2016.

Glenmark Pharmaceuticals is a research-driven, global, integrated pharmaceutical organization. Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). 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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