Friday 18 March 2016

Glenmark Pharma gets tentative USFDA nod for Lacosamide Oral Solution

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for its Lacosamide Oral Solution, 10 mg/mL, the generic version of Vimpat Oral Solution, 10 mg/mL of UCB, Inc. 

glenmark pharma
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for its Lacosamide Oral Solution, 10 mg/mL, the generic version of Vimpat Oral Solution, 10 mg/mL of UCB, Inc. Glenmark will market this product upon receiving final approval of its Lacosamide Oral Solution, 10 mg/mL ANDA. The patent listed in the Orange Book for Vimpat Oral Solution, 10 mg/mL is scheduled to expire on March 17, 2022.

According to IMS Health sales data for the 12 month period ending January 2016, the Vimpat market achieved annual sales of approximately $55.4 million.

Glenmark’s current portfolio consists of 108 products authorized for distribution in the U.S. marketplace and 61 ANDA’s pending approval with the U.S. FDA. 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.

Stock view:

Glenmark Pharmaceuticals Ltd is currently trading at Rs. 794, down by Rs. 17.1 or 2.11% from its previous closing of Rs. 811.1 on the BSE.

The scrip opened at Rs. 812 and has touched a high and low of Rs. 815 and Rs. 792.65 respectively. So far 95259(NSE+BSE) shares were traded on the counter. The current market cap of the company is Rs. 22885.85 crore.

The BSE group 'A' stock of face value Rs. 1 has touched a 52 week high of Rs. 1261.95 on 21-Aug-2015 and a 52 week low of Rs. 671.5 on 12-Feb-2016. Last one week high and low of the scrip stood at Rs. 843.5 and Rs. 800 respectively.

The promoters holding in the company stood at 46.47 % while Institutions and Non-Institutions held 42.5 % and 11.02 % respectively.

The stock is currently trading below its 200 DMA.

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