Glenmark shines following USFDA nod

Glenmark Pharmaceutical Inc., USA (Glenmark) has received tentative United States Foods & Drug Administration (US FDA) approval for Dronedarone Tablets, 400 mg. The tablet is a generic version of Multaq tablets, 400 mg of Sanofi-Aventis US.

Glenmark operates in three businesses, which includes drug discovery, formulation business and Glenmark Generics Limited (GGL), a subsidiary of the Company. Its drug discovery is focused on the areas of inflammation, metabolic disorders and pain. Glenmark's formulations business focuses on therapeutic areas, including dermatology, anti-infective, respiratory, cardiac, diabetes, gyneacology, central nervous system (CNS) and oncology. Company's businesses focus on segments, including dermatology, hormones, controlled substances, oncology and modified release products. It has approximately 14 manufacturing facilities in around four countries and has around six research and development centers.

The Multaq tablets are used to treat atrial fibrillation or atrial flutter, types of abnormal heart rhythms. The Multaq market achieved annual sales on an around USD 425.7 million (Rs 2840.48 crore), according IMS Health sales data for the 12 months period ending November 2015.

Glenmark has a current portfolio consisting of 104 products authorised for distribution in the US marketplace and 62 ANDAs are at a stage of pending approval with the USFDA. Further, the company continues to identify and explore external development partnerships to supplement and to gain growth for its existing pipeline and portfolio.

On the other hand, Glenmark concluded an agreement with Roche/OSI regarding ongoing patent disputes relating to the anti-cancer medicine 'Erlotinib Hydrochloride'. Additionally, the company also reached settlement agreement with Forest Laboratories, LLC, Forest Laboratories Holdings, and Royalty Pharma Collection Trust to settle and dismiss outstanding patent litigation related to company's abbreviated new drug application for Milnacipran hydrochloride 12.5 mg, 25 mg, 50 mg , and 100 mg tablets. Milnacipran hydrochloride is a generic version of Forest’s Savella that is used treat chronic pain caused by fibromyalgia.

Share price of Glenmark increased by 2.32 per cent on bourses in early trades and is trading at Rs 942.5 on intraday basis.