Glenmark Pharma on Monday said its $613 million (over Rs 2,745 crore) out licensing deal with Sanofi has been approved by the US authorities and has also received an upfront payment of $25 million (over Rs 110 crore) from the French drug-maker.

Last month Glenmark Pharmaceuticals SA, a wholly-owned subsidiary of Glenmark Pharmaceuticals, had out licensed its novel monoclonal antibody ‘GBR 500’ aimed at treating digestive system disorders, to French drug-maker Sanofi for as much as $613 million.

“The GBR 500 deal signed by Glenmark in May 2011 with Sanofi has received clearance from the Hart-Scott-Rodino Antitrust Improvements Act, US,” Glenmark said in a filing to the Bombay Stock Exchange (BSE).

Following that clearance, the deal has now become effective and Glenmark has also received the first upfront payment of $25 million, it added.

The Hart-Scott-Rodino Act provides the Federal Trade Commission and the Department of Justice with information about large mergers and acquisitions before they occur.

As per the deal, the Mumbai-based firm would receive an upfront payment of $50 million from Sanofi.

In addition, Glenmark could receive potential success- based development, regulatory and commercial payments at different intervals, the company had said earlier.

GBR 500 is currently undergoing early-stage human trials as a treatment for Crohn’s disease (a form of inflammatory bowel disease), but is considered to have potential for treatment of other inflammatory conditions, such as multiple sclerosis and ulcerative colitis.

As per the deal, Sanofi will have exclusive marketing rights for products developed using GBR 500 in North America, Europe, Japan, Argentina, Chile and Uruguay, while it will co-market the products with Glenmark in Russia, Brazil, Australia and New Zealand.

Glenmark will retain exclusive marketing rights in India and other countries in the rest of the world. The company has six different molecules under different stages of development, including GBR 401, GBR 600, GBR 900.

Glenmark had acquired GBR 500 and GBR 600 from a Canadian pharmaceutical company at the early stages of its development, he said.

Shares of Glenmark were today trading at Rs 317.05 on BSE in late afternoon trade, up 1.47 per cent from its previous close.

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