Can receive upto $613 million milestone payments

Glenmark Pharmaceuticals S.A (GPSA), a wholly-owned subsidiary of Glenmark Pharmaceuticals Limited India (GPL), has entered into an agreement with Sanofi to grant Sanofi a licence for the development and commercialisation of GBR 500, a novel monoclonal antibody for the treatment of Crohn's Disease (a form of inflammatory bowel disease) and other inflammatory conditions.

The transaction is expected to close in the coming month subject to customary closing conditions, including the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

Under the agreement, Glenmark will receive an upfront payment of $50 million, of which $25 million will be paid upon closing of the transaction and $25 million, which is contingent upon Sanofi's positive assessment of certain data to be provided by Glenmark.

In addition, Glenmark could receive potential success-based development, regulatory and commercial milestone payments. The total of these payments could reach $613 million. In addition, Glenmark is eligible to receive tiered double-digit royalties on sales of products commercialised under the licence. Sanofi will have exclusive marketing rights for North America, Europe, Japan, Argentina, Chile and Uruguay. Sanofi and Glenmark will co-market in Russia, Brazil, Australia and New Zealand, and Glenmark will retain exclusive marketing rights in India and other countries in the rest of the world.

GBR 500 is an antagonist of the VLA-2 (alpha2beta1) integrin.

It is a first-in-class therapeutic monoclonal antibody and has established proof of concept in animal models across a range of anti-inflammatory conditions.

Glenmark has completed Phase-I dosing of GBR 500 in the U.S. and the drug has been well tolerated with a good pharmacokinetic profile. Plans are in place to initiate clinical proof of concept studies in Crohn's Disease. Sanofi has licensed the rights to all therapeutic indications.

“There continues to be a strong medical need for safer and more efficacious products for the treatment of inflammatory diseases,” said Elias Zerhouni, M.D., President, Global Research & Development, Sanofi.

“GBR500 brings an innovative approach to Sanofi's immuno-inflammation portfolio, which we believe may address a significant gap in treating inflammatory diseases which would be of huge benefit to patients”.

According to Glenn Saldanha MD and CEO of GPL, “This collaboration, on a novel first-in-class monoclonal antibody, validates Glenmark's world-class innovative R&D capabilities in the drug discovery arena. We are pleased to have this second licensing collaboration with Sanofi, one of the largest pharmaceutical companies in the world and the first one from Glenmark in the field of novel biologics”.

Glenmark is a leading player in the discovery of new molecules, both NCEs (new chemical entity) and NBEs (new biological entity). It has eight molecules in various stages of clinical development and is primarily focussed in the areas of inflammation and pain. It has 12 manufacturing facilities in four countries and five R&D centres.

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