Date: 2011-05-16
Type of information: Licensing agreement
Compound: GBR 500
Company: Sanofi (France) Glenmark Pharmaceuticals (India)
Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases
Type agreement: licensing
development
commercialisation
Action mechanism: GBR 500 is an antagonist of the VLA-2 (alpha2-beta1) integrin. This first-in-class therapeutic agent is a monoclonal antibody that has established proof of concept in animal models across a range of anti-inflammatory conditions.
Disease: Crohn’s disease and other inflammatory conditions
Details: Glenmark Pharmaceuticals has entered into an agreement with Sanofi to grant Sanofi a license for the development and commercialization of GBR 500, a novel monoclonal antibody for the treatment of Crohn’s 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.
Sanofi will have exclusive marketing rights for North America, Europe, Japan, Argentina, Chile and Uruguay. Sanofi and Glenmark will comarket 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. Glenmark has completed Phase I dosing of GBR 500 in the US 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.
Financial terms: Under the terms of 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 commercialized under the license.
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