Glenmark Pharmaceuticals Out-Licenses Novel Monoclonal Antibody, GBR 500, to SanofiBy Glenmark Pharmaceuticals Ltd., PRNE
Sunday, May 15, 2011
Combined Upfront and Potential Development, Regulatory and Commercial Milestone Payments Could Total US$613 Mn
MUMBAI, India, May 16, 2011 - Glenmark Pharmaceuticals S.A (GPSA), a wholly owned subsidiary
of Glenmark Pharmaceuticals Limited India (GPL), announced today that it has
entered into an agreement with Sanofi to grant Sanofi a license for the
development and commercialization of GBR 500, a novel monoclonal antibody for
the treatment of Crohn's Disease and other inflammatory conditions. The
transaction is expected to close in the coming month subject to customary
closing conditions, including the expiration or early termination of the
waiting period under the HSR Antitrust Improvements Act.
Under the terms of the agreement, Glenmark will receive an
upfront payment of US$ 50 million, of which US$ 25 million will be paid upon
closing of the transaction and US$ 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 US$613 Mn. In addition, Glenmark is eligible to receive tiered
double-digit royalties on sales of products commercialized under the license.
GBR 500 is an antagonist of the VLA-2 (alpha2-beta1) 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 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.
"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".
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".
Contact: Jason D'souza, +91-9820215005
Tags: Glenmark Pharmaceuticals Ltd., India, May 16, Mumbai