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No gain without pain
June 2010
by Lori Lesko  |  Email the author
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PARIS—Global pharmaceutical company sanofi-aventis has joined hands with Glenmark Pharmaceutical Ltd. India in a multimillion-dollar license agreement targeted at developing and commercializing a new chronic pain treatment for osteoarthritic and diabetic neuropathic pain. The centerpiece of the deal is a molecule called GRC 15300, in the early stage of human trials.

Marc Cluzel, executive vice president of research and development at sanofi-aventis, says GRC 15300 "brings an innovative approach to sanofi-aventis' pain portfolio, which we believe may have promise to address a significant gap in treating chronic pain."  

Glenmark will receive a $20 million upfront payment as well as development, regulatory and commercial milestone payments of up to $325 million—and tiered royalties on sales of products commercialized under the license. Glenmark CEO Glenn Saldanha says the company will also be eligible to receive royalties in double-digit percentages of potential sales once the product is launched in about five years, and the percentage of royalties received from such deals are typically in the mid-teens.

The goal of the partnership will be to advance GRC 15300 as well as potentially other promising drug candidates, Saldanha says. One of the vanilloid receptor (TRPV3) antagonist molecules, GRC 15300 is currently in Phase I clinical development as a potential next-generation treatment for various pain conditions. There is a rising market in chronic pain medication and the available therapy has huge gaps, and Saldanha notes that unlike other pain treatments already on the market, GRC 15300 is a first-in-class molecule, with a peak sales potential of $3 billion.

The TRPV3 receptor is an ion channel protein that mediates and influences cell signaling, including the nerve cell that generates some types of pain, he says. Inhibitors of TRPV3 are predicted to be useful in the treatment of inflammation, various pain conditions and other diseases and disorders.

TRPV3 "has been known in the literature for quite some time as a potential target for pain and dermatology indications," Saldanha says. "However, Glenmark was the first company to work around the complexities associated with this target to bring a TRPV3 antagonist into the clinics for the first time."

The companies have agreed to divvy up the world markets. sanofi-aventis will have exclusive marketing rights for North America, the European Union and Japan, subject to Glenmark's right to co-promote the products in the U.S. and five Eastern European countries. sanofi-aventis will also have co-marketing rights in 10 other countries, including Brazil, Russia and China, whereas Glenmark will retain exclusive rights in India and other countries in the rest of the world.

The agreement marks sanofi-aventis' first partnership with India in the pharmaceutical research arena. Glenmark had been struggling to find a licensing partner since 2008, when Eli Lilly & Co. pulled out of their drug development pact.

Sriram Rathi, an analyst with Centrum Broking, reported that investors have been waiting for the past two years for Glenmark to sign on to a deal like the one with sanofi-aventis to bring back the confidence of investors into the company's R&D pipeline.

Warning against over-optimism, Rathi said the full impact of the deal is as yet unknown since the molecule is in the initial stages of development—and could fail. In August 2009, Glenmark's experimental drug for chronic obstructive pulmonary disease, which it was jointly developing with U.S.-based Forest Laboratories, failed to meet desired targets during mid-stage trials in patients with a breathing ailment, according to news reports.
This latest deal has given new life to Glenmark's research program. In fact, shares of Glenmark jumped more than 11 percent during early trades on May 3, the day the partnership was announced.

"This deal with sanofi is our fifth licensing deal and our fourth molecule—clearly reaffirming our status as a leading discovery player in the Asia region," Saldanha says. "Our drug discovery model is based on discovering best-in-class or first-in-class molecules and taking them to clinical trials, and thereafter, out-license these molecules to big pharma who will take it forward in clinical development."

Glenmark has eight molecules in various stages of clinical development and is primarily focused in the areas of inflammation (asthma/COPD, rheumatoid arthritis, etc.), metabolic disorders (diabetes, obesity, etc.) and pain (neuropathic pain and inflammatory pain), he said.

"Glenmark has been active in the area of TRP research for over half a decade," he said. "Our programs started with research in TRPV1 area and we were able to successfully bring a TRPV1 antagonist into the clinics. Glenmark has built a very strong expertise in the TRP space by virtue of its in-depth understanding of both chemistry and biology."
 
 
Code: E061002

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