Glenmark licences out diabetic neuropathy pain drug molecules to Sanofi-Aventis

Glenmark and Sanofi-Aventis signed licence agreement to develop agents to treat chronic pain India’s Glenmark Pharmaceuticals has licensed out its pain drug candidate to Sanofi-Aventis for development and commercialization.

Glenmark Pharmaceuticals S.A, a wholly owned subsidiary of Glenmark Pharmaceuticals has entered into an agreement with Sanofi-aventis to grant Sanofi-Aventis a license for the development and commercialization of novel agents to treat chronic pain, the company announced in press release.

Glenmark’s pain drug candidates portfolio consists the new class of agents called vanilloid receptor (TRPV3) antagonist molecules. This includes Glenmark’s first-in-class clinical compound, GRC 15300.

GRC 15300 is currently in phase I clinical development as a potential next-generation treatment for various pain conditions, including diabetic neuropathic pain and osteoarthritic pain.

Under the terms of the agreement, Glenmark will receive an upfront payment of US $20 million, as well as development, regulatory and commercial milestone payments. All such payments could reach a total of U.S. $ 325 million. In addition, Glenmark is eligible
to receive tiered double-digit royalties on sales of products commercialized under the license.

Sanofi-aventis will have exclusive marketing rights for North America, European Union and Japan subject to Glenmark’s right to co-promote the products in the United States 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 of the rest of the world.

“There continues to be a medical need for safer and more efficacious products for the treatment of painful diabetic neurophathy and osteoarthritis pain,” stated Marc Cluzel, M.D., executive vice president, Research & Development, sanofi-aventis.

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

Glenmark Pharmaceuticals Ltd is headquartered at Mumbai, India. 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]. The company has a significant presence in branded generics markets across emerging economies including India. GPL along with its subsidiary has twelve manufacturing facilities in four countries and has five R&D centres.

In August 2009, Glenmark Pharmaceuticals and US partner Forest Laboratories said oglemilast (GRC 3886) – a drug they were developing to treat chronic obstructive pulmonary disease (COPD) failed in a mid-stage trial COPD has an estimated market worth about $5 billion.

Glenmark signed a deal worth USD 190 mn with Forest Laboratories for developing and marketing Oglemilast for the North American region in 2004.Following the deal, Glenmark received USD 15 million as milestone payments from Forest Labs in the year 2008.

Glenmark Pharmaceuticals’s drug drug discovery programme suffered another setback when Eli Lilly and Co of US suspended clinical trials of its pain drug molecule GRC 6211, in October 2008.

GRC 6211 has been outlicensed to Eli Lilly as potential treatment for arthritis-related pain in a $260 million (about Rs1,290 crore) deal signed in October 2007.

Eli Lilly said it has decided to stop further development of the drug molecule, GRC 6211, after certain adverse findings in early October.

Last year, German drug company Merck KGaA also ended a licensing deal with Glenmark for its diabetes drug after it decided to withdraw diabetes projects from its research portfolio.

In 2004, Glenmark also signed a deal worth USD 53 mn with Teijin Pharma Ltd for developing and marketing oglemilast for the Japanese territory.

Glenmark is among the few Indian pharmaceutical players targeting new drug discovery and biologics research. Glenmark has a strong pipeline of 13 research programs.

Glenmark has completed preclinical development for initiating Phase I trials for GBR 500 – a monoclonal antibody for inflammation.

Glenmark’s molecule for neuropathic pain, osteoarthritis – GRC 10693, was to enter Phase I trials last year. GRC 10693 was Glenmark’s fifth molecule to enter clinical trials.

Glenmark initiated Phase I studies for GBR 500 – a novel biologic molecule – by filing its IND application with the US-FDA, in 2008.

GBR 600, an anti-platelet monoclonal antibody, received approval from MHRA, UK to commence Phase I studies.