Sanofi-Aventis Enters First R&D Pact In India For Glenmark's Pain Drugs; Instills Optimism In India's R&D Capabilities

MUMBAI - An extensive worldwide search for novel agents to treat chronic neuropathic pain has brought together Sanofi-Aventis and Indian drug maker Glenmark Pharma through a development and commercialization deal for transient receptor potential vanilloid (TRPV3) antagonist molecules.

The deal - the first ever research agreement in India by the French drug company - includes a first-in-class clinical compound coded GRC 15300, currently in Phase I trials in the United Kingdom.

Sanofi Aventis' Executive Vice President R&D Marc Cluzel was in India in March and it is believed that the finer contours of the deal with Glenmark were finalized then.

As part of the total value of $325 million deal, Glenmark said it will receive an upfront payment of $20 million in addition to development, regulatory and commercial milestone payments in different stages.

Glenmark will also be eligible to receive tiered double-digit royalties on the commercialized products. "We expect to launch the product in the next four to five years at the least but these estimates are subject to successes at various stages," Glenmark's Chief Executive Glenn Saldanha told local televsion after the announcement.

"GRC 15300 and its associated program brings an innovative approach to Sanofi-Aventis' pain portfolio," Cluzel noted. "We are very pleased to collaborate with Glenmark Pharmaceuticals on the development of this new program, which we believe may have promise to address a significant gap in treating chronic pain."

The TRPV3 receptor is an ion channel protein that mediates and influences cell signaling, including 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.

Sanofi-Aventis and Glenmark have carefully divided the marketing rights for the potential products according to their strengths in respective geographies. Glenmark will retain exclusive marketing rights in India and the rest of the world while the two will go for a co-marketing agreement in countries like Russia, China and Brazil.

In what is seen by analysts as a big positive, Glenmark will have co-promotion rights for the drug in the U.S. and five undisclosed Eastern European countries.

The worldwide market for pain management drugs is said to be close to $20 billion of which Glenmark's compound could address a market opportunity of $2-3 billion, according to the company's website. Glenmark has rated its TRPV3 products as potential next-generation treatment for various pain conditions, including diabetic neuropathic pain and osteoarthritic pain.

Among the other big products marketed in the pain management segment are Pfizer's Neurontin (gabapentin) and Lyrica (pregabalin) while Eli Lilly has Cymbalta (duloxetine).

In July 2007, Pfizer signed a deal valued at $195 million with Hydra Biosciences for TRPV3 antagonist candidates in preclinical development. There are no updates on the progress made in that developemnt deal.

In October 2007, Lilly obtained rights to Glenmark's range of TRPV1 compounds through a $260 million deal but within a span of a year, the deal was called off without explanation (Also see "Lilly Acquires Rights To TRPV-1 Receptor Antagonists From Glenmark" - Scrip, 31 Oct, 2007.).

Over the last seven years, Glenmark has signed early-stage drug development partnerships with companies like Forest Labs, Japan's Teijin Pharma, Merck of Germany and Lilly for therapeutics for diabetes, respiratory disorders and pain management.

However, a string of clinical setbacks raised doubts about the scalability of Glenmark's pipeline. "This deal puts us back in shape despite a long spell of negativity and we will continue to be driven by innovation," Saldanha explained. He predicted more deals for his company's pipeline of experimental drugs.

In a March interview, Sanofi-Aventis India Managing Director Shailesh Ayyangar indicated that the company is studying the research landscape in India in preparation for partnerships (Also see "Sanofi-Aventis India Managing Director Shailesh Ayyangar On Building Infrastructure In India To Bring Affordable Drugs To Patients In Rural Markets: An Interview With PharmAsia News (Part 1 of 2)" - Scrip, 15 Mar, 2010.).

- Vikas Dandekar ([email protected])