Glenmark’s Pain Drug Fails To Meet Primary Endpoint, Path Of Another Altered By Sanofi
This article was originally published in PharmAsia News
Executive Summary
Indian drug maker Glenmark disclosed that Sanofi shelved research on one of its compounds and altered the indication of another biologic for multiple sclerosis treatment.
MUMBAI - Sanofi’s GRC 15300 has not been able to meet its primary endpoint in a clinical trial for chronic pain, according to Indian company Glenmark Pharmaceuticals Ltd., the company Sanofi licensed the product from in May 2010.
In a May 8 release on its fourth quarter earnings, Glenmark said the compound did not meet the primary endpoint in the Phase II proof of concept trial.
Glenmark had received $25 million in upfront and milestone payments from Sanofi during the course of the agreement. The upfront payment alone was $20 million (Also see "Sanofi-Aventis Enters First R&D Pact In India For Glenmark's Pain Drugs; Instills Optimism In India's R&D Capabilities" - Scrip, 3 May, 2010.).
The original licensing deal was valued at a potential total of $325 million.
GRC 15300 is a first-in-class vanilloid receptor inhibitor (TRPV3) for chronic pain and was predicted to be used in treatment of inflammation, various pain conditions like diabetic neuropathic pain and osteoarthritic pain including a few other diseases and disorders. The Sanofi-Glenmark deal was for TRPV3 antagonist molecules, including GRC 15300.
A Glenmark spokesman said as per the agreement, Sanofi will now return the set of molecules back to Glenmark. The company picked the most potential compound from a set of promising leads. In a 2010 interview, Glenmark CEO Glenn Saldanha had briefed PharmAsia News about its extensive research in the field of pain management agents, hoping that the company will be able to lead global research (Also see "Glenmark Claims Lead In New Pain Management Compound; Files For Multiple Patents" - Scrip, 31 Aug, 2010.).
In another significant change for its licensing relationship with Glenmark, Sanofi also altered its plans to develop GBR 500, a novel monoclonal antibody licensed from Glenmark. According to Glenmark, Sanofi has terminated the ulcerative colitis Phase II proof-of-concept study and replaced it with a new Phase II proof-of-concept study for multiple sclerosis.
Originally in 2011, the deal was signed for a record $613 million in potential payments to develop the compound for Crohn’s disease and other inflammatory conditions. Glenmark received an upfront payment of $50 million in exchange for the compound (Also see "Sanofi Continues Search For Novel Compounds In Asia, Inking Deal With India's Glenmark For Phase I Biologic" - Scrip, 16 May, 2011.).
In an interview with CNBC TV18, a leading business news channel in India, Saldanha said he expected more milestones payments from Sanofi on the new indications depending upon the progress made.
At the last count, Glenmark said it had three new chemical entities and an equal number of biologics in research, with a substantial portion focused on drugs to treat chronic pain.
Saldanha highlighted compounds like GRC 17536 for inflammation and neuropathic pain. Another pain compound, a biologic coded GBR 900, has progressed satisfactorily, he indicated. He said a few may get out-licensed in a year or two years.
For the full year ended March 2014, Glenmark’s revenues grew by 19%, reaching $994 million compared to $911 million seen in the previous year.
Analysts were measured about the company’s research pipeline but noted that the overall operations are now larger as compared to a few years ago and so a negative impact of a research-related setback can be absorbed at the present valuations. Glenmark said it spends nearly 10% of its sales in various research projects, of which new drug discovery is a substantial portion.