Ranbaxy Files For Phase I Trial On First Compound From GSK Deal
This article was originally published in PharmAsia News
Executive Summary
MUMBAI - A year after identifying a potential compound targeted at respiratory inflammation for joint development with GSK Pharma, India's largest drug maker, Ranbaxy has submitted an application to the Drug Controller General of India to initiate Phase I trials
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MUMBAI - A year after identifying a potential compound targeted at respiratory inflammation for joint development with GSK Pharma, India's largest drug maker, Ranbaxy has submitted an application to the Drug Controller General of India to initiate Phase I trials. Ranbaxy has successfully completed required regulatory safety and toxicity studies on the drug candidate and also plans to seek regulatory approval in countries outside India to initiate Phase I trials as early as possible, Ranbaxy stated. Highlighting the GSK Pharma alliance, Pradip Bhatnagar, Ranbaxy's senior vice president of new drug discovery research, said, "The long-standing vibrant collaboration between GSK and Ranbaxy has been the key for this success. This achievement also reflects the discovery and development capabilities of Ranbaxy's R&D team." The announcement is a dose of good news for Ranbaxy, which has been embroiled in a high-profile U.S. FDA investigation regarding alleged good manufacturing practices deviations (Also see "Two Months On, U.S. DOJ Withdraws Motion Against Ranbaxy" - Scrip, 8 Oct, 2008.). As per the multi-year research agreement with GSK, Ranbaxy is responsible for conducting Phase I and II clinical studies through proof of concept. GSK then has the option to conduct further development through final registration and commercialization. Ranbaxy could receive over $100 million in potential milestone payments for every product developed and subsequently launched by GSK for multiple indications. The deal envisages double-digit royalties on worldwide net sales to Ranbaxy. The research collaboration between Ranbaxy and GSK was signed in 2003 and later expanded in 2007 (Also see "Ranbaxy/GSK Partnership Yields First Drug Candidate" - Scrip, 3 Apr, 2007.). Indian and multinational drug companies are increasingly collaborating to conduct joint research for discovery of new chemical compounds (Also see "A Tale Of Two Giants; Tracking India And China’s Rise In The Pharmaceutical Market" - Scrip, 4 Aug, 2008.). - Vikas Dandekar ([email protected]) |