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news.Ranbaxy Laboratories has submitted an investigational new drug application to the Drug Controller General of India for permission to initiate Phase-I human clinical trials. The investigational new drug application is for the respiratory inflammation candidate that the joint GlaxoSmithKline-Ranbaxy steering committee had identified earlier in 2007.
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Ranbaxy has completed all the required regulatory safety and toxicity studies on the drug candidate and also plans to seek regulatory approval in other countries outside India in order to initiate Phase-I human clinical trials at the earliest.
Pradip Bhatnagar, senior vice president of new drug discovery research at Ranbaxy, said: “The long-standing vibrant collaboration between GlaxoSmithKline’s (GSK’s) Center of Excellence for External Drug Discovery and Ranbaxy has been the key for this success. This achievement also reflects the discovery and development capabilities of Ranbaxy’s R&D team.”
As per the multi-year R&D collaboration agreement, Ranbaxy will be responsible for conducting Phase I and Phase II clinical studies through proof of concept. GSK will then have the option to conduct further development through final registration and commercialization.
Ranbaxy could receive over $100 million in potential milestone payments for a product developed by Ranbaxy and subsequently launched by GSK in multiple indications and up to double digit royalties on worldwide net sales.
This is reported to be yet another major landmark in the GSK-Ranbaxy R&D collaboration, initiated in 2003, and further expanded in February 2007. The new milestone payments and royalties, as enumerated in the revised agreement, will apply to this current development program and to future discovery programs.