The Hindu Business Line : Ranbaxy seeks nod for human clinical trials for new drug

New Delhi, Oct.13 Ranbaxy Laboratories Ltd announced on Monday that it has submitted an Investigational New Drug (IND) application to the Drug Controller General of India seeking permission to initiate Phase-I human clinical trials for a respiratory inflammation drug.

The drug is part of the research and development collaboration between Ranbaxy and GlaxoSmithKline. As per the agreement, Ranbaxy will be involved in conducting phase I and phase II clinical studies, while GlaxoSmithKline will have the choice to develop and market the product. Ranbaxy could receive over $100 million in potential milestone payments.

Ranbaxy has successfully completed all the required regulatory safety and toxicity studies and plans to seek regulatory approval in other countries to initiate Phase-I human clinical trials at the earliest.

‘Major landmark’ in collaboration

Commenting on the progress of the alliance, Dr Pradip Bhatnagar, Senior Vice-President, New Drug Discovery Research (NDDR), Ranbaxy, said, “The long-standing vibrant collaboration between GSK’s CEEDD and Ranbaxy has been the key for this success. This achievement also reflects the discovery and development capabilities of Ranbaxy’s R&D team.”

“This is 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 programme and to future discovery programmes,” said a press release. The Ranbaxy-GSK alliance envisages research workflow to emanate from a wide range of therapeutic areas of interest to Ranbaxy and GSK, including anti-infectives, respiratory, and oncology.