Ranbaxy-GSK submits IND application for respiratory inflammation candidate

13 October 2008

Ranbaxy Laboratories Limited and GSK have submitted a joint investigational new drug (IND) application for respiratory inflammation candidate to the Drug Controller General of India for permission to initiate Phase-I human clinical trials.

Earlier this year, GlaxoSmithKline approved further development of the respiratory drug by Ranbaxy under a research and development collaboration pact between the two companies, signed in April 2007. The two companies are collaborating on two research programmes - one in chronic obstructive pulmonary disease (COPD) and the other in anti-infectives. (See: Ranbaxy-GSK alliance to develop respiratory drug)

Chronic obstructive pulmonary disease (COPD), which encompasses both chronic bronchitis and emphysema, is one of the commonest respiratory disorders of adults in the developed world.

A committee of senior members from GSKs Center of Excellence for External Drug Discovery (CEEDD) and Ranbaxy's New Drug Discovery Research (NDDR) team had last year identified the compound to advance into preclinical investigation.

Dr Pradip Bhatnagar, senior vice president, New Drug Discovery Research (NDDR), Ranbaxy, said, "The long-standing collaboration between GSK's CEEDD and Ranbaxy has been the key for this success."

Ranbaxy plans to seek regulatory approval in other countries outside India in order to initiate Phase-I human clinical trials, after it has successfully completed the necessary regulatory safety and toxicity studies on the drug candidate in India.

As per the multi-year R&D collaboration agreement, Ranbaxy will be conducting Phase I and Phase II clinical studies through Proof of Concept while GSK will have the option to conduct further development through final registration and commercialisation.