Ranbaxy-GSK alliance to develop respiratory drug

Mumbai: Pharma majors Ranbaxy Laboratories Ltd and GlaxoSmithKline (GSK) are jointly developing a drug for the treatment of respiratory inflammation under their multi-year R&D collaboration agreement.

A committee consisting of senior members from GSKs center of excellence for external drug discovery (CEEDD) and Ranbaxy''s new drug discovery research (NDDR) team has chosen the compound for preclinical investigation.

As per the multi-year agreement signed recently, Ranbaxy would be able to further profile this drug candidate through pre-clinical studies needed to support an investigational new drug (IND) application.

Ranbaxy would also be responsible for conducting Phase I and Phase II clinical studies. GSK would then have the option to conduct further development through to final commercialisation, it added.

The two companies are collaborating on two research programmes - one in chronic obstructive pulmonary disease (COPD) and the other in anti-infectives.

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.

GSK, at a recent pipeline update, announced two key compounds had progressed into Phase II development; 681313 and 856553 are both p38 kinase inhibitors to treat COPD, although the first is also being tested for rheumatoid arthritis, atherosclerosis and pain. These two drug candidates represented a significant proportion of all GSK drugs moving into Phase II.

Under the expanded tie-up, Ranbaxy could receive over $100 million in potential milestone payments for a product developed by it. The amount may increase after the drug is subsequently launched by GSK in multiple indications and could net its double-digit royalties on worldwide net sales, a Ranbaxy statement said.

GSK has been forced to outsource research and refocus its business due to increasing costs, pipeline shortages and patent expiries.

"This is a great moment for our scientists. The agreement presents a unique opportunity to demonstrate the India centric advantages of high quality research and development to deliver value at the cutting edge," said Ranbaxy''s CEO Brian W Tempest: "I believe the arrangement with GSK is path-breaking and acknowledges the higher level of R&D maturity prevalent today in our state-of-the art labs in India ," he added.