GlaxoSmithKline, Ranbaxy to expand R&D alliance

New Delhi: Ranbaxy Laboratories and GlaxoSmithKline (GSK) are expanding their existing R&D association. The new agreement could, claims Ranbaxy, help it earn over $100 million (Rs 440 crore) in potential `milestone payments' and up to double digit in royalties on worldwide net sales for a product developed by it and subsequently launched by GSK in multiple indications.

Meanwhile, GSK is also believed to be seeking an injunction in a New Jersey court to stop the Indian company from launching in the US a generic version (valacyclovir) of its drug Valtrex.

'Our announcement today is reflective of the mature nature of our relationship with GSK. You can call it co-opitation,' said Mr Malvinder Mohan Singh, CEO and Managing Director, Ranbaxy.

However, he added that his company had only received the US Food and Drug Authority's approval for valacyclovir, and it had not announced a launch or heard from GSK regarding the said injunction.

GSK had also filed a patent infringement case in 2003 against Ranbaxy for Valtrex, whose patent expires in 2009. GSK `s third quarter sales of Valtrex was up 26 per cent to £215 million, or Rs 1,864 crore.

The two companies had also entered into an R&D arrangement in 2003, whose scope was expanded today.

Ranbaxy, which was earlier conducting early clinical work up to the stage of candidate selection, will now also conduct clinical proof of concept. GSK's Center of Excellence for External Drug Discovery (CEEDD) will be responsible for further clinical developments, getting regulatory approval and commercialisation, with Ranbaxy retaining the right to co-commercialise the product in India.

Future projects


The two companies are already working on two programmes. Their future projects will include development of anti-infectives, metabolic, respiratory and oncology products.

'This expanded agreement builds on the success of the existing collaboration and furthers our CEEDD strategy of building a strong pipeline through to clinical proof of concept via external R&D collaborations,' said Mr Maxine Gowen, Senior Vice President, CEEDD, GSK.