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Ranbaxy/GSK Partnership Yields First Drug Candidate

This article was originally published in The Pink Sheet Daily

Executive Summary

Ranbaxy will develop a respiratory disease candidate through proof of concept under an expanded discovery agreement inked with GSK in February.

Ranbaxy and GlaxoSmithKline have identified the first clinical candidate to be developed under their discovery alliance, the two firms announced April 2.

The compound is targeted for asthma and chronic obstructive pulmonary disease, Ranbaxy VP-Corporate Development Shyam Bishen told "The Pink Sheet" DAILY.

The selection is significant for Ranbaxy not only because the Gurgaon, India, firm will receive a milestone payment from its U.K. partner, but also because it marks a milestone toward Ranbaxy becoming a discovery-research pharmaceutical company.

In February, Ranbaxy and GSK amended a 2003 agreement, under which Ranbaxy provided early stage discovery services for two GSK programs, to give the Indian firm expanded development responsibilities for drug candidates through proof of concept (1 (Also see "GSK/Ranbaxy Deal Gives Indian Firm Greater Development Charge" - Pink Sheet, 6 Feb, 2007.)). GSK will market products that come of the collaboration worldwide with the exception of India, where Ranbaxy will retain rights.

"This program has been running for less than two years, and we are already at this stage, which is quite remarkable," Bishen said. "It normally takes ... close to three years for a company to get to this stage where you can have a molecule for a clinical candidate."

"For the new deal, we ... will be taking another two or three programs - we have not decided how many - with GSK in various therapeutic areas where we will do the discovery and take molecules all the way up to proof of concept," Bishen said. "Sometimes we take early hits from their screens, or we can take targets from them and do our own screen, using our own database and our own chemicals."

Ranbaxy has the ability to conduct human studies, but it also takes advantage of contract research organizations, Bishen said. "For this molecule, we have not decided yet whether we will do all of it 100 percent in house or outsource some part of it."

The company now has two new chemical entities under development. Ranbaxy is also developing a malaria drug (RBX 11160), now in Phase IIb, that was discovered by its own internal drug discovery research group, Bishen said.

Looking forward, Bishen said Ranbaxy is "actively talking to several companies, including biotech companies" for further partnerships, alliances and acquisitions.

"I am spearheading the effort to work with big pharma and biotech companies, where we can establish more GSK-type alliances," he said. In addition, he said, Ranbaxy is looking for opportunities at both inlicensing and outlicensing of products both in development and on the market.

In February, Ranbaxy announced it had formed an alliance with another Indian company, Zenotech Laboratories, to develop generic biologics (2 (Also see "Ranbaxy’s First Biosimilar Target Will Be Amgen’s Neupogen" - Pink Sheet, 8 Feb, 2007.)).

- Shirley Haley ([email protected])

Editor's note: Additional coverage of Asia is provided at 3 Pharm Asia News, F-D-C Reports' new free site for Asian biotech and pharmaceutical news.

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