Ranbaxy’s achieves landmark in GSK drug research

Starts Phase I Clinical Studies for Respiratory Inflammation Program

Ranbaxy Laboratories Limited (Ranbaxy) announced today that its New Drug Discovery/Development Research (NDDR) team has achieved a significant landmark in its collaborative research program with GlaxoSmithKline (GSK).  Ranbaxy has initiated Phase I clinical studies on the lead compound for Respiratory Inflammation. Phase I studies will be conducted in India and Europe.  After the successful completion of Phase-I studies, Ranbaxy will progress the candidate to end of  Proof of Concept (Phase IIa clinical trials).

Ranbaxy will receive a milestone payment for initiating Phase I studies and will also be responsible for conducting Phase II clinical studies through to Proof of Concept. After the successful completion of the Phase IIa studies, GSK will then have the option to conduct further development through to final commercialization.

Commenting on this significant achievement, Dr. Sudershan Arora, President, Drug Development and Clinical Research, Ranbaxy, said, "Ranbaxy’s development team has the capability to conduct clinical studies on NCEs and is looking forward to advancing this lead compound through to Proof of Concept studies.”  Dr. Pradip Bhatnagar, Sr. VP of Drug Discovery Research stated, “My team and I are elated with this achievement. Ranbaxy’s discovery team has worked hard on optimizing early hits obtained from GSK and is excited that its efforts are brought to fruition.”

Ranbaxy could receive over $100 Mn in potential milestone payments for a product developed by Ranbaxy and subsequently launched by GSK in multiple indications and up to double digit royalties on worldwide net sales. The Ranbaxy-GSK collaboration was initiated in 2003, and further expanded in February 2007.  Several research programs are being pursued within the Ranbaxy-GSK alliance against anti-infective, respiratory and oncology indications.

Ranbaxy Laboratories Limited, India's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary "platform technologies," resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.