Nicholas Piramal India Ltd (NPIL) will have stake in the development and marketing of a major potential drug from Eli Lilly, makers of Prozac, the best-selling and much-abused drug for manic depression.
The new chemical is in the field of metabolic disorders, and could bring in more than $100 million (Rs 444.2 crore) in milestone payments and royalties for the Indian drug researcher.
The company would also have marketing rights for the new therapy in India once the drug comes out commercially.
While neither NPIL nor Robert W Armstrong, representative of Eli Lilly, were forthcoming about the exact nature of the drug, discussions indicate that the drug could be related to diabetes or related heart complications. India is the current 'diabetes capital' of the world, and has one of the highest rates of incidence among all countries.
The tieup for Eli Lilly is the second this financial year, after its August 2006 agreement with Hyderabad-based Suven Life Sciences to collaborate on pre-clinical research of Central Nervous System related therapies. Prozac is an example of this kind of drug.
NPIL will mainly design and implement Phase I and II human clinical trials of the new drug. Further, it would have exclusive marketing rights and royalties in certain markets other than India, NPIL chairman Ajay Piramal said.
Payments would be for the first drug candidate though there is a possibility of four more such leads coming to NPIL for similar development.
The payments would include the cost of the trials, which would officially be sponsored by Eli Lilly. There would be equal representation from the two companies in the ethics committee to oversee the clinical trials. A named sponsor and an ethics committee are mandatory for any human clinical trial.
NPIL will be responsible for the design and execution of the global clinical development program, including IND-enabling non-clinical studies and human clinical trials up to Phase III, said a release from the company.