By Seema Singh
Matching the Indian pharmaceutical companies’ marathon drug development alliances with global counterparts, Mumbai-based Nicholas Piramal (NPIL) said Friday it has entered into a new deal with Eli Lilly to develop and commercialize some of Lilly’s pre-clinical drug candidates.
Bucking the general trend and notion that the global pharma industry is not ready for a collaboration model that shares risk and reward, the current alliance is said to “equitably share risk and reward.”
NPIL will be responsible for the design and execution of the global clinical development program, including Investigational New Drug application-enabling non-clinical studies and human clinical trials up to Phase III.
In return, NPIL would receive a callback payment, potential milestone payments of up to $100 million, and royalties on sales upon successful launch of the first compound.
The agreement, which is expected to serve as a prototype for joint development of several pre-clinical drug candidates from Lilly in multiple therapeutic areas, is also said to set a new benchmark in global alliances for drug discovery and development.
“This is indeed a unique partnership,” said Swati Piramal, director of strategic alliances and communications at NPIL.
Indianapolis-based Lilly, which recently has been on a deal binge in India, conceded that this is a “novel collaboration.”
India“NPIL has both strategic interest and capabilities to advance Lilly’s molecules through early clinical development,” said Robert W. Armstrong, vice president of global external research and development for Lilly.
Indian Deal Wave
Recent months have produced a veritable global pharmaceutical alliance season in India. Several global giants—including Merck, Wyeth, GlaxoSmithKline, and AstraZeneca—have sewn up deals with Indian drug or bioinformatics companies. But Lilly stands out for signing the most agreements.
IndiaIn September 2006 the company agreed to develop new drugs with Hyderabad-based Suven Life Sciences for central nervous system disorders, which are the second largest therapeutic category worldwide and also one of the fastest growing.
Financial details were not available, but Suven, which has expertise in R&D in diseases like Alzheimer’s, schizophrenia, depression, Parkinson’s disease, and dementia, will get milestone payments from Lilly. Suven will also receive potential downstream payments if the identified drug targets are taken up by Lilly for further development.
In November of last year, Lilly entered into an agreement with the largest software company in India, Tata Consultancy Services (TCS), to advance its clinical research and development.
clinical research and development.
Under this multiyear agreement, TCS will establish a dedicated facility for Lilly at Noida, near New Delhi, and will provide services in statistical analysis, clinical data management, and medical writing.
New Delhi“The goal of our relationship with TCS has several dimensions beyond reducing cost and risk, including gaining access to a global talent pool, increasing flexibility and scalability of our resources, and maintaining a global workflow that is operational 24 hours a day,” said Dr. Steve Ruberg, group director of global medical information sciences at Lilly, in a statement at the time announcing the agreement.
The Lilly-TCS alliance is considered to be a milestone as it shows the improved confidence of global pharma, which has not previously outsourced statistical analysis to any Indian company. Analysts believe this would change the way big drug companies deal with their Asian counterparts.