AHMEDABAD, India—Facing sluggish drug pipelines and increasing competition from generic drugs, many large pharmaceutical companies are moving toward outsourcing their drug research and development to firms in countries such as India to help cut costs and shorten the time for a drug launch. Seeking to capitalize on those efficiencies and expand its focus on cardiovascular therapies is Eli Lilly & Co., which announced in April that it struck a drug discovery and research pact with India's Zydus Cadila Healthcare focused in the area of cardiovascular research.
According to the companies, the target of the alliance is to increase productivity in drug discovery and development by synergizing the unique strengths of both companies. It is a collective research program that may continue for up to six years.
Per the agreement, Lilly will provide chemical starting points as well as expertise and feedback regarding toxicology, ADME, chemistry, biology, clinical and regulatory aspects. Zydus, which will initiate drug discovery efforts along with conducting preclinical studies and clinical trials through Phase II, is eligible to receive milestone payments of up to $300 million and royalties on sales upon the successful launch of any compounds derived from the research program. Lilly will have an option to license any resulting molecules at different stages.
This is the first collaboration between Lilly and Zydus Cadila, but Lilly has similar deals with many other Indian firms, including Piramal Life Sciences, Suven Life Sciences and Jubilant Organosys. According to Lilly spokeswoman Judy Kay Moore, the collaborations are "reflective of Lilly's move from a fully-integrated pharmaceutical company, or FIPCO, to a fully-integrated pharmaceutical network, or FIPNet. With FIPNet, Lilly is casting a much wider net to better leverage and amplify its R&D investments. The collaboration between Zydus Cadila and Lilly is an example of FIPNet."
The agreement with Zydus Cadila could also potentially boost Lilly's pipeline of cardiovascular drugs, but the cupboard isn't bare, according to officials.
"The U.S. Food and Drug Administration is evaluating whether prasugrel (Effient) should be approved in the United States for the treatment of patients with acute coronary syndromes (ACS) managed with percutaneous coronary intervention (PCI)," says Dr. William Chin, vice president of discovery research and clinical investigation at Lilly.
On Feb. 23, Daiichi Sankyo Co. Ltd. and Lilly announced that the European Commission granted marketing authorization for Efient (the European spelling of the drug) for the prevention of atherothrombotic events in patients with ACS under PCI.
"In addition, the Trilogy trial is underway, which is evaluating the safety and efficacy of prasugrel compared to clopidogrel in medically-managed ACS patients," adds Chin.
Trilogy, which began in 2008, will ultimately include approximately 10,000 patients at more than 800 hospitals in 35 countries. Lilly also has a compound in Phase I development that will study atherosclerosis.
The agreement will also likely produce a boost for Zydus Cadila, which last year signed similar pacts. Last year, Zydus Cadila signed a research agreement with Sweden's Karo Bio AB for a new drug to treat inflammatory diseases. The company also signed a pact with U.S.-based Prolong Pharmaceuticals Inc. to develop a therapeutic protein to treat severe anemia.
The Zydus Research Centre, the dedicated research arm of the group, brings a robust team of more than 350 research professionals to the agreement. The center is engaged in new drug discovery, novel biologics and newer drug discovery systems research. The group has a strong research pipeline of six new molecular entities in various stages of clinical trials, five of which are targeted at cardiometabolic disorders.
"We have built strong discovery and development capabilities in the cardiometabolic disease area, and this is a wonderful opportunity to unite efforts, share expertise, complement strengths and develop new potential cardiovascular therapies," said Pankaj R. Patel, chairman and managing director of Zydus Cadila, in a statement.
