TOKYO and INDIANAPOLIS, Sept. 26 Daiichi SankyoCompany, Limited, (TSE: 4568) and Eli Lilly and Company (NYSE: LLY) confirmedtoday that the U.S. Food and Drug Administration (FDA) did not complete itsreview for the prasugrel new drug application (NDA) by the Prescription DrugUser Fee Act goal date of September 26, 2008. The proposed indication forprasugrel is for the treatment of patients with acute coronary syndromes (ACS)being managed with an artery-opening procedure known as percutaneous coronaryintervention (PCI).
"We remain engaged in collaborative and productive discussions with theFDA regarding the details of our application. This is a very large, complexsubmission, and it should not be surprising that delays occur," said JenniferStotka, M.D., vice president for Global Regulatory Affairs at Lilly. "DaiichiSankyo and Lilly will not speculate on the timing or what the outcome will be.However, the review is very far along, and we remain optimistic."
"Daiichi Sankyo and Lilly remain confident in the submission package forprasugrel and look forward to bringing this medication to the market for ACSpatients who are being managed with PCI," said John Alexander, M.D., M.P.H.,global head of research and development, Daiichi Sankyo Company, Limited.
Daiichi Sankyo Company, Limited (TSE: 4568), and Eli Lilly and Company(NYSE: LLY) are co-developing prasugrel, an investigational oral antiplateletagent discovered by Daiichi Sankyo and its Japanese research partner, UbeIndustries, Ltd., as a potential treatment, initially for patients with acutecoronary syndromes who are managed with PCI. Prasugrel works by inhibitingplatelet activation and subsequent aggregation by blocking the P2Y12 adenosinediphosphate (ADP) receptor on the platelet surface. Antiplatelet agentsprevent platelets from clumping or sticking together, which can result inclogged arteries and may lead to heart attack or stroke.
About Daiichi Sankyo Company, Limited
A global pharma innovator, Daiichi Sankyo Co., Ltd., was established in2005 through the merger of two leading Japanese pharmaceutical companies. Thisintegration created a more robust organization that allows for continuousdevelopment of novel drugs that enrich the quality of life for patients aroundthe world. A central focus of Daiichi Sankyo's research and development iscardiovascular disease, including therapies for dyslipidemia, hypertension,diabetes, and acute coronary syndromes. Equally important to the company isthe discovery of new medicines in the areas of infectious diseases, cancer,bone and joint diseases, and immune disorders. For more information, visitwww.daiichisankyo.com.
Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is the U.S.subsidiary of Daiichi Sankyo Co., Ltd. For more information on DaiichiSankyo, Inc., please visit www.dsus.com.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growingportfolio of first- in-class and best-in-class pharmaceutical products byapplying the latest research from its own worldwide laboratories and fromcollaborations with eminent scientific organizations. Headquartered inIndianapolis, Ind., Lilly provides answers - through medicines and information- for some of the world's most urgent medical needs.
Editor's Note: Please note this press release will be Daiichi Sankyo andLilly's only statement at this time.
This press release contains certain forward-looking statements about thepotential of the investigational compound prasugrel (CS-747, LY640315) andreflects Daiichi Sankyo's and Lilly's current beliefs. However, as with anypharmaceutical compound under development, there are substantial risks anduncertainties in the process of development and regulatory review. There is noguarantee that the compound will receive re