Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Takashi Shoda, President and Representative Director
(Code no.: 4568, First Section, Tokyo, Osaka and Nagoya Stock Exchanges)
Please address inquiries to Toshiaki Sai, General Manager,
Corporate Communications Department
Telephone: +81-3-6225-1126
http://www.daiichisankyo.com/
FDA Continues to Review Prasugrel New Drug Application
TOKYO AND INDIANAPOLIS, Ind. (September 26, 2008) - Daiichi Sankyo Company,Limited, (TSE:4568) and Eli Lilly and Company (NYSE: LLY) confirmed today that the U.S. Food and Drug Administration (FDA) did not complete its review for the prasugrel new drug application (NDA) by the Prescription Drug User Fee Act goal date of September 26, 2008. The proposed indication for prasugrel is for the treatment of patients with acute coronary syndromes (ACS) being managed with an artery-opening procedure known as percutaneous coronary intervention (PCI).
"We remain engaged in collaborative and productive discussions with the FDA regarding the details of our application. This is a very large, complex submission, and it should not be surprising that delays occur," said Jennifer Stotka, M.D., vice president for Global Regulatory Affairs at Lilly. "Daiichi Sankyo 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 for prasugrel and look forward to bringing this medication to the market for ACS patients who are being managed with PCI," said John Alexander, M.D., M.P.H., global head of research and development, Daiichi Sankyo Company, Limited.
About prasugrel
Daiichi Sankyo Company, Limited (TSE: 4568), and Eli Lilly and Company (NYSE:LLY) are co-developing prasugrel, an investigational oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner, Ube Industries, Ltd., as a potential treatment, initially for patients with acute coronary syndromes who are managed with
PCI. Prasugrel works by inhibiting platelet activation and subsequent aggregation by blocking the P2Y12 adenosine diphosphate (ADP) receptor on the platelet surface.
Antiplatelet agents prevent platelets from clumping or sticking together, which can result in clogged arteries and may lead to heart attack or stroke.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of firstin-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.
P-LLY
Editor's Note: Please note this press release will be Daiichi Sankyo and Lilly's only statement at this time.
This press release contains certain forward-looking statements about the potential of the investigational compound prasugrel (CS-747, LY640315) and reflects Daiichi Sankyo's and Lilly's current beliefs.
However, as with any pharmaceutical compound under development, there are substantial risks and uncertainties in the process of development and regulatory review. There is no guarantee that the compound will receive regulatory approval, that the regulatory approval will be for the indication(s) anticipated by the companies, or that later studies and patient experience will be consistent with study findings to date. There is also no guarantee that the compound will prove to be commercially successful.
For further discussion of these and other risks and uncertainties, see Lilly's filing with the United States
Securities and Exchange Commission and Daiichi Sankyo's filings with the Tokyo Stock Exchange. Daiichi Sankyo and Lilly undertake no duty to update forward-looking statements.
