FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel

Investigational antiplatelet agent submitted for treatment of patients with
acute coronary syndrome being managed with percutaneous coronary intervention

TOKYO and INDIANAPOLIS, Feb. 21 /PRNewswire-FirstCall/ -- Daiichi Sankyo
Company, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: LLY) today
announced that the U.S. Food and Drug Administration (FDA) accepted and
designated Priority Review for the New Drug Application for prasugrel, for
patients with acute coronary syndrome being managed with percutaneous coronary
intervention (PCI). The NDA for prasugrel was submitted to the agency on Dec.
26, 2007.
A priority designation by the FDA sets the PDUFA (Prescription Drug User
Fee Act) goal date. The PDUFA goal for priority applications is to have an
action provided for 90 percent of applications within six months. FDA can
take three different actions - approved, approvable with further discussion,
or not approved.
"We are greatly pleased to learn that the FDA has determined the
application meets its criteria for such a review, and we look forward to
working with the agency as it continues its review process," said Dr. J.
Anthony Ware, Lilly vice president for cardiovascular/acute care.
"If approved, prasugrel will provide physicians and acute coronary
syndrome patients an alternative medicine that may further help reduce the
risk of heart attacks," said John Alexander, M.D., M.P.H., global head of
research and development, Daiichi Sankyo Company, Ltd.
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 syndrome 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 Daiichi Sankyo Company, Limited
Daiichi Sankyo Company, Limited, established in 2005 after the merger of
two leading century-old Japanese pharmaceutical companies, is a global
pharmaceutical innovator, continuously generating innovative drugs that enrich
the quality of life for patients around the world. The company uses its
cumulative knowledge and expertise in the fields of cardiovascular disease,
cancer, metabolic disorders, and infection as a foundation for developing an
abundant product lineup and R&D pipeline.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-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
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.
(Logo: here )
SOURCE Eli Lilly and Company

Joedy Isert of Eli Lilly and Company, +1-317-276-5592, or cell
+1-317-007-8544; or Rich Salem of Daiichi Sankyo (U.S.A.), +1-973-695-8330, or
cell +1-973-563-1086; or Shigemichi Kondo of Daiichi Sankyo (Tokyo),
81-3-6225-1126