REG-Lilly (Eli) & Co: FDA Extends Review Period for Prasugrel

* Reuters is not responsible for the content in this press release.

Tue Jun 24, 2008 8:49am EDT

                                                                                                                       . 
Date: June 23, 2008

Refer to: Tammy Hull
Eli Lilly and Company
317-651-9116 (office)
317-614-5132 (cell)

Kim Wix
Daiichi Sankyo (U.S.A.)
973-695-8338 (office)
908-656-5447 (cell)

Shigemichi Kondo
Daiichi Sankyo (Tokyo)
81-3-6225-1126 (office)


              FDA Extends Review Period for Daiichi Sankyo, Lilly              
                  Investigative Antiplatelet Drug, Prasugrel                   

 Companies confirm the start of TRILOGY ACS clinical trial to study Prasugrel  
             against Clopidogrel in medically managed ACS patients             

TOKYO AND INDIANAPOLIS, Ind. (June 23, 2008) - Daiichi Sankyo Company, Limited,
(TSE:4568) and Eli Lilly and Company (NYSE: LLY) said that the U.S. Food and
Drug Administration (FDA) has extended the review period for the prasugrel new
drug application (NDA) based on supplemental information provided during the
review period. This three month extension allows the FDA time to complete its
review. The prasugrel NDA was granted priority review by the FDA in February
2008. The new FDA action date for prasugrel is 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).

Daiichi Sankyo and Lilly also confirm the start this month, as planned, of the
TRILOGY ACS trial, a large Phase III clinical trial to compare the effects of
prasugrel against clopidogrel (Plavix/Iscover) in medically managed ACS
patients.

"We remain confident in our prasugrel submission package," said Jennifer
Stotka, M.D., vice president for Global Regulatory Affairs at Lilly. "The
TRITON trial encompassed a large amount of data from over 13,000 patients. We
will continue to work closely with the FDA throughout the review process and
continue discussions to determine if any requirements under the new FDA
Amendment Act (FDAAA) legislation will apply."

"The initiation of the TRILOGY ACS trial demonstrates our continued commitment
to investigate prasugrel as a potential therapy for ACS patients who are
medically managed," said John Alexander, M.D., M.P.H., global head of research
and development, Daiichi Sankyo Company, Limited.

About Trilogy ACS

The study, TRILOGY ACS (TaRgeted platelet Inhibition to cLarify the Optimal
strateGy to medicallY manage Acute Coronary Syndromes), will include
approximately 10,000 patients at more than 800 hospitals in 35 countries.

Daiichi Sankyo and Lilly are conducting the study in conjunction with the Duke
Clinical Research Institute (DCRI), the world's largest academic clinical
research organization and a part of Duke University Medical Center.

The study is a multi-center, double-blind, randomized, controlled trial to
evaluate the safety and efficacy of prasugrel against clopidogrel in reducing
the risk of cardiovascular death, heart attack or stroke in ACS patients who
are to be medically managed without a planned artery-opening procedure.

Acute coronary syndromes, which comprises heart attacks and unstable angina
(chest pain), affects more than 1.4 million people in the United States
annually. Despite currently available treatments, 320,000 people experience
recurrent heart attacks each year.

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 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

                                     # # #                                     

Plavix/Iscover are registered trademarks of Sanofi-Synthelabo Inc.

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.

American Heart Association. Heart Disease and Stroke Statistics - 2008 Update.
Dallas, TX. American Heart Association. (Pg. 14)

American Heart Association. Heart Disease and Stroke Statistics - 2008 Update.
Dallas, TX. American Heart Association. (Pg. 12)



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