FDA Cardio Renal Advisory Committee to Review Daiichi Sankyo, Lilly Drug Prasugrel

Wednesday, December 31, 2008 General News
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TOKYO and INDIANAPOLIS, Dec. 31 Daiichi SankyoCompany, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: LLY) todayconfirmed that the U.S. Food and Drug Administration's (FDA) Cardiovascularand Renal Drugs Advisory Committee (CRDAC) will review prasugrel during anadvisory committee hearing on February 3, 2009. Prasugrel is aninvestigational antiplatelet agent for the treatment of patients with acutecoronary syndromes (ACS) who are being managed with an artery-openingprocedure known as percutaneous coronary intervention (PCI), which is usuallyfollowed by the placement of a stent to help keep the artery open.

Advisory committees provide the FDA with independent advice from outsidemedical experts during the review process. The companies will have furtherdiscussions with the FDA in preparation for the Advisory Committee Meeting.

"We welcome the opportunity to discuss any and all of the prasugrel datawith the advisory committee and the agency, just as we have throughout theongoing review," said John Alexander M.D., M.P.H., global head of research anddevelopment, Daiichi Sankyo Company, Limited.

"We have full confidence in the data submitted to the FDA and the overallbenefit-risk profile of prasugrel, and we look forward to this next step inpotentially bringing an important new alternative to the oral antiplateletmarket," said J. Anthony Ware, M.D., Lilly vice president andcardiovascular/acute care platform leader for prasugrel.

The Burden of Acute Coronary Syndromes

Acute coronary syndromes (ACS), which is comprised of heart attacks andunstable angina (chest pain), affects more than 1.4 million people in theUnited States annually.(i) Coronary heart disease, which can result in ACS,is the single most common cause of death in the European Union, accounting formore than 741,000 deaths in the EU each year.(ii) Coronary artery diseaseoccurs when the arteries become narrowed or clogged by cholesterol and fatdeposits and cannot supply enough blood to the heart. In some cases, a bloodclot may partially or totally block the blood supply to the heart resulting inACS.(iii) Many ACS patients are managed with PCI, which usually includes astent placement.

About prasugrel

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 syndrome 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

A global pharma innovator, Daiichi Sankyo Co., Ltd., was established in2005 through the merger of two leading Japanese pharmaceutical companies.This integration 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 arethrombotic disorders, malignant neoplasm, diabetes mellitus, and autoimmunedisorders. Equally important to the company are hypertension, hyperlipidemiaor atherosclerosis and bacterial infections. 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 andinformation -- for some of the world's most urgent medical needs.


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 regulatory approval, that theregulatory approval will be for the indication(s) anticipated by thecompanies, or that later studies and patient experience will be consistentwith study findings to date. There is also no guarantee that the compound willprove to be commercially successful. For further discussion of these and otherrisks and uncertainties, see Lilly's filing with the United States Securitiesand Exchange Commission and Daiichi Sankyo's filings with the Tokyo StockExchange. Daiichi Sankyo and Lilly undertake no duty to update forward-lookingstatements.

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

(ii) British Heart Foundation Health Promotion Research Group. EuropeanCardiovascular Disease Statistics 2008,http://www.ehnheart.org/content/ItemPublication.asp?docid=7069&level0=1500&level1=2157, Accessed April 24 2008.

(iii) WebMD Medical Reference in Collaboration with the Cleveland Clinic.Heart Disease: Coronary Artery Disease. June 2004.

(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO)

SOURCE Eli Lilly and Company

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