U.S. Regulators Approve Prasugrel for Reduction of Cardiovascular Events In Patients with Acute Coronary Syndromes Managed with Artery-Opening Procedure

จันทร์ 13 กรกฎาคม 2552 เวลา 09:35 น.

TOKYO and INDIANAPOLIS--13 Jul--PRNewswire-AsiaNet/InfoQuest

Daiichi Sankyo Company, Inc. and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) approved Effient(TM) (prasugrel) tablets for the reduction of thrombotic

cardiovascular events (including stent thrombosis) in patients with acute coronary syndromes who are managed with an artery-opening procedure known as percutaneous coronary intervention (PCI). PCI usually includes the placement of a stent to help keep the artery open.

Prasugrel works by reducing the tendency of platelets, the blood particles responsible for clotting, from sticking or clumping together. By blocking a specific receptor (P2Y12 adenosine diphosphate) on the platelet

surface, prasugrel prevents platelets from clumping, which can result in clogged arteries and may lead to heart attack or stroke.

Acute coronary syndrome includes heart attacks and unstable angina (heart-related chest pain at rest). ACS affects nearly 1.5 million people in the United States annually, many of whom undergo PCI.(i) In addition,

coronary heart disease, which can result in ACS, is the single most common cause of death in the European Union, accounting for more than 741,000 deaths in the EU each year.(ii) Heart attack is a major manifestation of coronary heart disease, which occurs when the arteries become narrowed or clogged by cholesterol and fat deposits. In some cases the plaque can rupture, resulting in a blood clot, which may partially or totally block the blood supply to portions of the heart, resulting in ACS.(iii) Many ACS patients undergo PCI to re-open the artery, which usually includes a stent placement.

Daiichi Sankyo Company, Limited and Lilly have co-developed prasugrel, an oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner, Ube Industries, Ltd.

On February 25, 2009, the European Commission granted marketing authorization for prasugrel for the prevention of atherothrombotic events in patients with ACS undergoing percutaneous coronary intervention.

This press release contains certain forward-looking statements about Effient for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndromes who are managed with percutaneous coronary intervention and reflects Daiichi Sankyo's and Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that the product will 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.

About Daiichi Sankyo Company, Limited

A global pharma innovator, Daiichi Sankyo Co., Ltd., was established in 2005 through the merger of two leading Japanese pharmaceutical companies. This integration created a more robust organization that allows for continuous development of novel drugs that enrich the quality of life for patients around the world. Areas of primary focus for Daiichi Sankyo research and development are thrombotic disorders, malignant neoplasm, diabetes mellitus, and autoimmune disorders. Equally important to the company are hypertension, hyperlipidemia or atherosclerosis, and bacterial infections.

For more information, visit www.daiichisankyo.com.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, IN, Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.

P-LLY

(i) American Heart Association. Heart Disease and Stroke Statistics -

2008 Update.

http://www.americanheart.org/downloadable/heart/1200082005246HS_Stats%202008.

final.pdf. Accessed December 9, 2008.

(ii) British Heart Foundation Health Promotion Research Group. European

Cardiovascular Disease Statistics 2008,

http://www.ehnheart.org/files/statistics%202008%20web-161229A.pdf, Accessed

December 9, 2008.

(iii) WebMD Medical Reference in Collaboration with the Cleveland Clinic.

Heart Disease: Coronary Artery Disease.

http://www.webmd.com/heart-disease/guide/heart-disease-coronary-artery-disease.

Accessed December 9, 2008.

(Logo: http://www.newscom.com/cgi-bin/prnh/20061120/DSLLOGO )

SOURCE: Eli Lilly and Company

CONTACT: Tammy Hull of Eli Lilly and Company,

+1-317-651-9116 (office),

+1-317-614-5132 (cell); or

Kim Wix of Daiichi Sankyo (U.S.A.),

+1-973-944-2338 (office),

+1-908-656-5447 (cell), or

Shigemichi Kondo of Daiichi Sankyo (Tokyo),

81-3-6225-1126 (office)

Logo: http://www.newscom.com/cgi-bin/prnh/20061120/DSLLOGO

--Distributed by AsiaNet ( www.asianetnews.net )--

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