Three European Analyses Showed Efient is Cost-Effective Compared with Clopidogrel in Patients with Acute Coronary Syndro

This economic model was based on individual patient data from TRITON-TIMI 38 over 12 months. Hospital admission costs were derived from a sub-analysis of 6,705 patients from eight countries, including Australia, Canada, France, Germany, Italy, Spain, the UK and the US. Patient outcomes were classified into UK DRGs. Cost of study drugs were estimated using public price per tablet (prasugrel at 1.70 pounds per day and clopidogrel at 1.26 pounds per day). Life expectancy was estimated based on in-trial cardiovascular and bleeding events, using a statistical model derived from a systematic literature review. The analysis adopted a lifetime horizon, assuming a maximum of 40 years survival. Andrew Davies, M.D., Oxford Outcomes, Oxford, England, and colleagues, performed this analysis.

About Prasugrel

Daiichi Sankyo Company, Limited, and Eli Lilly and Company co-developed prasugrel, an oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner, Ube Industries, Ltd. Prasugrel helps keep blood platelets from clumping together and developing a blockage in an artery. The European Commission granted marketing authorisation for prasugrel for the prevention of atherothrombotic events in patients with ACS undergoing PCI.

Important Safety Information about Prasugrel

In the EU prasugrel label, the risk of non-coronary artery bypass graft (non-CABG) major bleeding, including fatal bleeding, was higher with prasugrel (2.2 percent incidence) compared with clopidogrel (1.7 percent incidence). Compared with the overall study population, a higher risk of serious bleeding among prasugrel patients was most evident in three distinct patient populations that are readily identifiable: patients who weighed less than 60 kg (132 lbs), patients who were 75 years of age or older and patients who have had a prior transient ischemic attack (TIA) or stroke. Patients who weighed less than 60 kg, or were 75 years of age or older had increased exposure with prasugrel. In the EU prasugrel label, a 5 mg maintenance dose is recommended for patients who weigh less than 60 kg. Prasugrel is generally not recommended for use in patients 75 years or older; if treatment is deemed necessary in this age group, a 5 mg maintenance dose should be prescribed. Patients with prior TIA or stroke should not be treated with prasugrel.(4)

The EU prasugrel label includes a contraindication for patients with a history of TIA or stroke, as well as a warning for patients who weighed less than 60 kg (132 lbs) and patients who are 75 years of age or older. For the patients in TRITON-TIMI 38 without these risk factors, the efficacy of prasugrel compared with clopidogrel on the primary composite endpoint of CVD, nonfatal MI, or nonfatal stroke was 8.3 percent vs. 11.0 percent, respectively, and consistent with the significant efficacy benefit observed with prasugrel in the overall study population. In these same patients, the risk of serious bleeding was reduced but still higher with prasugrel compared with clopidogrel (2.0 percent vs. 1.5 percent, respectively).

An analysis weighing the risk of major bleeding and the reduction in heart attacks found an overall benefit favouring prasugrel compared with clopidogrel. For every 1,000 patients treated with prasugrel as compared with clopidogrel, there were 22 fewer patients with heart attacks and five more with non-CABG-related major bleeding events.

About Acute Coronary Syndrome

Acute coronary syndrome includes heart attacks and unstable angina (chest pain). 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.(5) In addition, ACS affects nearly 1.5 million people in the United States annually.(6) 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. Many ACS patients undergo PCI to re-open the artery, which usually includes a stent placement.

About Daiichi Sankyo Company, Limited

A global pharmaceutical innovator, Daiichi Sankyo Co., Ltd., was established in 2005 through the merger of two leading Japanese pharmaceutical companies. This integration created a more robust organisation 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, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

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.

Efient(R) is a registered trademark of Eli Lilly and Company.

Plavix(R) is a registered trademark of Sanofi-Aventis Corp.

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(1) Bruggenjurgen B, Lindgren P, Ehlken B, et al. 2007. Long-term cost-effectiveness of clopidogrel in patients with acute coronary syndrome without ST-segment elevation in Germany. Eur J Health Econ 8: 51-57.

(2) Mahoney EM, Mehta S, Yuan Y, et al. 2006. Long-term cost-effectiveness of early and sustained clopidogrel therapy for up to 1 year in patients undergoing percutaneous coronary intervention after presenting with acute coronary syndromes without ST-segment elevation. Am Heart J 151: 219-27.

(3) McCollam P, Etemad L. 2005. Cost of care for new-onset acute coronary syndrome patients who undergo coronary revascularization. J of Invasive Cardiology 17: 307-11.

(4) European Summary of Product Characteristics.

(5) British Heart Foundation Health Promotion Research Group. European Cardiovascular Disease Statistics 2008, http://www.ehnheart.org/files/statistics%202008%20web-161229..., Accessed October 15, 2009.

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

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Derin Denham (Outside of US) of Eli Lilly and Company, +1-317-277-6749 (office), +1-317-370-1435 (cell), or Tammy Hull (US) of Eli Lilly and Company, +1-317-651-9116 (office), +1-317-614-5132 (cell); Dr. Michaela Paudler-Debus of Daiichi Sankyo Europe GmbH, +49(0)89-78-08-685 (office), +49(0)172-845-8974 (cell), or Shigemichi Kondo of Daiichi Sankyo (Tokyo), +81-3-6225-1126 (office)