prasugrel related Press Releases

New Analysis Evaluated Impact of Genetic Variation on Response to Prasugrel

Calisha Myers — Tue, 05 May 2009 11:41:47 -0400

New Analysis Evaluated Impact of Genetic Variation on Response to Prasugrel

TOKYO and INDIANAPOLIS, Ind., May 5, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- A new substudy from 1,466 patients from the Phase III TRITON-TIMI 38 clinical trial showed that patients who took prasugrel and had a reduced function of the CYP2C19 gene did not have an increased risk of cardiovascular death, heart attack or stroke compared with those patients who had normal function. The substudy results were published online in Circulation on May 4, 2009(1).

Prasugrel is a "prodrug" that requires the use of cytochrome P450 (CYP) enzymes to convert the drug into the active metabolite. Approximately 30 percent of Caucasians and 60 percent of Asians have reduced function in the CYP2C19 gene, which is part of the CYP system and encodes the enzymes that are responsible for converting prasugrel into its active form(2).

In the substudy, researchers examined how variation in cytochrome P450 (CYP) genes affected the response to prasugrel. In prasugrel-treated patients with acute coronary syndromes (ACS) who underwent an artery-opening procedure known as percutaneous coronary intervention (PCI), the incidence of the combined endpoint of cardiovascular death, heart attack or stroke was 8.5 percent (N=407) in those who carried at least one variant in the CYP2C19 gene that reduced its function versus 9.8 percent (N=1048) in patients without a genetic variant (P=0.27). In addition, the rate of stent thrombosis in carriers of the reduced-function variant in the CYP2C19 gene compared with non-carriers treated with prasugrel was 0.5 percent vs. 1.0 percent, respectively (P=0.48). The results also showed that rates on non-CABG-related TIMI major or minor bleeding did not significantly differ by genetic variant among those treated with prasugrel.

"It is well documented in the medical literature that particular genetic variants in the CYP2C19 gene are associated with an increased risk of cardiovascular outcomes in patients treated with clopidogrel," said Jessica Mega, M.D., M.P.H., Associate Physician at Brigham and Women's Hospital in Boston and Investigator at the TIMI Study Group. "We wanted to test if these genetic variants have a similar effect in patients who took prasugrel. Our findings showed that variation in the CYP2C19 gene did not appear to influence the rate of cardiac events in patients treated with prasugrel in this study."

About the Genetic Analysis

This pre-specified analysis was designed to examine whether there is a genetic variation in DNA that could affect patient response to antiplatelet therapy. The pharmacogenetic analyses with prasugrel examined DNA samples from 1,466 patients from the TRITON-TIMI 38 clinical trial.

The genetic subanalysis was not powered to make efficacy comparisons between clopidogrel and prasugrel based on genetic variations.

The main TRITON-TIMI 38 clinical trial, previously published in the New England Journal of Medicine in November 2007 (Vol. 357 No.20), compared prasugrel with clopidogrel in patients with ACS undergoing PCI. In the primary analysis of the study, prasugrel reduced the risk of the combined endpoint of cardiovascular death, heart attack, or stroke by 19 percent (9.9 percent versus 12.1 percent), with an increased risk of major bleeding by 32 percent compared with clopidogrel (2.4 percent vs. 1.8 percent), which included life-threatening and fatal bleeding.(3)

About Acute Coronary Syndromes

Acute coronary syndromes, which is comprised of heart attacks and unstable angina (chest pain), affects nearly 1.5 million people in the United States annually.(4) 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) Heart attack is a major manifestation of coronary heart disease, which occurs when the arteries become narrowed or clogged by cholesterol and fat deposits and cannot supply enough blood to the heart. In some cases, a blood clot may partially or totally block the blood supply to the heart resulting in ACS.(6) Many ACS patients are managed with PCI, which usually includes a stent placement.

About Prasugrel

Daiichi Sankyo Company, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: LLY) are co-developing prasugrel, an investigational oral antiplatelet agent invented by Daiichi Sankyo and its Japanese research partner Ube Industries, Ltd., as a potential treatment, initially for patients with acute coronary syndromes undergoing 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

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 focus for Daiichi Sankyo's research and development are cardiovascular disease, including therapies for dyslipidemia, hypertension, diabetes, and acute coronary syndromes. Equally important to the company is the discovery of new medicines in the areas of infectious diseases, cancer, bone and joint diseases, and immune disorders. For more information, visit www.daiichisankyo.com.

Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is the U.S. subsidiary of Daiichi Sankyo Co., Ltd. For more information on Daiichi Sankyo, Inc., please visit www.dsus.com.

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.

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.

P-LLY

(1) Mega J, Close S, Wiviott S, Shen L, Hockett R, Brandt J, Walker J, Antman E, Macias B, Braunwald E, Sabatine M, Cytochrome P450 Genetic Polymorphisms and the Response to Prasugrel. Circulation. 2009 May 19

(2) Myrand SP, Sekiguchi K, Man MZ, Lin X, Tzeng RY, Teng CH, Hee B, Garrett M, Kikkawa H, Lin CY, Eddy SM, Dostalik J, Mount J, Azuma J, Fujio Y, Jang IJ, Shin SG, Bleavins MR, Williams JA, Paulauskis JD, Wilner KD. Pharmacokinetics/genotype associations for major cytochrome P450 enzymes in native and first- and third-generation Japanese populations: comparison with Korean, Chinese, and Caucasian populations. Clin Pharmacol Ther. 2008 Sep;84(3):347-61.

(3) Wiviott, S, Braunwald, E, et al. Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes. New England Journal of Medicine. November 2007;357:2001-15.

(4) American Heart Association. Heart Disease and Stroke Statistics - 2008 Update. http://www.americanheart.org/downloadable/heart/1200082005246HS_Stats%202008.final.pdf. Accessed August 13, 2008.

(5) British Heart Foundation Health Promotion Research Group. European Cardiovascular Disease Statistics 2008, http://www.ehnheart.org/files/statistics%202008%20web-161229A.pdf, Accessed August 13, 2008.

(6) 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 August 13, 2008.

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SOURCE Eli Lilly and Company

European Commission Approves EFIENT(R) (prasugrel) for Patients with Acute Coronary Syndrome Undergoing PCI

Calisha Myers — Mon, 23 Feb 2009 15:01:42 -0500

European Commission Approves EFIENT(R) (prasugrel) for Patients with Acute Coronary Syndrome Undergoing PCI

TOKYO and INDIANAPOLIS, Feb. 23 /PRNewswire-FirstCall/ -- Heart patients with acute coronary syndrome (ACS) undergoing an artery-opening procedure will soon have a new treatment option to help prevent heart attacks. Daiichi Sankyo Company, Limited and Eli Lilly and Company (NYSE:LLY) announced today that the European Commission has granted marketing authorization for EFIENT(R) (pronounced Ef-ee-ent) (prasugrel) for the prevention of atherothrombotic events in patients with ACS undergoing percutaneous coronary intervention (PCI).

The approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on December 18, 2008.

"This European approval is good news for doctors and patients since more than 700,000 people die from heart attacks in the European Union each year," said Takashi Shoda, president and chief executive officer of Daiichi Sankyo Co., Ltd. "We believe Efient will become an important new treatment for patients with ACS undergoing PCI, a severe disease with potentially life-threatening consequences."

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.

"The approval of Efient helps to meet an important medical need. Survivors of heart attacks have a substantial risk of suffering from one or more additional heart attacks," said John C. Lechleiter, Ph.D., chairman, president and chief executive officer of Lilly. "This action is a major step forward in giving healthcare professionals and patients in European countries a new antiplatelet option for treating ACS."

In a large Phase III study, prasugrel was superior to Plavix(R)/Iscover(R) (clopidogrel) in reducing the risk of suffering major cardiovascular events (combined endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke) in ACS patients undergoing PCI. 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.

The U.S. Food and Drug Administration is evaluating whether prasugrel should be approved in the United States for the treatment of patients with acute coronary syndromes (ACS) managed with percutaneous coronary intervention (PCI). The proposed name for prasugrel in the US is Effient(TM).

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. as a treatment initially for patients with acute coronary syndromes who are undergoing PCI.

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.(1) In addition, ACS affects nearly 1.5 million people in the United States annually.(2) 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.(3) Many ACS patients undergo PCI to re-open the artery, which usually includes a stent placement.

About Daiichi Sankyo

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. A central focus of Daiichi Sankyo's 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.

Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is the U.S. subsidiary of Daiichi Sankyo Co., Ltd. For more information on Daiichi Sankyo, Inc., please visit www.dsus.com.

(1) 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.

(2) American Heart Association. Heart Disease and Stroke Statistics - 2008 Update. http://www.americanheart.org/downloadable/heart/1200082005246HS_Stats%202008.f inal.pdf. Accessed December 9, 2008.

(3) 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.

About Eli Lilly and Company

This press release contains certain forward-looking statements about the potential of prasugrel (CS-747, LY640315) and reflects Daiichi Sankyo's and Lilly's current beliefs. However, as with any pharmaceutical compound, there are substantial risks and uncertainties in the process of development, regulatory review, and commercialization. There is no guarantee that the compound will receive regulatory approvals, that the regulatory approvals 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.

Plavix(R)/Iscover(R) are registered trademarks of sanofi-aventis.

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

Effient(TM) is a trademark of Eli Lilly and Company.

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Source: Eli Lilly and Company

CONTACT: Carole Copeland (OUS), +1-317-277-3661 (office),
+1-317-610-6196 (cell), or Tammy Hull (U.S.A.), +1-317-651-9116 (office),
+1-317-614-5132 (cell); Olaf Lamberz, Daiichi Sankyo (Europe GmbH),
+49-89-7808-442 (office), or Kim Wix, Daiichi Sankyo (US), +1-973-695-8338
(office), +1-908-656-5447 (cell), or Shigemichi Kondo, Daiichi Sankyo (Tokyo),
+81-3-6225-1126 (office)

Prasugrel Receives Unanimous Approval Recommendation from FDA Advisory Committee

Calisha Myers — Wed, 04 Feb 2009 08:26:00 -0500

Prasugrel Receives Unanimous Approval Recommendation from FDA Advisory Committee

TOKYO and INDIANAPOLIS, Feb. 3 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee voted 9 to 0 that prasugrel, an investigational antiplatelet agent, should be approved for the treatment of patients with acute coronary syndromes (ACS) managed with an artery-opening procedure known as percutaneous coronary intervention (PCI), Daiichi Sankyo Company, Limited, and Eli Lilly and Company (NYSE: LLY) announced today.

The Advisory Committee voted unanimously that prasugrel should be approved for the treatment of patients with acute coronary syndromes undergoing PCI. The FDA is not bound by the committee's recommendation, but it takes its advice into consideration when reviewing new drug applications.

"We are very proud of the prasugrel data," said John Alexander M.D., M.P.H., global head of research and development, Daiichi Sankyo Company, Limited. "Today's scientific exchange set the stage for a potential FDA approval of prasugrel, and the future availability of this significant scientific advancement for the treatment of ACS-PCI patients."

"We will continue to work closely with the FDA as the agency moves toward an action on the new drug application for prasugrel," said J. Anthony Ware, M.D., Lilly vice president and cardiovascular/acute care platform leader for prasugrel. "It is important for patients to have multiple treatment options, and currently, ACS patients undergoing PCI have few options. Today's vote by the advisory committee members is a positive step for patients."

"Prasugrel represents an important new option for patients with ACS who are managed with PCI," said lead TRITON-TIMI 38 investigator Elliott Antman, M.D., director of the Samuel A. Levine Cardiac Unit at Brigham and Women's Hospital (BWH) in Boston and senior investigator with BWH's TIMI Study Group. "In a large head-to-head trial, TRITON, showed that prasugrel was superior to clopidogrel, the current standard of care. While the benefit of prasugrel is accompanied by an increased risk of serious bleeding events, appropriate selection of patients and doses may help mitigate this risk."

The committee reviewed comprehensive data primarily from the TRITON TIMI- 38 clinical trial. Results from the TRITON trial showed that prasugrel taken with aspirin reduced the relative risk of the combined endpoint of cardiovascular death, non-fatal heart attacks or non-fatal stroke by 19 percent more than clopidogrel (Plavix(R)/Iscover(R)) taken with aspirin. These benefits were accompanied by an increased risk of serious bleeding with prasugrel overall, some of which included life-threatening and even fatal bleeding. When the risk of this type of bleeding was compared to the benefit of reduced heart attack, there were five more TIMI major bleeding events, but 22 fewer heart attacks for every 1,000 patients treated with prasugrel compared to every 1,000 patients treated with clopidogrel.(i) The overall risk of cardiovascular death and the risk of increased stroke were not statistically different between treatment groups.

FDA reviewers will consider the panel's favorable recommendation in its review of the new drug application that Lilly submitted for prasugrel on behalf of the alliance with Daiichi Sankyo, Limited, on December 26, 2007.

The Burden of Acute Coronary Syndromes

Acute coronary syndromes (ACS), which includes heart attack and unstable angina (chest pain), affects more than 1.4 million people in the United States annually.(ii) 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.(iii) Coronary artery disease occurs when the arteries become narrowed or clogged by cholesterol and fat deposits and cannot supply enough blood to the heart. In some cases, a blood clot may partially or totally block the blood supply to the heart resulting in ACS.(iv) Many ACS patients are managed with PCI, which usually includes a stent placement.

About prasugrel

Daiichi Sankyo Company, Limited , 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

A global pharma innovator, Daiichi Sankyo Company, 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. A central focus of Daiichi Sankyo's 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.

Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is the U.S. subsidiary of Daiichi Sankyo Company, Ltd. For more information on Daiichi Sankyo, Inc., please visit www.dsus.com.

About Eli Lilly and Company

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

P-LLY

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(i) Wiviott, S, Braunwald, E, et al. Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes. New England Journal of Medicine. November 2007; 357: 2001-15.

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

(iii) British Heart Foundation Health Promotion Research Group. European Cardiovascular Disease Statistics 2008, http://www.ehnheart.org/content/ItemPublication.asp?docid=7069&level0=1500&lev el1=2157, Accessed April 24 2008.

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

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Source: Eli Lilly and Company

CONTACT: Tammy Hull, Eli Lilly and Company, +1-317-651-9116 (office), +1-
317-614-5132 (cell); Kimberly Wix, Daiichi Sankyo (U.S.A.), +1-973-695-8338
(office), +1-908-656-5447 (cell); or Shigemichi Kondo, Daiichi Sankyo (Tokyo),
+81-3-6225-1126 (office)

Prasugrel Receives Positive Opinion from the European Committee for Medicinal Products for Human Use (CHMP)

Calisha Myers — Fri, 19 Dec 2008 09:17:01 -0500

Prasugrel Receives Positive Opinion from the European Committee for Medicinal Products for Human Use (CHMP)

TOKYO and INDIANAPOLIS, Dec 18, 2008 /PRNewswire-FirstCall via COMTEX News Network/ --

Daiichi Sankyo Company, Limited (TSE: 4568), and Eli Lilly and Company (NYSE: LLY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval of prasugrel for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI).

The CHMP positive opinion is now referred for final action to the European Commission, which grants approval in the European Union. The Commission usually makes a decision about whether to approve a new drug candidate within two to three months of CHMP issuing its recommendation. Upon approval, this new oral antiplatelet agent is expected to be marketed throughout the European Union under the proposed brand name EFIENT(TM).

"We are extremely pleased by the CHMP positive recommendation for approval of prasugrel in Europe," said John Alexander, M.D., M.P.H., global head of research and development, Daiichi Sankyo Company, Limited. "Based on the study results and the positive recommendation, we are hopeful that prasugrel will be approved as a new treatment option for patients with ACS undergoing PCI."

The submission package contains data from several trials, including the landmark TRITON-TIMI 38, a head-to-head superiority study that evaluated the safety and efficacy of prasugrel compared with clopidogrel (Plavix(R)/Iscover(R)) in reducing atherothrombotic events (combined endpoint of cardiovascular death, non-fatal heart attack, or non-fatal stroke) in 13,608 patients with acute coronary syndromes undergoing PCI. These data were presented at the American Heart Association Scientific Sessions and simultaneously published online in the New England Journal of Medicine in November 2007.

"Cardiovascular disease remains a significant cause of death and disability worldwide, and this positive opinion is an important step in making this new treatment available to help prevent heart attacks in the ACS patient," said J. Anthony Ware, M.D., Lilly vice president for cardiovascular/acute care.

Cardiovascular disease kills an estimated 17.5 million people worldwide each year, and acute heart attacks and unstable angina, called acute coronary syndromes, affect more than 800,000 people in Europe each year. (1,2)

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 undergoing 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. Lilly, on behalf of its alliance partner, Daiichi Sankyo, submitted a Marketing Authorization Application for prasugrel to the European Medicines Agency in February 2008.

About Acute Coronary Syndromes

Acute coronary syndromes, which is comprised of heart attacks and unstable angina (chest pain), affects nearly 1.5 million people in the United States annually.(3) ACS, a fatal consequence of coronary heart disease, is the single most common cause of death in the European Union, accounting for more than 741,000 deaths in the EU each year.(4) Heart attack is a major manifestation of coronary heart disease, which occurs when the arteries become narrowed or clogged by cholesterol and fat deposits and cannot supply enough blood to the heart. In some cases, a blood clot may partially or totally block the blood supply to the heart resulting in ACS.(5) Many ACS patients undergo PCI, which usually includes a stent placement.

About Daiichi Sankyo

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. A central focus of Daiichi Sankyo's 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

Plavix(R)/Iscover(R) are registered trademarks of sanofi-aventis.

P-LLY

(1) World Health Organization,
http://www.who.int/cardiovascular_diseases/en/

(2) Bertrand M, CURE study investigator and Professor of Cardiology, University of Lille, France. Sanofi-Synthelabo and Bristol-Myers Squibb Company press release, "CPMP Recommends Granting Marketing Authorization In the European Union For Plavix(R)/Iscover(R) (clopidogrel) for the Treatment of Acute Coronary Syndrome with Non ST Segment Elevation," June 27, 2002.

(3) American Heart Association. Heart Disease and Stroke Statistics - 2008 Update. http://www.americanheart.org/downloadable/heart/1200082005246HS_Stats%202008.f inal.pdf. Accessed December 9, 2008.

(4) 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.

(5) 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.

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SOURCE Eli Lilly and Company

FDA Continues to Review Prasugrel New Drug Application

Fri, 26 Sep 2008 21:19:23 -0400

FDA Continues to Review Prasugrel New Drug Application

TOKYO and INDIANAPOLIS, Sept. 26 /PRNewswire-FirstCall/ -- Daiichi Sankyo Company, Limited, (TSE: 4568) and Eli Lilly and Company (NYSE: LLY) confirmed today that the U.S. Food and Drug Administration (FDA) did not complete its review for the prasugrel new drug application (NDA) by the Prescription Drug User Fee Act goal date of 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).

"We remain engaged in collaborative and productive discussions with the FDA regarding the details of our application. This is a very large, complex submission, and it should not be surprising that delays occur," said Jennifer Stotka, M.D., vice president for Global Regulatory Affairs at Lilly. "Daiichi Sankyo and Lilly will not speculate on the timing or what the outcome will be. However, the review is very far along, and we remain optimistic."

"Daiichi Sankyo and Lilly remain confident in the submission package for prasugrel and look forward to bringing this medication to the market for ACS patients who are being managed with PCI," said John Alexander, M.D., M.P.H., global head of research and development, Daiichi Sankyo Company, Limited.

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

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. A central focus of Daiichi Sankyo's research and development is cardiovascular disease, including therapies for dyslipidemia, hypertension, diabetes, and acute coronary syndromes. Equally important to the company is the discovery of new medicines in the areas of infectious diseases, cancer, bone and joint diseases, and immune disorders. For more information, visit www.daiichisankyo.com.

Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is the U.S. subsidiary of Daiichi Sankyo Co., Ltd. For more information on Daiichi Sankyo, Inc., please visit www.dsus.com.

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

Editor's Note: Please note this press release will be Daiichi Sankyo and Lilly's only statement at this time.

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SOURCE Eli Lilly and Company

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

Maureen Martino — Tue, 24 Jun 2008 12:09:43 -0400

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, June 23, 2008 /PRNewswire-FirstCall/ -- Daiichi Sankyo Company, Limited, and Eli Lilly and Company 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(R)/Iscover(R)) 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 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.(1) Despite currently available treatments, 320,000 people experience recurrent heart attacks each year.(2)

About prasugrel

Daiichi Sankyo Company, Limited , and Eli Lilly and Company 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(R)/Iscover(R) are registered trademarks of Sanofi-Synthelabo Inc.

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

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

CONTACT: Tammy Hull, Eli Lilly and Company, +1-317-651-9116 (office),+1-317-614-5132 (cell); Kim Wix, Daiichi Sankyo (U.S.A.), +1-973-695-8338(office), +1-908-656-5447 (cell); Shigemichi Kondo, Daiichi Sankyo (Tokyo),+81-3-6225-1126 (office)

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

Maureen Martino — Fri, 22 Feb 2008 08:38:05 -0500

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, February 21, 2008 /PRNewswire-FirstCall/ -- Daiichi Sankyo Company, Limited and Eli Lilly and Company 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 , and Eli Lilly and Company 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

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

Daiichi Sankyo, Lilly Submit NDA for Investigational Antiplatelet Drug, Prasugrel, to FDA

Maureen Martino — Fri, 04 Jan 2008 10:44:07 -0500

Daiichi Sankyo, Lilly Submit New Drug Application for Investigational Antiplatelet Drug, Prasugrel, with U.S. Food and Drug Administration

If Approved for Marketing in the United States, Trade Name Will be Effient(TM)
TOKYO and INDIANAPOLIS, Jan 04, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Daiichi Sankyo Company, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: LLY) today announced that on Wednesday, Dec. 26, 2007, they submitted a New Drug Application (NDA) for prasugrel to the U.S. Food and Drug Administration (FDA). Prasugrel is an oral antiplatelet agent, initially in development for the treatment of patients with acute coronary syndrome (ACS) who are managed with percutaneous coronary intervention (PCI), including coronary stenting.

If approved for marketing in the United States, the trade name for prasugrel will be Effient™, company officials added.

"We are elated," said J. Anthony Ware, M.D., Lilly vice president and cardiovascular/acute care platform leader for prasugrel. "We feel confident in the strength and completion of this submission package, and plan to complete our submission in Europe in the first quarter of 2008. The benefit/risk profile of this compound, in comparison with the current standard of care, has the potential to improve outcomes for ACS patients undergoing PCI."

The NDA is based upon data from several trials, including the landmark TRITON-TIMI 38 clinical trial, which evaluated the safety and efficacy of prasugrel compared with clopidogrel (Plavix®/Iscover®) in reducing ischemic events such as non-fatal heart attack, non-fatal stroke and cardiovascular death in 13,608 patients. In the study, treatment with prasugrel resulted in a:

-- 19 percent relative risk reduction compared with clopidogrel in all ACS patients in the primary composite endpoint of non-fatal heart attack, non-fatal stroke or cardiovascular death (p<0.001).
-- 52 percent reduction compared with clopidogrel in stent thrombosis (p<0.0001).
-- 30 percent relative risk reduction compared to clopidogrel in a subset of patients with diabetes (p<0.001) on the composite endpoint of non- fatal heart attack, non-fatal stroke, or cardiovascular death.

Risk reductions in the primary composite endpoint with prasugrel compared to clopidogrel were seen as early as three days and continued to diverge for 15 months (the duration of the trial.)

Though the incidence of non-coronary artery bypass grafting(non-CABG) bleeding in TRITON was low in both the prasugrel and clopidogrel treatment groups, prasugrel-treated patients experienced significantly higher non-CABG major bleeding (2.2% vs. 1.7%, respectively) and higher rates of life- threatening bleeding (1.3% vs. 0.8%, respectively). Death from cardiovascular causes (2% vs. 2.2%, respectively) and all-cause death (2.8% vs. 2.9%, respectively) was comparable among prasugrel-treated patients and clopidogrel- treated patients. The overall results demonstrated that for every 1,000 patients treated with prasugrel as compared with clopidogrel, there were 22 fewer patients with heart attacks and five more non-CABG-related TIMI major bleeds.

"Given the overall results from TRITON, this submission is particularly meaningful considering that cardiovascular disease is the leading cause of death in the United States and worldwide, killing 16.7 million people each year," said John Alexander, M.D., M.P.H., global head of research and development, Daiichi Sankyo Company, Limited.

Acute heart attacks and unstable angina, called acute coronary syndrome, affect more than 840,000 Americans each year and 800,000 people in Europe.(i,ii) Utilizing current medical interventions and treatments, 300,000 people continue to experience recurrent heart attacks and 450,000 people die from heart attacks annually in the U.S.(iii)

About prasugrel

Daiichi Sankyo Company, Limited (TSE: 4568), and Eli Lilly and Company (NYSE: LLY) are co-developing prasugrel, an investigational oral antiplatelet agent invented 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

About Eli Lilly and Company

PRESS RELEASE: In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel

Maureen Martino — Mon, 05 Nov 2007 09:07:06 -0500

In Landmark Phase III Head-to-Head Study, Prasugrel Statistically Superior to Clopidogrel in Reducing Risk of Heart Attack

Investigational compound reduces risk of major cardiovascular events by 19 percent, significantly improves net clinical benefit despite increased bleeding

TOKYO and INDIANAPOLIS, Nov 04, 2007 -- In the pivotal Phase III head-to-head TRITON TIMI-38 clinical trial, the investigational antiplatelet agent prasugrel produced a highly significant 19 percent reduction in relative risk (p=0.0004) for the composite endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke when compared with clopidogrel (PlavixÂ®/IscoverÂ®) in the treatment of patients across the full spectrum of acute coronary syndrome undergoing percutaneous coronary intervention.

A significant reduction in the risk for the composite endpoint favoring prasugrel (60 mg loading dose/10 mg maintenance dose) over clopidogrel (300 mg LD/75 mg MD) was observed as early as three days. The absolute difference in this endpoint continued to increase over the course of the 15-month, 13,608- patient trial.

In the important subgroup of patients with diabetes, prasugrel reduced the relative risk of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke by 30 percent (p<0.001). In addition, in the key secondary endpoint of stent thrombosis, prasugrel reduced the recurrence of stent thrombosis (a new clot that develops at the stent site) by 52 percent (p<0.0001).

TRITON also showed that treatment with prasugrel significantly reduced the relative risk of cardiovascular death, non-fatal heart attack and non-fatal stroke by 21 percent in patients with STEMI (ST-elevation myocardial infarction, or high-risk heart attack) (p=0.02) and 18 percent in patients suffering from UA (unstable angina, or chest pain)/NSTEMI (non-STEMI) (p=0.002). In addition, prasugrel-treated patients experienced a 34 percent decline in urgent target vessel revascularization (a procedure to reopen blocked arteries) (p<0.001) and a 42 percent reduction in heart attack with subsequent death from cardiovascular causes (p=0.02).

While the overall incidence of non-CABG (coronary artery bypass grafting) bleeding in TRITON was low in both the prasugrel and clopidogrel treatment groups, prasugrel-treated patients experienced a statistically significant increase in non-CABG (coronary artery bypass grafting) major bleeding compared to clopidogrel-treated patients (2.4 vs. 1.8 percent, or 146 vs. 111 patients, p=0.03), including higher rates of life-threatening bleeding (1.4 vs. 0.9 percent, or 85 vs. 56 patients, p=0.01). Though infrequent, fatal bleeding was statistically more frequent among prasugrel-treated than clopidogrel-treated patients (0.4 percent vs. 0.1 percent, or 21 vs. five patients, p=0.002). However, death from cardiovascular causes occurred less frequently among prasugrel-treated patients than clopidogrel-treated patients (2.1 percent vs. 2.4 percent, or 133 vs. 150 patients, p=0.31), as did all-cause death (3.0 percent vs. 3.2 percent, or 188 vs. 197 patients, p=0.64).

The study identified three distinct patient subpopulations with a higher risk of major bleeding in both treatment arms - patients who were 75 years of age or older, weighed less than 60 kg (132 lbs.), or had a prior history of transient ischemic attack (TIA) or stroke. Researchers are evaluating pharmacokinetic data from several prasugrel studies, including TRITON, to determine whether a lower dose of prasugrel might be appropriate for some patients. Among patients without any of these risk factors (80 percent of the 13,608-patient TRITON study), there was no significant difference in major bleeding between prasugrel- and clopidogrel-treated patients (2 percent vs. 1.5 percent, p=0.17).

Based on an analysis using the combined endpoint of all-cause death, heart attack, stroke and major bleeding, the net clinical benefit for prasugrel compared with clopidogrel was a significant 13 percent reduction in overall events (12.2 vs. 13.9, p=0.004). In the subpopulations defined as being at greater risk of bleeding, the net clinical benefit was not different between prasugrel- and clopidogrel-treated patients (p=0.43). Without the subpopulations defined as being at greater bleeding risk, the net clinical benefit was 20 percent (10.2 vs. 12.5, p<0.001).

Overall, for every 1,000 people treated with prasugrel compared to clopidogrel in the study, there were 23 fewer heart attacks and an additional six major bleeding complications.

"Our study provides compelling evidence that the prasugrel regimen tested is superior to standard dose clopidogrel as an antiplatelet therapy to support patients undergoing coronary stenting," said Elliott Antman, M.D., senior investigator with the TIMI Study Group at Harvard Medical School and director of the Samuel A. Levine Cardiac Unit at Brigham and Women's Hospital in Boston. "With the data from TRITON and other studies, we expect to define populations at particular bleeding risk to help establish clear guidance for using this promising therapy."

Antman announced the initial study results today at the American Heart Association's 2007 Scientific Sessions in Orlando, Florida (abstract 07-LBCT- 20660-AHA). Prasugrel is being co-developed by Daiichi Sankyo Company, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: LLY).

"The TRITON data demonstrate the statistical superiority of this new antiplatelet therapy to prevent heart attacks, and validate our decision to test prasugrel head to head against clopidogrel," said J. Anthony Ware, M.D., Lilly cardiovascular platform leader for prasugrel. "We are very pleased with the trial's outcome and are excited by the potential for these results to help us further tailor prasugrel therapy to assure the greatest benefit from this novel treatment."

Cardiovascular disease is the leading cause of death in the U.S. and worldwide, killing 16.7 million people each year(i). Acute heart attacks and unstable angina, called acute coronary syndrome, affect more than 840,000 Americans each year and 800,000 in Europe(i,ii). Utilizing current medical interventions and treatments, 300,000 people continue to experience recurrent heart attacks and 450,000 people die from heart attacks annually in the U.S(iv).

"TRITON confirms the statistically superior clinical benefit of prasugrel as a third-generation oral antiplatelet that may advance cardiovascular care," said John Alexander, M.D., M.P.H., global head of research and development, Daiichi Sankyo Company, Limited. "Given the promising TRITON results, Daiichi Sankyo and Lilly are expeditiously finalizing our submission package and are still hopeful to submit to the FDA by year end."

About the TRITON TIMI-38 study

TRITON TIMI-38 was a Phase III, multi-center, randomized, double blind, parallel group, head-to-head clinical trial comparing the effects of prasugrel versus clopidogrel in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI). PCI is a procedure to open blockages in heart arteries including the use of coronary stenting. The study enrolled 13,608 patients at 707 trial sites in 30 countries.

The primary endpoint of the study was to compare the effects of prasugrel to clopidogrel on the composite incidence of cardiovascular death, non-fatal heart attack and non-fatal stroke during a median period of at least 12 months following PCI. Key secondary objectives included rehospitalization for a cardiac ischemic event; the need for additional procedures to restore blood flow (urgent target vessel revascularization) at 30 days; and stent thrombosis. Key safety endpoints included non-CABG major, life threatening and minor bleeding as well as the overall safety and tolerability of prasugrel.

Patients were randomly assigned to one of two treatment groups and given a loading dose of either prasugrel 60 mg or the approved loading dose of clopidogrel 300 mg anytime between randomization and one hour after the completion of the PCI procedure, followed by a daily maintenance dose of either prasugrel 10 mg or clopidogrel 75 mg. All patients also received a daily low dose of aspirin.

Antiplatelet agents are critical for both acute and maintenance therapy to inhibit platelet activation and subsequent aggregation that occur in diseased arteries and as adjunct therapy to invasive procedures such as percutaneous coronary intervention.

About prasugrel

Daiichi Sankyo Company, Limited (TSE: 4568), and Eli Lilly and Company (NYSE: LLY) are co-developing prasugrel, an investigational oral antiplatelet agent invented by Daiichi Sankyo and its Japanese research partner Ube Industries, Ltd., as a potential treatment, initially for patients with acute coronary syndrome undergoing 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

About Eli Lilly and Company