2007-11-04

Daiichi Sankyo, Lilly Announce New Prasugrel Head-to-Head Phase III Study Against Clopidogrel


Tokyo and Indianapolis, November 4 (ots/PRNewswire) -

- Duke Clinical Research Institute to lead multinational studywith investigational compound; will include 10,000 medically managedpatients with acute coronary syndrome

A large Phase III clinical trial is anticipated to begin in thesecond quarter of 2008 to compare the effects of prasugrel, aninvestigational oral antiplatelet agent, against clopidogrel(Plavix(R)/Iscover(R)) in medically managed patients with acutecoronary syndrome (ACS), a group of common heart conditions thatincludes unstable angina (chest pain) and heart attacks(1).

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

Daiichi Sankyo Company, Limited (TSE: 4568) and Eli Lilly andCompany (NYSE: LLY), which are co-developing prasugrel, will conductthe study in conjunction with the Duke Clinical Research Institute(DCRI), the world's largest academic clinical research organizationand a part of Duke University Medical Center. Lead study investigatoris E. Magnus Ohman, M.D., Professor of Cardiology at Duke UniversitySchool of Medicine.

About TRILOGY ACS

The study is a multi-center, double-blind, randomized, controlledtrial that will include approximately 10,000 patients, with about 800hospitals in 35 countries participating. TRILOGY ACS will evaluatethe safety and efficacy of prasugrel against clopidogrel in reducingthe risk of cardiovascular death, heart attack or stroke in ACSpatients who are to be medically managed without plannedrevascularization (a procedure to reopen blocked arteries).Currently, more than 50 percent of patients presenting with ACSworldwide are managed without acute intervention.

"TRILOGY ACS, which will be one of the largest of its kind, willbe a very important study as it will focus on a group of medicallymanaged patients with ACS who have not been extensively studied inthe past," said lead study investigator E. Magnus Ohman, M.D.,Professor of Cardiology at Duke University School of Medicine.

When patients present with ACS, their symptoms are secondary to alack of adequate oxygen delivery to the heart, usually due to asignificant narrowing or blockage of one or more of the coronaryarteries due to plaque. This plaque has the potential to rupture atany time and cause an arterial clot (thrombus) to form, which canblock oxygenated blood from reaching the heart muscle. Antiplateletmedications help to reduce the incidence of this acute thrombusformation.

"The announcement of this study demonstrates our continuedconfidence in the clinical research surrounding prasugrel," said JohnAlexander, M.D., M.P.H., global head of research and development,Daiichi Sankyo Company, Limited.

About cardiovascular disease

Cardiovascular disease is the leading cause of death in the U.S.and worldwide, killing 16.7 million people each year(2). Acute heartattacks and unstable angina, called acute coronary syndrome, affectmore than 840,000 Americans each year and 800,000 in Europe(3,4).Even with current medical interventions, 300,000 people experiencerecurrent heart attacks and 500,000 people die from heart attacksannually in the United States(5).

About prasugrel

Daiichi Sankyo Company, Limited (TSE: 4568), and Eli Lilly andCompany (NYSE: LLY) are co-developing prasugrel, an investigationaloral antiplatelet agent invented by Daiichi Sankyo and its Japaneseresearch partner Ube Industries, Ltd., as a potential treatment,initially for patients with acute coronary syndrome undergoing PCI.Prasugrel works by inhibiting platelet activation and subsequentaggregation by blocking the P2Y12 adenosine diphosphate (ADP)receptor on the platelet surface. Antiplatelet agents preventplatelets from clumping or sticking together, which can result inclogged arteries and may lead to heart attack or stroke.

About Daiichi Sankyo Company, Limited

Daiichi Sankyo Company, Limited, established in 2005 after themerger of two leading century-old Japanese pharmaceutical companies,is a global pharmaceutical innovator, continuously generatinginnovative drugs that enrich the quality of life for patients aroundthe world. The company uses its cumulative knowledge and expertise inthe fields of cardiovascular disease, cancer, metabolic disorders,and infection as a foundation for developing an abundant productlineup and R&D pipeline.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing agrowing portfolio of first in class and best-in-class pharmaceuticalproducts by applying the latest research from its own worldwidelaboratories and from collaborations with eminent scientificorganizations. Headquartered in Indianapolis, Ind., Lilly providesanswers - through medicines and information - for some of the world'smost urgent medical needs. Building on the strong foundation ofReoPro(R) (abciximab), Lilly is in the process of building a robustcardiovascular pipeline. Lilly has multiple cardiovascular drugs inthat pipeline - in every stage from pre-clinical and Phase I to thePhase III trials for prasugrel.

This press release contains certain forward-looking statementsabout the potential of the investigational compound prasugrel(CS-747, LY640315) and reflects Daiichi Sankyo's and Lilly's currentbeliefs. However, as with any pharmaceutical compound underdevelopment, there are substantial risks and uncertainties in theprocess of development and regulatory review. There is no guaranteethat 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 beconsistent with study findings to date. There is also no guaranteethat the compound will prove to be commercially successful. Forfurther discussion of these and other risks and uncertainties, seeLilly's filing with the United States Securities and ExchangeCommission and Daiichi Sankyo's filings with the Tokyo StockExchange. Daiichi Sankyo and Lilly undertake no duty to updateforward-looking statements.

Plavix(R)/Iscover(R) are registered trademarks of Sanofi-Synthelabo Inc. P-LLY 1 American Heart Association. Heart Disease and Stroke Statistics - 2007 Update. Dallas, TX. American Heart Association. (Pg. 12) 2 World Health Organization. The Atlas of Heart Disease and Stroke - Types of cardiovascular disease, 2005. 3 American Heart Association. Heart Disease and Stroke Statistics - 2006 Update. Dallas, TX. American Heart Association. 4 Bertrand CURE study 5 American Heart Association. Heart Disease and Stroke Statistics - 2007 Update. Dallas, TX. American Heart Association. (Pg. 10) (Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )

ots Originaltext: Eli Lilly and CompanyIm Internet recherchierbar: http://www.presseportal.de

Contact:Joedy Isert of Eli Lilly and Company, +1-317-276-5592, +1-317-997-8544 (cell); Jo-ann Straat of Daiichi Sankyo (New Jersey),+1-973-359-2602 (office); Shigemichi Kondo of Daiichi Sankyo (Tokyo),+81-3-6225-1126 (office)/ Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO , PRN Photo Desk, photodesk@prnewswire.com

Eli Lilly and Company

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Daiichi Sankyo, Lilly Announce New Prasugrel Head-to-Head Phase III Study Against Clopidogrel

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