Tokyo and Indianapolis, November 4 (ots/PRNewswire) -
- Duke Clinical Research Institute to lead multinational study
with investigational compound; will include 10,000 medically managed
patients with acute coronary syndrome
A large Phase III clinical trial is anticipated to begin in the
second quarter of 2008 to compare the effects of prasugrel, an
investigational oral antiplatelet agent, against clopidogrel
(Plavix(R)/Iscover(R)) in medically managed patients with acute
coronary syndrome (ACS), a group of common heart conditions that
includes unstable angina (chest pain) and heart attacks(1).
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 Company, Limited (TSE: 4568) and Eli Lilly and
Company (NYSE: LLY), which are co-developing prasugrel, will conduct
the study in conjunction with the Duke Clinical Research Institute
(DCRI), the world's largest academic clinical research organization
and a part of Duke University Medical Center. Lead study investigator
is E. Magnus Ohman, M.D., Professor of Cardiology at Duke University
School of Medicine.
About TRILOGY ACS
The study is a multi-center, double-blind, randomized, controlled
trial that will include approximately 10,000 patients, with about 800
hospitals in 35 countries participating. TRILOGY ACS will 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 planned
revascularization (a procedure to reopen blocked arteries).
Currently, more than 50 percent of patients presenting with ACS
worldwide are managed without acute intervention.
"TRILOGY ACS, which will be one of the largest of its kind, will
be a very important study as it will focus on a group of medically
managed patients with ACS who have not been extensively studied in
the 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 a
lack of adequate oxygen delivery to the heart, usually due to a
significant narrowing or blockage of one or more of the coronary
arteries due to plaque. This plaque has the potential to rupture at
any time and cause an arterial clot (thrombus) to form, which can
block oxygenated blood from reaching the heart muscle. Antiplatelet
medications help to reduce the incidence of this acute thrombus
"The announcement of this study demonstrates our continued
confidence in the clinical research surrounding prasugrel," said John
Alexander, 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 heart
attacks and unstable angina, called acute coronary syndrome, affect
more than 840,000 Americans each year and 800,000 in Europe(3,4).
Even with current medical interventions, 300,000 people experience
recurrent heart attacks and 500,000 people die from heart attacks
annually in the United States(5).
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
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. Building on the strong foundation of
ReoPro(R) (abciximab), Lilly is in the process of building a robust
cardiovascular pipeline. Lilly has multiple cardiovascular drugs in
that pipeline - in every stage from pre-clinical and Phase I to the
Phase III trials for prasugrel.
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
@@start.t1@@ Plavix(R)/Iscover(R) are registered trademarks of Sanofi-Synthelabo Inc.
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 )@@end@@
ots Originaltext: Eli Lilly and Company
Im Internet recherchierbar: http://www.presseportal.ch
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