Companies confirm the start of TRILOGY ACS clinical trial to study Prasugrel against Clopidogrel in medically managed ACS patients TOKYO and INDIANAPOLIS, June 23
TOKYO and INDIANAPOLIS, June 23 /PRNewswire-FirstCall/ -- Daiichi Sankyo
Company, Limited, (TSE:4568) and Eli Lilly and Company (NYSE: LLY) 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 Duke University 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 (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
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.
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.
(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)
(Logo: http://www.newscom.com/cgi-bin/prnh/20061120/DSLLOGO )
SOURCE Eli Lilly and Company
