TOKYO and INDIANAPOLIS, Dec. 18 /PRNewswire-FirstCall/ -- 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
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.
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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20061120/DSLLOGO )
