Advertisement
The CHMP positive opinion is now referred for final action to the EuropeanCommission, which grants approval in the European Union. The Commissionusually makes a decision about whether to approve a new drug candidate withintwo to three months of CHMP issuing its recommendation. Upon approval, thisnew oral antiplatelet agent is expected to be marketed throughout the EuropeanUnion under the proposed brand name EFIENT(TM).
Advertisement
"We are extremely pleased by the CHMP positive recommendation for approvalof prasugrel in Europe," said John Alexander, M.D., M.P.H., global head ofresearch and development, Daiichi Sankyo Company, Limited. "Based on the studyresults and the positive recommendation, we are hopeful that prasugrel will beapproved as a new treatment option for patients with ACS undergoing PCI."
The submission package contains data from several trials, including thelandmark TRITON-TIMI 38, a head-to-head superiority study that evaluated thesafety and efficacy of prasugrel compared with clopidogrel(Plavix(R)/Iscover(R)) in reducing atherothrombotic events (combined endpointof cardiovascular death, non-fatal heart attack, or non-fatal stroke) in13,608 patients with acute coronary syndromes undergoing PCI. These data werepresented at the American Heart Association Scientific Sessions andsimultaneously published online in the New England Journal of Medicine inNovember 2007.
"Cardiovascular disease remains a significant cause of death anddisability worldwide, and this positive opinion is an important step in makingthis new treatment available to help prevent heart attacks in the ACSpatient," said J. Anthony Ware, M.D., Lilly vice president forcardiovascular/acute care.
Cardiovascular disease kills an estimated 17.5 million people worldwideeach year, and acute heart attacks and unstable angina, called acute coronarysyndromes, 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 antiplateletagent discovered by Daiichi Sankyo and its Japanese research partner UbeIndustries, Ltd., as a potential treatment, initially for patients with acutecoronary syndromes who are undergoing PCI. Prasugrel works by inhibitingplatelet activation and subsequent aggregation by blocking the P2Y12 adenosinediphosphate (ADP) receptor on the platelet surface. Antiplatelet agentsprevent platelets from clumping or sticking together, which can result inclogged arteries and may lead to heart attack or stroke. Lilly, on behalf ofits alliance partner, Daiichi Sankyo, submitted a Marketing AuthorizationApplication for prasugrel to the European Medicines Agency in February 2008.
About Acute Coronary Syndromes
Acute coronary syndromes, which is comprised of heart attacks and unstableangina (chest pain), affects nearly 1.5 million people in the United Statesannually.(3) ACS, a fatal consequence of coronary heart disease, is thesingle most common cause of death in the European Union, accounting for morethan 741,000 deaths in the EU each year.(4) Heart attack is a majormanifestation of coronary heart disease, which occurs when the arteries becomenarrowed or clogged by cholesterol and fat deposits and cannot supply enoughblood to the heart. In some cases, a blood clot may partially or totally blockthe blood supply to the heart resulting in ACS.(5) Many ACS patients undergoPCI, which usually includes a stent placement.
About Daiichi Sankyo
A global pharma innovator, Daiichi Sankyo Co., Ltd., was established in2005 through the merger of two leading Japanese pharmaceutical companies. Thisintegration created a more robust organization that allows for continuousdevelopment of novel drugs that enrich the quality of life for patients aroundthe world. A central focus of Daiichi Sankyo's research and development arethrombotic disorders, malignant neoplasm, diabetes mellitus, and autoimmunedisorders. Equally important to the company are hypertension, hyperlipidemiaor atherosclerosis and bacterial infections. For more information, visitwww.daiichisankyo.com.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growingportfolio of first-in-class and best-in-class pharmaceutical products byapplying the latest research from its own worldwide laboratories and fromcollaborations with eminent scientific organizations. Headquartered inIndianapolis, 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 thepotential of the investigational compound prasugrel (CS-747, LY640315) andreflects Daiichi Sankyo's and Lilly's current beliefs. However, as with anypharmaceutical compound under development, there are substantial risks anduncertainties in the process of development and regulatory review. There isno guarantee that 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 be consistentwith study findings to date. There is also no guarantee that the compoundwill prove to be commercially successful. For further discussion of these andother risks and uncertainties, see Lilly's filing with the United StatesSecurities and Exchange Commission and Daiichi Sankyo's filings with the TokyoStock 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
(2) Bertrand M, CURE study investigator and Professor of Cardiology,University of Lille, France. Sanofi-Synthelabo and Bristol-Myers SquibbCompany press release, "CPMP Recommends Granting Marketing Authorization Inthe European Union For Plavix(R)/Iscover(R) (clopidogrel) for the Treatment ofAcute Coronary Syndrome with Non ST Segment Elevation," June 27, 2002.
(3) American Heart Association. Heart Disease and Stroke Statistics - 2008Update.http://www.americanheart.org/downloadable/heart/1200082005246HS_Stats%202008.final.pdf. Accessed December 9, 2008.
(4) British Heart Foundation Health Promotion Research Group. EuropeanCardiovascular Disease Statistics 2008,http://www.ehnheart.org/files/statistics%202008%20web-161229A.pdf, AccessedDecember 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 )(1) World Health Organization,http://www.who.int/cardiovascular_diseases/en/
SOURCE Eli Lilly and Company
