European Commission Approves EFIENT(R) (prasugrel) for Patients with Acute Coronary Syndrome Undergoing PCI

General Press Releases Tuesday February 24, 2009 08:28
TOKYO and INDIANAPOLIS--24 Feb--PRNewswire-AsiaNet/InfoQuest

Heart patients with acute coronary syndrome (ACS) undergoing an artery-opening procedure will soon have a new treatment option to help prevent heart attacks. Daiichi Sankyo Company, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: LLY) announced today that the European Commission has granted marketing authorization for EFIENT(R) (prasugrel) for the prevention of atherothrombotic events in patients with ACS undergoing percutaneous coronary intervention (PCI).

In a large Phase III study, EFIENT (pronounced Ef-ee-ent) was superior to Plavix(R)/Iscover(R) (clopidogrel) in reducing the risk of suffering major cardiovascular events (combined endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke) in ACS patients undergoing PCI. The approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency on December 18, 2008. "Despite the proven benefits of current antiplatelet therapies, many ACS patients continue to experience life-threatening recurrent events," said Professor Gilles Montalescot at Pitie-Salpetriere Hospital, Paris. "Findings from the Phase III study showed that treatment with prasugrel significantly reduced the risk of cardiovascular events compared with the current standard of care, clopidogrel."

"This European approval is good news for doctors and patients. Using current medical interventions and treatments, people continue to experience recurrent heart attacks and more than 700,000 people die from heart attacks in the European Union each year," said Takashi Shoda, president and chief executive officer of Daiichi Sankyo Co., Ltd. "We believe prasugrel will become an important new treatment for patients with ACS undergoing PCI, a severe disease with potentially life-threatening consequences."

Prasugrel works by reducing the tendency of platelets, the blood particles responsible for clotting, from sticking or clumping together. By blocking a specific receptor (P2Y12 adenosine diphosphate) on the platelet surface, prasugrel prevents platelets from clumping, which can result in clogged arteries and may lead to heart attack or stroke. Daiichi Sankyo and Lilly anticipate making prasugrel available in the coming weeks.

"The approval of prasugrel helps to meet an important medical need. Survivors of heart attacks have a substantial risk of suffering from one or more additional heart attacks," said John C. Lechleiter, Ph.D., chairman, president and chief executive officer of Lilly. "This action is a major step forward in giving healthcare professionals and patients in European countries a new antiplatelet option for treating ACS."

Landmark Head-to-Head Study

The European Commission decision follows the CHMP's positive opinion, which was based on its review of several clinical trials, including TRITON-TIMI 38, a head-to-head superiority study that evaluated the safety and efficacy of prasugrel compared with clopidogrel in reducing atherothrombotic events in 13,608 patients with ACS undergoing PCI. The trial showed that prasugrel taken with aspirin was superior to clopidogrel taken with aspirin in reducing the relative risk of the combined endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke in patients with ACS undergoing PCI by 19 percent (observed rates of 9.4 percent vs 11.5 percent, respectively). Prasugrel also reduced the risk of stent-related clots - potentially fatal

events - by 50 percent compared with clopidogrel.(1)

The risk of non-coronary artery bypass graft (non-CABG) major bleeding, including fatal bleeding, was higher with prasugrel (2.2 percent incidence) compared with clopidogrel (1.7 percent incidence). Compared with the overall study population, a higher risk of serious bleeding among prasugrel patients was most evident in three distinct patient populations that are readily identifiable: patients who weighed less than 60 kg (132 lbs), patients who were 75 years of age or older and patients who have had a prior transient ischemic attack (TIA) or stroke. Patients who weighed less than 60 kg, or were 75 years of age or older had increased exposure with prasugrel. A 5 mg maintenance dose is recommended for patients who weigh less than 60 kg.

Prasugrel is generally not recommended for use in patients 75 years or older; if treatment is deemed necessary in this age group, a 5 mg maintenance dose should be prescribed. Patients with prior TIA or stroke should not be treated with prasugrel.

An analysis weighing the risk of major bleeding and the reduction in heart attacks found an overall benefit favoring prasugrel compared with clopidogrel. For every 1,000 patients treated with prasugrel as compared with clopidogrel, there were 22 fewer patients with heart attacks and five more with major

bleeding events.
About Acute Coronary Syndrome

Acute coronary syndrome includes heart attacks and unstable angina (chest pain). Coronary heart disease, which can result in ACS, is the single most common cause of death in the European Union, accounting for more than 741,000 deaths in the EU each year.(2) In addition, ACS affects nearly 1.5 million

people in the United States annually.(3) Heart attack is a major manifestation of coronary heart disease, which occurs when the arteries become narrowed or clogged by cholesterol and fat deposits. In some cases the plaque can rupture, resulting in a blood clot, which may partially or totally block the blood supply to portions of the heart, resulting in ACS.(4) Many ACS patients undergo PCI to re-open the artery, which usually includes a stent placement.

Daiichi Sankyo Company, Limited, and Eli Lilly and Company co-developed prasugrel, an oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner Ube Industries, Ltd. (TSE:4208) as a treatment initially for patients with acute coronary syndromes who are undergoing PCI.

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 prasugrel (CS-747, LY640315) and reflects Daiichi Sankyo's and Lilly's current beliefs. However, as with any pharmaceutical compound, there are substantial risks and uncertainties in the process of development, regulatory review, and commercialization. There is no guarantee that the compound will receive regulatory approvals, that the regulatory approvals 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. EFIENT(R) is a registered trademark of Eli Lilly and Company in the European Union.
P-LLY
(1) Efient Summary of Product Characteristics.
(2) 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.
(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) 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 )
SOURCE Eli Lilly and Company
CONTACT: Carole Copeland (OUS), Eli Lilly and Company,
+1-317-277-3661 - office, or cell, +1-317-610-6196; or Tammy Hull (U.S.A.),
Eli Lilly and Company, +1-317-651-9116 - office, or cell, +1-317-614-5132;
Olaf Lamberz,
Daiichi Sankyo (Europe GmbH), +49-89-7808-442 - office; or
Kim Wix, Daiichi Sankyo (US), +1-973-695-8338 - office, or
cell, +1-908-656-5447; or
Shigemichi Kondo, Daiichi Sankyo (Tokyo), +81-3-6225-1126 - office
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20061120/DSLLOGO
--Distributed by AsiaNet ( www.asianetnews.net )--

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