Daiichi Sankyo and Lilly Respond to Speculation on Status of Prasugrel New
Drug Application
TOKYO and INDIANAPOLIS, Oct. 16 /PRNewswire-FirstCall/ -- In response to
recent media speculation regarding the status of the prasugrel new drug
application (NDA), Daiichi Sankyo Company, Limited (TSE: 4568) and Eli Lilly
and Company (NYSE: LLY) reiterated today that they continue to have
discussions with the FDA regarding the review of this application. The
companies have not been notified of any regulatory action for the new drug
application (NDA) or of any decision to have an advisory committee to review
prasugrel. Prasugrel is an investigational antiplatelet agent for the
treatment of patients with acute coronary syndromes (ACS) who are being
managed with an artery-opening procedure known as percutaneous coronary
intervention (PCI), which is usually followed by the placement of a stent to
help keep the artery open.
"Daiichi Sankyo and Lilly are engaged in an ongoing dialogue with the
FDA," said Jennifer Stotka, M.D., Lilly vice president of Global Regulatory
Affairs. "We remain confident in the overall benefit-risk profile of
prasugrel, and we believe this drug should be approved so that we can bring
this valuable treatment option to ACS patients, a population at risk for
further cardiovascular events."
"The FDA can schedule an Advisory Committee at any time during the review
of an application. If one is called, then we will be prepared to
participate," said John Alexander, M.D., M.P.H., global head of research and
development, Daiichi Sankyo Company, Limited.
Lilly, on behalf of its alliance partner, Daiichi Sankyo, submitted a new
drug application to the FDA for prasugrel in December 2007. Lilly, on behalf
of the alliance, also submitted a Marketing Authorization Application for
prasugrel to the European Medicines Agency in February 2008.
In the TRITON-TIMI 38 clinical trial of more than 13,000 patients, the
primary measure showed that prasugrel taken with aspirin reduced the relative
risk of the combined endpoint of cardiovascular death, non-fatal heart attacks
or non-fatal stroke by 19 percent more than clopidogrel
(Plavix(R)/Iscover(R)) taken with aspirin. These benefits were accompanied by
an increased risk of serious bleeding with prasugrel overall, some of which
may be life threatening. Overall, for every 1,000 people treated, there were
six more TIMI major bleeding events, but 23 fewer heart attacks in patients
taking prasugrel compared with patients taking clopidogrel(i). The risk of
cardiovascular death overall in the study was not statistically different
between treatment groups [prasugrel (2.0%) compared with clopidogrel (2.2%)].
About Daiichi Sankyo Company, Limited
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 is
cardiovascular disease, including therapies for dyslipidemia, hypertension,
diabetes, and acute coronary syndrome. Equally important to the company is
the discovery of new medicines in the areas of infectious diseases, cancer,
bone and joint diseases, and immune disorders. For more information, visit
www.daiichisankyo.com.
Daiichi Sankyo, Inc. (www.dsus.com) headquartered in Parsippany, New
Jersey, is the U.S. subsidiary of Daiichi Sankyo Co., Ltd.
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 is a registered trademark of Sanofi Aventis Corp.
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.
(i) Wiviott, S, Braunwald, E, et al. Prasugrel versus Clopidogrel in
Patients with Acute Coronary Syndromes. New England Journal of Medicine.
November 2007; 357: 2001-15.
(Logo: http://www.newscom.com/cgi-bin/prnh/20061120/DSLLOGO )
SOURCE Eli Lilly and Company
Tamara Hull of Eli Lilly and Company, +1-317-651-9116 (office),
+1-317-377-8358 (cell); or Kimberly Wix of Daiichi Sankyo (U.S.A.),
+1-973-695-8338 (office), +1-908-656-5447 (cell); or Shigemichi Kondo of
Daiichi Sankyo (Tokyo), 81-3-6225-1126 (office)
