Daiichi Sankyo, Lilly Submit New Drug Application for Investigational Antiplatelet Drug, Prasugrel, with U.S. Food and Drug Administration
TOKYO and INDIANAPOLIS, Jan. 4 - Daiichi Sankyo
Company, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: LLY) today
announced that on Wednesday, Dec. 26, 2007, they submitted a New Drug
Application (NDA) for prasugrel to the U.S. Food and Drug Administration
(FDA). Prasugrel is an oral antiplatelet agent, initially in development
for the treatment of patients with acute coronary syndrome (ACS) who are
managed with percutaneous coronary intervention (PCI), including coronary
stenting.
If approved for marketing in the United States, the trade name for
prasugrel will be Effient(TM), company officials added.
“We are elated,” said J. Anthony Ware, M.D., Lilly vice president and
cardiovascular/acute care platform leader for prasugrel. “We feel confident
in the strength and completion of this submission package, and plan to
complete our submission in Europe in the first quarter of 2008. The
benefit/risk profile of this compound, in comparison with the current
standard of care, has the potential to improve outcomes for ACS patients
undergoing PCI.”
The NDA is based upon data from several trials, including the landmark
TRITON-TIMI 38 clinical trial, which evaluated the safety and efficacy of
prasugrel compared with clopidogrel (Plavix(R)/Iscover(R)) in reducing
ischemic events such as non-fatal heart attack, non-fatal stroke and
cardiovascular death in 13,608 patients. In the study, treatment with
prasugrel resulted in a:
— 19 percent relative risk reduction compared with clopidogrel in all ACS
patients in the primary composite endpoint of non-fatal heart attack,
non-fatal stroke or cardiovascular death (p<0.001).
— 52 percent reduction compared with clopidogrel in stent thrombosis
(p<0.0001).
— 30 percent relative risk reduction compared to clopidogrel in a subset
of patients with diabetes (p<0.001) on the composite endpoint of non-
fatal heart attack, non-fatal stroke, or cardiovascular death.
Risk reductions in the primary composite endpoint with prasugrel
compared to clopidogrel were seen as early as three days and continued to
diverge for 15 months (the duration of the trial.)
Though the incidence of non-coronary artery bypass grafting(non-CABG)
bleeding in TRITON was low in both the prasugrel and clopidogrel treatment
groups, prasugrel-treated patients experienced significantly higher
non-CABG major bleeding (2.2% vs. 1.7%, respectively) and higher rates of
life- threatening bleeding (1.3% vs. 0.8%, respectively). Death from
cardiovascular causes (2% vs. 2.2%, respectively) and all-cause death (2.8%
vs. 2.9%, respectively) was comparable among prasugrel-treated patients and
clopidogrel- treated patients. The overall results demonstrated that for
every 1,000 patients treated with prasugrel as compared with clopidogrel,
there were 22 fewer patients with heart attacks and five more
non-CABG-related TIMI major bleeds.
“Given the overall results from TRITON, this submission is particularly
meaningful considering that cardiovascular disease is the leading cause of
death in the United States and worldwide, killing 16.7 million people each
year,” said John Alexander, M.D., M.P.H., global head of research and
development, Daiichi Sankyo Company, Limited.
Acute heart attacks and unstable angina, called acute coronary
syndrome, affect more than 840,000 Americans each year and 800,000 people
in Europe.(i,ii) Utilizing current medical interventions and treatments,
300,000 people continue to experience recurrent heart attacks and 450,000
people die from heart attacks annually in the U.S.(iii)
About prasugrel
Daiichi Sankyo Company, Limited (TSE: 4568), and Eli Lilly and Company
(NYSE: LLY) are co-developing prasugrel, an investigational oral
antiplatelet agent invented by Daiichi Sankyo and its Japanese research
partner Ube Industries, Ltd., as a potential treatment, initially for
patients with acute coronary syndrome 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.
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-Synthelabo
Inc. Effient(TM) is a trademark of Eli Lilly and Company.
P-LLY
(i) American Heart Association. Heart Disease and Stroke Statistics -
2006 Update. Dallas, TX. American Heart Association.
(ii) Bertrand CURE study
(iii) American Heart Association. Heart Attack and Angina Statistics.
URL: http://www.americanheart.org/presenter.jhtml?identifier=4591.
Last accessed July 26, 2007.
SOURCE Eli Lilly and Company
