Daiichi Sankyo, Lilly Announce New Prasugrel Head-to-Head Phase III Study Against Clopidogrel

Daiichi Sankyo, Lilly Announce New Prasugrel Head-to-Head Phase III Study Against Clopidogrel

November 05, 2007

Duke Clinical Research Institute to lead multinational
study with investigational compound; will include 10,000
medically managed patients with acute coronary syndrome


    TOKYO and INDIANAPOLIS, Nov. 5 /Xinhua-PRNewswire/ -- A
large Phase III clinical trial is anticipated to begin in
the second quarter of 2008 to compare the effects of
prasugrel, an investigational oral antiplatelet agent,
against clopidogrel (Plavix(R)/Iscover(R)) in medically
managed patients with acute coronary syndrome (ACS), a
group of common heart conditions that includes unstable
angina (chest pain) and heart attacks(1).

    ( Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
 
    The study, TRILOGY ACS (TaRgeted platelet Inhibition to
cLarify the Optimal strateGy to medicallY manage Acute
Coronary Syndromes), will include approximately 10,000
patients at more than 800 hospitals in 35 countries. 

    Daiichi Sankyo Company, Limited (TSE: 4568) and Eli
Lilly and Company (NYSE: LLY), which are co-developing
prasugrel, will conduct the study in conjunction with the
Duke Clinical Research Institute (DCRI), the world's
largest academic clinical research organization and a part
of Duke University Medical Center. Lead study investigator
is E. Magnus Ohman, M.D., Professor of Cardiology at Duke
University School of Medicine.

    About TRILOGY ACS

    The study is a multi-center, double-blind, randomized,
controlled trial that will include approximately 10,000
patients, with about 800 hospitals in 35 countries
participating.  TRILOGY ACS will evaluate the safety and
efficacy of prasugrel against clopidogrel in reducing the
risk of cardiovascular death, heart attack or stroke in ACS
patients who are to be medically managed without planned
revascularization (a procedure to reopen blocked arteries).
Currently, more than 50 percent of patients presenting with
ACS worldwide are managed without acute intervention.

    "TRILOGY ACS, which will be one of the largest of
its kind, will be a very important study as it will focus
on a group of medically managed patients with ACS who have
not been extensively studied in the past," said lead
study investigator E. Magnus Ohman, M.D., Professor of
Cardiology at Duke University School of Medicine.
 
    When patients present with ACS, their symptoms are
secondary to a lack of adequate oxygen delivery to the
heart, usually due to a significant narrowing or blockage
of one or more of the coronary arteries due to plaque. This
plaque has the potential to rupture at any time and cause an
arterial clot (thrombus) to form, which can block oxygenated
blood from reaching the heart muscle. Antiplatelet
medications help to reduce the incidence of this acute
thrombus formation.
  
    "The announcement of this study demonstrates our
continued confidence in the clinical research surrounding
prasugrel," said John Alexander, M.D., M.P.H., global
head of research and development, Daiichi Sankyo Company,
Limited.

    About cardiovascular disease

    Cardiovascular disease is the leading cause of death in
the U.S. and worldwide, killing 16.7 million people each
year(2). Acute heart attacks and unstable angina, called
acute coronary syndrome, affect more than 840,000 Americans
each year and 800,000 in Europe(3,4). Even with current
medical interventions, 300,000 people experience recurrent
heart attacks and 500,000 people die from heart attacks
annually in the United States(5). 

    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 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.  

    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.  Building on the strong
foundation of ReoPro(R) (abciximab), Lilly is in the
process of building a robust cardiovascular pipeline. Lilly
has multiple cardiovascular drugs in that pipeline - in
every stage from pre-clinical and Phase I to the Phase III
trials for prasugrel.  

    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.

    P-LLY

    1 American Heart Association.  Heart Disease and Stroke
Statistics - 2007
      Update.  Dallas, TX. American Heart Association. (Pg.
12)
    2 World Health Organization. The Atlas of Heart Disease
and Stroke - Types
      of cardiovascular disease, 2005.
    3 American Heart Association.  Heart Disease and Stroke
Statistics - 2006
      Update.  Dallas, TX. American Heart Association.
    4 Bertrand CURE study
    5 American Heart Association.  Heart Disease and Stroke
Statistics - 2007
      Update.  Dallas, TX. American Heart Association. (Pg.
10)


    For more information, please contact:

     Joedy Isert
     Eli Lilly and Company
     Cell: [phone] / [phone]

     Jo-ann Straat
     Daiichi Sankyo (New Jersey)
     Tel:  [phone] (office)

     Shigemichi Kondo
     Daiichi Sankyo (Tokyo)
     Tel:  [phone] (office)