Indianapolis and Tokyo (ots/PRNewswire)

In three early-phase
trials,(1,2,3) an investigational platelet inhibitor, prasugrel
(CS-747, LY640315), demonstrated significantly higher and more
consistent inhibition of platelet aggregation (IPA) compared to both
placebo and the current standard of care, clopidogrel (Plavix(R)).

While each study was distinct in design and outcome, all three
showed that prasugrel prevented platelets from aggregating better
than clopidogrel. The data showed that response to prasugrel was
consistent in terms of less variability in response rates and IPA
achieved.

Data from these studies were presented this week at the American
College of Cardiology annual scientific sessions in Orlando, Fla.

"The results from these early studies are very encouraging," said
John T. Brandt, MD, a senior-level physician at Eli Lilly and Company
(NYSE: LLY). "A more consistent, faster and greater level of platelet
inhibition could have important implications for patient care." Eli
Lilly and Company and Sankyo Company, Ltd. (TSE: 4501) are developing
prasugrel as a potential treatment for patients who have suffered a
heart attack or unstable angina (heart-related chest pain).

A Phase III clinical study with prasugrel is ongoing, the
TRITON-TIMI 38 study. This study compares the effects of prasugrel
with clopidogrel in up to 13,000 patients with acute coronary
syndrome who are to undergo percutaneous coronary intervention (PCI).
PCI is a procedure to open blockages in heart arteries, including the
use of coronary stents. The primary focus of the study is to compare
the agents' ability to prevent heart attack, stroke and death in
patients who undergo PCI. The secondary focus is to look at the
impact on bleeding, hospitalization for recurrent heart-related chest
pain (ischemia) or the need for additional procedures to restore
blood flow (urgent target vessel revascularization). Investigators
interested in enrolling patients in TRITON-TIMI 38 should call (800)
385-4444.

"We're looking forward to building on the data presented here at
ACC," said Eugene Braunwald, MD, Distinguished Hersey Professor of
Medicine, Harvard Medical School, Boston, MA, and lead investigator
of the TRITON-TIMI 38 study. "TRITON is testing whether prasugrel's
differential effects on platelets will translate into clinical
benefits for patients."

Added Fortunato Senatore, MD, PhD, a senior-level physician at
Sankyo: "We are hopeful that prasugrel will be a promising addition
to the developing class of ADP receptor antagonists. This class of
drug has revolutionized the practice of cardiology, particularly with
respect to percutaneous coronary intervention."

Heart disease and stroke kill about 17 million people a year,
which is almost one-third of all deaths globally. By 2020, heart
disease and stroke will become the leading cause of both death and
disability worldwide, with the number of fatalities projected to
increase to over 20 million a year and by 2030 to over 24 million a
year.(4)

About the Studies

In one Phase I study ("Superior Responder Rate for Inhibition of
Platelet Aggregation With a 60 mg Loading Dose of Prasugrel (CS-747,
LY640315) Compared With a 300 mg Loading Dose of Clopidogrel" -
abstract 868-5), 68 healthy subjects were randomized to receive
either a 60 mg loading dose of prasugrel or the approved 300 mg
loading dose of clopidogrel in a 2-way cross-over design. In this
study, all prasugrel-treated patients (100%) achieved a greater than
25 percent inhibition of platelet aggregation compared to 42.4% of
clopidogrel-treated patients who achieved this level of platelet
inhibition (p less than or equal to .001).

In a separate, double-blind, placebo-controlled multiple oral dose
Phase I study ("A Comparison of Prasugrel (CS-747, LY640315) With
Clopidogrel on Platelet Function in Healthy Male Volunteers" -
abstract 868-8), 30 healthy male volunteers were randomized to
receive potential maintenance doses of prasugrel 5 mg, 10 mg or 20
mg, the approved clopidogrel maintenance dose of 75 mg, or placebo.
Study medications were taken once daily for 10 days and bleeding
times and platelet aggregation were measured in laboratory tests.
After 10 days, the maximum level of platelet inhibition was greater
for all prasugrel doses than for 75 mg clopidogrel (p less than or
equal to 0.011).

The third Phase I study ("Inhibition of Platelet Aggregation with
Prasugrel (CS-747, LY640315), a Novel Thienopyridine P2Y(12) Receptor
Antagonist, Compared with Clopidogrel in Aspirin-Treated Patients
with Atherosclerotic Vascular Disease" - abstract 1126-136) was
conducted in 101 patients with stable atherosclerotic vascular
disease. Aspirin-treated patients were randomly assigned to one of
five oral dosing regimens (four prasugrel dosing regimens and one
clopidogrel dosing regimen). Patients receiving 40 and 60 mg loading
doses of prasugrel achieved significantly higher levels of platelet
inhibition compared to the approved 300 mg loading dose of
clopidogrel (p < 0.05). After 28 days, patients receiving 10 and 15
mg maintenance doses of prasugrel achieved higher levels of platelet
inhibition than those taking the 75 mg dose of clopidogrel (p less
than or equal to 0.0002). There was a trend toward more bruising and
minor bleeding with the 15 mg maintenance dose of prasugrel.

About Prasugrel

Prasugrel is an investigational anti-platelet agent designed to
prevent platelet activation and aggregation by blocking adenosine
diphosphate receptors on the platelet surface. This novel oral
compound was discovered by Sankyo and Ube Industries, Ltd. (TSE:
4208). It is being investigated as a potential treatment for higher
risk patients with acute coronary syndrome who undergo percutaneous
coronary intervention (PCI).

About Lilly

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, 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. Additional information is available
at www.lilly.com. P-LLY

About Sankyo

Sankyo Co., Ltd. of Tokyo, one of Japan's largest pharmaceutical
companies, has a long history of discovering new classes of drugs,
including the statin class of lipid-lowering drugs. Beginning with
the discovery of the first statin, mevastatin, and the co-discovery
of lovastatin, the first statin to be marketed, Sankyo has been a
pioneer in the cardiovascular disease arena. Additionally, Sankyo
discovered, developed, manufactures and markets pravastatin sodium
and olmesartan medoxomil, an angiotensin II receptor blocker (ARB).
For further information about Sankyo and its products, log on to
http://www.sankyo.co.jp/english/.

This press release contains certain forward-looking statements
about the potential of the investigational compound prasugrel
(CS-747, LY640315) and reflects Lilly's current beliefs. However, as
with any pharmaceutical product under development, there are
substantial risks and uncertainties in the process of development and
regulatory review. There is no guarantee that the product will
receive regulatory approvals, or that the regulatory approval will be
for the indication(s) anticipated by the company. There is also no
guarantee that the product 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. Lilly undertakes no duty to update forward-looking
statements.

Plavix(R) is a registered trademark of Sanofi-Synthelabo Inc.

(1) A Comparison of Prasugrel (CS-747, LY640315) With Clopidogrel
on Platelet Function in Healthy Male Volunteers; Fumitoshi Asai,
Joseph A. Jakubowski et al. Presented at American College of
Cardiology March 9, 2005

(2) Inhibition of Platelet Aggregation With Prasugrel (CS-747,
LY640315), A Novel Thienopyridine P2Y12 Receptor Antagonist, Compared
With Clopidogrel in Aspirin-Treated Patients With Atherosclerotic
Vascular Disease; Lars Wallentin, John T. Brandt et al. Presented at
American College of Cardiology March 8, 2005

(3) Superior Responder Rate for Inhibition of Platelet Aggregation
With a 60 mg Loading Dose of Prasugrel (CS-747, LY640315) Compared
With a 300 mg Loding Dose of Clopidogrel; John T. Brandt, Christopher
D. Payne et al, Presented at American College of Cardiology March 9,
2005

(4) World Health Organization Web site, http://www.who.int/en/,
accessed March 2005

(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
           http://www.newscom.com/cgi-bin/prnh/20040827/SANKYO )

Contact:

Judy Kay Moore of Eli Lilly and Company, +1-317-277-6265, Pager:
+1-877-432-7248; Jo-ann Straat of Sankyo (New Jersey), office:
+1-973-359-2602, or Hiroki Hanashima of Sankyo (Tokyo), office:
+81-3-5255-7034; Photo: NewsCom:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
http://www.newscom.com/cgi-bin/prnh/20040827/SANKYO , PRN Photo Desk,
photodesk@prnewswire.com