Mortality Data Presented for Patients Treated with Efient(R)/Effient(R) (Prasugrel) Who Underwent Isolated Coronary Artery Bypass Surgery

Chicago, November 16 (ots/PRNewswire) - New results from an
observational substudy from TRITON-TIMI 38 presented today at the
American Heart Association (AHA) Scientific Sessions annual meeting
showed that patients treated with Efient(R)/Effient(R) (prasugrel)
prior to coronary artery bypass graft surgery (CABG) had a reduced
overall mortality rate compared to patients treated with Plavix(R)
(clopidogrel) (2.3 percent versus 8.7 percent respectively,
p=0.016).(1)

This retrospective analysis involved 346 patients with acute
coronary syndrome (ACS) who had received either study drug and
subsequently underwent isolated CABG at some point during the
15-month TRITON-TIMI 38 trial.(2)

In addition to all-cause mortality, this same analysis found that
the risk-adjusted rate of cardiovascular death at 30 days was also
lower in patients treated with prasugrel compared with those
receiving clopidogrel (0.6 percent versus 5.8 percent respectively,
p=0.038).(3) Prasugrel-treated patients experienced a statistically
significantly higher volume of chest tube blood loss at 12 hours
post-CABG compared to the clopidogrel-treated patients (655 +/- 580
milliliters with Effient versus 503 +/- 378 milliliters with
clopidogrel.(1)

"This analysis showed that prasugrel was associated with a
significantly lower mortality rate compared with clopidogrel among
these CABG patients but with a significantly higher risk of serious
bleeding events," said Peter K. Smith, M.D., professor of surgery and
division chief of Cardiovascular and Thoracic Surgery at Duke
University Medical Center and lead investigator for the retrospective
CABG analysis. "This analysis helps better define the risk of
mortality for physicians who care for the ACS patients who may be
targeted for PCI but end up undergoing CABG instead."

The prasugrel prescribing information includes a warning and
precaution against starting prasugrel in patients likely to undergo
urgent CABG surgery. The risk of bleeding is increased in patients
receiving prasugrel who undergo CABG. If possible, prasugrel should
be discontinued at least 7 days prior to CABG.(4)

Study Methodology

TRITON-TIMI 38 was a Phase III, randomized, double-blind,
head-to-head clinical trial comparing the effects of prasugrel versus
clopidogrel in patients with ACS who were managed with percutaneous
coronary intervention (PCI), a procedure to open blockages in heart
arteries, including the use of coronary stenting. The study enrolled
13,608 patients at 707 trial sites in 30 countries.

The primary endpoint of the study was the combined incidence of
cardiovascular death, non-fatal heart attack or non-fatal stroke
during at least 12 months following PCI. Patients were randomly
assigned to one of two treatment groups and given a loading dose of
either prasugrel 60 mg or the FDA-approved loading dose of
clopidogrel 300 mg, followed by a daily maintenance dose of either
prasugrel 10 mg or clopidogrel 75 mg. All patients also received a
daily dose of aspirin (75 mg to 325 mg).(4,5)

This retrospective analysis included newly collected data on 346
patients who underwent isolated CABG following withdrawal of study
drug, either prasugrel (n=173) or clopidogrel n=173), during the
TRITON-TIMI 38 study.(2) Possible baseline imbalances between arms
were adjusted using European System for Cardiac Operative Risk
Evaluation (EuroSCORE) and Society of Thoracic Surgeons (STS)
scoring, two widely accepted and standardized methods of calculating
cardiac operative mortality risk.(2) Bleeding was measured by chest
tube blood loss, a standard methodused by surgeons.(2) Despite the
adjustment for predicted risk of mortality at the time of CABG, this
non-randomized comparison between prasugrel and clopidogrel may be
subject to potential residual biases.(2)

About TRITON-TIMI 38 Results

In the overall TRITON-TIMI 38 trial, treatment with prasugrel
produced a statistically significant 18 percent reduction in the
relative risk of the combined measure of cardiovascular death,
nonfatal heart attack or nonfatal stroke compared with clopidogrel in
people with chest pain at rest or milder heart attacks (UA/NSTEMI)
and a 21 percent reduction in the combined endpoint in people with
more severe heart attacks (STEMI). In TRITON-TIMI 38, patients
treated with prasugrel also experienced a 50 percent relative risk
reduction in stent-related clots when compared with clopidogrel,
regardless of stent type. Additionally, a retrospective analysis of
TRITON-TIMI 38 showed that treatment with prasugrel resulted in a 26
percent reduction in the primary endpoint of cardiovascular death,
myocardial infarction or stroke compared with clopidogrel among
patients aged 75 years or younger who weighed at least 60 kg and had
no known history of stroke or TIA.(6)

In the TRITON-TIMI 38 trial, 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).(4,5) 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,
patients who were 75 years of age or older and patients who have had
a prior transient ischemic attack (TIA) or stroke. 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, a 5 mg dose of prasugrel may be
used after careful risk-benefit evaluation. Patients with prior TIA
or stroke should not be treated with prasugrel.

About Prasugrel

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. Prasugrel helps keep blood platelets from clumping together and
developing a blockage in an artery. The European Commission granted
marketing authorization for prasugrel for the prevention of
atherothrombotic events in patients with ACS undergoing PCI in 2009.
Worldwide prasugrel has been approved in more than 65 countries.

About Acute Coronary Syndromes

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.(7) In
addition, ACS affects nearly 1.5 million people in the United States
annually.(8) 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.(9) Many ACS
patients undergo PCI to re-open the artery, which usually includes a
stent placement.

About Daiichi Sankyo

The Daiichi Sankyo Group is dedicated to the creation and supply
of innovative pharmaceutical products to address the diversified,
unmet medical needs of patients in both mature and emerging markets.
While maintaining its portfolio of marketed pharmaceuticals for
hypertension, hyperlipidemia, and bacterial infections, the Group is
engaged in the development of treatments for thrombotic disorders and
focused on the discovery of novel oncology and
cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo
Group has created a "Hybrid Business Model," which will respond to
market and customer diversity and optimize growth opportunities
across the value chain. For more information, please visit
http://www.daiichisankyo.com

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of 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. Additional
information about Lilly is available at http://www.lilly.com.

This press release contains certain forward-looking statements
about prasugrel for the reduction of thrombotic cardiovascular events
(including stent thrombosis) in patients with acute coronary
syndromes who are managed with percutaneous coronary intervention and
reflects Daiichi Sankyo's and Lilly's current beliefs. However, as
with any pharmaceutical product, there are substantial risks and
uncertainties in the process of development and commercialization.
There is no guarantee that future study results and patient
experience will be consistent with study findings to date or that the
product will 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.

Efient(R)/Effient(R) is a registered trademark of Eli Lilly and
Company.

Plavix(R) is a registered trademark of Sanofi-Aventis Corp.

P-LLY

(1) Smith PK, Despotis GJ, Goodnough LT, Levy, J, Poston, R,
Short, M, et al. Mortality benefit with prasugrel in TRITON-TIMI 38
coronary artery bypass grafting (CABG) cohort: Risk adjusted
retrospective data analysis. Abstract presented at: 2010 American
Heart Association Scientific Sessions; November 2010; Chicago, IL.

(2) Smith PK, Despotis GJ, Goodnough LT, Levy, J, Poston, R,
Short, M, et al. Mortality benefit with prasugrel in TRITON-TIMI 38
coronary artery bypass grafting (CABG) cohort: Risk adjusted
retrospective data analysis. Study presented at: 2010 American Heart
Association Scientific Sessions; November 2010; Chicago, IL.

(3) Data on File at Eli Lilly and Company. Coronary Artery Bypass
Grafting Cardiovascular Death Data Table.

(4) European Medicines Agency. Summary of Product
Characteristics.

(5 Wiviott SD, Braunwald E, McCabe CH et al. Prasugrel versus
clopidogrel in patients with acute coronary syndromes. New England
Journal of Medicine. 2007:357(20);2001-2015.

(6) Wiviott S, Antman E and Braunwald. New Drugs and
Technologies: Prasugrel. DOI: 10.1161 Circulation AHA.109.921502
p394-403.

(7) British Heart Foundation Health Promotion Research Group.
European Cardiovascular Disease Statistics 2008. Updated 2008.
Accessed November 4, 2010.

(8) American Heart Association. Heart Disease and Stroke
Statistics - 2008 Update. Dallas, TX. American Heart Association.
(Pg. 14).

(9) WebMD Medical Reference in Collaboration with the Cleveland
Clinic. Heart Disease: Coronary Artery Disease. Accessed March 5,
2010.

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ots Originaltext: Eli Lilly and Company
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Contact:
CONTACT: Tammy Hull, Eli Lilly and Company, +1-317-651-9116
(office),+1-317-614-5132 (cell); Dr. Michaela Paudler-Debus, Daiichi
Sankyo EuropeGmbH, +49-(0)89-78-08-685 (office), +49-(0)172-845-8974
(cell); ShigemichiKondo, Daiichi Sankyo (Tokyo), +81-3-6225-1126
(office)