New Analysis Showed Efient(R) Cost-Effective Compared with Clopidogrel for Patients with Acute Coronary Syndromes Undergoing PCI

Tokyo and Indianapolis (ots/PRNewswire) - Results from a
health economic substudy of the TRITON-TIMI 38 clinical trial showed
that among patients with acute coronary syndrome (ACS) managed with
percutaneous coronary intervention (PCI), including stenting,
treatment with Efient(R) (prasugrel) compared with branded
clopidogrel (Plavix(R)) was more cost effective, and in most cases
cost saving. These results were published in Circulation on January
5, 2010.(1)

In the pre-specified analysis of 6,705 patients, treatment with
prasugrel compared with clopidogrel reduced total hospitalisation
costs over approximately 15 months, not including the cost of study
drugs, by US$530 per patient. This cost offset estimate includes
bleeding-related costs that a sensitivity analysis showed were not a
major driver of the overall cost difference between the two
treatments.

The analysis also found that, including cost of the active study
drugs as well as costs associated with the initial and subsequent
hospitalisations, treatment with prasugrel compared with clopidogrel
decreased cumulative medical costs by US$221 per patient over the
14.7-month study. Study drug costs used in the analysis were the net
wholesale price as of August 2009, which was US$5.45 per day for
prasugrel and US$4.62 per day for clopidogrel.

"Results of the cost-effectiveness analysis showed that treatment
with prasugrel was highly cost effective and an economically dominant
option," said David J. Cohen, M.D., M.Sc., director of cardiovascular
research, Saint Luke's Mid America Heart Institute and professor of
medicine, University of Missouri-Kansas City. "These favourable
results were found in an analysis that considered only the first 30
days of treatment, as well as an analysis that considered the time
period starting from 31 days through the rest of the follow-up
period. These analyses are important because the results provide the
healthcare community, including formulary decision makers, with new
data regarding the cost-effectiveness of prasugrel for patients with
ACS undergoing PCI."

"Dominant" is a health economics term used when a new treatment
yields greater clinical effectiveness at lower costs. In TRITON-TIMI
38, prasugrel plus aspirin (ASA) was shown to significantly reduce
the rate of a combined endpoint of cardiovascular death, non-fatal
heart attack, or non-fatal stroke compared to clopidogrel plus ASA.
In addition, patients treated with prasugrel also had significantly
fewer stent thromboses (stent-related blood clots) compared to those
treated with clopidogrel. These benefits were accompanied by a
significantly higher risk of bleeding, which in some cases were
life-threatening or even fatal in patients treated with prasugrel
compared with clopidogrel.

The analysis also compared prasugrel to generic clopidogrel at a
hypothetical cost of US$1 per day. When compared to clopidogrel at
this lower cost, treatment with prasugrel in the subpopulation as a
whole was economically dominant (e.g., cost saving) during the first
30 days of treatment. After day 31, it continued to be a
cost-effective therapy relative to many other accepted medical
interventions.

"The hypothetical comparison with generic clopidogrel is
important because the patent exclusivity for clopidogrel will expire
in the US in 2011 or 2012 and is already facing generic competition
in several countries in the EU. Results from this comparison to
generic clopidogrel will be useful information for the medical
community, especially payers, in the future," said Dr. Cohen, "and
suggest that the overall benefit of prasugrel was still favourable
relative to its higher cost in this setting."

Study Methodology

TRITON-TIMI 38 was a Phase III, randomised, double-blind,
head-to-head clinical trial comparing the effects of prasugrel versus
clopidogrel in patients with ACS who were managed with 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 a median period of 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).

The economic analysis was completed using data from 6,705 study
patients enrolled in eight pre-specified countries, including the
United States, Australia, Canada, France, Germany, Italy, Spain and
the United Kingdom. The primary economic measure was total in-trial
costs including hospitalisation and medication costs. The approach to
estimating costs was to multiply counts of resource use
(hospitalisations, physician costs, procedures, medications) by price
weights derived from comparable populations of US patients. All costs
other than study drug costs were assessed in 2005 US dollars.

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 authorisation for prasugrel for the prevention of
atherothrombotic events in patients with ACS undergoing PCI.

About Acute Coronary Syndrome

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.(2) In
addition, ACS affects nearly 1.5 million people in the United States
annually.(3) 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. Many ACS
patients undergo PCI to re-open the artery, which usually includes a
stent placement.

Important Safety Information about Prasugrel

In the EU prasugrel label, 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). 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 (132 lbs),
patients who were 75 years of age or older and patients who have had
a prior transient ischemic attack (TIA) or stroke. Patients who
weighed less than 60 kg, or were 75 years of age or older had
increased exposure with prasugrel. In the EU prasugrel label, 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 in this age group, a
5 mg maintenance dose should be prescribed. Patients with prior TIA
or stroke should not be treated with prasugrel.

The EU prasugrel label includes a contraindication for patients
with a history of TIA or stroke, as well as a warning for patients
who weighed less than 60 kg (132 lbs) and patients who are 75 years
of age or older. For the patients in TRITON-TIMI 38 without these
risk factors, the efficacy of prasugrel compared with clopidogrel on
the primary composite endpoint of CVD, nonfatal MI, or nonfatal
stroke was 8.3 percent vs. 11.0 percent, respectively, and consistent
with the significant efficacy benefit observed with prasugrel in the
overall study population. In these same patients, the risk of serious
bleeding was reduced but still higher with prasugrel compared with
clopidogrel (2.0 percent vs. 1.5 percent, respectively).

An analysis weighing the risk of major bleeding and the reduction
in heart attacks found an overall benefit favouring prasugrel
compared with clopidogrel. For every 1,000 patients treated with
prasugrel as compared with clopidogrel, there were 22 fewer patients
with heart attacks and five more with non-CABG-related major bleeding
events.

About Daiichi Sankyo

A global pharmaceutical innovator, Daiichi Sankyo Co., Ltd., was
established in 2005 through the merger of two leading Japanese
pharmaceutical companies. This integration created a more robust
organisation that allows for continuous development of novel drugs
that enrich the quality of life for patients around the world. Areas
of primary focus for Daiichi Sankyo research and development are
thrombotic disorders, malignant neoplasm, diabetes mellitus, and
autoimmune disorders. Equally important to the company are
hypertension, hyperlipidemia or atherosclerosis and bacterial
infections. For more information, visit 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 organisations. 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 www.lilly.com.

This press release contains certain forward-looking statements
about Efient for the reduction of thrombotic cardiovascular events
(including stent thrombosis) in patients with acute coronary syndrome
undergoing 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 commercialisation. 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) is a registered trademark of Eli Lilly and Company.

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

P-LLY

(1) Mahoney EM, Wang K, et al. Cost-Effectiveness of Prasugrel
versus Clopidogrel in Patients with Acute Coronary Syndromes and
Planned PCI: Results from the TRITON-TIMI 38 Trial. Circulation.
2010; 121: 71-79.

(2) British Heart Foundation Health Promotion Research Group.
European Cardiovascular Disease Statistics 2008,
http://www.ehnheart.org/files/statistics%202008%20web-161229A.pdf,
Accessed Oct. 15, 2009.

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

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ots Originaltext: Eli Lilly and Company
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Contact:
CONTACT: Derin Denham, Eli Lilly and Company, +1-317-277-6749
(office),+1-317-370-1435 (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)