New ESC Guidelines Recommend Efient® (Prasugrel) as First-line Antiplatelet Therapy for Patients with Non-ST Segment Myocardial Infarction and Unstable Angina Acute Coronary Syndromes

Paris (ots/PRNewswire) -

In new guidelines from the European Society of Cardiology (ESC),
prasugrel - a once daily oral antiplatelet medicine - received a
Class I recommendation for use in patients undergoing percutaneous
coronary intervention (PCI) after experiencing a non-ST-segment
elevation acute coronary syndrome (which comprises non-ST segment
elevation myocardial infarction or NSTEMI - a type of heart attack -
and unstable angina or UA).(1) The highest available recommendation,
Class I recognizes that prasugrel is considered a "beneficial, useful
and effective" treatment option for first line use in these
patients.(1)

The Guidelines Committee endorsed the use of prasugrel in
UA/NSTEMI patients (especially those with diabetes) who are
clopidogrel naive in whom coronary anatomy is known and who are
proceeding to PCI.(1) The guidelineswere presented at the ESC
Congress 2011 in Paris and are published in the European Heart
Journal.(1)

"UA and NSTEMI patients are at high risk of cardiovascular
events, and they often represent a challenge in clinical practice.
There is a significant body of evidence which showed that prasugrel
can form part of an appropriate management strategy to minimize risk
for these patients," said Professor Gilles Montalescot, Head of the
Cardiac Care Unit at Pitie-Salpetriere Hospital, Paris, France. "The
guidelines, based on the latest clinical evidence, set out clear
recommendations that offer alternative treatment options, such as
prasugrel, for treating some of these high risk patients."

In the updated guidelines - titled Management of acute coronary
syndromes in patients presenting without persistent ST-segment
elevation - prasugrel was recommended regardless of a patient's
genetic status, and the guidelines state prasugrel does not appear to
be affected by CYP inhibitors, including proton pump inhibitors.(1)

NSTEMI and UA accounts for about 2.5 million hospital admissions
worldwide each year.(2) In developed countries NSTEMI is the most
frequent type of ACS and represents the largest group of patients
undergoing PCI. Despite advances in medical and interventional
treatments, the mortality and morbidity remain high and equivalent to
that of patients with severe heart attacks (known as STEMI) after the
initial month.(3) However, patients with NSTEMI constitute a
heterogeneous group of patients with a highly variable prognosis.
Therefore, early risk stratification is essential for selection of
medical as well as interventional treatment strategies.(3)

This new recommendation is based on the clinical evidence for
prasugrel in UA/NSTEMI patient population in the TRITON-TIMI 38
study, which led to a level of evidence 'B' ('data derived from a
single randomized clinical trial').(1)In the TRITON-TIMI 38 study,
which included 10,074 patients withchest pain at rest (UA) or
experiencing NSTEMI (74 percent of the study population), treatment
with prasugrel produced a statistically significant 18 percent
reduction in the relative risk of the combined endpoint of
cardiovascular death, nonfatal heart attack or nonfatal stroke
compared with clopidogrel.(4) In this patient population, the
incidence of non-CABG-related TIMI major (2.2 percent with prasugrel
vs. 1.6 percent with clopidogrel) and minor (2.3 percent with
prasugrel and 1.6 percent with clopidogrel) bleeding was
statistically significantly higher in patients treated with prasugrel
compared to clopidogrel.(5)

The publication of the guidelines comes just a few months after
the addition of prasugrel to the joint American Heart Association
(AHA), American College of Cardiology (ACC) and the Society for
Cardiovascular Angiography and Interventions (SCAI) clinical practice
guidelines in the United States, in which it was granted a Class I
recommendation in UA/NSTEMI patients.(6)

Granted marketing authorization by the European Commission in
February 2009, prasugrel, co-administered with acetylsalicylic acid
(ASA), is indicated for the prevention of atherothrombotic events in
patients with ACS undergoing primary or delayed PCI.

About TRITON-TIMI 38 (4)

In the TRITON-TIMI 38 trial of 13,608 patients with ACS
undergoing PCI, treatment with prasugrel produced a statistically
significant 19 percent (P<0.001) reduction in the relative risk of
the combined endpoint of cardiovascular death, nonfatal heart attack
or nonfatal stroke compared with clopidogrel. This was driven
primarily by a reduction in heart attack.

In the TRITON-TIMI 38 clinical trial, the risk of non-coronary
artery bypass graft (non-CABG) TIMI 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,
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 after careful individual
benefit/risk evaluation, a 5 mg maintenance dose of prasugrel should
be used (following a 60 mg loading dose). 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. To date
prasugrel has been approved in more than 65 countries worldwide.

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 more than one 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.

The company's world headquarters are in Tokyo. Its European base
is located in Munich. DAIICHI SANKYO EUROPE has affiliates in 12
European countries in addition to a global manufacturing site located
in Pfaffenhofen, Germany.

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) is a registered trademark of Eli Lilly and Company.

References

(1) The Task Force for the management of acute coronary syndromes
(ACS) in patients presenting without ST-segment elevation of the
European Society of Cardiology (ESC). ESC Guidelines for the
management of acute coronary syndromes in patients presenting without
persistent ST-segment elevation. European Heart Journal. Published
online 26 August 2011. Available at: http://www.escardio.org/guidelin
es-surveys/esc-guidelines/GuidelinesDocuments/Guidelines-NSTE-ACS-FT.
pdf

(2) Grech ED et al. Acute coronary syndrome: unstable angina and
non-ST segment elevation myocardial infarction.BMJ 2003; 326:
1259-1261

(3) Wijins W, Kolh P, Danchin N et al. Guidelines on myocardial
revascularization The Task Force on Myocardial Revascularization of
the European Society of Cardiology (ESC) and the European Association
for Cardio-Thoracic Surgery (EACTS). European Heart Journal. 2010;
31: 2501-2555

(4) Wiviott et al. Prasugrel versus Clopidogrel in Patients with
Acute Coronary Syndromes. N Engl J Med 2007;357:2001-15

(5) Efient (prasugrel) prescribing information EU. Daiichi
Sankyo, Inc. and Eli Lilly and Company

(6) 2011 ACCF/AHA Focused update of the guidelines for the
management of patients with unstable angina/non-ST elevation
myocardial infarction (Updated 2007 guideline): A report of the
American College of Cardiology Foundation/American Heart Association
Task Force on Practice Guidelines

(7) British Heart Foundation Health Promotion Research Group.
European Cardiovascular Disease Statistics 2008.
http://www.ehnheart.org Accessed August 2011

(8) Roger VL, Go AS, Lloyd-Jones DM, et al. for the American
Heart Association Statistics Committee and Stroke Statistics
Subcommittee. Heart disease and stroke statistics - 2011 update.
Circulation. 2011;123:e1-e192.

(9) WebMD Medical Reference in Collaboration with the Cleveland
Clinic. Heart Disease: Coronary Artery Disease. http://www.webmd.com.
Accessed August 2011

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ots Originaltext: Eli Lilly and Company
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Contact:
Christina D. Gaines, APR, Eli Lilly and Company, +1-317-276-3845
(office), +1-317-366-2568 (cell); Dr. Michaela Paudler-Debus, Daiichi
Sankyo Europe GmbH, +49-(0)89-78-08-685 (office), +49-(0)172-845-8974
(cell); Kimberly Wix, Daiichi Sankyo, Inc., +1-973-944-2338 (office),
+1-908-656-5447 (cell)