LEL Lilly(Eli)

 
TIDMLEL 
 
Date: November 16, 2011 
 
Refer to: Christina D. Gaines, APR 
 
Eli Lilly and Company 
 
+1-317-276-3845 (office) 
 
+1-317-366-2568 (cell) 
 
Kimberly Wix 
 
Daiichi Sankyo (U.S.A.) 
 
973-944-2338 (office) 
 
908-656-5447 (cell) 
 
Michaela Paudler-Debus 
 
Daiichi Sankyo (Tokyo) 
 
81-3-6225-1126 (office) 
 
New Analysis of Data Presented at AHA Regarding Effect of Effient® (Prasugrel) 
                  on Cardiovascular Events in STEMI Patients 
 
                          According to Timing of PCI 
 
Data provide further insight into how the timing of PCI may affect outcomes in 
            STEMI patients at risk for future cardiovascular events 
 
ORLANDO, FL (November 16, 2011) - An analysis of the TRITON-TIMI 38 trial 
presented today in an oral session at the American Heart Association (AHA) 
Scientific Sessions meeting examined the effect of Effient® (prasugrel) on 
cardiovascular (CV) events (CV death, myocardial infarction [MI] and stroke) 
compared to clopidogrel relative to the timing of percutaneous coronary 
intervention (PCI) in acute coronary syndrome (ACS) patients with ST-segment 
elevation myocardial infarction (STEMI). 
 
At 15 months, primary PCI patients with STEMI had an 11 percent relative risk 
reduction in CV events, and secondary PCI patients had a 35 percent relative 
risk reduction with Effient compared to clopidogrel (HR 0.89, 95% CI 0.69-1.13; 
and HR 0.65, 95% CI 0.46-0.93, respectively). Absolute risk reduction for 
Effient compared to clopidogrel was 1.3 percent for the primary PCI group and 
4.6 percent for the secondary PCI group.1 
 
"Not all ST-elevation MI patients are treated with primary PCI; therefore, 
understanding the effects of more potent inhibition of platelets in ACS 
patients who are treated with primary PCI or those treated with delayed PCI is 
important for choosing antiplatelet therapies," said lead author Jacob A. 
Udell, MD, MPH, Clinical Fellow, Cardiovascular Medicine, Brigham & Women's 
Hospital. "These data demonstrate that efficacy and bleeding rates for Effient 
are consistent with the overall TRITON-TIMI 38 trial results irrespective of 
when STEMI patients undergo intended PCI." 
 
In the study, primary PCI was defined as PCI within 12 hours from onset of 
acute coronary syndrome (ACS) symptoms and secondary PCI was defined as PCI 
more than 12 hours after initial onset or initial medical therapy. Of the 3,534 
STEMI patients from the TRITON-TIMI 38 trial who were included in this 
analysis, 2,340 (68 percent) underwent primary PCI and 1,085 underwent 
secondary PCI. Randomization to Effient or clopidogrel occurred at presentation 
if primary PCI was intended or at the time of secondary PCI. The primary 
endpoint of the analysis was a reduction in the composite of CV death, MI and 
stroke. 
 
In this analysis, TIMI major non-CABG bleeding events at 15 months occurred in 
3 percent of prasugrel-treated primary PCI patients and 1.9 percent of 
clopidogrel-treated patients (HR=1.52, p=0.13); TIMI non-CABG major or minor 
bleeding occurred in this patient group in 5 percent of clopidogrel-treated 
patients and 6 percent of prasugrel-treated patients (HR=1.33, p=0.12). In 
secondary PCI patients, TIMI major non-CABG bleeding events occurred in 2.5 
percent of clopidogrel-treated patients and 0.9 percent of prasugrel-treated 
patients (HR=0.39, p=0.07); TIMI non-CABG major or minor bleeding events 
occurred in 5 percent of clopidogrel-treated patients compared to 3 percent of 
prasugrel-treated patients (HR=0.57, p=0.09).1 TIMI major non-CABG bleeding 
events associated with prasugrel as compared to clopidogrel were consistent in 
the STEMI cohort compared to the overall trial. Within the PCI subgroup, the 
hazard of bleeding with primary PCI at 15 months was HR 1.52 [CI 0.87-2.65] and 
for secondary PCI at 15 months was HR 0.39 [CI 0.14-1.11].1 
 
Overall TRITON-TIMI 38 Study Methodology 
 
TRITON-TIMI 38 was a head-to-head study comparing Effient (60-mg loading dose 
[LD], followed by a 10-mg once-daily maintenance dose) plus aspirin (ASA) with 
Plavix (clopidogrel) (300-mg LD, followed by a 75-mg once-daily maintenance 
dose) plus ASA in 13,608 patients with ACS managed with percutaneous coronary 
intervention (PCI), a procedure to open blockages in heart arteries, including 
the use of coronary stenting. The median duration of study treatment was 14.5 
months. 
 
The primary endpoint of the study was the combined incidence of cardiovascular 
death, non-fatal heart attack or non-fatal stroke in patients followed for 6-15 
months following PCI. The study showed that treatment with Effient 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 Plavix in people with chest pain at rest or milder heart 
attacks (unstable angina/ non-ST segment myocardial infarction) (9.3 vs. 11.2 
percent respectively, p=0.002) and a 21 percent significant reduction in the 
combined endpoint in people with more severe heart attacks (ST elevation 
myocardial infarction) (9.8 vs. 12.2 percent respectively, p=0.019).3 This 
corresponds to a 1.9 percent absolute risk reduction for UA/NSTEMI patients 
treated with Effient and a 2.4 percent absolute risk reduction for STEMI 
patients treated with Effient.2 TRITON-TIMI 38 patients treated with Effient 
also experienced a 50 percent relative risk reduction (corresponding to 1.3 
percent absolute risk reduction) in stent-related clots when compared with 
Plavix, regardless of stent type (1.1 percent vs. 2.4 percent respectively, p 
<0.001).2 In TRITON, the risk of non-coronary artery bypass graft (non-CABG) 
major bleeding, including fatal bleeding, was higher with Effient (2.2 percent 
incidence) compared with Plavix (1.7 percent incidence) (p=0.029).2 The rate of 
TIMI major or minor bleeding was significantly greater with Effient than Plavix 
(5.0 percent vs. 3.8 percent respectively, p=0.002). The risk of coronary 
artery bypass graft (CABG) major bleeding, including fatal bleeding, was higher 
with Effient (13.4 percent incidence) than Plavix (3.2 percent incidence) (p 
<0.001).2 In TRITON-TIMI 38, the LD of Plavix was delayed relative to the 
placebo-controlled trials that supported its approval for ACS. 
 
Compared with the overall study population, a higher risk of serious bleeding 
among Effient patients was most evident in three distinct patient populations 
that are readily identifiable: patients who weighed less than 132 lbs (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 may be 
considered for patients who weigh less than 132 lbs.3 Effient is generally not 
recommended for use in patients 75 years or older,3 except in high risk 
patients (diabetes or prior MI), where its effects appears to be greater and 
its use may be considered.3 Patients with prior TIA or stroke should not be 
treated with Effient.3 
 
About Effient 
 
Daiichi Sankyo Company, Limited (TSE: 4568), and Eli Lilly and Company (NYSE: 
LLY) co-developed Effient, an oral antiplatelet agent discovered by Daiichi 
Sankyo and its Japanese research partner, Ube Industries, Ltd. Effient helps 
keep blood platelets from clumping together and developing a blockage in an 
artery. Effient is approved by the U.S. Food and Drug Administration for the 
reduction of thrombotic cardiovascular events (including stent thrombosis) in 
patients with ACS who are managed with an artery-opening procedure known as 
PCI. PCI usually includes the placement of a stent to help keep the artery 
open. 
 
About Acute Coronary Syndrome 
 
ACS, which includes heart attack and a type of chest pain called unstable 
angina, affects more than one million people in the United States annually. The 
annual incidence of new heart attacks is estimated to be approximately 610,000 
and about 325,000 people will have a recurrent attack.4 Each year, 
approximately 645,000 people with ACS are managed with PCI, which typically 
includes the implantation of a stent that restores blood flow to blocked 
arteries in the heart. ACS results in significant illness and death, costing 
Americans more than $150 billion each year.5 Nearly 60 percent of the U.S 
healthcare costs of ACS are due to re-hospitalization.5 Strategies to prevent 
recurrent heart attacks and re-hospitalization are important to improve patient 
outcomes and reduce the cost burden of ACS.5 
 
Important Safety Information 
 
 
What is the most important information patients should know about Effient? 
 
What should patients tell their doctor before taking Effient? 
 
Patients should tell their doctor about all of their medical conditions, 
allergies, and medicines they are taking. 
 
What are the possible side effects of Effient? 
 
Bleeding is the most common side effect of Effient. 
 
TTP, a rare but life-threatening condition, has been reported with Effient, 
sometimes after a short time (less than 2 weeks). Patients should get medical 
attention right away if they develop the following unexpected symptoms of TTP: 
fever, weakness, yellowing of the skin or eyes, or if skin becomes very pale or 
dotted with purple spots. 
 
Serious allergic reactions can happen with Effient, or if the patient has had a 
serious allergic reaction to the medicines Plavix® (clopidogrel) or 
ticlopidine. Patients should get medical help right away if they get any of 
these symptoms of a severe allergic reaction: swelling or hives of their face, 
lips, in or around their mouth, or throat, trouble breathing or swallowing, 
chest pain or pressure, dizziness or fainting. 
 
Other side effects may occur. 
 
For more information about Effient, please see the Full Prescribing Information 
at http://pi.lilly.com/us/effient.pdf, including Boxed Warning regarding 
bleeding risk and Medication Guide http://pi.lilly.com/us/effient-ppi.pdf. You 
may also learn more about Effient at www.Effient.com. 
 
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 www.daiichisankyo.com. 
 
Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is a member of 
the Daiichi Sankyo Group. For more information on Daiichi Sankyo, Inc., please 
visit www.dsi.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 www.lilly.com. 
 
This press release contains certain forward-looking statements about Effient 
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. 
 
Effient® is a registered trademark of Eli Lilly and Company. 
 
Plavix® is a registered trademark of Sanofi-Aventis Corp. 
 
P-LLY 
 
                                      ### 
 
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Udell JA et al. Benefit of Prasugrel in ST-elevation Myocardial Infarction 
According to Timing of Percutaneous Coronary Intervention: Insights from the 
TRITON-TIMI 38 Study. To be presented at the American Heart Association 
Scientific Sessions; November 2011; Orlando FL. 
 
Wiviott, S.D. et al. Prasugrel versus Clopidogrel in Patients with Acute 
Coronary Syndromes. New England Journal of Medicine 2007 Vol 357 (20); 
2001-2015. 
 
Effient (prasugrel) prescribing information. Daiichi Sankyo, Inc. and Eli Lilly 
and Company. 
 
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. 
 
Kolansky DM. Acute coronary syndromes: Morbidity, mortality, and 
pharmacoeconomic burden. Amer. J. of Managed Care. 2009;15:S36-S41. 
 
Effient® (prasugrel) can cause bleeding. If patients have unexplained or 
excessive bleeding while on Effient, they should contact their doctor right 
away as some bleeding can be serious, and sometimes fatal. Patients should not 
take Effient if they currently have abnormal bleeding, such as stomach or 
intestinal bleeding, bleeding in their head, or have a history of stroke, or 
"mini-stroke" (also known as transient ischemic attack or TIA). 
 
Patients should get medical help right away if they suddenly have slurring of 
speech, weakness or numbness in one part of their body, blurry vision, and/or 
severe headache. These may be symptoms of a stroke or TIA. If patients have a 
stroke or TIA while taking Effient, their doctor will probably stop Effient. 
 
Before having any surgery, patients should talk to their doctor about stopping 
Effient. If possible, patients should stop taking Effient at least 1 week (7 
days) before any surgery, as instructed by their doctor who prescribed Effient. 
 
Patients may also have a higher risk of bleeding if they take Effient and they: 
a) are age 75 or older, b) weigh less than 132 pounds, c) are taking 
anticoagulants (eg, warfarin) or regular daily use of NSAIDs, d) have had 
recent trauma, such as an accident or surgery, e) have severe liver problems, 
or f) have a stomach ulcer. 
 
Patients should not stop taking Effient without talking to the doctor who 
prescribes it for them. People who are treated with angioplasty and have a 
stent, and stop taking Effient too soon, have a higher risk of a blood clot in 
the stent, having a heart attack, or dying. 
 
 
 
END 
 

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