Merck Announces Top-Line Results of TRA-2P Study of Vorapaxar


February 7, 2012 8:30 am ET

Company Will Review Data FromTRA-2P and TRACER With External Experts to Inform Next Steps

Merck (NYSE:MRK), known outside the United States and Canada as MSD,
today announced the top-line results of the TRA-2P (Thrombin Receptor
Antagonist in Secondary Prevention of
atherothrombotic ischemic events) study of vorapaxar. Merck is
developing vorapaxar, an investigational oral Protease Activated
Receptor 1 (PAR-1) thrombin receptor antagonist, for the prevention of
thrombosis, or clot formation, and the reduction of cardiovascular

TRA-2P showed that the addition of vorapaxar to standard of care
significantly reduced the risk of the protocol-specified primary
endpoint of the composite of cardiovascular death (CVD), heart attack
(myocardial infarction, or MI), stroke or urgent coronary
revascularization compared to standard of care. There was a significant
increase in bleeding, including intracranial hemorrhage (ICH), among
patients taking vorapaxar in addition to standard of care, although
there was a lower risk of ICH in patients without a history of stroke.

The full results of TRA-2P will be presented at the American College of
Cardiology Scientific Sessions in March.

“In developing vorapaxar, Merck and our scientific collaborators set a
very high bar – would the addition of vorapaxar to standard of care
provide incremental benefit in preventing clots?” said Peter S. Kim,
president, Merck Research Laboratories. “We are pleased that TRA-2P met
its primary endpoint, and we look forward to discussing the results with
the scientific community.”

Merck will review the data from both TRA2-P and TRACER with the
investigators and other outside experts to help better understand the
profile of this investigational medicine in specific patient populations
and to determine next steps, including potential regulatory filings.

Vorapaxar has been evaluated in two major clinical outcomes studies:
TRA-2P TIMI 50 ( identifier: NCT00526474
) was led by the Thrombolysis in Myocardial Infarction (TIMI) Study
Group of Brigham and Women’s Hospital. TRA-2P was a secondary prevention
study in 26,449 patients with a heart attack, an ischemic stroke, or
documented peripheral vascular disease. TRACER (Thrombin Receptor
Antagonist for Clinical Event Reduction in
Acute Coronary Syndrome), ( identifier: NCT00527943)
was an acute care, hospital-based study of approximately 12,944 patients
with non-ST-segment-elevation acute coronary syndrome. The study was led
by the Duke Clinical Research Institute, and results were presented in
2011 at the American Heart Association Scientific Sessions and published
in the January 5, 2012 issue of The New England Journal of
(Vol. 366, No. 1). The news release can be found at

About Merck

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Forward-Looking Statement

This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. Such statements may include,
but are not limited to, statements about the benefits of the merger
between Merck and Schering-Plough, including future financial and
operating results, the combined company’s plans, objectives,
expectations and intentions and other statements that are not historical
facts. Such statements are based upon the current beliefs and
expectations of Merck’s management and are subject to significant risks
and uncertainties. Actual results may differ from those set forth in the
forward-looking statements.

The following factors, among others, could cause actual results to
differ from those set forth in the forward-looking statements: the
possibility that the expected synergies from the merger of Merck and
Schering-Plough will not be realized, or will not be realized within the
expected time period; the impact of pharmaceutical industry regulation
and health care legislation; the risk that the businesses will not be
integrated successfully; disruption from the merger making it more
difficult to maintain business and operational relationships; Merck’s
ability to accurately predict future market conditions; dependence on
the effectiveness of Merck’s patents and other protections for
innovative products; the risk of new and changing regulation and health
policies in the United States and internationally and the exposure to
litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can be
found in Merck’s 2010 Annual Report on Form 10-K and the company’s other
filings with the Securities and Exchange Commission (SEC) available at
the SEC’s Internet site (

Pam Eisele, 908-423-5042
Skip Irvine, 267-305-5397
Carol Ferguson, 908-423-4465

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