Merck Announces HPS2-THRIVE Study of TREDAPTIVE™ (Extended-Release Niacin/Laropiprant) Did Not Achieve Primary Endpoint


December 20, 2012 8:30 am ET

Merck (NYSE:MRK), known outside the United States and Canada as MSD,
today announced that the HPS2-THRIVE (Heart Protection Study
2-Treatment of HDL to Reduce the Incidence
of Vascular Events) study of TREDAPTIVE(extended-release
niacin/laropiprant) did not meet its primary endpoint. Merck and the
investigators are informing regulatory agencies of these results. The
company is also preparing communications to health care providers in
countries where the medicine is currently available, and will continue
to work with regulators to provide updated information to health care
providers. Based on the current understanding of these new data and
until further analyses can be completed, Merck is recommending that
providers not start new patients on TREDAPTIVE. Merck does not plan to
seek regulatory approval for the medicine in the United States.

HPS2-THRIVE was independently conducted by the Clinical Trial Service
Unit at Oxford University and funded by Merck. The study enrolled 25,673
patients considered to be at high risk for cardiovascular events. Of
those enrolled, 14,741 were from Europe (the United Kingdom and
Scandinavia) and 10,932 were from China. Patients in the study were
followed for a median of 3.9 years. HPS2-THRIVE compared extended
-release niacin and laropiprant plus statin therapy versus statin
therapy. It was not designed to assess directly the separate effects of
either extended-release niacin or laropiprant.

In the study, adding the combination of extended-release niacin and
laropiprant to statin therapy did not significantly further reduce the
risk of the combination of coronary deaths, non-fatal heart attacks,
strokes or revascularizations compared to statin therapy. In addition,
there was a statistically significant increase in the incidence of some
types of non-fatal serious adverse events in the group that received
extended-release niacin/laropiprant.

With the agreement of the independent research team at Oxford
University, Merck is sharing results from the study with regulatory
agencies in countries where the medicine is approved (under the brand
names TREDAPTIVE or CORDAPTIVE) and in other countries as well. The
investigators are conducting additional analyses, including regional
analyses, to further understand the results. They anticipate reporting
the detailed study results in the first quarter of 2013.

“While we are disappointed in these results, we thank the investigators
who have conducted the study and the patients who have participated in
it,” said Peter S. Kim, Ph.D., president, Merck Research Laboratories.
“We are committed to working closely with the independent research team
at Oxford University and with regulatory agencies to understand the
results and determine next steps.”


TREDAPTIVE/CORDAPTIVE has been approved in approximately 70 countries,
including in Europe, and is sold in approximately 40 countries.
TREDAPTIVE is also sold under the brand names PELZONT in Italy and
TREVACLYN in Italy and Portugal. Sales through the first three quarters
of 2012 were approximately $13 million.

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. These statements are based
upon the current beliefs and expectations of Merck’s management and are
subject to significant risks and uncertainties. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.

Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; Merck’s ability to accurately
predict future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign risk;
dependence on the effectiveness of Merck’s patents and other protections
for innovative products; and the exposure to litigation, including
patent 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 2011 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 (

Media Contacts:
Pamela Eisele, 908-423-5042
Skip Irvine, 267-305-5397
Investor Contact:
Carol Ferguson, 908-423-4465

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