Merck Provides Update on Next Steps for TREDAPTIVE™ (extended-release niacin/laropiprant)


January 11, 2013 7:39 am ET

Merck (NYSE: MRK), known as MSD outside of the United States and Canada,
today announced the company is taking steps to suspend the availability
of TREDAPTIVE (extended-release niacin/laropiprant) tablets
worldwide. TREDAPTIVE is not approved for use in the United States.

Merck is taking these steps based on the current understanding of the
preliminary data from the HPS2-THRIVE (Heart Protection Study
2-Treatment of HDL to Reduce the Incidence
of Vascular Events) study, and in consultation with
regulatory authorities. As previously reported by Merck (Dec.
20, 2012 news release
), HPS2-THRIVE did not achieve its primary
endpoint of reduction of major vascular events, and there was a
statistically significant increase in the incidence of some types of
non-fatal serious adverse events in the group that received TREDAPTIVE
compared to statin therapy. The decision to suspend availability of the
medicine is aligned with the recommendation of the European Medicine
Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) based on the
trial’s results.

In countries where the medicine is currently available, Merck has begun
informing regulatory agencies of the company’s decision. Merck is
working with these agencies to develop communications for health care
providers and to suspend the availability of TREDAPTIVE, with the timing
to be based on individual country regulations and processes.

Merck is recommending that physicians stop prescribing TREDAPTIVE. Merck
is also recommending that physicians review treatment plans for patients
taking TREDAPTIVE in a timely manner to discontinue TREDAPTIVE and
consider other changes in therapy to achieve their dyslipidemia
management goals. In the meantime, Merck encourages patients with
questions to speak with their health care provider, and to not
discontinue therapy without first speaking with their physician.

“Patients currently taking TREDAPTIVE are our priority, and we are
committed to continue to work with regulatory agencies around the world
to ensure that physicians have appropriate information as we take steps
to suspend the availability of TREDAPTIVE,” said Michael Rosenblatt,
M.D., Chief Medical Officer, Merck.

About the HPS 2-THRIVE Study

HPS2-THRIVE was independently conducted by the Clinical Trial Service
Unit at Oxford University and funded by Merck. With the agreement of the
independent research team at Oxford University, Merck is sharing results
from the study with regulatory agencies. The investigators are
conducting additional analyses to further understand the results. They
anticipate reporting the detailed study results in the first quarter of

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, nonfatal 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.

Preliminary analyses suggest that the adverse events fall within the
following broad categories: blood and lymphatic, gastrointestinal,
infections, metabolism, musculoskeletal, respiratory and skin.
Additional analyses are ongoing to understand the adverse events within
these categories.

TREDAPTIVE 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 and CORDAPTIVE in other markets around the world. Sales through
the first three quarters of 2012 were approximately $13 million.

About Merck

Today’s Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside of the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies, and
consumer care and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to
healthcare through far-reaching policies, programs and partnerships. For
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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 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 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 (

Pamela Eisele, 908-423-5042
Skip Irvine, 267-305-5397
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088

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