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

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

Business Wire

WHITEHOUSE STATION, N.J. -- January 11, 2013

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 2013.

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 more information, visit www.merck.com and
connect with us on Twitter, Facebook and YouTube.

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
(www.sec.gov).

Contact:

Merck
Media:
Pamela Eisele, 908-423-5042
or
Skip Irvine, 267-305-5397
or
Investors:
Carol Ferguson, 908-423-4465
or
Justin Holko, 908-423-5088
 
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