|[January 15, 2014]
Merck Statement on FDA Advisory Committee for Vorapaxar, Merck's Investigational Antiplatelet Medicine
WHITEHOUSE STATION, N.J. --(Business Wire)--
known as MSD outside the United States and Canada, today said it was
pleased with the U.S. Food and Drug Administration (FDA)'s
Cardiovascular and Renal Drugs Advisory Committee's recommendation for
approval of vorapaxar. Vorapaxar is the company's investigational
antiplatelet medicine for the reduction of atherothrombotic events, when
added to standard of care, in patients with a history of heart attack
and no history of stroke or transient ischemic attack.
"There are approximately 7.6 million Americans who have survived a heart
attack. Each year, about 190,000 of them have a recurrent heart attack,
so there remains a need for additional treatment options," said Dr.
Daniel Bloomfield, vice president, Cardiovascular Diseases, Merck
Research Laboratories. "The results of today's Advisory Committee mark
an important milestone in our effort to bring vorapaxar to appropriate
patients with a history of heart attack. We look forward to working with
the FDA as it completes its review."
The FDA is not bound by the Committee's guidance, but takes its advice
into consideration when reviewing investigational medicines.
Vorapaxar, proposed trade name ZONTIVITY™, is a first-in-class
protease-activated receptor-1 (PAR-1) antagonist designed to inhibit the
formation of blood clots. PAR-1 is a receptor activated by thrombin,
known to be a potent platelet activator. Vorapaxar inhibits
thrombin-induced platelet aggregation by inhibiting PAR-1 receptors on
Data supporting the filing of this new drug application are from the
26,449 patient TRA 2°P - TIMI 50 trial, a randomized, double-blind,
placebo-controlled study of vorapaxar used in addition to standard
therapy including other antiplatelet agents. Patients included in the
study had a histor of myocardial infarction, ischemic stroke, or
peripheral artery disease and had a median follow-up of 2.5 years.
Today's Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside 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,
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. There can be no
guarantees with respect to pipeline products that the products will
receive the necessary regulatory approvals or that they will prove to be
commercially successful. 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 2012 Annual Report on Form 10-K and the company's other
filings with the Securities and Exchange Commission (SEC (News - Alert)) available at
the SEC's Internet site (www.sec.gov).
ZONTIVITY™ is a registered trademark of Merck & Co., Inc., Whitehouse
Station, N.J., USA
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