Merck, Sharp & Dohme (MSD) today announced that the Committee for
Medicinal Products for Human Use (CHMP) has recommended marketing
approval for TREDAPTIVE(TM) (nicotinic
acid/laropiprant, MSD) 1000 mg / 20 mg modified-release tablets for the
treatment of mixed dyslipidemia or primary hypercholesterolemia.
TREDAPTIVE, the name of CORDAPTIVE (TM)(ER
niacin/laropiprant) in the European Union (EU), combines a nicotinic
acid (niacin) and laropiprant, a novel flushing pathway inhibitor.
The proposed indication for modified-release nicotinic acid/laropiprant
is for the treatment of dyslipidemia, in particular in patients with
combined mixed dyslipidemia which is characterized by elevated levels of
LDL-cholesterol (LDL-C) and triglycerides and low levels of
HDL-cholesterol (HDL-C), or primary hypercholesterolemia (heterozygous
familial and non-familial). This treatment should be used in combination
with a statin when the cholesterol lowering effect of statins is
inadequate, or as monotherapy when statins are considered inappropriate
or not tolerated. Diet and other non-pharmacological treatments, such as
exercise and weight loss, should continue during therapy with
modified-release nicotinic acid/laropiprant.
The CHMP issued a positive opinion following a review of comprehensive
data supporting the efficacy, safety and tolerability profile of
modified-release nicotinic acid/laropiprant. Marketing authorization
from the European Commission is expected by early July and will apply to
the 27 countries that are members of the EU, plus Norway and Iceland.
CHMP recommendations do not apply to regulatory decisions by the US Food
and Drug Administration (FDA) and investors should make no inferences
about pending FDA regulatory actions based on the recommendation by the
CHMP.
About Merck Sharp & Dohme
Merck & Co., Inc. (Whitehouse Station, N.J., U.S.A.), which operates in
many countries as Merck Sharp & Dohme or MSD, is a global
research-driven pharmaceutical company dedicated to putting patients
first. Established in 1891, the Company currently discovers, develops
manufactures and markets vaccines and medicines to address unmet medical
needs. The Company devotes extensive efforts to increase access to
medicines through far-reaching programs that not only donate its
medicines but help deliver them to the people who need them. Merck also
publishes unbiased health information as a not-for-profit service. For
more information, visit www.merck.com.
Forward-Looking Statement
This press release contains "forward-looking statements" as that term is
defined in the Private Securities Litigation Reform Act of 1995. These
statements are based on management´s current expectations and involve
risks and uncertainties, which may cause results to differ materially
from those set forth in the statements. The forward-looking statements
may include statements regarding product development, product potential
or financial performance. No forward-looking statement can be guaranteed
and actual results may differ materially from those projected. Merck
undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events, or
otherwise. Forward-looking statements in this press release should be
evaluated together with the many uncertainties that affect Merck´s
business, particularly those mentioned in the risk factors and
cautionary statements in Item 1A of Merck´s Form 10-K for the year ended
Dec. 31, 2007, and in any risk factors or cautionary statements
contained in the Company´s periodic reports on Form 10-Q or current
reports on Form 8-K, which the Company incorporates by reference.
