Empresas y finanzas

TREDAPTIVE(TM) Recommended for EU Approval for the Treatment of Mixed Dyslipidemia or Primary Hypercholesterolemia



    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.