JANUVIA(R), First in New Class of Oral Treatments Known as DPP-4 Inhibitors, Recommended for Approval for the Treatment of Type 2 Diabetes in the European Union



    Editor's Note: For Use by Reporters in the European Union Only.

    JANUVIA(R)(1) (sitagliptin), Merck, Sharp & Dohme's treatment for
    patients with type 2 diabetes, today received a positive opinion from
    the Committee for Medicinal Products for Human Use (CHMP) of the
    European Medicines Evaluation Agency (EMEA) in Europe. The CHMP
    opinion recommends that JANUVIA be approved in the European Union for
    the treatment of type 2 diabetes. Following the conclusion of the CHMP
    review, the opinion for JANUVIA will be transmitted to the European
    Commission (EC). If the EC adopts the opinion, JANUVIA will be the
    first and only prescription medication in a new class of drugs known
    as dipeptidyl peptidase-4 (DPP-4) inhibitors, which enhance the body's
    own ability to lower blood sugar (glucose) when it is elevated. The
    decision will be applicable to the 27 countries that are members of
    the European Union, including the United Kingdom, Germany, France,
    Italy and Spain. JANUVIA is currently approved in eleven countries
    including the United States and Mexico. Marketing authorization from
    the European Commission is expected in early April after the adoption
    of the opinion.

    The CHMP, comprised of regulators from all European Union
    countries, gave the positive opinion following a review of
    comprehensive data supporting the efficacy and safety and tolerability
    profile of JANUVIA. The submission package consisted of studies
    involving approximately 4,000 patients with type 2 diabetes treated
    with JANUVIA.

    JANUVIA has been investigated in patients with type 2 diabetes to
    improve glycaemic control in combination with metformin when diet and
    exercise, plus metformin, do not provide adequate glycaemic control.
    JANUVIA has also been studied as add on therapy with PPAR gamma
    agonists in patients with type 2 diabetes mellitus in whom use of a
    PPAR gamma agonist (e.g. a thiazolidinedione) is appropriate. In
    addition, JANUVIA has been studied as monotherapy in many patients.

    In a clinical study, JANUVIA plus metformin, compared to treatment
    of a sulfonylurea (SU) plus metformin, showed comparable glucose
    lowering efficacy. In this study patients taking JANUVIA plus
    metformin lost weight (-1.5 kg) compared to patients taking glipizide
    plus metformin who gained weight gain (+1.1 kg). Hypoglycaemia (when
    blood sugar becomes too low) was more common in patients treated with
    glipizide plus metformin (32 percent) compared to patients treated
    with JANUVIA plus metformin (4.9 percent). In the overall phase III
    clinical programme the incidence of hypoglycaemia in patients taking
    JANUVIA was similar to patients taking placebo (1.2 percent, JANUVIA
    vs. 0.9 percent, placebo). In clinical trials of up to 2 years in
    duration, patients have received treatment with JANUVIA alone or in
    combination with metformin, a sulfonylurea (with or without metformin)
    or a PPAR gamma agent. In these trials, the rate of discontinuation
    due to adverse experiences considered drug-related was 0.8 percent
    with JANUVIA and 1.5 percent with other treatments. No adverse
    reactions considered as drug-related were reported in patients treated
    with JANUVIA occurring in excess (> 0.2 % and difference > 1 patient)
    of that in patients treated with control. Reported adverse events
    included nausea (common), somnolence, upper abdominal pain, diarrhoea
    and hypoglycaemia (uncommon).** JANUVIA should not be used in patients
    with type 1 diabetes or for the treatment of diabetic ketoacidosis, as
    it would not be effective in these settings.

    About JANUVIA

    JANUVIA (sitagliptin) is an oral, once daily, potent and highly
    selective DPP-4 inhibitor. DPP-4 inhibitors work by enhancing a
    natural body process that lowers blood sugar, the incretin system.
    When blood sugar is elevated, incretins work in two ways to help the
    body regulate high blood sugar levels: they trigger the pancreas to
    increase the release of insulin and signal the liver to reduce its
    production of glucose. DPP-4 inhibitors enhance the body's own ability
    to control blood sugar levels by increasing the active levels of these
    incretin hormones in the body, helping to decrease blood sugar levels
    in patients with type 2 diabetes.

    Expanding Clinical Trial Program for JANUVIA

    MSD's clinical development program for JANUVIA is robust and
    continues to expand with 43 studies completed or under way, and four
    more studies set to begin this year. There are about 6,700 patients in
    the Company's clinical studies with about 4,700 of these patients
    being treated with JANUVIA. Additionally, about 1,100 patients have
    been treated with JANUVIA for more than a year.

    About Merck

    Merck & Co., Inc., which operates in many countries as MSD (Merck
    Sharp & Dohme), is a global research-driven pharmaceutical company
    dedicated to putting patients first. Established in 1891, Merck
    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 Merck 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.

    Forwarding-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 cautionary statements in Item 1 of Merck's Form 10-K
    for the year ended Dec. 31, 2005, and in its periodic reports on Form
    10-Q and Form 8-K, which the company incorporates by reference.

    *Frequencies are defined as: very common (=> 1/10); common
    (=> 1/100, < 1/10); uncommon (=> 1/1,000, < 1/100); rare (=> 1/10,000,
    < 1/1,000); and very rare (< 1/10,000).

    (1) JANUVIA is a registered trademark of Merck & Co., Inc., which
    operates in many countries as MSD (Merck, Sharp & Dohme).