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Expanded Labelling for Januvia(R) (sitagliptin) Approved by European Commission



    Merck Sharp & Dohme (MSD) today announced that the European
    Commission has approved ´Januvia´ (sitagliptin) for two additional
    uses for patients with type 2 diabetes. This now makes sitagliptin the
    only dipeptidyl peptidase-4 inhibitor (DPP-4 inhibitor) approved as an
    add-on therapy to a sulphonylurea (´dual therapy´), or a sulphonylurea
    plus metformin (´triple therapy´), in the European Union (EU). It
    remains the only DPP-4 inhibitor indicated for once-daily use.

    With this new approval for the two additional uses, the product is
    now indicated to improve glycaemic control in combination with a
    sulphonylurea when diet and exercise plus maximal tolerated dose of a
    sulphonylurea alone do not provide adequate glycaemic control, and
    when metformin is inappropriate due to contraindications or
    intolerance; and to improve glycaemic control in combination with a
    sulphonylurea and metformin when diet and exercise plus dual therapy
    with these agents do not provide adequate glycaemic control.

    Sitagliptin was approved in the European Union in March 2007 for
    the treatment of type 2 diabetes in combination with either metformin
    or, in certain patients, with a PPAR(gamma) agonist (i.e.
    thiazolidinedione) when diet and exercise plus either agent do not
    provide adequate glycaemic control. It should not be used in patients
    with type 1 diabetes or for the treatment of diabetic ketoacidosis.

    "The approval of these new indications is another step forward in
    helping to combat type 2 diabetes. It is important because it provides
    physicians and patients with more options to achieve reduced glycaemic
    levels," said Stefan Oschmann, President, Europe, Middle East, Africa
    and Canada, Merck & Co., Inc.

    The approval of the indication extensions was based on phase III
    clinical trial results supporting the tolerability and efficacy of
    sitagliptin 100 mg once-daily in combination with glimepiride (a
    sulphonylurea) alone or with glimepiride plus metformin.(1) Overall,
    the trial data showed that the addition of sitagliptin significantly
    reduced HbA1c levels and fasting plasma glucose levels, and was
    generally well tolerated.(1)

    In clinical trials in combination with a sulphonylurea
    (glimepiride), with or without metformin, sitagliptin demonstrated an
    overall incidence of adverse reactions higher than that seen with
    placebo, in part related to a higher incidence of hypoglycaemia with
    the treatment compared to placebo (12.2 percent vs. 1.8 percent,
    respectively). The higher rate of hypoglycaemia is commonly seen when
    antihyperglycaemic agents are used in combination with sulphonylurea
    agents. When sitagliptin is used in combination with a sulphonylurea,
    a lower dose of the sulphonylurea may be considered to reduce the risk
    of hypoglycaemia.

    In controlled clinical studies in combination therapy with
    metformin or pioglitazone, the overall incidence of adverse reactions,
    hypoglycaemia, and discontinuation of therapy due to clinical adverse
    reactions with sitagliptin were similar to placebo. In these clinical
    studies, the most common adverse reactions reported (greater than or
    equal to 5 percent and higher than placebo) were stuffy or runny nose
    and sore throat, upper respiratory infection, and headache.

    Dosing of ´Januvia´

    The recommended dose is 100 mg once daily, with or without food,
    for all adopted indications.

    No dosage adjustment is needed for patients with mild to moderate
    hepatic insufficiency. The product has not been studied in patients
    with severe hepatic insufficiency. For patients with mild renal
    insufficiency (creatinine clearance (CrCl) => 50 ml/min), no dosage
    adjustment is required. Clinical study experience in patients with
    moderate or severe renal insufficiency is limited. Therefore, use of
    sitagliptin is not recommended in this patient population.

    No dosage adjustment is necessary based on age. Limited safety
    data are available in patients =>75 years of age and care should be
    exercised.

    No liver function tests need to be performed prior to the
    initiation of treatment.

    Use in specific populations

    Sitagliptin should not be used during pregnancy or during breast
    feeding. It is not recommended for use in children below 18 years of
    age due to a lack of data on its safety and efficacy.

    Worldwide availability

    The adoption of the indication extension will be applicable to the
    27 countries that are members of the EU, including the United Kingdom,
    Germany, France, Italy and Spain. It is estimated that over 53 million
    people in Europe have diabetes.(2) It has so far received approval in
    more than 60 countries and is available in every region around the
    world. As a result of this worldwide availability, there have been
    over three million prescriptions for sitagliptin.(3)

    Expanding clinical development programme

    Merck & Co., Inc.´s clinical development programme for sitagliptin
    is robust and continues to expand with 49 studies completed or
    underway and five more studies set to begin this year. There have been
    more than 9,400 patients in the Company´s clinical studies, with about
    6,000 of these patients being treated with the product. Additionally,
    about 2,300 patients have been treated with sitagliptin for more than
    one year and of these 400 patients have been treated for at least 2
    years.

    About Merck & Co., Inc., of Whitehouse Station, N.J., U.S.A.

    Merck & Co., Inc. 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
    programme that not only donate its medicines but help deliver them to
    the people who need them. Merck & Co., Inc. 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. MSD 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 MSD´s business, particularly those mentioned in the risk
    factors and cautionary statements in Item 1A of MSD´s Form 10-K for
    the year ended Dec. 31, 2006, and in its periodic reports on Form 10-Q
    and Form 8-K, which the Company incorporates by reference.

    (1) Hermansen K, Kipnes M, Luo E et al. Efficacy and safety of the
    dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2
    diabetes mellitus inadequately controlled on glimepiride alone or on
    glimepiride and metformin. Diabetes, Obesity and Metabolism 2007
    9(5):733-745.

    (2) International Diabetes Federation: Diabetes Atlas, 3rd ed.
    2006 Chapter 1, p.28.

    (3) IMS Health, NPA(TM) Weekly, TRxs, week ending October 20, 2006
    - week ending December 21, 2007.

    Januvia(R) is a registered trademark of Merck & Co., Inc., of
    Whitehouse St, NJ, USA known in many countries as Merck Sharp & Dohme