FDA Advisory Committee Unanimously Recommends Accelerated Approval of ISENTRESS(TM) (raltegravir), Merck's Investigational Oral Integrase Inhibitor, for Treatment of HIV



    Merck & Co., Inc. announced today that the Antiviral Drugs
    Advisory Committee of the U.S. Food and Drug Administration (FDA)
    voted unanimously to recommend accelerated FDA approval of
    ISENTRESS(TM) (raltegravir) in combination with other antiretroviral
    therapy (ART) for the treatment of HIV infection in
    treatment-experienced patients with ongoing viral replication despite
    existing therapy.

    If approved, ISENTRESS would be the first in a new class of
    antiretroviral agents called integrase inhibitors available for the
    treatment of HIV. The FDA is not bound by the committee's
    recommendation but takes its advice into consideration when reviewing
    investigational medicines.

    The FDA granted ISENTRESS priority review status, a designation
    for investigational products that address unmet medical needs. Under
    the priority review designation, the FDA is expected to review and act
    on the New Drug Application for ISENTRESS within six months of
    submission. Merck anticipates FDA action by mid-October.

    "ISENTRESS is an important example of our ongoing commitment to
    HIV research," said Peter S. Kim, Ph.D., president, Merck Research
    Laboratories. "Despite the availability of various treatment options,
    the HIV epidemic continues, so there remains a need for new
    therapeutic approaches. This positive recommendation signals an
    important step forward for the treatment of patients living with HIV."

    In addition to the FDA regulatory application, Merck is also
    moving forward with regulatory filings in countries outside of the
    United States.

    The advisory committee's recommendation was based on review of
    efficacy and safety results from studies with ISENTRESS used in
    combination with optimized background therapy in treatment-experienced
    HIV-infected patients who had failed antiretroviral therapies, and who
    had HIV resistant to at least one drug in each of three classes of
    oral ARTs.

    About ISENTRESS

    ISENTRESS works to inhibit the insertion of HIV DNA into human DNA
    by the viral integrase enzyme. Inhibiting integrase from performing
    this essential function blocks the ability of the virus to replicate
    and infect new cells. There are drugs in use that inhibit two other
    enzymes critical to the HIV replication process - protease and reverse
    transcriptase - but currently no approved drugs that inhibit
    integrase.

    Prevalence of HIV/AIDS

    In 2003, over one million Americans were living with HIV and it is
    estimated that approximately 40,000 new cases of HIV/AIDS are
    diagnosed each year in the U.S. (i) Worldwide, an estimated 40 million
    people are infected with HIV/AIDS, and more than four million new
    infections occurred in 2006.(ii) AIDS is one of the top causes of
    infectious disease-related mortality worldwide, responsible for nearly
    three million deaths last year alone.(iii)

    Merck HIV research

    Merck's efforts to develop investigational treatments and a
    vaccine against HIV/AIDS have been under way for more than 20 years
    and continues today. Merck began its HIV integrase inhibitor research
    in 1993, and Merck was the first to demonstrate inhibition of HIV
    integrase in vitro and in vivo.

    About Merck

    Merck & Co., Inc. 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.

    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, 2006, and in its
    periodic reports on Form 10-Q and Form 8-K, which the company
    incorporates by reference.

    ISENTRESS(TM) is a trademark of Merck & Co., Inc.

    (i) CDC HIV/AIDS Fact Sheet "A Glance at the HIV/AIDS Epidemic,"
    June 2007

    (ii) UNAIDS, 2006 Report on the Global AIDS Epidemic

    (iii) UNAIDS and WHO. AIDS Epidemic Update. December 2006.