FDA Approves Twice Daily Dosing (BID) of VIRACEPT(R) - Agouron's HIV Protease Inhibitor

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FDA Approves Twice Daily Dosing (BID) of VIRACEPT(R) - Agouron's HIV Protease Inhibitor

    LA JOLLA, Calif., Nov. 29 /PRNewswire/ -- Agouron Pharmaceuticals, Inc.
today announced that the Food and Drug Administration (FDA) has approved twice
daily dosing (BID) of VIRACEPT(R) (nelfinavir mesylate) for the treatment of
HIV infection. Approval supports 1250mg BID dosing of VIRACEPT based on data
that showed comparable anti-HIV effects and safety to the previously approved
750mg three times daily dosing (TID).
    "We are gratified that the FDA has approved twice daily dosing for
VIRACEPT," said Peter Johnson, Agouron's president and chief executive
officer.  "This simpler and more convenient dosing schedule for VIRACEPT, that
preserves its safety, tolerability, and anti-HIV potency, will further enhance
the utility of the most extensively prescribed HIV protease inhibitor in the
United States."
    The clearance was based principally on interim results from a pivotal
phase III trial involving more than 500 patients that showed similar decreases
in plasma HIV RNA and increases in CD4+ T cell counts between 1250mg BID and
750mg TID dosing of VIRACEPT, and a similar safety profile, when used in
combination with standard doses of Zerit(R) (d4T or stavudine) and Epivir(R)
(3TC or lamivudine).
    VIRACEPT is indicated for the treatment of HIV infection when
antiretroviral therapy is warranted.  This indication is based on analyses of
surrogate marker changes in patients who received VIRACEPT in combination with
nucleoside analogs or alone for up to 24 weeks.  At present, there are no
results from controlled trials evaluating the effect of therapy with VIRACEPT
on clinical progression of HIV infection, such as survival or the incidence of
opportunistic infections.
    VIRACEPT is generally well-tolerated when taken 1250 mg BID or 750 mg TID.
In study 542, diarrhea of moderate or greater intensity occurred in 14% to 18%
of patients receiving VIRACEPT 1250 mg BID or 750 mg TID with stavudine or
lamivudine.  New onset or exacerbation of diabetes mellitus and hyperglycemia,
changes in the distribution of body fat, and increased bleeding in patients
with hemophilia types A and B have been reported with protease inhibitors.

    For further information about Agouron Pharmaceuticals, Inc., or about
VIRACEPT, please dial toll free 1-888-VIRACEPT (847-2237).  To receive full
prescribing information for VIRACEPT via fax, dial 1-888-288-9639.

    Agouron Pharmaceuticals, Inc., a wholly owned subsidiary of the
Warner-Lambert Company (NYSE: WLA), is an integrated pharmaceutical company
committed to the discovery, development, manufacturing, and marketing of
innovative therapeutic products engineered to inactivate proteins that play
key roles in cancer, AIDS, and other serious diseases.  Agouron employs more
than 1,100 people of whom approximately 700 are engaged in research and
development.

    VIRACEPT(R) and Agouron(R) are registered trademarks of Agouron
Pharmaceuticals, Inc.
    Zerit(R) is a registered trademark of Bristol-Myers Squibb Company.
    Epivir(R) is a registered trademark of Glaxo Wellcome Oncology/HIV.

SOURCE Agouron Pharmaceuticals, Inc.

http://www.agouron.com
Company News On-Call:

http://www.prnewswire.com/comp/019650.html or fax,
800-758-5804, ext. 019650
CONTACT:
Joy Schmitt, Associate Director, Product
Public Relations, of Agouron Pharmaceuticals, 858-622-3220