LA JOLLA, Calif., Dec. 23 /PRNewswire/ -- Agouron Pharmaceuticals, Inc.
(Nasdaq-NNM: AGPH) today announced it has submitted to the U.S. Food and Drug
Administration (FDA) a New Drug Application (NDA) covering its anti-HIV drug
VIRACEPT(R) (nelfinavir mesylate).  Agouron is the first company to petition
FDA for simultaneous approval of its HIV protease inhibitor for adults and for
children.
    The NDA seeks accelerated approval of both tablet and pediatric oral
powder formulations of VIRACEPT based principally on results from three
pivotal phase II/III clinical trials evaluating the safety and efficacy of the
drug in more than 700 HIV-infected subjects.  These pivotal studies evaluated
daily doses of 1500 or 2250 mg of VIRACEPT taken alone, in combination with
the approved drug Zerit(TM) (d4T), or in combination with the approved drugs
Retrovir(R) (AZT) and Epivir(TM) (3TC).  Primary endpoints followed in these
six-month clinical trials in adults were improvements in two surrogate markers
for efficacy: decreases in HIV RNA in plasma and increases in CD4+ T cells in
plasma.  The NDA also included results from a small clinical study showing
that appropriate blood levels of VIRACEPT can be achieved safely in children.
    "The submission of the NDA for Agouron's first commercial product,
VIRACEPT, is an event of great significance for our company and, we believe,
for the field of HIV disease," said Peter Johnson, Agouron's president and
chief executive officer.  "That we have been able to reach this point just
three years after first synthesizing the drug in our laboratories is a credit
to the relentless devotion and effort of more than 100 Agouron employees on
the VIRACEPT development team; of our partners and colleagues in the
pharmaceutical group at Japan Tobacco Inc.; and of the staff and management of
PAREXEL International Corporation, a leading contract research organization,
who, with uncommon dedication, anchored the processes of data management and
analysis.  It is also testimony to a spirit of proactive cooperation in drug
development now present at FDA."
    VIRACEPT is a synthetic chemical compound designed to inhibit HIV
protease-an enzyme that plays an essential role in the replication of HIV.
VIRACEPT is being developed by Agouron in collaboration with the
pharmaceutical division of Japan Tobacco Inc.
    Agouron Pharmaceuticals, Inc. is a pioneer and leader in technologies
permitting the rational design of novel, small molecule drugs based upon the
molecular structures of proteins which play key roles in human disease.
Agouron is currently applying these technologies to the design and development
of novel drugs for treatment of cancer, AIDS, and other serious diseases.

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