Viracept

[David Almada]

FDA CLEARS AGOURON TO MARKET VIRACEPT - A NEW HIV PROTEASE INHIBITOR FOR
ADULTS AND CHILDREN

The Food and Drug Administration (FDA) has given Agouron Pharmaceuticals,
Inc. clearance to market the company's HIV protease inhibitor VIRACEPT
(nelfinavir mesylate) in the United States, under the provisions of the
FDA's accelerated approval process. VIRACEPT is the first HIV protease
inhibitor to be cleared for marketing simultaneously in an adult
formulation and in a pediatric formulation.

"Today's approval of VIRACEPT is important for the field of HIV disease,"
said Dr. William Powderly, Washington University School of Medicine, St.
Louis. "The anti-HIV potency of VIRACEPT, coupled with its favorable
safety and tolerability will make a valuable contribution to our ability to
hit the virus hard and early with combination therapy."

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 analogues 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's recommended dose is 750 mg three times daily (TID). To
facilitate patients' access to VIRACEPT, Agouron has established a patient
assistance program to actively help people find ways of paying for
VIRACEPT. Agouron will provide VIRACEPT without charge to those patients
whose need is greatest and who are least able to pay for the drug. In
addition, Agouron will provide VIRACEPT without charge to any child in the
United States who is not covered by public or private health insurance.
For information on the VIRACEPT Assistance Program for both adults and
children, call toll free 1-888-777-6637.

Agouron will make VIRACEPT available to all AIDS Drug Assistance Programs
(ADAPs), including those that purchase products through
government-discounted pricing and will offer rebates to any ADAP that is
unable to purchase products at the government discounted rates. In
addition, Agouron will make VIRACEPT available to Medicaid.

VIRACEPT has been evaluated in clinical trials involving more than 1,000
people to date and has been made available without charge to an additional
3,000 patients through the VIRACEPT Expanded Access Program. Expanded
access programs represent an effort by FDA to make investigational drugs
available at the earliest opportunity to people for whom no other
comparable or satisfactory therapy exists. In clinical studies of
VIRACEPT, the most commonly observed adverse event of moderate or greater
severity was diarrhea which was generally controlled with over-the-counter
medication.

alm...@isat.com - David Almada - Priority Pharmacy – 3935 First Ave.,
San Diego, California 92103 –
Phone: 1-800-487-7113 Fax: 1-800-487-7118