LA JOLLA, Calif., Jan. 8 /PRNewswire/ -- Agouron Pharmaceuticals, Inc.
(Nasdaq-NNM: AGPH) today announced that it will enlarge the expanded access
program which supplies the company's HIV protease inhibitor, VIRACEPT(R),
(nelfinavir mesylate), without charge to qualified adults with advanced HIV
disease.
People will now qualify for the VIRACEPT Expanded Access Program if they
are unable to take indinavir (Crixivan(R) and/or ritonavir (Norvir(R)) due to
intolerance or prior failure and who have had CD4+ T cell counts of less than
or equal to 100 cells/mm3 during any past medical examination. Previously the
eligibility criteria for the VIRACEPT Expanded Access Program were more
restrictive. Expanded access programs represent an effort by the Food and
Drug Administration (FDA) to make investigational drugs available at the
earliest opportunity to people for whom no other comparable or satisfactory
therapy exists.
A toll free information service is available for physicians, health care
professionals and people interested in the VIRACEPT Expanded Access Program.
1-800-621-7111 is available Monday through Friday from 8:00 a.m. to 6:00 p.m.
EST to answer calls. Calls placed before or after these hours will be
promptly returned during business hours.
Agouron announced last month its submission to the U.S. Food and Drug
Administration (FDA) of a New Drug Application (NDA) covering both tablet and
pediatric powder formulations of VIRACEPT. Equivalent regulatory submissions
are expected to be made in Canada and Europe later this year.
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 the development
and application of technologies that enable the atom by atom design of novel
synthetic drugs based upon the molecular structures of target 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.
SOURCE Agouron Pharmaceuticals Inc.
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CONTACT: Investor Contact: Donna Nichols, Senior Director, Corporate Communications, 619-622-3009 or http://www.agouron.com or Media Contact: Joy Schmitt, Manager, Product Public Relations, 619-622-3220, both of Agouron Pharmaceuticals Inc.
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