LA JOLLA, Calif., Jan. 7 /PRNewswire/ -- Agouron Pharmaceuticals, Inc.
(Nasdaq-NNM: AGPH) today announced that its HIV protease inhibitor VIRACEPT(R)
(nelfinavir mesylate) will be made available to HIV-infected children aged
2 to 13 years through an expanded access program. Encouraged by preliminary
evidence of safety and tolerability from an ongoing study of VIRACEPT in
children, the company will make the drug available without charge to any HIV-
infected child until the drug is approved for marketing in the United States.
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 comparable or satisfactory therapy exists.
Agouron announced last month that it submitted a New Drug Application (NDA)
for VIRACEPT covering both tablet and pediatric powder formulations in the
United States. No pediatric formulation of an HIV protease inhibitor has yet
been approved by FDA. HIV protease inhibitors have been available for
children only through small clinical trials.
In recognition of the unmet need for HIV treatment options for children,
an oral powder formulation of VIRACEPT has been developed simultaneously with
a tablet formulation for adults. The oral powder formulation of VIRACEPT can
be mixed with milk, formula or soft foods such as pudding. Pharmacokinetic
data from an initial pediatric study show that blood levels of VIRACEPT
comparable to those seen in adults can be achieved by administration of either
the oral powder or tablets. VIRACEPT has been generally safe and well
tolerated by children in the study. Preliminary results of the pediatric
study are expected to be presented at The Fourth Conference on Retroviruses
and Opportunistic Infections later this month.
A toll free information service will be available after January 7, 1997
for physicians, health care professionals and parents interested in the
VIRACEPT Pediatric Expanded Access Program. 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 returned during operating hotline hours.
Agouron is currently conducting the VIRACEPT Expanded Access Program for
people 13 years of age and older, unable to use any of the three approved HIV
protease inhibitors because of intolerance, contraindication or prior failure
and who have CD4+ T cell counts of less than or equal to 50 cells/mm3. To
date, more than 1,000 people have enrolled in the program.
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.
SOURCE Agouron Pharmaceuticals Inc.
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CONTACT: Investor Relations: Donna Nichols, Senior Director, Corporate Communications, 619-622-3009 or http://www.agouron.com, or Media: Joy Schmitt, Manager, Product Public Relations, 619-622-3220
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