LA JOLLA, Calif., March 6 /PRNewswire/ -- Agouron Pharmaceuticals, Inc.
(Nasdaq: AGPH) today announced that the Japanese Ministry of Health and
Welfare has approved the company's HIV protease inhibitor VIRACEPT(R)
(nelfinavir mesylate) tablets in Japan. The commercial launch in Japan of
VIRACEPT by Japan Tobacco Inc. (JT) is expected later this month. Development
of VIRACEPT was conducted collaboratively by Agouron and the pharmaceutical
division of JT.
VIRACEPT has been evaluated in clinical trials involving more than 8000
people throughout the world, and was the first HIV protease inhibitor in the
U.S. and in the European Union (15 countries) to receive simultaneous
marketing clearance for use in adults and children. VIRACEPT is now approved
for marketing in 25 countries worldwide.
The most commonly observed adverse event of moderate or greater severity
in clinical trials of VIRACEPT was diarrhea, which was generally controlled
with over-the-counter medications. New onset or exacerbation of diabetes
mellitus and hyperglycemia, as well as increased bleeding in patients with
hemophilia types A and B, have been reported with protease inhibitors.
In the United States, 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.
Agouron Pharmaceuticals, Inc. is an integrated pharmaceutical company
committed to discovery, development, manufacturing, and marketing of small-
molecule drugs engineered to inactivate proteins which play key roles in
cancer, AIDS, and other serious diseases.
For further information about Agouron Pharmaceuticals, Inc., or about
VIRACEPT, please see Agouron's website at http://www.agouron.com or dial toll
free 1-888-VIRACEPT (847-2237). To receive full prescribing information for
VIRACEPT via fax, dial 1-888-288-9639.
VIRACEPT(R) is a registered trademark of Agouron Pharmaceuticals, Inc.
SOURCE Agouron Pharmaceuticals, Inc.
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Related links:
http://www.agouron.com
CONTACT:
Donna Nichols, Vice President, Corporate
Communications, 619-622-3009; Media Contact: Joy Schmitt
Manager, Product Public Relations, 619-622-3220 both of Agouron
Pharmaceuticals, Inc.
CNOC: http://www.prnewswire.com or fax, 800-758-5804, ext.
019650
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