LA JOLLA, Calif., May 6 /PRNewswire/ -- Agouron Pharmaceuticals, Inc.
(Nasdaq-NNM: AGPH) today announced that it will start a Canadian Expanded
Access Program, which will supply Agouron's HIV protease inhibitor,
VIRACEPT(TM) (nelfinavir mesylate) in Canada to qualified adults with advanced
HIV disease -- without charge. A second treatment option is enrollment in a
clinical trial run by the Canadian HIV Trials Network that is currently
recruiting patients. Additionally, children age two to twelve years will have
access to VIRACEPT through Health Canada's Emergency Drug Release Program.
The Canadian VIRACEPT(TM) Expanded Access Program
People age thirteen years or older may now enroll in the Canadian VIRACEPT
Expanded Access Program if they are unable to take indinavir (Crixivan(R))
and/or ritonavir (Norvir(TM)) due to intolerance or prior failure, and if they
have had CD4+ T cell counts of less than or equal to 100 cells/MM3 at any
point in their medical history.
A toll-free information service is available for physicians, healthcare
professionals, and people interested in the Canadian VIRACEPT Expanded Access
Program. Questions will be answered by calling: (800) 621-7111, Monday
through Friday, from 8:00 a.m. to 6:00 p.m. EST (USA). Calls placed before or
after these hours will be promptly returned during business hours.
The Emergency Drug Release Program
Children age two to twelve years may qualify for VIRACEPT upon physician
recommendation under the mandates of the Emergency Drug Release Program
(EDRP). For more information, contact the EDRP at: (613) 941-2108, Monday
through Friday from 8:30 a.m. to 4:30 p.m. EST (Canada).
Agouron recently submitted a New Drug Submission (NDS) to the Canadian
Drugs/Medical Devices Directorate seeking regulatory approval to market
VIRACEPT in Canada. "We are hopeful the Directorate will expedite Agouron's
application," said Peter Johnson, Agouron's president and chief executive
officer. "In the meantime, we are gratified Canadians have access to VIRACEPT
now through these programs and the clinical trial that is running under the
auspices of the CTN."
The Canadian HIV Trials Network
HIV treatment opportunities are available for up to 450 Canadians with
CD4+ T cell counts of less than or equal to 1OO cells/mm3, who have never
before taken VIRACEPT, indinavir, and/or ritonavir, to enroll in a large
ongoing comparative clinical trial conducted by the Canadian HIV Trials
Network (CTN) in collaboration with the US-based Terry Beirn Community
Programs for Clinical Research on AIDS (CPCRA). For enrollment and site
information, please call CTN toll free at: (800) 661-4664. Or call the CPCRA
for information at: (800) TRIALS-A. This clinical endpoint trial will
evaluate and compare disease progression or death in HIV-infected people
taking either VIRACEPT + nucleoside analogs (i.e., AZT, 3TC, ddI, ddC, d4T),
or ritonavir (Norvir) + nucleoside analogs. Rates of occurrence of adverse
events or discontinuation from the study, as well as changes in CD4+ T cells
and plasma HIV RNA will also be compared between the two treatment groups in
this joint American-Canadian effort.
The U.S. Food and Drug Administration (FDA) has recently given Agouron
clearance to market VIRACEPT in the United States under the provisions of the
FDA's accelerated approval process. 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. 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.
The CTN is funded by Health Canada under the National AIDS Strategy. The
CPCRA is funded by the National Institute of Allergy and Infectious Diseases
(NIAID) of the National Institutes of Health (NIH). The CPCRA was created to
establish community-based treatment programs for all persons with HIV
infection in the communities where these HIV-infected patients live and
receive their primary care.
Agouron Pharmaceuticals, Inc. is an integrated pharmaceutical firm
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.
VIRACEPT(TM) is a trademark of Agouron Pharmaceuticals, Inc. and is
registered in the United States and in other countries. Crixivan(R) is a
registered trademark of Merck & Co., Inc. Norvir(TM) is a trademark of Abbott
Laboratories, Inc.
SOURCE Agouron Pharmaceuticals Inc.
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CONTACT: Investors: 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, both of Agouron Pharmaceuticals.
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