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FOSTER CITY, Calif.--(BUSINESS WIRE)--April 4, 2003--Gilead
Sciences (Nasdaq:GILD) today announced details of the Gilead Access
Program, which will provide access to Viread(R) (tenofovir disoproxil
fumarate), the company's once-a-day antiretroviral medication for HIV,
at no profit in every country in Africa and in 15 additional countries
in other parts of the world classified as "least developed" by the
United Nations (UN).
The Gilead Access Program is now open to receive requests for the
drug from the 68 eligible nations. The program has been designed to
expeditiously review requests for Viread and to ship drug directly to
treatment programs in the eligible countries.
"The Gilead Access Program was created in consultation with
experts and advocates, with the objective of making Viread available
where the need is greatest and in a way that best addresses the
treatment landscape in the developing world," said John C. Martin,
PhD, President and CEO, Gilead Sciences. "Based on its efficacy,
positive resistance and side effect profile, and once-daily dosing, we
believe that Viread will be a particularly important treatment option
for physicians and patients in these regions."
Gilead will make Viread available to any private or public program
treating people with HIV/AIDS in the 68 nations for US$39 for a 30-day
supply, or $1.30 per day. The price for supplying Viread represents
Gilead's cost of manufacturing the drug and administering the program.
"Price is just one component of the access equation, but it is an
important piece, and we have worked diligently to reduce the cost of
providing Viread in the countries where it is needed most," said Dr.
Martin. "In creating this program, we also have included other
elements designed to meet the needs of treaters in resource-challenged
settings, such as a streamlined and rapid review of requests, and
shipment of drug direct to treatment programs, without expensive or
Key Features of the Program
The Gilead Access Program is comprised of four main elements
designed to improve access to Viread on a sustainable basis:
Sale of the drug at no profit in the 53 nations of Africa and in
15 other UN-designated "least-developed" countries.
Simplified purchasing in which Gilead will provide Viread directly
to treatment programs, avoiding the cost and delay frequently caused
by third-party suppliers.
Information and guidance to programs seeking access to Viread,
including technical assistance in the preparation of requests for
reduced-price access to the drug.
Research to optimize HIV treatment strategies through clinical
trials that help to define the best method for delivering anti-HIV
therapy in resource-challenged settings. Gilead is participating in
the "Development of Antiretroviral Therapies" (DART) study, a
3,000-patient clinical trial sponsored by the United Kingdom's Medical
Research Council that began earlier this year in Uganda and Zimbabwe.
The DART study is designed to evaluate antiretroviral management
strategies adapted for use in parts of the world where resources are
limited. Gilead also is participating with Family Health
International, with the support of the Bill and Melinda Gates
Foundation, in a multinational study to evaluate the potential use of
Viread as a method of preventing transmission of HIV.
Request forms can be submitted via the Internet or by email, mail
or fax. The company will be prepared to ship Viread to qualifying
programs as soon as requests forms are reviewed and approved.
Requests will be reviewed by independent experts, and programs
requesting drug will be evaluated based on their ability to provide
quality and sustainable patient care. Gilead will take appropriate
steps to ensure that Viread shipments reach their intended destination
and, to the extent possible, will monitor the recipient programs to
ensure that quality care is being provided.
Complete program information and requests forms are available at
www.gileadaccess.org. Programs without Internet access can call the
Gilead Access Program in the United States at 1-800-GILEAD-5
(1-800-445-3235) or 1-650-574-3000 or in Uganda at +256-41-340-806.
Gilead also announced that the company is completing plans for
reduced price access to Viread in middle-income developing countries
in Eastern Europe, Asia and Latin America.
Viread is the first nucleotide analogue reverse transcriptase
inhibitor (NtRTI) approved for the treatment of HIV in the United
States and Europe. Since approval, more than 100,000 patients have
been prescribed Viread as part of combination therapy. The U.S. Food
and Drug Administration approved Viread for marketing in October 2001
and the European Commission granted approval in February 2002.
In clinical trials and expanded access programs, approximately
10,000 patients have been treated with Viread in combination with
other antiretroviral products for periods up to four years. The drug
works by blocking reverse transcriptase, an enzyme involved in the
replication of HIV. The approved dose of Viread for the treatment of
HIV infection is 300 mg once daily taken orally with a meal, in
combination with other anti-HIV medications.
In the United States, Viread is indicated for use in combination
with other antiretroviral agents for the treatment of HIV-1 infection.
This indication is based on analyses of plasma HIV-1 RNA levels and
CD4 cell counts in a controlled study of Viread of 24 weeks duration
and in a controlled, dose-ranging study of Viread of 48 weeks
duration. Both studies were conducted in treatment-experienced adults
with evidence of HIV-1 viral replication despite ongoing
antiretroviral therapy. Studies in antiretroviral-naive patients are
ongoing; consequently, the risk-benefit ratio for this population has
yet to be determined.
Assessment of adverse reactions is based on two studies (902 and
907) in which 653 treatment-experienced patients received treatment
with Viread 300 mg (n=443) or placebo (n=210) for 24 weeks followed by
extended treatment with the drug. Adverse event rates in the Viread
group were similar to those in the placebo-treated patients.
The most common adverse events in patients receiving Viread were
mild to moderate gastrointestinal events such as nausea, diarrhea,
vomiting and flatulence. Laboratory abnormalities observed in clinical
studies occurred with similar frequency in the Viread and
In clinical practice, a number of adverse events, including renal
impairment, nausea, rash and asthenia (weakness) have been reported.
Renal impairment occurred most often in patients with underlying
systemic or renal disease, or in patients taking concomitant
nephrotoxic agents. Lactic acidosis and severe hepatomegaly with
steatosis, including fatal cases, have been reported with the use of
nucleoside analogues alone or in combination with other
Gilead Sciences is a biopharmaceutical company that discovers,
develops and commercializes therapeutics to advance the care of
patients suffering from life-threatening diseases worldwide. The
company has six marketed products and focuses its research and
clinical programs on anti-infectives. Headquartered in Foster City,
CA, Gilead has operations in the United States, Europe and Australia.
Note to Editors: Viread is a registered trademark of Gilead
For full U.S. prescribing information on Viread, please call the
Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235) or
CONTACT: Gilead Sciences
Susan Hubbard, 650/522-5715 (Investors)
Amy Flood, 650/522-5643 (Media)
SOURCE: Gilead Sciences