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Tenofovir Access Program in 68 Developing Countries
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Press Release
GILEAD LAUNCHES ACCESS PROGRAM TO PROVIDE ANTI-HIV THERAPY VIREAD¨
IN 68 DEVELOPING COUNTRIES AT NO PROFIT
Foster City, CA, April 4, 2003 - Gilead Sciences (Nasdaq: GILD) today
announced details of the Gilead Access Program, which will provide access to
Viread¨ (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 time-consuming intermediaries."
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.
Program Details
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.
About Viread
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-na•ve 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 placebo-treated groups.
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
antiretrovirals.
About Gilead
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.
For information about the Intl program contact:
Susan Hubbard, Investors
(650) 522-5715; Amy Flood, Media
(650) 522-5643
Viread is a registered trademark of Gilead Sciences, Inc.
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 visit www.viread.com.
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