Gilead Sciences Announces Termination of Its U.S.
Development Program for Adefovir Dipivoxil for HIV
BusinessWire
Friday December 3 4:31pm
FOSTER CITY, Calif.--(BW HealthWire)--Dec. 3, 1999--Gilead
Sciences (NASDAQ: GILD) announced today the termination of
its U.S. HIV development program for the investigational
agent adefovir dipivoxil 60 mg. This decision follows a
U.S. Food and Drug Administration (FDA) Advisory Committee
meeting on November 1, 1999, at which the Committee
recommended against accelerated approval of adefovir
dipivoxil at this time for the treatment of HIV patients
with disease progression.
In subsequent discussions with the FDA, Agency officials
advised Gilead that additional results from controlled
clinical trials would be required to further clarify the
efficacy and safety of adefovir dipivoxil 60 mg.
Additionally, the FDA indicated that it intended to issue
a "not approvable letter" on the Company's new drug
application (NDA) by the December 29, 1999 NDA action
date, based on currently available data. As a result of
these discussions, Gilead has determined that an
additional investment of time and resources in this
product is not appropriate given the other opportunities
in Gilead's clinical pipeline.
"As indicated by the more than 9,000 patients with limited
treatment options who have enrolled in the adefovir
dipivoxil expanded access program over the past two years,
we believe there is a significant need among patients for
new treatment options - especially those that may offer
antiviral activity against HIV strains that are resistant
to commonly used medications," said John C. Martin, Ph.D.,
President and Chief Executive Officer of Gilead Sciences.
"Although we respect the suggestions of the Advisory
Committee and the FDA for further clinical research, we
believe it would be in the best interests of our
shareholders and the HIV community if we allocate our
resources to other development programs."
Gilead will focus its development efforts on its other
late-stage clinical candidates. Tenofovir disoproxil
fumarate (tenofovir DF) entered multinational Phase III
clinical studies for the treatment of HIV infection
earlier this week. Based on preclinical and preliminary
clinical data, tenofovir DF appears to have a better
profile than adefovir dipivoxil for HIV, in terms of both
antiviral activity and safety. Additionally, the Company
is developing adefovir dipivoxil for the treatment of
hepatitis B virus infection (HBV). As compared to the HIV
indication, adefovir dipivoxil for HBV is administered at
lower doses (10 mg or 30 mg once per day) and has been
shown to have potent antiviral activity. Adefovir
dipivoxil for HBV is in long-term Phase III studies at
multiple clinical sites in the United States, Europe and
Asia.
Adefovir Dipivoxil for HIV - U.S. Clinical Trials and
Expanded Access Program Status
Gilead has decided to halt new enrollment in its U.S.
clinical trials and the expanded access program for
adefovir dipivoxil for HIV. Patients now receiving
adefovir dipivoxil in U.S. clinical trials will be given
the opportunity to enroll in the expanded access program.
Patients enrolled in the expanded access program will be
able to continue to receive adefovir dipivoxil for as long
as they and their treating physicians believe they are
benefiting from the treatment. Because the average length
of therapy on the expanded access program has been
approximately nine months, the Company believes that its
ongoing obligations under the program will be minimal by
the end of 2000.
European Development
In September 1999, Gilead filed a Marketing Authorisation
Application (MAA) for adefovir dipivoxil for HIV with the
European Medicines Evaluation Agency (EMEA), under the
centralized procedure for approval of human therapeutic
products in all member states of the European Community.
The Company anticipates receiving initial comments on the
MAA from the EMEA during the first quarter of 2000. At
that time, Gilead will evaluate the prospects for
continued development of adefovir dipivoxil for HIV in
Europe.
Gilead Sciences, headquartered in Foster City, CA, is an
independent biopharmaceutical company that seeks to
provide accelerated solutions for patients and the people
who care for them. The Company discovers, develops,
manufactures and commercializes proprietary therapeutics
for challenging infectious diseases (viral, fungal and
bacterial infections) and cancer. Gilead maintains
research, development or manufacturing facilities in
Foster City, CA, Boulder, CO, San Dimas, CA, and
Cambridge, UK, and sales and marketing organizations in
the United States, Europe and Australia. For more
information about Gilead, please visit the Company Web
site at www.gilead.com.
For more information on Gilead Sciences, please call the
Gilead Corporate Communications Department at
1-800-GILEAD-5 (1-800-445-3235) or visit the corporate Web
site at www.gilead.com.
Adefovir Dipivoxil for HIV - U.S. Clinical Trials and
Expanded Access Program Status
