FOSTER CITY, Calif.--Gilead Sciences, Inc. today announced that the European
Commission has granted Marketing Authorisation for Emtriva(TM)
(emtricitabine, 200 mg hard capsules and 10 mg/mL oral solution) in
all 15 member states of the European Union. On July 24, 2003 the
Committee for Proprietary Medicinal Products (CPMP), the scientific
committee of the European Medicines Evaluation Agency (EMEA), issued a
positive opinion on Emtriva.
Emtriva is the newest nucleoside reverse transcriptase inhibitor
(NRTI) for the treatment of HIV infection, and is dosed as a single
capsule taken once a day as part of combination therapy. The drug
works by inhibiting reverse transcriptase, an enzyme crucial for HIV
replication. By interfering with this process, the drug can help to
lower the amount of HIV, or "viral load," in a patient's body and
increase the number of immune system cells (called T cells or CD4
cells). Both of these changes are generally associated with improving
a patient's health and decreasing the likelihood of AIDS-related
illnesses. Emtriva will be available in individual European countries
as local reimbursement approvals are obtained.
"Physicians and patients know that adherence is crucial to
treatment success, and by reducing the number of pills a patient must
take each day and improving a patient's ability to tolerate therapy,
adherence may be improved," said Dr. Francois Raffi of the Centre
Hospitalier Universitaire de Nantes, France. "With its once-daily
dosing, favorable safety and tolerability profile and potent activity
against HIV, Emtriva offers a new treatment option in the fight
Emtriva is Gilead Sciences' second once-daily antiretroviral for
the treatment of HIV. The compound was licensed from Emory University
in the United States in 1996. Gilead's first anti-HIV medication,
Viread(R) (tenofovir disoproxil fumarate), a one-tablet, once-daily
nucleotide reverse transcriptase inhibitor, was cleared for marketing
by the European Commission in February 2002. The company is developing
a fixed-dose co-formulation of Emtriva and Viread, which could
potentially be available by 2005. Emtriva is Gilead's third antiviral
to receive approval in less than two years, following Viread for HIV
and Hepsera(R) (adefovir dipivoxil 10 mg) for chronic hepatitis B,
which received European approval in March 2003.
"The approval of our second anti-HIV medication in the European
Union reflects Gilead's commitment to improving the lives of people
with HIV through the introduction of more tolerable treatments," said
John C. Martin, PhD, President and CEO of Gilead Sciences. "Emtriva
and Viread offer physicians and patients an effective, once-daily
foundation for the management of HIV disease."
The Marketing Authorisation Application (MAA) for Emtriva was
submitted for review under the centralized procedure in January 2003
by Triangle Pharmaceuticals, which was acquired by Gilead Sciences
later that month. The U.S. Food and Drug Administration (FDA) granted
marketing approval for Emtriva 200 mg hard capsules in the United
States on July 2, 2003.
HIV in Europe
An increasing number of people are living with HIV in Western
Europe. An estimated 570,000 people were living with HIV in 2002, an
increase of 10 percent compared to 520,000 in 2000. A recent study
found that 10 percent of newly infected patients in Europe from 1999
to 2002 had strains of the virus that were resistant to HIV
medications. Resistance is more likely to emerge when patients fail to
adhere to their drug regimens.
Emtriva is indicated for the treatment of HIV-infected adults and
children in combination with other antiretroviral agents. This
indication is based on studies in treatment-naive patients and
treatment-experienced patients with stable virological control. There
is no experience with the use of Emtriva in patients who are failing
their current regimen or who have failed multiple regimens. When
deciding on a new regimen for patients who have failed an
antiretroviral regimen, careful consideration should be given to the
patterns of mutations associated with different medicinal products and
the treatment history of the individual patient. Where available,
resistance testing may be appropriate.
Emtriva is dosed once daily and can be taken with or without food.
In controlled clinical studies, Emtriva has been shown to effectively
suppress HIV replication when taken in combination with other
antiretroviral medications. Emtriva has reduced the level of HIV in
the blood for up to 48 weeks among patients starting antiretroviral
treatment for the first time, as well as in treatment-experienced
individuals with stable virological control.
More than 2000 HIV-infected adults have been treated with Emtriva
for periods of 10 days to 200 weeks in Phase I, II and III clinical
trials. Adverse drug reactions with at least a possible relationship
to study drug were evaluated. Assessment of these adverse drug
reactions is based on data from three studies in adults (n=1479) and
two pediatric studies (n=114). In the adult studies, 1039
treatment-naive and 440 treatment-experienced patients received
Emtriva (n=814) or comparator medicinal product (n=665) for 48 weeks
in combination with other antiretroviral medicinal products. In the
pediatric studies, treatment-naive (n=83) and treatment-experienced
(n=31) pediatric patients aged four months to 18 years were treated
with Emtriva in combination with other antiretroviral agents.
The most common adverse reactions observed in the studies
described above include headache, diarrhea, nausea and elevations in
creatine kinase. Additionally, as outlined in the U.S. prescribing
information, skin discoloration was observed at a higher frequency in
Emtriva versus control groups. Skin discoloration, manifested by
hyperpigmentation (excess pigmentation) on the palms and/or soles, was
generally mild and asymptomatic. The mechanism and clinical
significance of this adverse event are unknown.
Special warnings and precautions for use are included in the
Summary of Product Characteristics regarding monitoring of patients
with renal impairment who may require dose or dose interval
adjustment. Special warnings and precautions for use also are included
for monitoring of patients co-infected with HIV and HBV after stopping
Emtriva treatment for evidence of exacerbations of hepatitis B, as
exacerbations have been seen following discontinuation of Emtriva in
chronic hepatitis B-infected patients, and monitoring of patients with
chronic hepatitis B or C who are at an increased risk of experiencing
severe, and potentially fatal, hepatic adverse events when treated
with combination antiretroviral therapy. 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. Combination antiretroviral therapy has also
been associated with lipodystrophy.
Emtriva is available as a 200 mg capsule for use in adults and
also is available as a 10 mg/mL oral solution for use in infants older
than four months of age, children and patients who are unable to
swallow hard capsules and patients with renal insufficiency who
require dose reduction. Please refer to the Summary of Product
Characteristics for Emtriva 10 mg/mL oral solution.
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 seven 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
This press release includes forward-looking statements, within the
meaning of the Private Securities Litigation Reform Act of 1995 that
are subject to risks, uncertainties and other factors including risks
and uncertainties related to the stability, pharmacokinetics and
ultimately the company's ability to obtain regulatory approval of a
co-formulation of Emtriva and Viread, the risk that the safety and
efficacy data obtained in controlled clinical trials for Emtriva will
not be observed in an uncontrolled clinical setting, and the risk that
physicians may not see advantages of Emtriva over lamivudine and may
therefore be reluctant to prescribe Emtriva. Risks are described in
detail in the Gilead Annual Report on Form 10-K for the year ended
December 31, 2002 and in Gilead's Quarterly Reports on Form 10-Q, all
of which are on file with the U.S. Securities and Exchange Commission.
All forward-looking statements are based on information currently
available to Gilead and Gilead assumes no obligation to update any
such forward-looking statements.
Emtriva is a trademark and Viread and Hepsera are registered
trademarks of Gilead Sciences, Inc.
For more information please call the Gilead Public Affairs
Department at 1-800-GILEAD-5 (1-800-445-3235), or visit
CONTACT: Gilead Sciences, Inc.
Susan Hubbard, 650-522-5715 (Investors)
Amy Flood, 650-522-5643 (Media)
SOURCE: Gilead Sciences, Inc.