Gilead Sciences' Hepatitis B Drug Hepsera Approved for Marketing in European
FOSTER CITY, Calif.--(BUSINESS WIRE)--March 11, 2003--Gilead Sciences, Inc.
(Nasdaq:GILD) today announced that the European
Commission granted Marketing Authorisation for Hepsera(TM) (adefovir
dipivoxil 10 mg) in all 15 member states of the European Union. Hepsera is
indicated in Europe for the treatment of chronic hepatitis B in adults with
compensated liver disease with evidence of active viral replication,
persistently elevated serum alanine aminotranseferase (ALT) levels and
histological evidence of active liver inflammation and fibrosis; or
decompensated liver disease. On November 21, 2002, the Committee for
Proprietary Medicinal Products (CPMP), the scientific committee of the
European Medicines Evaluation Agency (EMEA), issued a positive opinion on
More than 400 million people worldwide have chronic hepatitis B, which is
caused by infection with the hepatitis B virus (HBV), and between one quarter
and one third of these individuals are expected to develop progressive liver
disease, such as cirrhosis and liver cancer. Approximately nine million
people are chronically infected with HBV in Europe. An estimated one million
people die annually from complications of chronic hepatitis B making it one
of the leading causes of death worldwide.
"To date, the limitations of available hepatitis B drugs, such as poor
tolerability and rapid development of viral resistance, have made them
unsuitable or ineffective for many patients," said Professor Stephanos
Hadziyannis, MD, Department of Medicine, Henry Dunant Hospital, Athens,
Greece. "In clinical studies, Hepsera significantly reduced disease
progression in a wide range of patients. Broad efficacy, good tolerability
and a low risk of resistance make Hepsera an important advancement in the
treatment of chronic hepatitis B."
Hepsera is administered as a once-daily 10 mg tablet and works by blocking
HBV DNA polymerase, an enzyme involved in the replication of the virus in the
body. The U.S. Food and Drug Administration (FDA) cleared Hepsera for
marketing in the United States on September 20, 2002. Regulatory filings for
the drug also have been completed in Australia, Switzerland, Turkey and
Canada, and additional regulatory filings are planned in other countries in
the coming months.
"The approval of Hepsera by the European Commission comes less than a year
after Gilead filed its Marketing Authorisation Application with the European
authorities, demonstrating the important unmet medical need Hepsera will
address for physicians and their patients with chronic hepatitis B," said
John C. Martin, PhD, President and CEO, Gilead Sciences.
Access to Hepsera
In July 2002, Gilead initiated an early access program to provide Hepsera to
chronic hepatitis B patients with lamivudine-resistant virus. To date, over
1,600 patients have enrolled in Hepsera early access programs in France,
Italy, Greece, Spain, Portugal, Germany, the United Kingdom, Canada and
Australia. The Hepsera early access programs will continue until the drug is
commercially available to patients in these countries. For more information
regarding the Early Access Program for Hepsera in Europe, please call +33 1
44 90 34 75.
Clinical Studies of Hepsera
Two placebo-controlled studies and a number of additional studies have
evaluated Hepsera in a wide range of patients. The placebo-controlled studies
included patients with compensated liver function and either "e"
antigen-positive (HBeAg-positive) or "e" antigen-negative (HBeAg-negative, or
precore mutant) chronic hepatitis B. The 48-week results from these two
pivotal studies were published in the February 27 edition of the New England
Journal of Medicine. Precore mutant hepatitis B infects up to approximately
50 percent of chronic hepatitis B carriers worldwide, and is most prevalent
in countries of the Mediterranean and Southeast Asia, where between 30 and 80
percent of chronic hepatitis B patients are estimated to be infected with
this strain. Hepsera also has been studied in patients who were treated with
and developed resistance to lamivudine, including patients wait-listed for
liver transplantation, post-liver transplantation patients and patients
co-infected with HIV.
In clinical studies, Hepsera reversed or slowed the progression of liver
damage, reduced HBV DNA levels in the blood and increased rates of
seroconversion and normalization of ALT levels (an indicator of liver
function) significantly more effectively than placebo in treatment-naive
patients and in patients with prior interferon treatment.
Tolerability and Safety Profile
The adverse reactions considered at least possibly related to treatment in
the first 48 weeks of therapy with Hepsera were asthenia (weakness),
headache, abdominal pain, nausea, flatulence, diarrhea and dyspepsia. With
extended treatment, mild to moderate, reversible, increases in serum
creatinine were observed infrequently in patients with chronic hepatitis B
and compensated liver disease treated with Hepsera for a median of 49 weeks
and a maximum of 109 weeks. Changes in serum creatinine were observed very
commonly in patients with pre- and post-liver transplantation with
lamivudine-resistant hepatitis B and multiple risk factors for changes in
renal function who were treated with Hepsera for up to 129 weeks, with a
median time on treatment of 19 and 56 weeks, respectively. Clinical and
laboratory evidence of exacerbations of hepatitis has been observed after
discontinuation of treatment with Hepsera. Special warnings and precautions
for use are included in the Summary of Product Characteristics regarding
monitoring of renal function and post-treatment exacerbations of hepatitis,
use in patients with underlying renal impairment or patients co-infected with
HIV, and occurrence of nucleoside analogue-associated lactic acidosis and
severe hepatomegaly with steatosis.
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.
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 that could cause actual results to
differ materially from those referred to in the forward-looking statements.
The reader is cautioned not to rely on these forward-looking statements.
These and other risks are described in detail in the Gilead Annual Report on
Form 10-K for the year ended December 31, 2001 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.
Hepsera is a trademark of Gilead Sciences, Inc.
For more information on Gilead Sciences, please visit the company's web site
at www.gilead.com or call the Gilead Public Affairs Department at
1-800-GILEAD-5 (1-800-445-3235) or 1-650-574-3000.