BCHE release
BioChem Pharma's Discovery, Epivir®-HBV™
(Lamivudine), Recommended for Approval by U.S.
FDA Advisory Committee for the Treatment of Chronic
Hepatitis B
Laval, Quebec, Canada – BioChem Pharma Inc.
(NASDAQ: BCHE; ME, TSE: BCH) announced that
Epivir®/HBV™ was unanimously recommended for
approval for the treatment of chronic hepatitis B in adults by
the Antiviral Drugs Advisory Committee to the U.S. Food
and Drug Administration (FDA) today. If approved by the
FDA, Epivir-HBV will be the first oral antiviral treatment for
chronic hepatitis B. While the favorable recommendation of
the advisory committee is not binding, the FDA typically
follows the advice of its expert panel members.
Epivir-HBV was discovered by BioChem Pharma and
licensed to Glaxo Wellcome in 1990. Under the terms of a
license agreement, BioChem Pharma will receive royalties
from Glaxo Wellcome on sales of lamivudine. Glaxo
Wellcome has the right to develop, manufacture and sell
lamivudine worldwide, subject to special arrangements for
Canada, where BioChem Pharma and Glaxo Wellcome
have formed a commercialization partnership.
"We are pleased with the recommendation by the
committee for the approval of Epivir-HBV," said Dr. Gervais
Dionne, Executive Vice President, BioChem Pharma Inc.
"Epivir-HBV represents a treatment advance for patients
with chronic hepatitis B, which is one of the leading causes
of death worldwide."
Hepatitis B is a potentially fatal liver disease and has been
estimated to be the ninth most common cause of death
worldwide. Approximately 350 million people have chronic
infection with hepatitis B virus (HBV) and nearly one-third of
these individuals are expected to develop serious
progressive liver disease. In the United States, there are
approximately one million persons chronically infected with
HBV and it is estimated that less than one percent have
been treated. Chronic hepatitis B can cause progressive
liver inflammation, leading to cirrhosis (severe liver
scarring), liver failure, and liver cancer. It has been
estimated that chronic HBV infection accounts for 5,000
deaths per year in the U.S. The most important goal of
hepatitis B therapy is reducing the progressive liver
inflammation that occurs when the immune system attacks
hepatitis B infected liver cells. An antiviral treatment such as
Epivir-HBV, which directly interferes with viral replication,
can reduce the level of infection, thus leading to reduced
attack on the liver by the immune system.
"Epivir-HBV, once approved, will provide a new and
important first-line option for physicians treating patients with
chronic hepatitis B," said Willis Maddrey, M.D., MACP,
Executive Vice President for Clinical Affairs, Professor of
internal medecine, University of Texas, at Dallas Medical
Center. "Epivir-HBV, which must be taken only once a day,
is a convenient oral medication with few side effects."
The safety and efficacy of Epivir-HBV in the treatment of
patients with chronic hepatitis B were evaluated in four
controlled studies in 967 patients with chronic hepatitis B.
These studies showed that treatment with Epivir-HBV 100
mg once a day for one year was associated with more
frequent improvements in liver histology, more frequent
HBeAg (hepatitis B «e» antigen) seroconversion, and more
frequent normalization of serum ALT (alanine
aminotransferase) concentrations compared with placebo.
In clinical trials, the frequencies of adverse reactions in
patients with chronic hepatitis B receiving Epivir-HBV 100
mg vs. placebo were similar. The most common adverse
reactions were: malaise and fatigue (37 percent vs. 31
percent), headache (27 percent vs. 23 percent), nausea and
vomiting (21 percent vs. 27 percent) and abdominal
pain/discomfort (17 percent vs. 23 percent). In addition,
lactic acidosis and severe hepatomegaly with steatosis,
including fatal cases, have been reported with the use of
nucleoside analogues alone or in combination, including
lamivudine and other antiretrovirals.
Lamivudine, the generic name for Epivir-HBV, is cleared for
marketing for the treatment of chronic hepatitis B in New
Zealand, Pakistan and the Philippines.
BioChem Pharma is an international biopharmaceutical
company dedicated to the research, development and
commercialization of innovative products for the prevention,
detection and treatment of human diseases. The Company
lists its common shares on the Montreal and Toronto
exchanges (BCH) and on the NASDAQ National Market
(BCHE). |
