NEW YORK, Dec. 11 /PRNewswire/
ICN Pharmaceuticals, Inc. (NYSE: ICN) said today that its
licensing partner Schering-Plough Corporation (NYSE: SGP) has been
informed that the U.S. Food and Drug Administration (FDA) has
approved REBETRON(TM) Combination Therapy containing REBETOL(R)
(ribavirin, USP) Capsules and INTRON(R) A (interferon alfa-2b,
recombinant) Injection for the treatment of chronic hepatitis C in
patients with compensated liver disease previously untreated with
alpha interferon therapy.
The FDA decision was based on clinical data from two pivotal
multicenter Phase III studies involving previously untreated
patients. Results of these studies showed that REBETRON Combination
Therapy resulted in a significant increase in the number of
patients showing a sustained loss of detectable* hepatitis C virus
as compared to patients receiving standard alpha interferon
monotherapy.
Schering-Plough has exclusive rights to market oral ribavirin
for hepatitis C in all major world markets through a licensing
agreement with ICN. REBETOL is an oral formulation of ribavirin, a
synthetic nucleoside analog with broad- spectrum antiviral
activity. ICN Pharmaceuticals currently markets ribavirin as
VIRAZOLE(R) in a variety of dosage forms for at least one of 10
indications in 44 countries, including in the United States and the
European Union for aerosol use for the treatment of hospitalized
infants and young children with severe lower respiratory infection
due to respiratory syncytial virus.
*Defined as HCV RNA below limit of detection using a
research-based RT-PCR assay at 24 weeks post-treatment.
The FDA action represents the second indication this year for
REBETRON Combination Therapy for the treatment of chronic hepatitis
C. On June 3, the FDA approved REBETRON Combination Therapy for the
treatment of chronic hepatitis C in patients with compensated liver
disease who have relapsed following alpha interferon therapy. Prior
to REBETRON Combination Therapy, the only drugs approved in the
United States for treating hepatitis C had been alpha interferon
monotherapies.
"It is gratifying that ribavirin, a drug discovered and
developed by ICN, is playing a major role in the combination
treatment for chronic hepatitis C," said Milan Panic, chairman and
chief executive officer of ICN Pharmaceuticals. "As part of
REBETRON combination therapy, ribavirin should help mitigate a
serious health problem and bring new hope to the patients afflicted
with this life threatening disease."
"Research into the treatment of many viral diseases has
demonstrated that combination therapies rather than monotherapy may
offer the best potential for more effective treatment," commented
Willis C. Maddrey, M.D., professor of medicine at the University of
Texas Southwestern Medical Center in Dallas and a world-renowned
hepatologist.
Some 4 million Americans are chronically infected with the
hepatitis C virus and approximately 70 percent of infected patients
go on to develop chronic liver disease, according to the Centers
for Disease Control and Prevention (CDCP). Hepatitis C infection
contributes to the deaths of an estimated 8,000 to 10,000 Americans
each year. This toll is expected to triple by the year 2010 and
exceed the number of annual deaths due to AIDS, according to the
CDCP. The American Liver Foundation has reported that liver failure
due to hepatitis C infection is the leading cause of liver
transplants in the United States.
In Europe, 1 to 2 percent of the general population is
chronically infected with the hepatitis C virus. According to a
study conducted by the World Health Organization (WHO), as many as
5 million Europeans are chronically infected with the disease.
Clinical Trials with Previously Untreated Patients
The safety and efficacy of REBETRON Combination Therapy were
evaluated in two multicenter, double-blind clinical trials
involving 1,711 patients with compensated chronic hepatitis C and
detectable HCV RNA who were previously untreated with alpha
interferon therapy.
Patients were randomized to receive subcutaneous injections of
INTRON A 3 million international units (MIU) three times per week
and either oral REBETOL 1,000-1,200 mg or a matched placebo daily
for 24 or 48 weeks followed by 24 weeks of off-therapy follow
up.
Results of these studies showed that patients receiving REBETRON
Combination Therapy had a significantly improved virologic and
histologic response compared to patients receiving INTRON A alone.
Six months after therapy was completed, 198 of 496 patients (40
percent) who were treated with 48 weeks of REBETRON Combination
Therapy had undetectable virus levels as compared to 73 of the 491
patients (15 percent) who were treated with 48 weeks of INTRON A
alone.
Warnings and Contraindications
Hemolytic anemia associated with REBETRON Combination Therapy
may exacerbate symptoms of coronary disease or deteriorate cardiac
function. It is advised that complete blood counts (CBC) be
obtained at baseline and at week 2 and week 4 of therapy or more
frequently if clinically indicated. The most common adverse
experiences associated with REBETRON Combination Therapy are "flu-
like" symptoms, such as headache, fatigue, myalgia and fever, which
appear to decrease in severity as treatment continues. Severe
psychiatric adverse events may manifest in patients receiving
therapy with interferons, including INTRON A therapy. DEPRESSION
AND SUICIDAL BEHAVIOR, INCLUDING SUICIDAL IDEATION, SUICIDAL
ATTEMPTS AND COMPLETED SUICIDES, MAY OCCUR.
Combination REBETOL/INTRON A therapy must not be used by women,
or male partners of women, who are or may become pregnant during
therapy and the six months after stopping therapy. Combination
REBETOL/INTRON A therapy should not be initiated until a report of
a negative pregnancy has been obtained immediately prior to
initiation of therapy. Women of childbearing potential and men must
use effective contraception (two reliable forms) during treatment
and during the 6-month post-treatment follow-up period. Significant
teratogenic and/or embriocidal effects have been demonstrated for
ribavirin in all animal species in which adequate studies have been
conducted. These effects occurred at doses as low as one-twentieth
of the recommended human dose of REBETOL. If pregnancy occurs in a
patient or partner of a patient during treatment or during the 6
months after treatment stops, physicians are encouraged to report
such cases by calling 800-727-7064.
Dosage
The recommended dosage of REBETRON Combination Therapy is 3 MIU
of INTRON A injected subcutaneously three times per week and
1,000-1,200 mg of REBETOL capsules administered orally in a divided
daily (morning and evening) dose. Patients weighing 75 kg (165
pounds) or less should receive 1,000 mg of REBETOL daily, while
patients weighing more than 75 kg should receive 1,200 mg of
REBETOL daily.
The recommended duration of treatment with REBETRON Combination
Therapy for patients previously untreated with interferon is 24 to
48 weeks. The duration of treatment should be individualized to the
patient depending on baseline disease characteristics, response to
therapy and tolerability of the regimen. After 24 weeks of
treatment, virologic response should be assessed. Treatment
discontinuation should be considered in any patient who has not
achieved an HCV-RNA below the limit of detection of the assay by 24
weeks. There are no safety and efficacy data on treatment with
REBETRON Combination Therapy for longer than 48 weeks in the
previously untreated patient population.
In patients who relapse following interferon therapy, the
recommended duration of treatment with REBETRON Combination Therapy
is 24 weeks. There are no safety and efficacy data on treatment for
longer than 24 weeks in the relapse patient population.
INTRON A is a recombinant version of naturally occurring alpha
interferon, which has been shown to exert both antiviral and
immunomodulatory effects. Schering-Plough markets INTRON A, the
world's largest-selling alpha interferon, for 16 major antiviral
and anticancer indications worldwide.
ICN manufactures and markets a broad range of prescription and
non- prescription pharmaceuticals and biomedical research products
in over 90 countries. The company employs some 17,000 people
worldwide. ICN has operations in North and Latin America, Western,
Central and Eastern Europe, and the Pacific Rim countries.
Additional information is available on the corporate website at
http://www.icnpharm.com.
THE 'SAFE HARBOR' STATEMENT UNDER THE PRIVATE SECURITIES
LITIGATION REFORM ACT OF 1995. This press release contains
forward-looking statements that involve risks and uncertainties
including, but not limited to, projections of future sales,
operating income, returns on invested assets, regulatory approval
processes, financial impact of devaluations, the progress of FDA
reviews, and other risks detailed from time to time in the
Company's Securities and Exchange Commission filings.
SOURCE ICN Pharmaceuticals, Inc.
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