PISCATAWAY, N.J.--(BUSINESS WIRE)--May 1, 2000 via NewsEdge
Corporation - Enzon, Inc. (NASDAQ: ENZN) announced that
Schering-Plough Corporation (NYSE: SGP) today reported at the 35th
Annual Meeting of the European Association for the Study of the
Liver (EASL) results of a Phase II dose ranging study of
PEG-INTRON(TM) combined with Ribavirin.
The results were presented by Rafael Esteban Mur, M.D.,
professor of medicine, Servei de Medicina Interna-Hepatologia,
Hospital Vall d'Hebron, Barcelona, Spain, at a satellite symposium
sponsored by Schering-Plough. "The results of this study indicate
that REBETOL (ribavirin, USP) enhances the antiviral activity of
PEG-INTRON and that sustained virologic response with the
combination therapy is dose dependent," Esteban Mur said. "While
preliminary, these results are encouraging." The combination of
PEG-INTRON and REBETOL is currently being studied in Phase III
trials to further define its clinical profile.
A total of 72 patients with chronic hepatitis C and compensated
liver disease were enrolled into the Phase II, open-label,
randomized, active controlled study. Patients in this study
received either PEG-INTRON (0.35, 0.7 or 1.4 ug/kg) once weekly
alone or in combination with daily REBETOL (600, 800 or 1,000-1,200
mg) for 24 weeks, with 24 weeks of follow up. Patients treated with
PEG-INTRON 0.35, 0.7 or 1.4 ug/kg in combination with REBETOL had
sustained virologic responses at 48 weeks of 17%, 53% and 60%,
respectively, compared to 0%, 44% and 42% for patients receiving
the same doses of PEG-INTRON alone. Fewer patients in this study
than in the PEG-INTRON Phase III monotherapy study were genotype 1
(44% vs. 70% respectively) and fewer had high viral load (58% vs.
74% HCV-RNA > 2 million copies/ml). In this study, the tolerance
profile of PEG-INTRON/REBETOL was comparable to the known tolerance
profile of INTRON A/REBETOL.
Schering-Plough also formally presented the Phase III data
comparing PEG-INTRON (peginterferon alfa-2b) Injection to INTRON(R)
A (interferon alfa-2b, recombinant) Injection as monotherapy for
the treatment of hepatitis C that was reported in a study abstract
last week.
Schering-Plough on Dec. 23, 1999 submitted a Biologics License
Application (BLA) to the U.S. Food and Drug Administration (FDA)
seeking marketing approval for PEG-INTRON for the treatment of
chronic hepatitis C. On Feb. 17, 2000, the European Union's (EU)
Committee for Proprietary Medicinal Products (CPMP) of the European
Agency for the Evaluation of Medicinal Products (EMEA) issued a
positive opinion recommending approval of PEG-INTRON for the
treatment of hepatitis C. The CPMP opinion serves as the basis for
European Commission approval, which would result in one single
Marketing Authorization with unified labeling that would be valid
in all 15 EU-Member States.
Some 4 million Americans are infected with the hepatitis C
virus, according to the Centers for Disease Control and Prevention
(CDC). As many as 5 million Europeans (1% to 2% of the general
population) are chronically infected with the hepatitis C virus,
according to a study conducted by the World Health Organization
(WHO). Chronic hepatitis C is the leading cause of chronic liver
disease and the most common reason for liver transplant, according
to WHO.
PEG-INTRON is a longer-acting form of INTRON A that uses
proprietary PEG technology developed by Enzon. Schering-Plough
holds an exclusive worldwide license to PEG-INTRON. Under the
Company's licensing agreement with Schering-Plough, Enzon is
entitled to royalties on worldwide sales of PEG-INTRON and
milestone payments. Enzon will receive an additional $2 million
millstone payment upon approval of PEG-INTRON.
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, worldwide for 16 major
antiviral and anticancer indications.
REBETOL is an oral formulation of ribavirin, a synthetic
nucleoside analog with broad-spectrum antiviral activity.
Enzon is a biopharmaceutical company developing and
commercializing enhanced therapeutics for life-threatening diseases
through the application of its proprietary technologies, PEG
Modification or PEG and Single-Chain Antibody (SCA(R)) technology.
Enzon's research activities are focused on applying its
technologies to enhance performance of compounds with know
therapeutic efficacy. In addition to two FDA approved products,
Enzon has several products in various stages of clinical
development by itself and with partners. Enzon develops and markets
products on its own and through its alliance partners, which in
addition to Schering-Plough include Alexion Pharmaceuticals, Baxter
Healthcare, Bristol-Myers Squibb, Eli Lilly, and Rhone-Poulenc
Rorer Pharmaceuticals.
Certain statements made in this press release related to
potential government approvals, market potential, commercialization
and sales revenues of medical products and biologics, as well as
their therapeutic applications and outcomes, are forward-looking
and are made pursuant to the safe harbor provisions of the
Securities Litigation Reform Act of 1995. Such statements involve
risks and uncertainties, which may differ materially from those set
forth in these statements. In addition, the economic, competitive,
governmental, technological and other factors identified in the
Company's filings with the Securities and Exchange Commission could
affect such results.
This release is also available at http://www.enzon.com
CONTACT: Kenneth J. Zuerblis, 732/980-4717 | or | Noonan/Russo
Communications, Inc. | 212/696-4455 | Lisa Fern, Media Relations
x353 | Julio Cantre, Investor Relations x237
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