Monday May 1, 1:11 pm Eastern Time
Company Press Release
Schering-Plough Reports Results of Phase II
PEG-INTRON Plus Ribavirin Studies At European
Association for the Study of the Liver - EASL -
Meeting
PISCATAWAY, N.J.--(BUSINESS WIRE)--May 1, 2000--Enzon, Inc. (NASDAQ: ENZN - news) announced that
Schering-Plough Corporation (NYSE: SGP - news) 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© 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©)
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 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 |
