Report from 35th Annual meeting of the EASL

 Home

 What is Hepatitis

 How is it Transmitted

 Long Term Prognosis

 Complications of HCV

 Liver Biopsy

 Treatment Info (Interferon, Herbal, etc)

 Lab Tests (PCR, Genotype,etc.)

 Nutrition & Alternative Info

 Patient Information (Support Groups, Doctor Listing, etc)

 Related Webpages

 Transplant Info

 Site Search

 HCV Webrings

 My guestbookbook

 Site Awards

 FAQ & Disclaimers


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


Home | What is HCV | Transmission | Future | Complications | Biopsy | Treatment | Lab | Nutrition | Patient | Links | Transplant | Webrings | guestbookbook | Awards | FAQ |