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| | | ![]() Peg-Intron (Peginterferon Alfa-2b) As Safe As Intron A (Interferon Alfa-2b) In Hepatitis C Therapy PISCATAWAY, NJ -- April 19, 2000 -- Enzon, Inc. announced that results from a Phase III clinical trial comparing the safety and efficacy of Peg-Intron(TM) (peginterferon alfa-2b) Injection and Intron(R) A (interferon alfa-2b, recombinant) Injection as monotherapy for the treatment of hepatitis C will be presented by study investigators at the upcoming European Association for the Study of the Liver (EASL 2000) annual meeting on May 1, 2000. In this study, after 48-weeks of treatment plus a 24-week follow-up period, 25 percent of the patients treated with a once weekly dose of 1.0 ug/kg of Peg-Intron(TM) showed a sustained viral response as compared to 12 percent of patients receiving three MIU of Intron A three times a week. The trial also concluded that Peg-Intron was as safe as Intron A. Preliminary Phase II clinical results of combination therapy with Peg-Intron and Rebetol(R) (ribavirin) Capsules will also be presented by study investigators. Schering-Plough Corporation currently markets Intron A for hepatitis B and C, and various cancers, and Rebetron(TM) Combination Therapy, containing Intron A and Rebetol, for hepatitis C. Schering-Plough has reported that the 1999 aggregate worldwide sales of Intron A/Rebetron were approximately $1.1 billion. Monotherapy with Peg-Intron may provide an alternative treatment for hepatitis C patients who currently cannot tolerate Rebetron Combination Therapy. Schering-Plough in February 2000 announced that the European Union's (EU) Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) issued an opinion recommending approval of Peg-Intron for hepatitis C. Product approval by the EMEA is typically issued three months from the time that the Committee renders its opinion. Approval of this application for Peg-Intron will allow Schering-Plough to market Peg-Intron throughout the European Union. In December 1999, Schering-Plough submitted a Biologics License Application, or BLA, to the U.S. Food and Drug Administration (FDA) seeking marketing approval for Peg-Intron for the treatment of chronic hepatitis C. 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. Related Links: Enzon, Inc. and Schering-Plough Corporation.
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