To: biowa who wrote (17 ) 4/18/2000 12:05:00 PM From: scaram(o)uche Read Replies (1) | Respond to of 24
could go through roof, combination therapy will continue to prevail........ Tuesday April 18, 10:01 am Eastern Time Company Press Release Phase III Clinical Trial Results Reported for PEG-INTRON for the Treatment of Hepatitis C Results to be presented at the European Association for the Study of the Liver Annual Meeting PISCATAWAY, N.J.--(BUSINESS WIRE)--April 18, 2000-- Enzon, Inc. (NASDAQ: ENZN - news) announced today that results from a Phase III clinical trial comparing the safety and efficacy of PEG-INTRON(TM) (peginterferon alfa-2b) Injection and INTRON© 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. These results were reported in a study abstract, posted on easl.com . In this study, after 48-weeks of treatment plus a 24-week follow-up period, 25% 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% 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© (ribavirin) Capsules will also be presented by study investigators. Schering-Plough Corporation (NYSE: SGP - news) 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. A complete copy of the PEG-INTRON abstract is available at easl.com orjournals.munksgaard.dk . 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 Rhne-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: Enzon, Inc. Kenneth J. Zuerblis Vice President, Finance and Chief Financial Officer 732-980-4717 or Noonan/Russo Communications, Inc. 212-696-4455 Lisa Fern, Media Relations x353 Julio Cantre, Investor Relations x237