Enzon Announces Schering-Plough's Filing of PEG-INTRON for Marketing Approval in European Union.PISCATAWAY, N.J.--(BUSINESS WIRE)--Nov. 9, 1999-- Enzon, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ENZN) announced today that Schering-Plough Corporation (NYSE NYSE See: New York Stock Exchange : SGP) has submitted a centralized Marketing Authorization Application to the European Union's (EU) European Agency for the Evaluation of Medicinal Products (EMEA) seeking clearance to market PEG-INTRON (PEG-interferon alfa-2b) powder for solution for injection for the treatment of chronic hepatitis C in patients 18 years of age or older with compensated liver disease. The application, which proposes administration of PEG-INTRON subcutaneously once weekly for one year, is currently under CPMP review. PEG-INTRON is a modified form of Schering-Plough's INTRON(R) A (interferon alfa-2b, recombinant) that was developed using Enzon's PEG technology to have longer-acting properties. Schering-Plough is continuing its development of PEG-INTRON as a monotherapy for the treatment of hepatitis C in the United States, which is in Phase III clinical trials that began in July 1997. PEG-INTRON is also in Phase III clinical trials as combination therapy with REBETOL(R) (ribavirin ribavirin /ri·ba·vi·rin/ (ri?bah-vi´rin) a broad-spectrum antiviral used in the treatment of severe viral pneumonia caused by respiratory syncytial virus, particularly in high-risk infants; also used in conjunction with interferon , USP USP - unique sales point ) for hepatitis C. In addition, PEG-INTRON is in Phase III clinical trials for two cancer indications, malignant melanoma and chronic myelogenous leukemia Chronic myelogenous leukemia (CML) Also called chronic myelocytic leukemia, malignant disorder that involves abnormal accumulation of white cells in the marrow and bloodstream. Mentioned in: Bone Marrow Transplantation (CML 1. CML - A query language. ["Towards a Knowledge Description Language", A. Borgida et al, in On Knowledge Base Management Systems, J. Mylopoulos et al eds, Springer 1986]. 2. CML - Concurrent ML. ), as well as in early stage trials for various solid tumors. 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, for 16 major antiviral and anticancer indications worldwide. "This is certainly good news for Enzon, as well as Schering-Plough and patients suffering with the hepatitis C virus
Enzon is a biopharmaceutical company developing advanced therapeutics for life-threatening diseases through the application of its proprietary drug delivery and targeting technologies, PEG Modification, Pro Drug/Transport technology and Single-Chain Antigen-Binding (SCA(R)) Protein technology. Enzon's research activities are focused primarily in the area of oncology. In addition to two FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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. This release is also available at http://www.enzon.com |
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