Enzon Reports Schering-Plough's PEG-INTRON Accepted by the FDA For Review.Business &Medical Editors PISCATAWAY, N.J.--(BUSINESS WIRE)--Feb. 10, 2000 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 Corporations' (NYSE NYSE See: New York Stock Exchange : SGP SGP Singapore (ISO Country code) SGP Schering-Plough (stock symbol) SGP Stability and Growth Pact SGP Southern Great Plains SGP Staatkundig Gereformeerde Partij SGP Speedway Grand Prix ) Biologics License Application (BLA BLA abbr. Bachelor of Liberal Arts ) for PEG-INTRON(TM) has been accepted for standard review by the 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. . PEG-INTRON is a modified form of Schering-Plough's INTRON(R) A (interferon alfa-2b) that uses proprietary PEG technology developed by Enzon. Schering-Plough submitted its BLA to the FDA on Dec. 23, 1999 seeking marketing clearance for PEG-INTRON (peginterferon alfa-2b) for the treatment of chronic hepatitis C in patients 18 years of age or older with compensated liver disease. Under the Prescription Drug Users Fee Act, the FDA should act on Schering-Plough's BLA within 12 months from the date of receipt. While Schering-Plough had requested priority review status for the drug, which would have taken six months, the FDA granted a standard review. &uot;We have always assumed that PEG-INTRON would receive the standard twelve month FDA review,&uot; said Peter Tombros, Enzon's president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . Mr. Tombros further stated, &uot;Schering-Plough has to be commended for the speed at which they have conducted their clinical trial program.&uot; &uot;The Agency's acceptance of our application for PEG-INTRON moves us another step forward in the regulatory review of this product,&uot; said Tom Lauda, Executive Vice President of Schering-Plough Pharmaceuticals. &uot;We continue to be pleased with the progress of our PEG-INTRON filings.&uot; In Europe, Schering-Plough has submitted a centralized Marketing Authorization Application for PEG-INTRON to the European Union's (EU) European Agency for the Evaluation of Medicinal Products (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) seeking marketing approval for the same indication. Approval of the centralized Marketing Authorization Application for PEG-INTRON would result in unified labeling that would be valid in all 15 EU-Member States. The application is currently under CPMP CPMP Committee for Proprietary Medicinal Products CPMP Core-Plus Mathematics Project CPMP Crew Procedures Management Plan (NASA) CPMP Canadian Project Management Professional CPMP Corporate Planning and Management Practices review. 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 (Single Connector Attachment) An 80-pin plug and socket used to connect peripherals. With a SCSI drive, it rolls three cables (power, data channel and ID configuration) into one connector for fast installation and removal. (R)) Protein technology. Enzon's research activities are focused primarily in the area of oncology. 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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called 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 |
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