Enzon Announces Termination of Agreements with INEX.BRIDGEWATER, N.J. -- Enzon Pharmaceuticals, 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) today announced that it has entered into an agreement with INEX INEX Integrated Numerical Experiment INEX Internet Neutral Exchange Pharmaceuticals Corporation (TSX: IEX) to terminate the companies' partnership for the development and commercialization of INEX's proprietary oncology product, MARQIBO(R) (vincristine sulfate liposomes Liposomes Aqueous compartments enclosed by lipid bilayer membranes; liposomes are also known as lipid vesicles. Phospholipid molecules consist of an elongated nonpolar (hydrophobic) structure with a polar (hydrophilic) structure at one end. injection). E[acute accent]After a careful evaluation, ENZON determined it will not support further development of MARQIBO. In January 2005, the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (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. ) provided an action letter detailing MARQIBO is "not approvable" under the FDA's accelerated approval regulations for relapsed aggressive non-Hodgkin's lymphoma. The FDA's response also stated additional randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. controlled studies would need to be conducted prior to re-applying for approval. After a strategic analysis of the FDA's recommendation, required investment, development timeframe, and associated development risks, the Company concluded it would be in its best interest to redirect this investment to pursue other opportunities. E[acute accent]ENZON expects to pay INEX $5 million for certain contractual obligations, including development expenses and milestone payments. E[acute accent]About ENZON E[acute accent]Enzon Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development and commercialization of therapeutics to treat life-threatening diseases. The Company has developed or acquired a number of marketed products, including PEG-INTRON(R), marketed by Schering-Plough, and ABELCET(R), ONCASPAR(R), ADAGEN(R), and DEPOCYT(R), marketed in North America by ENZON's specialized sales force. ENZON's science-driven strategy includes an extensive drug development program that leverages the Company's macromolecular mac·ro·mol·e·cule n. A very large molecule, such as a polymer or protein, consisting of many smaller structural units linked together. Also called supermolecule. engineering technology platforms, including PEG modification and single-chain antibody (SCA(R)) technologies. Internal research and development efforts are complemented by strategic transactions that provide access to additional marketed products and promising clinical compounds. ENZON has several drug candidates in various stages of development, independently and with partners. Further information about ENZON and this press release can be found on the Company's web site at www.enzon.com. All information in this press release is as of March 17, 2005 and the Company undertakes no duty to update this information. |
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