Enzon Reinforces Commitment to Improving Patient Outcomes in Fungal Disease by Reinitiating CLEAR Registry.Business Editors/Health/Medical Writers BRIDGEWATER, N.J.--(BUSINESS WIRE)--May 14, 2003 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) has announced a major new initiative to reactivate re·ac·ti·vate v. 1. To make active again. 2. To restore the ability to function or the effectiveness of. re·ac and expand the CLEAR(R) (Collaborative Exchange of Antifungal Research) registry, a multicenter database developed for clinicians to share and exchange information regarding the clinical course of invasive fungal infections Fungal infections Several thousand species of fungi have been described, but fewer than 100 are routinely associated with invasive diseases of humans. and clinical experience with ABELCET(R) (Amphotericin B Lipid Complex amphotericin B lipid complex Warning - High-alert drug! Abelcet Pharmacologic class: Systemic polyene antifungal Therapeutic class: Antifungal Injection). "Enzon is committed to an expansive new effort to not only explore and analyze the wealth of data already collected since the mid 1990s, but to aggressively expand the database in 2003 and beyond to help define treatment strategies that ultimately may save more patients' lives," remarked Arthur Higgins, President and Chief Executive Officer, Enzon Pharmaceuticals, Inc. The existing CLEAR database is one of the most comprehensive registries in fungal disease. CLEAR encompasses prospectively-gathered data from a total of 3,514 patient records, collected from 1996-2000 in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. and Canada. The registry was designed and administered by a steering committee steer·ing committee n. A committee that sets agendas and schedules of business, as for a legislative body or other assemblage. steering committee Noun comprised of national thought leaders in infectious disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. , hematology, and oncology, with patient enrollment from over 150 institutions nationwide. Results from the CLEAR program were recently reviewed at a gathering of former steering committee members and program advisors, who met in New Orleans, Louisiana last month to discuss the existing data and recommendations for expanded program enrollment in 2003. It was noted, that the overall clinical response rates across a wide spectrum of fungal pathogens (both yeasts and molds) unequivocally support the efficacy and safety of ABELCET across the broadest spectrum of patients. Of particular significance, the CLEAR database documents efficacy and safety of ABELCET in rapidly emerging, more difficult to treat pathogens such as Fusarium Fusarium a genus of fungi; some species are plant pathogens and some are opportunistic infectious agents of humans and animals. Many also produce trichothecene toxins which cause poisoning of animals if the infected material, usually stored feed, is eaten. , Zygomycetes, and Candida infections that are resistant to standard treatments. The CLEAR experience reflects the largest known registry in these emerging fungal pathogens. The expanded registry will provide an opportunity to collect further experience and outcome data on ABELCET, particularly in combination with other antifungal agents antifungal agents, n.pl agents that inhibit, control, or kill fungi. The most common yeastlike fungus occurring in or near the oral cavity is C. albicans. . Enzon Pharmaceuticals is committed to rapidly reestablishing the momentum of the CLEAR program, with the hope that ongoing research and new insights will ultimately yield more successful paradigms to improve treatment outcomes in invasive fungal disease. Invasive fungal infections are life-threatening complications often affecting already compromised patients such as those suffering from cancer, HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. , recipients of lung and bone marrow transplants bone marrow transplant: see bone marrow. , and others. They can be caused by dozens of different pathogens that attack a patient with a weakened immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. . Effective treatment is critical and can mean the difference between life and death, and must often be initiated even in the absence of a specific diagnosis. ABELCET was approved for use by the US Food and Drug Administration (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. ) in November 1995. It is indicated for the treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B amphotericin B (ăm'fətĕr`ĭsĭn), antibiotic that halts the growth of several disease-causing fungi. Discovered in 1956, it is produced by bacteria of the genus Streptomyces. therapy. The adverse events most commonly reported with ABELCET are transient chills and/or fever during infusion of the drug. ABELCET is contraindicated in patients who have shown hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. to amphotericin B or any other component in the formulation. Please see full prescribing information before using ABELCET or any product mentioned in this press release. Enzon Pharmaceuticals is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat life-threatening diseases. The company has developed or acquired a number of marketed products, including ABELCET, which is marketed in North America by Enzon, and PEG-INTRON, marketed by Schering-Plough. Enzon's product-focused strategy includes an extensive drug development program that leverages the Company's PEG modification and single-chain antibody (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)) technologies. Internal research and development efforts are complemented by strategic transactions that provide access to additional products, projects, and technologies. Enzon has several drug candidates in various stages of development, independently and with partners. Except for the historical information herein, the matters discussed in this news release include forward-looking statements that may involve a number of risks and uncertainties. Actual results may vary significantly based upon a number of factors, which are described in the Company's Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. , Form 10-Q's and Form 8-K's on file with the SEC, including without limitation, Enzon's dependence on Schering-Plough's effective marketing of PEG-INTRON; Enzon's ability to sustain profitability; risks in obtaining and maintaining regulatory approval for indications and expanded indications, market acceptance of and continuing demand for Enzon's product, timing and results of clinical trials and the impact of competitive products and pricing, the NPS NPS National Park Service NPS Naval Postgraduate School NPS Net Promoter Score (customer management) NPS Non-Point Source pollution NPS Native Plant Society NPS Norfolk Public Schools (Virginia) and Enzon businesses may not be integrated successfully; costs related to the proposed merger may be significant and greater than we expect; and the NPS or Enzon stockholders may fail to approve the proposed merger. All information in this press release is as of May 14, 2003, and the Company undertakes no duty to update this information. Additional information and where to find it In connection with the proposed NPS/Enzon merger, NPS, Enzon, and Momentum Merger Corporation (which will be renamed by NPS and Enzon in connection with the proposed merger) have filed a joint proxy statement/prospectus with the Securities and Exchange Commission (the "SEC") in connection with the proposed merger. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS BECAUSE IT CONTAINS IMPORTANT INFORMATION ABOUT THE TRANSACTION. Investors and security holders may obtain a free copy of the joint proxy statement/prospectus (when it is available) and other documents filed by NPS and Enzon with the SEC at the SEC's web site at www.sec.gov or by contacting NPS at 801-583-4939 and through NPS' web site at www.npsp.com, or by contacting Enzon at 908-541-8678 and through Enzon's web site at www.enzon.com. Enzon and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Enzon and NPS in connection with the proposed merger transaction. Information regarding the special interests of these directors and executive officers in the transaction is included in the joint proxy statement/prospectus described above. Additional information regarding these directors and executive officers is also included in Enzon's proxy statement Proxy Statement A document containing the information that a company is required by the SEC to provide to shareholders so they can make informed decisions about matters that will be brought up at an annual stockholder meeting. for its 2002 Annual Meeting of Stockholders, which was filed with the SEC on or about October 28, 2002. This document is available free of charge at the SEC's web site at www.sec.gov or by contacting Enzon at 908-541-8678. NPS and its directors and executive officers also may be deemed to be participants in the solicitation of proxies from the stockholders of NPS and Enzon in connection with the transaction described herein. Information regarding the special interests of these directors and executive officers in the proposed merger transaction is included in the joint proxy statement/prospectus described above. Additional information regarding these directors and executive officers is also included in NPS' proxy statement for its 2002 Annual Meeting of Stockholders, which was filed with the SEC on or about April 19, 2002. This document is available free of charge at the SEC's web site at www.sec.gov or by contacting NPS at 801-583-4939 and through the NPS website at www.npsp.com. This release is also available at http://www.enzon.com |
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