ENZON RECEIVES APPROVAL TO MARKET LEUKEMIA DRUG IN GERMANY.PISCATAWAY, NJ--Nov. 17, 1994--(BUSINESS WIRE)--Enzon, Inc. (NASDAQ\NMS:ENZN) announced today that the German Federal Institute for Phamaceuticals and Medical Products (BGA) has granted marketing approval for ONCASPAR (pegaspargase pegaspargase /peg·as·par·gase/ (-as´pahr-jas) -asparaginase covalently linked to polyethylene glycol polyethylene glycol (PEG): see glycol., used as an antineoplastic in the treatment of acute lymphoblastic leukemia.), a drug used to treat patients with acute lymphoblastic leukemia lymphoblastic leukemia n. (ALL) who develop hypersensitivity antibody-mediated hypersensitivity A type of lymphocytic leukemia characterized by abnormal, often immature, lymphocytic cells or by the presence of unusually large numbers of immature lymphocytes occurring together with adult lymphocytes. 1. type II h.; see Gell and Coombs classification, under classification. 2. occasionally, any form of hypersensitivity in which antibodies, rather than T lymphocytes, are the primary mediators, i.e., types I–III. cell-mediated hypersensitivity type IV h. to the native
forms of L-asparaginase asparaginase /as·par·a·gin·ase/ (as-par´ah-jin-as?) an enzyme that catalyzes the deamination of asparagine; a preparation is used as an antineoplastic agent in acute lymphoblastic leukemia to reduce availability of asparagine to tumor cells. as·par·a·gin·ase . The product will be marketed after the Company makes an arrangement with a marketing partner and finalizes labeling and export issues. ALL is the most common form of childhood cancer. It is caused by a defect in the bone marrow which provokes an endless proliferation of abnormal white blood cells that flood the bone marrow, blood stream and lymphatic system lymphatic system (lĭmfăt`ĭk), network of vessels carrying lymph, or tissue-cleansing fluid, from the tissues into the veins of the circulatory system. The lymphatic system functions along with the circulatory system in absorbing nutrients from the small intestines., crowding out healthy cells. "This marketing approval for ONCASPAR in Germany should facilitate obtaining additional foreign approvals and allow us to maximize ONCASPAR's potential," stated Peter G. Tombros, Enzon's president and chief executive officer. Native L-asparaginase has been a mainstay in the induction phase (initial treatment) of chemotherapy for ALL. However, use of the unmodified form of L-asparaginase is limited due to allergic reactions and short half-life Half-life The point in the life of a mortgage-backed security guaranteed or issued by the Government National Mortgage Association, the Federal National Mortgage Association or the Federal Home Loan Mortgage Corporation when half the principal has been repaid. in blood (less than 1.5 days) which requires
injections every-other-day, and causes discomfort and inconvenience to
patients.ONCASPAR is a version of the enzyme L-asparaginase modified with Enzon's proprietary PEG technology where strands of a polymer -- polyethylene glycol (PEG) -- are attached to native L-asparaginase. This PEG process helps to disguise the enzyme and reduce its recognition by the immune system, with the goals of lowering immunogenic im·mu·no·gen·ic (  m y -n -j potential and
extending its circulating half-life.In July 1994, Rhone-Poulenc Rorer (RPR) was granted an exclusive license to obtain marketing approval and sell ONCASPAR in Canada. ONCASPAR was granted a marketing license by the U.S. Food and Drug Administration in February 1994, and is currently being marketed by RPR in the United States. In April, 1993, the Company received approval from the Russian Ministry of Health, in certain C.I.S. states of the former U.S.S.R., for therapeutic use of ONCASPAR in a broad range of cancers. Enzon is a biopharmaceutical company developing advanced therapeutics for life-threatening diseases through the application of its proprietary technologies. The Company's research and product development activities focus on blood substitutes, genetic diseases and cancer therapy. Enzon is currently developing a hemoglobin-based oxygen carrier and a treatment for Gaucher disease. Two products have been approved for marketing by the FDA - ADAGEN, for treatment of a form of Severe Combined Immunodeficiency combined immunodeficiency n. Disease, and ONCASPAR. The Company
also pursues commercialization of its technologies through strategic
partnering, including arrangements with Sanofi Winthrop, Eli Lilly,
Bristol- Myers Squibb and Baxter Health Care. Enzon is headquartered in
Piscataway, NJ. Immunodeficiency of both the B-cells and T-cells. CONTACT: Judi Glova
Public Relations
(908) 980-4564
or
Donna Brasko
Investor Relations
(908) 980-4577
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