FDA Begins Priority Review of NDA for Clofarabine in Pediatric Acute Leukemia; Filing Acceptance Indicates Start of Official Review Period.Business Editors/Health/Medical Writers NEW YORK--(BUSINESS WIRE)--June 3, 2004 Bioenvision, Inc. (Amex:BIV BIV Bivouac BiV Biventricular BIV Bovine Immunodeficiency Virus BIV Built-in Variable (plumbing) ) today reported that the U.S. 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. ) has accepted the filing of the New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any 21-673) for clofarabine for the treatment of refractory or relapsed acute leukaemia in children. The application was filed by ILEX Ilex a bush bearing berries containing saponins; cause vomiting, diarrhea. Called also holly. Products, Inc., Bioenvision's sublicensee of the U.S. and Canadian cancer indications for clofarabine. The acceptance of this filing indicates the start of the official review period. The NDA has been granted a priority review by the FDA. ILEX Products, Inc., a wholly owned affiliate of ILEX Oncology, Inc. (Nasdaq:ILXO), submitted the first part of the "rolling" NDA for clofarabine in October 2003, after the drug was granted fast-track designation in refractory and relapsed pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. leukaemia. On March 29, 2004, ILEX submitted the completed NDA package to the FDA. The application seeks marketing approval for clofarabine in refractory or relapsed acute pediatric leukaemias. Dr. Christopher B. Wood, Chairman 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. of Bioenvision, commented, "This is a very important stage in the development of clofarabine and is a vital first step in the global development of this drug. Bioenvision is currently conducting two Phase II clinical trials for clofarabine in Europe to further evaluate the drug's efficacy and safety profile in children with ALL and in adults with AML AML - A Manufacturing Language ." Historically, cancer drugs are approved and made available for adults first and then modified for children. If approved by the FDA, clofarabine would be the first drug to be labeled for pediatric leukaemia exclusively in more than a decade. Cure rates for pediatric leukaemia have improved dramatically over the past several decades. However, children who do not respond to initial therapy have a very poor prognosis and long-term remissions are rare. Clofarabine was previously granted orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the designation in the U.S. for the treatment of adult and pediatric acute lymphoblastic lymphoblastic pertaining to a lymphoblast; producing lymphocytes. leukaemia and acute myeloid myeloid /my·eloid/ (mi´e-loid) 1. medullary; pertaining to, derived from, or resembling bone marrow or the spinal cord. 2. having the appearance of myelocytes, but not derived from bone marrow. leukaemia. Orphan drug status provides for seven years of market exclusivity for the orphan drug indication following the FDA's marketing approval. In Europe, Bioenvision received 'Orphan Medicinal Product' designation for clofarabine as a treatment for ALL and AML from 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. ). Obtaining this designation provides Bioenvision with European marketing exclusivity for 10 years. About Clofarabine Clofarabine is a next generation purine nucleoside antimetabolite antimetabolite: see metabolite. antimetabolite Substance that competes with, replaces, or inhibits a specific compound within a cell, whose functioning is thereby disrupted. . Nucleoside analogues are antimetabolites that affect DNA synthesis. Clofarabine was rationally designed to combine many of the favourable properties of the two most commonly used nucleoside analogs, fludarabine and cladribine, but is reported to have greater potency at damaging the DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. of Leukemia cells than these other agents. (Blood, "Mitochondrial Toxicity of Deoxyadenoside Analogs", November 15, 2000, Volume 96, Number 10). Bioenvision is the exclusive worldwide developer of clofarabine, except for U.S./Canadian cancer applications which Bioenvision sublicensed exclusively to ILEX Oncology, Inc. (Nasdaq:ILXO). Bioenvision originally obtained its rights to develop clofarabine from Southern Research Institute, the inventor of clofarabine. About Bioenvision Bioenvision's (Amex:BIV) primary focus is the development and distribution of compounds and technologies for the treatment of cancer. Bioenvision has a broad pipeline of products for the treatment of cancer, including: clofarabine (in co-development with ILEX Oncology, Inc.), Modrenal(R) (for which Bioenvision has obtained regulatory approval for marketing in the United Kingdom for the treatment of post-menopausal breast cancer following relapse to initial hormone therapy), and other products in clinical trials. Bioenvision is also developing anti-infective technologies, including the OLIGON technology; an advanced biomaterial that has been incorporated into various FDA approved medical devices. For more information on Bioenvision please visit our Web site at www.bioenvision.com. Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995). Because these statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Specifically, factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to: risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and in Bioenvision's compounds under development in particular; the potential failure of Bioenvision's compounds under development to prove safe and effective for treatment of disease; uncertainties inherent in the early stage of Bioenvision's compounds under development; failure to successfully implement or complete clinical trials; failure to receive marketing clearance from regulatory agencies for our compounds under development; acquisitions, divestitures, mergers, licenses or strategic initiatives that change Bioenvision's business, structure or projections; the development of competing products; uncertainties related to Bioenvision's dependence on third parties and partners; and those risks described in Bioenvision's filings with the SEC. Bioenvision disclaims any obligation to update these forward-looking statements. |
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