Bioenvision Signs Manufacturing and Supply Agreements with Ferro Pfanstiehl for Production of Clofarabine.Business Editors/Health/Medical Writers NEW YORK--(BUSINESS WIRE)--June 17, 2003 Bioenvision, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : BIOV) today announced that it has signed two separate agreements with Ferro Pfanstiehl Laboratories, Inc. for the development and supply of clofarabine, Bioenvision's lead drug for the treatment of 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. and adult acute leukemias Leukemias, Acute Definition Leukemia is a cancer that starts in the organs that make blood, namely the bone marrow and the lymph system. Depending on their characteristics, leukemias can be divided into two broad types. . The agreements cover worldwide development and supply of clofarabine, excluding the United States and Canada. Ferro Pfanstiehl has more than 25 years of experience in potent compound manufacturing. The company's operations are conducted at its modern High Potency Manufacturing Facility in Waukegan, Illinois. The facility is SafeBridge Certified, ensuring compliance and proper assessment and management of risks. "We are delighted to have added Ferro Pfanstiehl to our development team," said Dr. Christopher B. Wood, Chairman and Chief Executive Officer of Bioenvision. "The clofarabine process is an excellent fit with Ferro's superior technical strength in fluorinated fluorinated material to which a fluoride has been added, e.g. water for human consumption treated as a prophylaxis against tooth decay. carbohydrate intermediate manufacture and its nucleoside handling capabilities." Dr. Wood continued, "The Ferro team also brings extensive process development, scale-up and regulatory experience to bear on the program, which will maximize the likelihood that clofarabine is successfully developed and commercialized." Clofarabine has shown a potential synergistic effect in combination with cytarabine (ara-C) in patients with acute myeloid leukemia (AML AML - A Manufacturing Language ). Ferro Pfanstiehl is the leading domestic manufacturer of ara-C. About Ferro Pfanstiehl Ferro Pfanstiehl Laboratories, Inc. manufactures proprietary fine chemicals and provides custom synthesis of high potency, active pharmaceutical ingredients. Pfanstiehl provides confidential process development and contract manufacturing services, bringing client products from the bench to commercial scale production. With strengths ranging from isolation and purification of naturally occurring substances to complex, multi-step syntheses, Pfanstiehl manufactures a diverse mix of products. Ferro Pfanstiehl is a division of Ferro Corporation, a global producer of performance materials sold to various manufacturers in approximately 30 markets worldwide. About Clofarabine Clofarabine (Cl-F-ara-A, CAFdA) is a second 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 analogs are antimetabolites that affect DNA synthesis. Clofarabine was rationally designed to combine many of the favorable properties of the two most commonly used nucleoside analogs, Fludarabine Fludara(R) by Schering AG (NYSE NYSE See: New York Stock Exchange : SHR SHR Shore SHR Spontaneously Hypertensive Rat SHR Staff Human Resources SHR Saskatoon Health Region (Saskatoon, SK, Canada) SHR Shift Logical Right SHR Sensible Heat Ratio SHR Supplementary Homicide Report SHR Steroid Hormone Receptor ) and Cladribine, Leustatin(R) by Johnson and Johnson (NYSE: JNJ JNJ Johnson and Johnson (stock symbol) JNJ Journal of Nursing Jocularity ), 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 mitochondrial pertaining to mitochondria. mitochondrial RNAs a unique set of tRNAs, mRNAs, rRNAs, transcribed from mitochondrial DNA by a mitochondrial-specific RNA polymerase, that account for about 4% of the total cell RNA that Toxity of Deoxyadenoside Analogs", November 15, 2000, Volume 96, Number 10). In a single centre Phase II study of Clofarabine in patients with refractory AML, 42% of the patients had a complete response rate (CR) and a further 13% had a partial response (CRp). About Bioenvision Bioenvision's (OTCBB: BIOV.OB) primary focus is the acquisition, 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, Modrenal(R) (for which Bioenvision has obtained regulatory approval for marketing in the United Kingdom for the treatment of advanced post-menopausal breast cancer), and other products in clinical trials. Bioenvision is also developing anti-infective technologies, including the OLIGON technology, an advanced biomaterial that has been approved for certain indications 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. in the U.S. 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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