BIVN Bioenvision (MM)

Bioenvision, Inc. (Nasdaq:BIVN) today announced the European Commission has granted marketing authorization for Evoltra(TM) (clofarabine) for the treatment of acute lymphoblastic leukemia (ALL) in pediatric patients who have relapsed or are refractory to at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. The licensed indication includes patients who were less than 21 years at the time of initial diagnosis of their leukemia. "This is a momentous day for children suffering from ALL and the doctors who treat them," said Hugh Griffith, Bioenvision's Chief Operating Officer. "By approving Evoltra(TM) in Europe the European Commission is giving patients and their families a new treatment option and new hope." Although the first-line treatment of children with leukemia is generally successful, patients with multiple relapsed or refractory leukemia have a low response rate and a very poor prognosis, with a median survival of approximately 8-10 weeks. In the pivotal clinical study with Evoltra(TM) a median survival of 66.6 weeks was achieved in the 30% of children who responded to treatment with Evoltra(TM). In addition to extending the life of children who responded to treatment, Evoltra(TM) also gives these children the opportunity to receive a bone marrow transplant, which offers the chance of a potential cure. Evoltra(TM) can now be marketed throughout all 25 member states of the European Union, which has a population of approximately 450 million. Evoltra(TM) has been granted orphan drug designation, providing marketing exclusivity for 10 years in Europe following this Marketing Authorization. "The launch of Evoltra(TM) into the European market is the cornerstone of Bioenvision's commercial strategy and enables Bioenvision to build a successful Evoltra(TM) franchise not only throughout Europe but also in other important world markets" said Dr. Christopher B. Wood, Bioenvision's Chairman and Chief Executive Officer. He added "we have recruited and trained a dedicated, specialist oncology sales team who will market Evoltra(TM) in Europe and that team will be expanded as the market grows". About Evoltra(TM) (clofarabine) The European Marketing Authorisation for Evoltra(TM) (clofarabine) is for the treatment of acute lymphoblastic leukemia (ALL) in pediatric patients who have relapsed or are refractory to at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients less than or equal to 21 years old at initial diagnosis. Clofarabine has been granted orphan drug designation for the treatment of both adult and pediatric ALL and AML in the U.S. and Europe. Bioenvision is also developing Evoltra(TM) for the treatment of adult acute myeloid leukemia (AML) as first-line therapy. The Company has completed enrollment of its Phase II clinical trial for the treatment of adult AML in elderly patients unfit for intensive chemotherapy and expects to file a Marketing Authorization Application in 2006 for the Company's first label-extension for Evoltra(TM). In addition, Bioenvision is also conducting late-stage preclinical development of Evoltra(TM) for the treatment of psoriasis and is planning further worldwide development of Evoltra(TM) in autoimmune diseases. Bioenvision holds an exclusive worldwide license for clofarabine (outside Japan and Southeast Asia) and an exclusive, irrevocable option to develop, market and distribute clofarabine for all human applications in Japan and Southeast Asia. Bioenvision granted an exclusive sublicense to Genzyme to co-develop clofarabine for cancer indications in the US and Canada. Genzyme is commercializing clofarabine for certain cancer indications in the US and Canada under the brand name Clolar(R). Bioenvision holds an exclusive license in the US and Canada for all non-cancer indications. Bioenvision originally obtained clofarabine development and commercialization rights under patents held by Southern Research Institute. About Bioenvision Bioenvision's primary focus is the acquisition, development, distribution and marketing of compounds and technologies for the treatment of cancer. Bioenvision has a broad pipeline of products for the treatment of cancer, including: Evoltra(TM), 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. Bioenvision is also developing anti-infective technologies, including the OLIGON(R) 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 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.