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BIVN Bioenvision (MM)

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Bioenvision's Evoltra(TM) Data Selected for Presentation at EHA's 11th Annual Congress

12/06/2006 9:15pm

Business Wire


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Bioenvision, Inc. (NASDAQ: BIVN) today announced that following selection by the European Hematology Association (EHA), data on it's Evoltra(TM) (clofarabine) in adult acute myeloid leukemia (AML) will be presented as a poster presentation at the EHA's 11th Annual Congress in Amsterdam. The EHA's congress is a leading hematology conference in Europe and this year a record number of abstracts were submitted for review by the EHA's Scientific Program Committee. Professor Alan Burnett, Chairman of the UK National Cancer Research Institute (NCRI), is the lead author on the poster presentation. The abstract is titled "Clofarabine as first-line treatment of elderly (greater than 65 yrs) AML patients with an unfavorable cytogenic profile who are unsuitable for standard treatment." The poster will be presented on Friday, June 16th, 2006. "We are excited that this important data on Evoltra(tm) in a difficult to treat and growing population has been chosen for a poster presentation at this prestigious meeting" said Hugh Griffith, Bioenvision's Chief Operating Officer. "The EHA's Congress is the ideal platform to present the next phase of Evoltra's(TM) clinical development program and follows the recent authorization of Evoltra(TM) by the EMeA for treatment of relapsed/refractory pediatric acute lymphoblastic leukemia." Bioenvision will be sharing information about Evoltra(TM) (clofarabine) at its booth throughout the congress. In addition, Bioenvision is proud to be sponsoring the Satellite Symposium "The MD Anderson Cancer Center approach to patients with hematological malignancies" taking place on the conference's "Super Thursday," June 15th. The EHA's annual congress is being held from June 15-18th at the Amsterdam RAI Convention Center. The meeting attracts more than 4,500 attendees from all over the world. 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." Evoltra(TM) (clofarabine) is not currently approved for adult AML. Clofarabine is in clinical development for the treatment of numerous other hematological cancers and solid tumors. 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. Evoltra(TM) (clofarabine) is a next generation purine nucleoside analog. 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. Clofarabine has been granted orphan drug designation for the treatment of both ALL and AML in the U.S. and Europe. In Europe, the designation provides marketing exclusivity for 10 years following Marketing Authorization. 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.

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