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BIVN Bioenvision (MM)

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Bioenvision (MM) NASDAQ:BIVN NASDAQ Common Stock
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Bioenvision's Evoltra(R) Advertisement Wins Industry Honor

05/12/2006 12:00pm

Business Wire


Bioenvision (NASDAQ:BIVN)
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Bioenvision, Inc. (NasdaqGM: BIVN) announced today the advertisement for its pediatric leukemia drug Evoltra® has been given the RX Club Show’s “Award of Excellence” for 2006. Founded in 1986 to showcase the top healthcare advertising from around the world, the RX Club Show is an annual international competition that honors the best examples of medical advertising and marketing. “We are proud to be honored with such a prestigious award," said Rob Bradbury, European Marketing Manager, Bioenvision. “It is peer recognition of our marketing excellence, and the innovation that Bioenvision has demonstrated in getting the Evoltra® brand and messages to our target audience.” Hugh Griffith, Chief Operating Officer added; “This further demonstrates the quality of our European sales and marketing organization and our ability to excel within the industry.” The winning Evoltra® advertisement features a young boy on a beach being held in the air in his father’s arms. The caption says “Time 2 keep dreams alive” which symbolizes the potential for Evoltra® to send a child’s leukemia into remission, giving him or her the opportunity to get a transplant and lead a full life. Evoltra® was approved by the European Commission in May 2006 and is available in all 25 countries of the European Union. About Evoltra® (clofarabine) The European Marketing Authorization for Evoltra® (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 is in clinical development for the treatment of other hematological cancers and solid tumors. Bioenvision is also conducting Phase I studies of Evoltra® for the treatment of psoriasis and is planning further worldwide development of Evoltra® in autoimmune diseases. Evoltra® (clofarabine) is a next generation purine nucleoside analog. Bioenvision holds an exclusive worldwide license (excluding U.S. and Canada) for the cancer applications of clofarabine and an exclusive worldwide license for all non-cancer indications. Bioenvision granted an exclusive sublicense to Genzyme Corporation to develop and commercialize clofarabine for certain cancer indications in the U.S. and Canada, which Genzyme markets under the name of Clolar®. 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®, Modrenal® (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® technology; an advanced biomaterial that has been incorporated into various FDA approved medical devices and Suvus®, an antimicrobial agent currently in clinical development for refractory chronic hepatitis C infection. 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. Bioenvision, Inc. (NasdaqGM: BIVN) announced today the advertisement for its pediatric leukemia drug Evoltra(R) has been given the RX Club Show's "Award of Excellence" for 2006. Founded in 1986 to showcase the top healthcare advertising from around the world, the RX Club Show is an annual international competition that honors the best examples of medical advertising and marketing. "We are proud to be honored with such a prestigious award," said Rob Bradbury, European Marketing Manager, Bioenvision. "It is peer recognition of our marketing excellence, and the innovation that Bioenvision has demonstrated in getting the Evoltra(R) brand and messages to our target audience." Hugh Griffith, Chief Operating Officer added; "This further demonstrates the quality of our European sales and marketing organization and our ability to excel within the industry." The winning Evoltra(R) advertisement features a young boy on a beach being held in the air in his father's arms. The caption says "Time 2 keep dreams alive" which symbolizes the potential for Evoltra(R) to send a child's leukemia into remission, giving him or her the opportunity to get a transplant and lead a full life. Evoltra(R) was approved by the European Commission in May 2006 and is available in all 25 countries of the European Union. About Evoltra(R) (clofarabine) The European Marketing Authorization for Evoltra(R) (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 is in clinical development for the treatment of other hematological cancers and solid tumors. Bioenvision is also conducting Phase I studies of Evoltra(R) for the treatment of psoriasis and is planning further worldwide development of Evoltra(R) in autoimmune diseases. Evoltra(R) (clofarabine) is a next generation purine nucleoside analog. Bioenvision holds an exclusive worldwide license (excluding U.S. and Canada) for the cancer applications of clofarabine and an exclusive worldwide license for all non-cancer indications. Bioenvision granted an exclusive sublicense to Genzyme Corporation to develop and commercialize clofarabine for certain cancer indications in the U.S. and Canada, which Genzyme markets under the name of Clolar(R). 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(R), 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 and Suvus(R), an antimicrobial agent currently in clinical development for refractory chronic hepatitis C infection. 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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