BIVN Bioenvision (MM)

Bioenvision, Inc. (NasdaqGM:BIVN) today announced it is expanding into Japan and Southeast Asia for the clinical and commercial development of Evoltra(R) (clofarabine) in this newly licensed territory. Bioenvision licensed these previously ungranted rights to manufacture, sell, market and distribute Evoltra in this region from Southern Research Institute of Birmingham, Alabama, the inventor of clofarabine. Bioenvision had the exclusive, irrevocable option to develop, market and distribute clofarabine in Japan and Southeast Asia; and converted it into an exclusive license. In Southeast Asia, Bioenvision successfully licensed these rights in the countries of Indonesia, Malaysia, Taiwan, Hong Kong, Singapore, Vietnam, Cambodia, Thailand, Laos, Philippines and South Korea. "Now that clofarabine has been approved in the U.S. and Europe, it is important for Bioenvision to establish a base of operations from which to develop clofarabine in Japan, the second largest pharmaceutical market in the world," said David P. Luci, Bioenvision's Chief Financial Officer and General Counsel. "Bioenvision's strategy is to develop clofarabine across therapeutic areas and across geographic locations. Succeeding to the Japanese rights is a critical step in this strategy." "We are pleased with the commitment Bioenvision has made to bring our latest innovative drug - clofarabine - to the largest patient populations possible," said Tina S. Rogers, Ph.D., interim CEO and vice president of the Drug Development Division at Southern Research. "Bioenvision's management has been successful in its European development strategy and we have every expectation they will do the same with the Japanese regulatory authorities." Japanese health officials recently announced their desire to expedite the clinical development of clofarabine in Japan. The Japanese Ministry of Health's Advisory Committee for the Usage of Unapproved Drugs has noted that clofarabine is approved in the U.S. and Europe but is not available in Japan. The Advisory Committee has publicly stated its position that clofarabine needs to be brought to immediate clinical development in Japan. "We are pleased to know the medical experts in Japan recognize the benefit of Evoltra(R) for critically ill children with leukemia," said Dr. Christopher B. Wood, Chairman and Chief Executive Officer of Bioenvision. "We will work closely with the Japanese authorities and oncologists to ensure Evoltra(R) is made available for clinical development in Japan as soon as possible." 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 late-stage preclinical development 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.