Healthcare Industry News: Genzyme
News Release - December 28, 2006
Bioenvision Provides Update on Evoltra(R) European Regulatory ActivitiesNEW YORK--(HSMN NewsFeed)--Bioenvision, Inc. (NasdaqGM:BIVN) today announced that it has completed the substantive work and analysis involved with finalizing the Marketing Authorization Application (MAA) to expand the Evoltra® (clofarabine) label and is now involved with the administrative aspects of formally submitting the filing to the European Medicines Agency (EMeA) for the use of Evoltra® in adult AML patients over 65 years and who are considered unsuitable for intensive therapy. The formal submission of the MAA is expected in the early part of Q1 2007. Bioenvision continues to expect a decision on this regulatory filing in calendar 2007.
"We are taking the appropriate steps to aggressively, but systematically, manage the valuable clofarabine franchise, which we believe has clinical applications in many forms of hematological malignancies and solid tumors and potentially autoimmune diseases," said Chris Wood, M.D., Chairman and CEO of Bioenvision. "As we announced at the ASH conference earlier this month, we are very pleased with the data that forms the basis of our pending Evoltra® filing."
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 has conducted nonclinical 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.
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.
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