Healthcare Industry News: Cytogen
News Release - February 7, 2007
Bioenvision Files with EMeA for Label Extension of Evoltra(R)Submission Seeks to Expand Evoltra Franchise into Adult AML Market
NEW YORK--(HSMN NewsFeed)--Bioenvision, Inc. (NasdaqGM:BIVN) today announced it has filed with the European Medicines Agency (EMeA) to expand the Evoltra®(clofarabine) label to include the treatment of acute myeloid leukemia (AML) in patients who are greater than or equal to 65-years-old and have one or more of the following: adverse Cytogenetics, secondary AML, aged greater than or equal to 70 years, or have greater than or equal to 1 significant comorbidity. Evoltra® is currently approved in Europe to treat pediatric patients with relapsed or refractory acute lymphoblastic leukemia (ALL) and where there is no other treatment option anticipated to result in a durable response.
"This filing represents our commitment to Evoltra® and our belief that this agent will help thousands of patients with leukemia of all ages around the world," said Hugh S. Griffith, Chief Operating Officer of Bioenvision. "We appreciate the efforts of all the people who made this filing possible and are grateful to all the participants in the AML studies." The application is based on the results of several studies, including the pivotal phase II study BIOV-121. In study BIOV-121, elderly patients treated with Evoltra® had a complete response rate of 44%. This response rate compares favorably with that of the current standards of care, low dose ara-C (20%) and hydroxyurea (0%). Evoltra® achieved a 45% median survival advantage over low dose ara-C and a 120% survival advantage over hydroxyurea.
"Many of the elderly patients with AML, especially those with poor prognostic factors, have few, if any, appropriate treatment options available," said Professor Christopher B. Wood, M.D., Chairman and Chief Executive Officer of Bioenvision. "Evoltra® could offer a new treatment option for physicians and a new hope for this patient population."
About Evoltra® (clofarabine)
Evoltra® is currently approved in Europe 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 a phase I clinical study 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 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 Suvus®, its anti-infective technology, which is 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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