Clofarabine Receives FDA Approval for Most Common Pediatric Leukemia
NEW YORK — Bioenvision, Inc. (Nasdaq:BIVN) announced today that the U.S. Food and Drug Administration has granted marketing approval for Clofarabine for the treatment of children with refractory or relapsed Acute Lymphoblastic Leukemia (ALL).
Clofarabine is indicated by FDA for the treatment of pediatric patients 1 to 21 years of age with relapsed or refractory ALL after at least two prior regimens.
According to the American Cancer Society, Leukemia is the most common childhood cancer with an incidence rate of approximately 3,600 new cases every year in the US. The FDA’s approval follows the recommendation made by the Oncology Drug Advisory Committee (ODAC) in Washington on Dec. 1st 2004.
Clofarabine was previously granted orphan drug designation for the treatment of adult and pediatric ALL and AML, both in the US and in Europe. In the U.S., orphan drug status extends seven years of market exclusivity for the orphan drug indication following the FDA’s marketing approval. The FDA also recently granted an additional six months market exclusivity to Clofarabine under the Best Pharmaceuticals for Children Act. In Europe, this designation provides European marketing exclusivity for 10 years.
Dr Christopher Wood Chief Executive Officer of Bioenvision stated, “this is a fantastic milestone in the development of Clofarabine. Following the exciting data that was released at the American Society of Hematology (ASH) at the beginning of December in both the adult and pediatric settings, more people who are involved in the treatment of acute leukemias, are realizing how vital Clofarabine is as part of their treatment options.”
“We look forward to more children being given the opportunity to benefit from Clofarabine in the US and are very confident that this momentum will help us bring these benefits to many other children in Europe and other parts of the world.”
Clofarabine is a next generation of the drug class purine nucleoside analogs which all inhibit DNA production necessary for cancer cell growth. Bioenvision, Inc. (NASDAQ:BIVN) sub-licensed Genzyme(Nasdaq:GENZ) the right to develop and market Clofarabine for human cancer indications in the United States and Canada. Bioenvision received milestone payments tied to the development of the compound and is entitled to royalties on North American sales. As is its exclusive right, Bioenvision is developing clofarabine in the rest of the world. Bioenvision originally obtained clofarabine development and commercialization rights under patents held by Southern Research Institute.
Bioenvision’s (Nasdaq: BIVN) primary focus is the development and distribution of compounds and technologies for the treatment of cancer. Bioenvision has a broad pipeline of products for the treatment of cancer, including: clofarabine (in co-development with Genzyme), 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 in clinical trials. Bioenvision is also developing anti-infective technologies, including the OLIGON 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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