Healthcare Industry News: Clolar
News Release - September 14, 2006
Bioenvision to Formally Launch Evoltra(R) Throughout EuropeBioenvision To Showcase Leukemia Drug At International Pediatric Oncology Conference
NEW YORK--(HSMN NewsFeed)--Sept. 14, 2006--Bioenvision, Inc. (NasdaqGM: BIVN) today announced the Company will be formally launching Evoltra® throughout Europe at the 38th Congress of the International Society of Pediatric Oncology (SIOP) in Geneva, Switzerland from September 17th-21st.
"This conference is the perfect platform for Bioenvision to share data on our new, innovative cancer drug Evoltra® (clofarabine) with hundreds of oncologists, pediatricians, hematologists, surgeons and nurses who treat pediatric patients all over the globe," said Dr. Christopher B. Wood, Chairman and Chief Executive Officer of Bioenvision.
The annual scientific conference of SIOP is the major international meeting for all healthcare professionals who treat children with cancer. 1700 specialists are expected to attend. Interim results from the Bioenvision European pediatric acute lymphoblastic leukemia study have been selected for oral presentation in the plenary scientific session on Tuesday, September 19th 2006. Dr Pamela Kearns, one of the Chief Investigators for this important study, will be making the presentation. Three additional abstracts have also been selected for poster presentations and focus on the most recent data from the pivotal study conducted in the US which led to both US and EU marketing approval.
Bioenvision is also sponsoring a dedicated satellite symposium entitled "New treatment options in pediatric acute leukemias" which will include presentations relating to Evoltra from Professor Rob Pieters, Dr Sima Jeha, Professor Vaskar Saha and Professor Andre Baruchel.
"The 38th Congress of SIOP is the most appropriate forum for our formal launch of Evoltra® throughout Europe. It provides an excellent stage to further communicate the benefits associated with Evoltra to the world's leading paediatric haematologists and oncologists," said Hugh S. Griffith, Chief Operating Officer of Bioenvision.
Evoltra® received marketing approval from the European Commission this summer for the treatment of relapsed and refractory acute lymphoblastic leukemia in children.
About Evoltra® (clofarabine)
The European Marketing Authorisation 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 late-stage preclinical development 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 for clofarabine (outside Japan and Southeast Asia) and an exclusive, irrevocable option to develop, market and distribute clofarabine for all human applications in Japan and Southeast Asia. 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 holds an exclusive license in the U.S. and Canada for all non-cancer indications. 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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