BIOENVISION TO DEVELOP EVOLTRA IN JAPAN, SOUTHEAST ASIA

Bioenvision has announced it will expand into Japan and Southeast Asia the clinical and commercial development of Evoltra (clofarabine). The company recently acquired the rights to manufacture, sell, market and distribute the leukemia drug in this newly licensed territory. In Southeast Asia, Bioenvision successfully licensed these rights in 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 Luci, Bioenvision's chief financial officer and general counsel.

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 committee has publicly stated its position that clofarabine needs to be brought to immediate clinical development in Japan, according to Bioenvision.

Evoltra is approved in Europe for the treatment of acute lymphoblastic leukemia in pediatric patients who have relapsed or are refractory to at least two prior regimens and where there is no other treatment option anticipated. The drug is also in clinical development for the treatment of other hematological cancers and solid tumors. Additionally, Bioenvision is conducting late-stage preclinical development of Evoltra for the treatment of psoriasis and is planning further development in autoimmune diseases.