Nippon Shinyaku Submits NDA in Japan for Trisenox

Nippon Shinyaku has informed Cell Therapeutics that it has submitted a new drug application (NDA) with a request for priority review for Trisenox in Japan.

Nippon Shinyaku entered into a marketing and distribution agreement for Trisenox with Cell Therapeutics in December 2002.

Nippon Shinyaku is seeking approval of Trisenox for the treatment of patients with relapsed or refractory acute promyelocytic leukemia (APL). Under the marketing and distribution agreement with Cell Therapeutics, Nippon Shinyaku is obligated to make a $500,000 milestone payment to Cell Therapeutics as a result of the NDA submission.

'This represents an opportunity to expand Trisenox into another geographic location in its initial label claim,' stated Edward F. Kenney, coo of Cell Therapeutics. 'We are pleased that Nippon Shinyaku has requested a priority review based on the perceived clinical benefit of Trisenox for these patients.'

Trisenox

Trisenox (arsenic trioxide) is marketed by Cell Therapeutics, Inc. Trisenox was approved for marketing in 2000 by the FDA to treat patients with relapsed or refractory Acute Promyelocytic Leukemia (APL), a rare, life-threatening form of cancer of the blood. Trisenox was granted marketing authorisation from the European Commission in March 2002. APL, one of eight subtypes of acute myeloid leukemia (AML), represents 10-15% of the more than 20,000 patients diagnosed with AML each year. Trisenox is currently being studied in more than 40 clinical trials in a variety of cancers.