Cell Therapeutics (CTI) and Chroma Therapeutics have entered into a co-development and license agreement providing CTI with exclusive marketing and co-development rights to Chroma's drug candidate tosedostat in North, Central and South America.
Tosedostat is an oral, aminopeptidase inhibitor that has demonstrated significant anti-tumor responses in blood related cancers and solid tumors in phase I-II clinical trials. CTI, in collaboration with Chroma, expects to commence a phase III clinical study in the U.S. and E.U. in elderly patients with relapsed or refractory acute myeloid leukemia (AML) for potential approval by the FDA and the EMA. The FDA and the EMA have granted tosedostat orphan drug status for AML.
CTI will make an upfront payment of $5 million and a milestone payment of $5 million when the AML pivotal trial is initiated, which is expected to occur in the fourth quarter of 2011. The agreement also includes development-based milestone payments related to AML, myelodysplastic syndrome (MDS) and certain other indications, as well as royalties on net sales in CTI's territories.
CTI will oversee development operations and commercialization activities in its territories and Chroma will oversee development operations and commercialization activities in the rest of the world. Subject to a funding cap of $50 million for the first three years, CTI will be responsible for 75% of development costs and Chroma will be responsible for 25% of development costs.