Date: 2011-03-14
Type of information: Licensing agreement
Compound: tosedostat
Company: Chroma Therapeutics (UK) Cell Therapeutics (USA)
Therapeutic area: Cancer - Oncology
Type agreement: co-development
licensing
Action mechanism: Tosedostat is an orally dosed aminopeptidase inhibitor which blocks the M1/17 family of aminopeptidases. Disrupting aminopeptidases deprives sensitive tumour cells of amino acids by blocking protein recycling, resulting in tumor cell death. Tosedostat has been studied in Phase I-II clinical trials both as a single agent and in combination with other chemotherapeutic agents. Such studies have demonstrated significant anti-tumour response without the typical side effects of conventional, non-targeted cytotoxic therapies. Initial target indications include AML, MDS and multiple myeloma.
Disease: relapsed or refractory acute myeloid leukemia - blood related cancers
Details: Chroma Therapeutics Ltd and Cell Therapeutics (CTI) 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. The Companies expect to commence a Phase III clinical study in the United States and Europe 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.
Financial terms: Pursuant to the terms of the agreement, CTI will make an upfront payment to Chroma 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 customary 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 commercialisation 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.
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