Innovive licenses TMRC's tamibarotene

Innovive Pharmaceuticals has acquired the exclusive North American rights to develop and commercialize tamibarotene, a novel synthetic retinoid for the treatment of acute promyelocytic leukemia (APL), a type of acute myeloid leukemia, from Tokyo, Japan-based drugmaker TMRC Co.

The agent was specifically designed to address challenges of APL resistance and the high rate of toxicity among patients treated with all-trans retinoic acid, which is the current first-line standard of care for APL in combination with chemotherapeutics. Current US National Comprehensive Cancer Network guidelines also recommend that patients undergo one to two years of maintenance therapy with ATRA following disease remission. However, this is associated with toxicities, including retinoic acid syndrome, a serious and sometimes fatal complication that occurs in up to 25% of patients, while many patients also develop resistance.

Tamibarotene is currently approved in Japan for the treatment of recurrent APL. A Phase III study is now underway in that country comparing ATRA to tamibarotene for APL maintenance treatment. In conjunction with data from the Japanese studies, findings from Innovive's pivotal study of the agent, which is scheduled to be completed in 2007, are expected to form the basis of a New Drug Application with the US Food and Drug Administration. Innovive plans to initiate a pivotal clinical study of tamibarotene in the domestic market in the first half of 2007 in refractory APL, and to file an NDA with the FDA in early 2008. The firm noted that a US approval in APL would not only generate revenue but could also provide a foundation for more launches from its hematology pipeline, including INNO-406, which is currently in Phase I testing.