Takeda Pharmaceutical Company Limited and BioNumerik Pharmaceuticals, Inc. announced the termination of their License and Development Alliance Agreement for the investigational new drug known as Tavocept for the territories of the United States and Canada.

Tavocept is an investigational new drug with potential for oncology and non-oncology indications that was originated and developed by BioNumerik. The initial development focus for Tavocept has been as an investigational new drug to prevent or mitigate the peripheral nerve damage, or neuropathy, that is known to be associated with certain commonly used classes of chemotherapy drugs, such as taxane and platinum agents.

Earlier this year, Takeda and BioNumerik announced the results from two double blind placebo controlled Phase III Trials focused on evaluating Tavocept's potential for a neuropathy related treatment indication. These trials consisted of a Phase III trial of weekly administration of paclitaxel (a widely used taxane drug) to patients with metastatic breast cancer enrolled from the United States, Russia, and Ukraine; and a Phase III trial involving administration of paclitaxel and cisplatin (a widely used platinum drug) every 3 weeks to patients with non-small cell lung cancer from Eastern and Western Europe. Although there were some encouraging trends and subgroup analyses observed, the trials did not meet their primary endpoints and they were inconclusive in terms of demonstrating a statistically significant effect of Tavocept in reducing the incidence of severe neuropathy caused by the administration of paclitaxel and/or cisplatin.

After the data from the trials was unblinded and analyzed, Takeda had notified BioNumerik that, given the additional time necessary to conduct additional clinical testing for a Tavocept neuropathy indication, one possible alternative was termination of the existing Tavocept License and Development Alliance Agreement for the United States and Canada (the "US and Canada Alliance Agreement"). Following further discussion by Takeda and BioNumerik over the last few months of the data from the trials as well as considerations regarding the alliance agreement and the future development of Tavocept, Takeda recently terminated the US and Canada Alliance Agreement.