Astellas, Ambit in FLT3 Pact

Ambit Biosciences and Astellas Pharma have entered into a worldwide agreement to jointly develop and commercialize FLT3 kinase inhibitors in oncology and non-oncology indications. This partnership includes AC220, Ambit’s lead clinical-stage investigational drug that entered into a Phase II clinical trial earlier this month in relapsed/refractory acute myeloid leukemia (AML), and other undisclosed FLT3 kinase inhibitors. AC220 is a novel, orally available, potent and highly selective small molecule that was specifically designed as a second generation FMS-like tyrosine kinase-3 (FLT3) inhibitor using Ambit’s proprietary drug discovery engine, KINOMEscan.

The companies will collaborate to develop AC220 for AML and other indications. The parties will also collaborate on an R&D program for a series of novel FLT3 inhibitors for a variety of oncology and non-oncology indications. The companies will share equally in the responsibilities and expenses for the development of AC220 and any additional products in the U.S. and Europe, while Astellas will have sole responsibility to fund development in all other territories. Ambit will receive an upfront cash payment of $40 million and will be eligible to receive pre-commercialization payments of as much as $350 million.

Astellas will have sole responsibility for funding and implementing the commercialization of all products, and Ambit will be entitled to post-approval milestone payments upon the achievement of certain sales thresholds, as well as tiered double-digit royalties on net sales. In the U.S., Ambit will also have the option to co-promote AC220 and other products under a profit sharing arrangement where Astellas and Ambit share equally in profits and losses generated from U.S. sales.