Ambit Biosciences and Astellas Pharma to jointly develop and commercialize FLT3 kinase inhibitors

Ambit Biosciences Corporation and Astellas Pharma Inc. today announced that they 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 2 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(TM).

The companies will collaborate to develop AC220 for AML and other indications. The parties will also collaborate on a research and development 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. Under the terms of the agreement, Ambit will receive an up-front cash payment of $40 million and will be eligible to receive pre-commercialization payments of up to $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.

"We are pleased to have entered into a great partnership with Ambit," stated Masafumi Nogimori, president and chief executive officer of Astellas. "We believe that AC220, as the most selective and advanced FLT3 kinase inhibitor, has the potential to provide a new treatment option for AML where high unmet medical needs exist. Astellas is strongly committed to focus on oncology and this partnership is a significant milestone to establish our franchise in oncology."

"With their strategic commitment to the development and commercialization of innovative oncology products, Astellas is an ideal partner for Ambit," said Scott Salka, Chief Executive Officer of Ambit Biosciences. "This collaboration establishes a comprehensive and global leadership position in the discovery and development of FLT3 kinase inhibitors, and we look forward to working closely with Astellas to explore the clinical utility of AC220 in AML and other indications."