Keywords: Astellas, Ambit Biosciences, FLT3 kinase inhibitors, Licensing

Ambit sells rights for FLT3 Kinase inhibitors to Japan’s Astellas for up to $390 million

Article | 18 December 2009

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Leading Japanese drugmaker Astellas Pharma has entered into a worldwide agreement to jointly develop and commercialize FLT3 kinase inhibitors in oncology and non-oncology indications developed by USA-based privately held firm Ambit Biosciences, in a deal that could generate as much as $390 million for the latter.

Specifically, under the terms of thedeal, 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. The companies will share equally in the responsibilities and expenses for the development of AC220 and any additional products in the USS and Europe, while Astellas will have sole responsibility to fund development in all other territories.

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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 a research and development program for a series of novel FLT3 inhibitors for a variety of oncology and non-oncology indications.

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 USA, 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 US sales.

Masafumi Nogimori, president and chief executive of Astellas, commented: "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.

Market forecast to reach $35 billion in 2013

The global market for kinase-targeted drugs is forecast to grow by 18% per annum, from $13 billion in 2008 to $35 billion in 2013. Among some of the leading FLT3 kinase inhibitors on the market areErbitux (cetuximab), Tarceva (erlotinib), Gleevec (imatinib) and Iressa (gefitinib).