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news.To research, develop and commercialise FLT3 kinase inhibitors in multiple indications
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Ambit Biosciences (Ambit) and Astellas Pharma (Astellas) have entered into a worldwide agreement to jointly develop and commercialise FLT3 kinase inhibitors in oncology and non-oncology indications.
The 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, orally available, potent and highly selective small molecule that was specifically designed as FMS-like tyrosine kinase-3 (FLT3) inhibitor using Ambit’s proprietary drug discovery engine, KINOMEscan.
Reportedly, the companies are expected to 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.
Additionally, the companies will share equally in the responsibilities and expenses for the development of AC220 and any additional products in the US and Europe, while Astellas will have sole responsibility to fund development in all other territories. As per the terms of the agreement, Ambit will receive an up-front cash payment of $40m and will be eligible to receive pre-commercialisation payments of up to $350m.
Furthermore, Astellas will have theresponsibility for funding and implementing the commercialisation of all products, and Ambit will be entitled to post-approval milestone payments upon the achievement of certain sales thresholds, and tiered royalties on net sales.
In the US, 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 CEO of Astellas, said: “We are pleased to have entered into a great partnership with Ambit. We believe that AC220 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.”