Ambit and Astellas Pharma: Working to release your inhibitors

They aim to develop FLT3 kinase inhibitors for AML and more

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SAN DIEGO—Ambit Biosciences Corp. and Astellas Pharma Inc. have entered into a worldwide agreement to develop and commercialize FLT3 kinase inhibitors in both oncology and non-oncology indications. This partnership includes AC220, Ambit's lead clinical-stage investigational drug that entered into a Phase II clinical trial last 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. Ambit will receive a $40 million upfront cash payment, up to $350 million in pre-commercialization milestones, and double-digit royalties with the option to co-promote and share profits in the United States. The companies will share equally in the responsibilities and expenses for the development of AC220 and any additional products in the United States and Europe, while Astellas will have sole responsibility to fund development in all other territories.

"We are pleased to have entered into a great partnership with Ambit," says Masafumi Nogimori, president and CEO 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. 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," says Scott Salka, CEO 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."

AC220 is a second-generation FLT3 inhibitor currently under evaluation in a Phase II clinical trial designed to support potential registration of AC220 as monotherapy treatment in adult and elderly patients with relapsed/refractory AML that have the internal tandem duplication (ITD) mutation in the FLT3 kinase. AML is one of the most common types of blood cancers in adults, and the FLT3 kinase is mutated and constitutively activated in 25 percent to 40 percent of such patients. FLT3 ITD mutations predict poor prognosis and decreased response to existing treatments, including chemotherapy and hematopoietic stem cell transplant. Ambit leveraged KINOMEscan, the company's high-throughput method for screening small-molecule compounds against a large number of human kinases, to advance AC220 from initial chemistry to clinical candidate selection for IND-enabling studies in only 18 months.

Ambit Biosciences is a privately held biopharmaceutical company engaged in the discovery and development of small molecule kinase inhibitors for the treatment of cancer, inflammatory disease and other indications. The company plans to commence several other clinical studies with AC220 in 2010. Ambit's clinical pipeline also includes AC480, an oral pan-HER inhibitor that was in-licensed from BMS. Ambit is conducting Phase II studies with AC480 in patients with solid tumor cancers. Additionally, Ambit has an advancing pool of preclinical candidates targeting BRAF (in collaboration with Cephalon), JAK2, Aurora, and CSF1R. Through its KINOMEscan Division, Ambit markets its technology as a profiling service.

Astellas Pharma, located in Tokyo, has approximately 15,000 employees worldwide. The company is committed to becoming a global category leader in urology, immunology and infectious diseases, neuroscience, DM complications and metabolic diseases and oncology.

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