San Diego and Tokyo (ots/PRNewswire) - Ambit Biosciences Corporation and Astellas Pharma Inc. today announced that the first presentation of interim data from a global multi-center Phase 2 study evaluating the investigational drug AC220, a potent and selective FLT3 inhibitor. The data will be presented in an oral session at the upcoming European Hematology Association (EHA) meeting in London. The abstract (#1019) can be accessed at the EHA Congress website at http://eha.eurocongres.com/16th/. Details of the presentation are as follows:
Title: "A Phase II Open-Label, AC220 Monotherapy Efficacy (ACE) Study in Patients with Acute Myeloid Leukemia (AML) With FLT3-ITD Activating Mutations: Interim Results"
Date & Time: Sunday, June 12, 2011, from 9:00am to 9:15am GMT (London)
Session Title: Acute Myeloid Leukemia - Clinical 2
Location: Hall S4, ExCeL London
Presenter: Mark Levis, MD, PhD, Associate Professor, Oncology and Medicine, Division of Hematologic Malignancies, Johns Hopkins (Baltimore, Maryland, USA)
AC220 is being developed in collaboration between Ambit Biosciences and Astellas Pharma Inc., and is a novel, potent, highly selective, orally bioavailable FMS-like tyrosine kinase-3 (FLT3) inhibitor. AC220 is currently under evaluation in a Phase 2 clinical trial as mono-therapy treatment for adult and elderly patients with relapsed/refractory AML that have an internal tandem duplication (ITD) mutation in the FLT3 gene. AML is one of the most common types of blood cancers in adults, with ITD mutations in the FLT3 gene occurring in 25-30 percent of AML patients. FLT3 ITD mutations confer poor prognosis, with early relapse and lower survival following treatment with existing therapies, including chemotherapy and hematopoietic stem cell transplant.
Acute myeloid leukemia is a form of blood cancer. According to the American Cancer Society, approximately 13,000 adults were newly diagnosed with AML in 2009 in the United States with approximately 9,000 expected to die of the disease in that year. AML is generally a disease of older people and is uncommon before the age of 40. The average age of a patient with AML is 67 and median survival for these patients is less than six months. The five-year survival rate for all AML patients is less than 15 percent. According to a report from Decision Resources, the U.S. AML market is expected to more than double by 2015.
About the Ambit/Astellas Collaboration
In December 2009, Ambit and Astellas entered into a global strategic partnership agreement to jointly research, develop and commercialize FLT3 kinase inhibitors in multiple indications, including the lead investigational compound, AC220. The companies are presently evaluating AC220 in a Phase 2 clinical trial in relapsed and refractory AML patients that have the internal tandem duplication (ITD) mutation in the FLT3 gene. The companies are also collaborating on a comprehensive development program to explore the utility of AC220 in other AML patient subpopulations. Additionally, the companies are collaborating on a research and development program for additional FLT3 inhibitors for a variety of oncology and non-oncology indications. The companies share equal responsibility and expenses for the development of products in the US and Europe, while Astellas has sole responsibility in the rest of the world. Astellas will be responsible for implementation of commercialization activities worldwide. Ambit received a $40 million up-front payment upon entering into the collaboration agreement, and is eligible to receive up to $350 million in development milestone payments, undisclosed sales milestones, and tiered, double-digit royalties on global revenues. Ambit also has an option to co-promote products in the U.S. where Astellas and Ambit share equally all profits and losses generated from U.S. sales.
About Ambit Biosciences
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. Ambit's lead compound, AC220, is a novel, potent, highly selective, orally bioavailable FMS-like tyrosine kinase-3 (FLT3) inhibitor, and is currently under clinical investigation in patients with relapsed or refractory AML. Ambit is developing AC220 in collaboration with Astellas Pharma Inc. as part of a worldwide agreement to jointly develop and commercialize FLT3 kinase inhibitors in oncology and non-oncology indications. In addition to AC220, Ambit's clinical pipeline includes AC480, an oral pan-HER inhibitor, and AC430, an oral JAK2 inhibitor. Ambit also has a pipeline of preclinical candidates which includes CEP-32496, a BRAF inhibitor licensed to Cephalon.
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through provision of innovative and reliable pharmaceuticals. Astellas has approximately 16,000 employees worldwide. The organization is committed to becoming a global category leader in Urology, Immunology & Infectious Diseases, Oncology, Neuroscience, and DM complications & Metabolic Diseases. For more information on Astellas Pharma Inc., please visit our website at http://www.astellas.com/en.
Contacts: Ambit Biosciences: Alan Fuhrman, Chief FinancialOfficer,
+1-858-334-2133; Doug Sherk/Jenifer Kirtland, EVC Group,+1-415-896-68
Media: Janine McCargo, EVC Group, +1-646-528-4034. AstellasPharma
Inc: Corporate Communications, +81-3-3244-3201 .