Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
News, developments and strategies related to eClinical, data management, data collection, ePRO, and more information technology used in the drug development chain. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
|
|
Astellas and Ambit to End Collaboration for Joint Development and Commercialization of FLT3 Kinase Inhibitors
Publish date: Mar 11, 2013
![]()
PR Newswire TOKYO and SAN DIEGO, March 12, 2013
TOKYO and SAN DIEGO, March 12, 2013
/PRNewswire/ -- Astellas Pharma Inc. (Astellas) (Tokyo: 4503) and Ambit Biosciences
Corporation today announced the companies will end their collaboration for the joint development and commercialization of
FMS-like tyrosine kinase-3 (FLT3) inhibitors, including quizartinib, effective September 3, 2013.
Astellas has exercised its right to terminate the worldwide license agreement signed in 2009, and over the months ahead the
companies will work together to transfer current development activities to Ambit. Upon the effective date of termination,
Ambit will regain all rights granted to Astellas and continue with the quizartinib clinical trial program. "While our decision is based on strategic reasons, we are proud of our collaborative work with Ambit, and we are committed
to working with Ambit on a smooth transition," said Yoshihiko Hatanaka, President and CEO of
Astellas. "We remain committed to the field of Oncology as a major area of focus for the company and will continue to pursue
our goal of becoming a Global Category Leader in Oncology."
Michael Martino, President and CEO of Ambit, said, "With the Phase 2 study results for quizartinib
that were presented at the ASH Annual Meeting last December, we and members of the medical community continue to be excited
about quizartinib and its potential to meet a significant, unmet need in acute myeloid leukemia (AML) patients. We are fully
committed to moving forward with the Phase 3 clinical trial plan and look forward to advancing this important drug candidate
toward approval."
About Quizartinib
Quizartinib (AC220) is a novel, potent, highly selective, orally bioavailable FMS-like tyrosine kinase-3 (FLT3) inhibitor
currently under evaluation in a Phase 2b clinical trial as monotherapy treatment for adult patients with relapsed or refractory
AML, and in two Phase 1 studies in a combination treatment regimen with chemotherapy, and as a maintenance therapy following
transplant, respectively.
About Astellas
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to
improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. Astellas
has approximately 17,000 employees worldwide. The organization is committed to becoming a global category leader in Urology;
Immunology including Transplantation and Infectious Diseases; Oncology; Neuroscience; and DM Complications and Kidney Diseases.
For more information on Astellas Pharma Inc., please visit the company website at www.astellas.com/en.
About Ambit Biosciences
Ambit is a privately held biopharmaceutical company focused on the discovery, development and commercialization of drugs
to treat unmet medical needs in oncology, autoimmune and inflammatory diseases by inhibiting kinases that are important drivers
for those diseases. Ambit's lead drug candidate, quizartinib (AC220), is a once-daily, orally-administered potent and selective,
inhibitor of FMS-like tyrosine kinase-3 (FLT3) and is currently under clinical development in patients with relapsed/refractory
acute myeloid leukemia (AML) and in newly diagnosed AML patients in combination with chemotherapy as well as maintenance following
a hematopoietic stem cell transplantation (HSCT). In addition to quizartinib, Ambit's clinical pipeline includes AC410, an
oral JAK2 inhibitor, and CEP-32496, a BRAF inhibitor licensed to Teva Pharmaceutical Industries Ltd. Ambit's preclinical portfolio
includes a proprietary CSF1R inhibitor program.
Contacts:
Ambit Contact:
Astellas Contact:
David Schull
Corporate Communications
Russo Partners
TEL: +81-3-3244-3201, FAX: +81-3-5201-7473
TEL: 212-845-4271
SOURCE Ambit Biosciences Corporation
|
|