AVEO is committed to discovering, developing and commercializing targeted cancer therapies to impact patients’ lives. To support these efforts, we continue to evaluate opportunities to collaborate with other pharmaceutical and biotechnology companies that share AVEO’s vision for oncology drug development, and we seek partnerships that align with our strategic, long-term corporate goals.
AVEO has entered into multiple types of strategic partnership arrangements with several leading pharmaceutical and biotech companies:
Exclusive Worldwide License Agreement with Novartis for the Development and Commercialization of AV-380 and Related Antibodies
In August 2015, AVEO announced an exclusive, worldwide license agreement with Novartis for the development and commercialization of AVEO’s first-in-class, potent, humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15), AV-380, and related antibodies, including modified or derivative forms of any such antibody.
GDF15 is a pro-inflammatory cytokine whose elevated circulating levels have been correlated with cachexia in cachectic cancer patients and several animal models of cancer cachexia. Cachexia is a complex metabolic syndrome associated with malnutrition and severe involuntary weight loss due to the loss of muscle and fat tissue, as well as the clinical manifestation of anemia, inflammation and suppression of immune functions. Cachexia is a serious and common complication in patients with advanced cancer and other chronic diseases. It affects some five million individuals in the United States.
Exclusive Licensing Agreement with Pharmstandard for Tivozanib in Russia, Ukraine and CIS
In August 2015, AVEO entered into an exclusive license agreement with Pharmstandard OJSC, Russia’s leading pharmaceutical company, for the development, manufacturing and commercialization of AVEO’s small molecule vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor tivozanib in the territories of Russia, Ukraine and the Commonwealth of Independent States (CIS), for all indications excluding ocular conditions.
Research and Exclusive Option Agreement with Ophthotech to Investigate Tivozanib for the Treatment of Ocular Diseases
In November 2014, AVEO entered into a research and exclusive option agreement with Ophthotech Corporation, under which Ophthotech received an exclusive license to investigate the potential of AVEO’s small molecule vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor, tivozanib, outside of Asia, for the potential treatment of non-oncologic diseases of the eye. Ophthotech will study tivozanib as a potential treatment for non-oncologic diseases of the eye during an option term, after which it may elect to continue development of an ocular formulation of tivozanib. Ophthotech has the exclusive option, exercisable at its sole discretion, to obtain additional development and commercialization rights to tivozanib and products containing tivozanib for non-oncologic eye indications in territories outside Asia.
Co-Development and Commercialization Partnership with Biodesix to Investigate Ficlatuzumab with a Companion Diagnostic for Treatment of NSCLC
In April 2014, AVEO and Biodesix announced a worldwide agreement to develop and commercialize AVEO’s hepatocyte growth factor (HGF) inhibitory antibody ficlatuzumab, with a
Biodesix® companion diagnostic test. The agreement and clinical development program will leverage VeriStrat®, a serum protein test that is commercially available to help physicians guide treatment decisions for patients with advanced non-small cell lung cancer (NSCLC). Under the agreement, AVEO and Biodesix are conducting a proof of concept study of ficlatuzumab in combination with erlotinib in advanced NSCLC patients selected using BDX 004, a serum protein biomarker test similar to VeriStrat®.
Exclusive, Worldwide In-Licensing Of GDF-15 Patents for Certain Symptoms Of Cachexia
In June 2012, AVEO entered into a license agreement with St. Vincent’s Hospital Sydney under which AVEO obtained an exclusive, worldwide license to research, develop, manufacture and commercialize products for therapeutic applications that benefit from inhibition or decreased expression or activity of GDF-15. AVEO is using this license for its AV-380 program in cachexia.
Funded Research Collaboration Utilizing AVEO's Proprietary Technology Platform
In December 2010, OSI Pharmaceuticals, Inc. (which is a wholly owned subsidiary of Astellas U.S. Holding Inc., a holding company owned by Astellas Pharma Inc.) exercised its option to internalize certain elements of AVEO’s proprietary technology platform, including components of the Human Response PlatformTM for the identification/characterization of novel epithelial-mesenchymal transition (EMT) agents and proprietary patient selection biomarkers, in support of OSI’s clinical development programs. The alliance between AVEO and OSI was anchored around developing molecularly targeted therapies to target the underlying mechanisms of EMT in cancer and to develop patient selection biomarkers to support OSI’s targeted medicine pipeline. EMT is a process of emerging significance in tumor growth and disease progression and a focal point of discovery and translational research in oncology drug development. The companies expanded their efforts in 2009 to validate cancer targets and to deploy key elements of AVEO’s Human Response Platform in support of OSI’s ongoing clinical development programs. The collaborative research portion of the arrangement ended in July 2011.
In-Licensing Of Tivozanib
In December 2006, AVEO entered into a license agreement with Kirin Brewery Co. Ltd. (now Kyowa Hakko Kirin) under which we obtained an exclusive license to research, develop, manufacture and commercialize tivozanib (f/k/a KRN951), pharmaceutical compositions thereof and associated biomarkers. AVEO’s exclusive license covers all territories in the world, except for Asia.