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. Importantly, as AVEO continues to build its commercial infrastructure, we seek collaborations 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:
Worldwide Agreement to develop and commercialize lead product candidate, tivozanib, outside of Asia
In February 2011, AVEO and Astellas Pharma Inc. entered into a worldwide agreement outside of Asia to develop and commercialize tivozanib for the treatment of a broad range of cancers. In February 2011, AVEO and Astellas Pharma Inc. entered into a worldwide agreement outside of Asia to develop and commercialize tivozanib for the treatment of a broad range of cancers. Subject to regulatory approval, AVEO will lead commercialization of tivozanib in North America, and Astellas will lead commercialization of tivozanib in the European Union (EU). The companies will share equally all North American and EU development and commercialization costs and profits for tivozanib. Outside of North America, EU and Asia, Astellas will be responsible for the development and commercialization costs of tivozanib and will be obligated to pay AVEO a tiered, double-digit royalty on sales in those territories. AVEO will be responsible for the manufacturing of tivozanib. AVEO and Astellas are currently evaluating tivozanib in Phase 2 studies in breast and colorectal cancer as part of the BATON (BiomarkerAssessment of Tivozanib in ONcology) clinical development program.
Pursuant to the terms of a licensing agreement between Kyowa Hakko Kirin and AVEO, Kyowa Hakko Kirin retains the rights to develop and commercialize tivozanib in Asia.
In-licensing of targeted clinical stage compounds
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. In return for ex-Asian rights, AVEO made an upfront payment of $5 million and committed to potential milestones payments which could total, in the aggregate, $60 million. Under the agreement, AVEO is also required to pay a tiered royalty on net sales in the AVEO territory, along with a specified percentage of revenue received from third parties for a sublicense to the tivozanib program.
Exclusive ex-North American option agreement for anti ERBB3 program
In March 2009, AVEO entered into an exclusive option and license agreement with Biogen Idec Inc. regarding the development and commercialization of AVEO’s discovery-stage ERBB3-targeted antibodies for the potential treatment and diagnosis of cancer and other diseases outside of the United States, Canada and Mexico. AVEO retains the exclusive right to commercialize ERBB3 antibody products in the United States, Canada and Mexico.
Under the terms of the agreement, Biogen Idec made an upfront cash payment of $5 million and made an upfront equity investment in AVEO of $30 million in March 2009. To date, AVEO has received an additional $15M in discovery and preclinical milestone payments and, if Biogen Idec exercises its option to obtain exclusive rights to commercialize ERBB3 antibody products in its territory, AVEO is eligible to receive an option exercise fee and regulatory milestone payments of $50 million in the aggregate.
Funded research collaboration utilizing AVEO's proprietary technology platform
In December 2010, AVEO and OSI Pharmaceuticals, Inc. (which is a wholly owned subsidiary of Astellas U.S. Holding Inc., a holding company owned by Astellas Pharma Inc.) announced that OSI exercised its option under the parties’ July 2009 agreement providing the right for OSI to internalize certain elements of AVEO’s proprietary technology platform, including components of the Human Response Platform™ for the identification/characterization of novel epithelial-mesenchymal transition (EMT) agents and proprietary patient selection biomarkers, in support of OSI’s clinical development programs. Under the terms of the agreement, OSI paid AVEO $25 million in license expansion fees.
The July 2009 agreement was an expansion of the drug discovery and translational research collaboration announced in October 2007. 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.