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:
In December 2015, AVEO entered into an exclusive license agreement granting EUSA Pharma European rights to tivozanib for the treatment of advanced renal cell carcinoma (“RCC”). The agreement also includes a number of additional territories outside North America, including South America and South Africa, and additional potential indications.
Under the terms of the agreement, EUSA Pharma paid AVEO an upfront research and development funding payment of $2.5 million, and AVEO is eligible to receive up to $394 million in potential payments and milestones, assuming successful achievement of specified development, regulatory and commercialization objectives, as well as a tiered royalty ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement’s territories. A percentage of milestone and royalty payments received by AVEO are due to Kyowa Hakko Kirin as a sublicensing fee.
In November 2014, AVEO entered into a research and exclusive option agreement with Ophthotech Corporation, under which it provided Ophthotech an exclusive license to investigate the potential of AVEO’s small molecule vascular endothelial growth factor tyrosine kinase inhibitor, tivozanib, outside of Asia for the treatment of non-oncologic diseases of the eye.
Under the terms of the agreement, Ophthotech paid AVEO an upfront fee of $500,000 to investigate tivozanib as a potential treatment for non-oncologic diseases of the eye. During the option term, if Ophthotech elects to continue development of the ocular formulation of tivozanib after its initial analysis, AVEO is eligible to receive up to $8 million in milestone payments based upon the achievement of specified research, development and business goals. Ophthotech has the exclusive right, exercisable through a $2 million option exercise, to obtain additional development and commercialization rights to tivozanib and products containing tivozanib for non-oncologic eye indications in territories outside Asia, subject to certain conditions, including outcomes of a proof of concept clinical trial.
If Ophthotech exercises its option, AVEO could also receive additional clinical and regulatory-based milestone payments of up to $50 million, sales based milestone payments of up to $45 million and double digit royalties on product sales. Ophthotech is responsible for all research and development activities and costs, and upon exercise of its option, further development and commercialization activities and costs for tivozanib ocular indications. A percentage of all milestone and royalty payments received by AVEO are due to Kyowa Hakko Kirin as a sublicensing fee.
In August 2015, AVEO announced an exclusive, worldwide license agreement with Novartis for the development and commercialization of AV-380, AVEO’s first-in-class, potent, humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15).
Under the agreement, AVEO received an upfront payment of $15 million as well as $3.5 million for its existing drug supply. AVEO is eligible to receive clinical, regulatory and sale-based milestone payments totaling $311 million assuming successful advancement of the product. AVEO will also be eligible to receive tiered royalties on product sales ranging from high single digits to a low double-digits. Novartis will be responsible for all clinical development, manufacturing and commercialization activities and costs associated with the product.
In March 2016, AVEO granted CANbridge Life Sciences worldwide rights, excluding the United States, Canada, and Mexico, to AV-203, AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate.
Under the terms of the collaboration and license agreement, CANbridge Life Sciences paid AVEO an upfront payment of $1 million and AVEO is eligible to receive up to $133 million in potential reimbursement and milestone payments, assuming the successful achievement of specified development, regulatory and commercialization objectives. AVEO is also eligible for a tiered royalty, with a percentage range in the low double digits, on net sales of AV-203 in the agreement’s territories.
In April 2014, AVEO entered into a worldwide agreement with Biodesix to develop and commercialize AVEO’s hepatocyte growth factor (HGF) inhibitory antibody ficlatuzumab.
Pursuant to this agreement Biodesix fully funded a study in NSCLC and will share 50% of all additional development, manufacturing and commercialization costs for the program. AVEO and Biodesix will equally share in any profits from the development of ficlatuzumab.