Agreement with Biogen Idec allows AVEO to seek partner to accelerate clinical development
CAMBRIDGE, Mass., March 20, 2014 – AVEO Oncology (NASDAQ: AVEO) today announced that it has regained worldwide rights to AV-203, a clinical-stage ErbB3 (HER3) inhibitory antibody candidate, from Biogen Idec.
"We are pleased to regain rights for AV-203 as we believe in the potential of this innovative therapy and are looking forward to maximizing its value," said Michael Bailey, chief business officer, AVEO Oncology. "As stated in our recently outlined strategy, this amended agreement enables us to seek a partner with established oncology capabilities that can accelerate and financially support the clinical development of AV-203."
In May 2013, AVEO successfully completed a Phase 1 safety study with AV-203 showing no dose limiting toxicities across the entire dose range up to and including the maximum administered dose of 20mg/kg. Results from the Phase 1 study are expected be presented at a scientific meeting in 2014. CLIA (Clinical Laboratory Improvements Amendment) validation has been completed for a biomarker for potential patient selection.
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 North America. AVEO retained the exclusive right to commercialize ErbB3 antibody products in North America. Under the terms of the amended agreement, Biogen waives its option to rights outside of North America to AV-203, thereby providing worldwide rights to AV-203 to AVEO. In exchange, AVEO will have certain financial obligations to Biogen with respect to amounts AVEO receives from certain development and sales milestones and royalties on net sales for AV-203.
AV-203 is a potent and selective ErbB3 (HER3) inhibitory antibody candidate designed to inhibit both ligand-dependent and ligand-independent ErbB3 signaling. ErbB3 is a receptor that is typically expressed in many human cancers, and AV-203 has demonstrated preclinical activity in a number of different tumor models including breast, head and neck, lung, ovarian and pancreatic cancers.
AVEO Oncology (NASDAQ: AVEO) is a biopharmaceutical company committed to discovering and developing targeted therapies designed to provide substantial impact in the lives of people with cancer by addressing unmet medical needs. AVEO's proprietary Human Response Platform provides the company unique insights into cancer and related disease biology and is being leveraged in the discovery and clinical development of its therapeutic candidates. For more information, please visit the company's website at www.aveooncology.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of AVEO within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "target," "potential," "could," "should," "seek," or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: AVEO's advancement of its business strategy, including entering into new strategic partnerships; AVEO's plans to initiate further studies of AV-203 and maximize its value; and the presentation of study results at scientific meetings. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: AVEO's ability to execute on its business strategy and enter into and maintain new strategic partnerships and collaboration agreements; AVEO's ability to successfully enroll and complete clinical trials and preclinical studies of its product candidates; AVEO's ability to demonstrate to the satisfaction of the FDA, or equivalent foreign regulatory agencies, the safety, efficacy and clinically meaningful benefit of its product candidates; AVEO's ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO's ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments and expenses related to AVEO's ongoing shareholder litigation and SEC inquiry; AVEO's ability to raise the substantial additional funds required to achieve its goals; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled "Risk Factors" included in AVEO's Annual Report on Form 10-K filed with the SEC on March 13, 2014 and in its other filings with the SEC. The forward-looking statements in this press release represent AVEO's views as of the date of this press release. AVEO anticipates that subsequent events and developments will cause its views to change. However, while AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO's views as of any date subsequent to the date of this press release.