CAMBRIDGE, Mass.--(BUSINESS WIRE)--AVEO Oncology (NASDAQ:AVEO) today announced that a registration dossier seeking to obtain marketing authorization of tivozanib as a first line treatment of advanced renal cell carcinoma (“RCC”) has been accepted by the Ministry of Health (“MoH”) of the Russian Federation. The dossier was submitted in December 2015 by Pharmstandard Group, the largest Russian pharmaceutical group (“Pharmstandard”). In August 2015, AVEO licensed Pharmstandard rights to the development, manufacture and commercialization of tivozanib in the territories of Russia, Ukraine and the Commonwealth of Independent States (CIS), for all indications other than non-oncologic diseases or conditions of the eye.
Marketing authorization is being sought by Pharmstandard based upon results from TIVO-1, AVEO’s global, randomized, controlled Phase 3 trial evaluating tivozanib compared to sorafenib in patients with advanced RCC. AVEO is eligible to receive $7.5 million in connection with the first marketing authorization of tivozanib in Russia, provided that Russian regulatory authorities grant marketing approval based on the results from TIVO-1. If Russian regulatory authorities require additional studies to be performed prior to approval, the amount potentially payable to AVEO upon approval would be $3.0 million. AVEO is also eligible to receive a high single-digit royalty on net sales, if any, in the above mentioned territories. A percentage of any milestone and royalty payments received by AVEO are due to Kyowa Hakko Kirin as a sublicensing fee.
“Acceptance of a registration dossier marks an important step toward potential approval of tivozanib in RCC in territories outside the United States,” said Michael Bailey, president and chief executive officer of AVEO. “We look forward to MoH review of the dossier as we work toward submitting a marketing authorization application to the European Medicines Agency with our partner EUSA Pharma. In parallel, we continue to work toward the potential initiation of a Phase 3 trial of tivozanib in third line RCC to potentially enable registration in the first- and third-lines in the U.S., as well as the potential initiation of a combination study with a checkpoint inhibitor. Both studies may provide important strategic datasets in a rapidly evolving treatment landscape in RCC.”
Tivozanib is an oral, once-daily, investigational vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been evaluated in several tumors types, including renal cell, colorectal and breast cancers.
AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The company is focused on developing and commercializing its lead candidate tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor 1, 2 and 3 receptors, in North America as a treatment for renal cell carcinoma and other cancers. AVEO is leveraging multiple partnerships to develop and commercialize tivozanib in non-oncologic indications worldwide and oncology indications outside of North America, as well as to progress its pipeline of novel therapeutic candidates in cancer and cachexia (wasting syndrome). For more information, please visit the company’s website at www.aveooncology.com.
AVEO 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 fact, contained in this press release are forward-looking statements. The words “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “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: the potential for tivozanib to obtain regulatory approval in RCC in territories outside the United States; expected payments from Pharmstandard; expected benefits of the Pharmstandard license agreement; expected submission of a marketing authorization application to the European Medicines Agency; and AVEO’s plans to initiate a Phase 3 trial of tivozanib to potentially enable registration in first- and third-line therapy in the U.S., as well as the potential initiation of a combination study with a checkpoint inhibitor and the potential for both studies to provide an important strategic dataset in RCC. 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 maintain its licensing agreements, including with Pharmstandard and EUSA Pharma, and its ability, and the ability of its licensees, to achieve development and commercialization objectives under these arrangements; AVEO’s ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies the safety, efficacy and clinically meaningful benefit of AVEO’s product candidates; AVEO’s ability to successfully implement its strategic plans; AVEO’s ability to successfully enroll and complete clinical trials 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, expenses and outcomes related to AVEO’s ongoing shareholder litigation and SEC investigation; AVEO’s ability to raise the substantial additional funds required to achieve its near term strategic plans, including U.S. clinical trials of tivozanib; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled “Risk Factors” in AVEO’s most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and 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 may cause its views to change. 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 other than the date of this press release.