June 03, 2015 07:09 PM Eastern Daylight Time
CAMBRIDGE, Mass.--(BUSINESS WIRE)--AVEO Oncology (NASDAQ:AVEO) today announced that, following pre-submission advisory meetings to discuss the potential submission of a Marketing Authorization Application (MAA) for tivozanib in Europe for the treatment of renal cell carcinoma (RCC), it has received written confirmation of support from the Rapporteur and co-Rapporteur for the filing of such an application. The Rapporteur (from Portugal) and Co-Rapporteur (from the United Kingdom) are the two appointed members of the Committee for Medicinal Products for Human Use (CHMP) who would lead the evaluation of the MAA, if submitted.
"cannot advise on [the] final outcome of the review."
The application would be based on the Company's existing dataset, which includes results from the Phase 3 TIVO-1 study of tivozanib in the first-line treatment of RCC in which tivozanib demonstrated a significant improvement over sorafenib in the study's primary endpoint of progression free survival. At the advisory meetings, AVEO provided data demonstrating that the discordance in overall survival (OS), the secondary endpoint of the study, was very likely attributable to the crossover design of the study. The final meeting minutes reflect that the Rapporteurs "did not see a 'blocking issue' with the OS trend" and that AVEO "clearly presented a credible story for the Rapporteurs to assess but one which would need to be supported with very careful reasoning." AVEO was also reminded that the Rapporteurs "cannot advise on [the] final outcome of the review."
"We are pleased that both the Rapporteur and Co-Rapporteur were supportive of an MAA filing for tivozanib in RCC using TIVO-1 as the pivotal study," said Michael Bailey, president and chief executive officer of AVEO. "We believe tivozanib may provide an important addition to the clinical armamentarium in the treatment of this disease. Based on our assessment of the economic and infrastructure requirements associated with filing an MAA and subsequently launching tivozanib in Europe, we are evaluating partnership opportunities to take tivozanib forward in this important market as we continue to prepare for a filing."
AVEO Oncology (AVEO) is a biopharmaceutical company committed to developing targeted therapies through biomarker-driven insights to provide improvements in patient outcomes where significant unmet medical needs exist. AVEO's proprietary Human Response Platform™ has delivered unique insights into cancer and related disease biology that AVEO is seeking to leverage in the clinical development strategy 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," "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 support of the Rapporteurs for of an MAA filing for tivozanib in RCC; the imbalance that caused the discordance in the Phase 3 TIVO-1 trial; and AVEO's plans and opportunities to take tivozanib forward. 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 demonstrate to the satisfaction of the FDA, EMA or other equivalent foreign regulatory agencies, include the Rapporteurs in Europe, the safety, efficacy and clinically meaningful benefit of its product candidates; AVEO's ability to successfully implement its restructuring and 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 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; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled "Risk Factors" included in AVEO's most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q 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.
Company, Media and Investors:
David Pitts, 212-600-1902