Company to Evaluate Potential for Submission of a Tivozanib MAA
for the Treatment of RCC
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 8, 2015--
AVEO Oncology (NASDAQ:AVEO) today announced that it has received written
confirmation from the European Medicine Agency (EMA) that tivozanib is
eligible for submission of an application for a European Union Marketing
Authorization under the Agency’s centralized procedure. Confirmation of
eligibility was given in response to the submission of a letter of
intent enabling the Company to evaluate the opportunity for submitting a
Marketing Authorization Application (MAA) for tivozanib with the EMA for
the treatment of renal cell carcinoma (RCC). Tivozanib is an oral,
potent, selective inhibitor of vascular endothelial growth factor
tyrosine kinase inhibitor (VEGF TKI) with a long half-life and activity
against all three VEGF receptors. Tivozanib has previously been granted
orphan drug designation in Europe for the treatment of RCC.
The letter of intent, which must be filed at least seven months prior to
submission of a MAA, initiates the process to address a number of
pre-submission requirements, including the assignment of a Rapporteur
and Co-Rapporteur, who are two appointed members of the Committee for
Human Medicinal Products (CHMP). The CHMP is the committee responsible
for preparing opinions on questions concerning human medicines.
Confirmation of eligibility for submission is not predictive of the
EMA’s approval of a MAA.
“Our letter of intent and the subsequent confirmation of eligibility by
the EMA are first steps in evaluating the potential for submission of a
tivozanib MAA in Europe for the treatment of RCC,” said Michael Bailey,
president and chief executive officer of AVEO. “AVEO and its global RCC
clinical advisors continue to believe that tivozanib has the potential
to offer RCC patients an alternative to existing therapies. With the
European rights to tivozanib recently regained, we now have the
opportunity to work with the EMA to fully evaluate the potential for a
MAA submission.”
AVEO remains encouraged by the clinical outcomes from its Phase 2 and
Phase 3 studies in RCC and the efficacy and tolerability profile that
tivozanib may offer to patients suffering from this challenging disease.
AVEO recently entered into an option agreement with Ophthotech to
investigate tivozanib for the potential treatment of non-oncologic
diseases of the eye, and the Company is actively pursuing partnerships
to advance the development of tivozanib in solid tumors.
About Renal Cell Carcinoma
Advanced renal cell carcinoma (RCC) is the ninth most commonly diagnosed
cancer in men and women in the U.S.1 Worldwide it is
estimated that more than 250,000 people are diagnosed and more than
100,000 people die from the disease each year.2 RCC is the
seventh most common cancer in Europe, with more than 115,000 new cases
diagnosed in 2012 (3% of the total).3 RCC accounts for more
than 90 percent of all kidney cancers.4
About Tivozanib
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.
About AVEO
AVEO Oncology (NASDAQ: AVEO) is a biopharmaceutical company committed to
developing targeted therapies through biomarker-driven insights to
provide substantial 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 are being leveraged in the clinical development of its therapeutic
candidates. For more information, please visit AVEO’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 plans to evaluate filing a MAA in Europe
for the treatment of RCC, the potential benefits of tivozanib to RCC
patients, AVEO’s plans to work with the EMA to evaluate the opportunity
for approval in Europe, and its plans to secure partnerships to advance
tivozanib. 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 successfully implement
and manage its recently announced restructuring and obtain the benefits
it expects to derive from the reduction in its workforce and internal
research functions; AVEO’s ability to execute on its business strategy
and enter into and maintain new strategic partnerships and collaboration
agreements, including with respect to tivozanib; 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, EMA or other 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; 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 Quarterly Report 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.
References
1U.S. Cancer Statistics Working Group. United States Cancer
Statistics: 1999–2007 Incidence and Mortality Web-based Report. Atlanta:
U.S. Department of Health and Human Services, Centers for Disease
Control and Prevention and National Cancer Institute; 2010. Available
at: www.cdc.gov/uscs
2Cancer Research UK. Available at: http://info.cancerresearchuk.org/cancerstats/world/the-global-picture/#Common;
http://publications.cancerresearchuk.org/downloads/Product/cs_pdf_worldwide_2011.pdf
3Cancer Research UK. Available at: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/kidney/incidence/uk-kidney-cancer-incidence-statistics#geog
4American Cancer Society. Available at: http://www.cancer.org/Cancer/KidneyCancer/OverviewGuide/kidney-cancer--adult--renal-cell-carcinoma-overview-what-is-kidney-cancer
Source: AVEO Oncology
Company, Media and Investor Contact:
Argot Partners
David
Pitts, 212-600-1902
aveo@argotpartners.com
