Oncologic Drugs Advisory Committee Meeting Scheduled for May 2, 2013
CAMBRIDGE, Mass. & NORTHBROOK, Ill.--(BUSINESS WIRE)--Feb. 27, 2013--
AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Global Development,
Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo:
4503), today announced that the U.S. Food and Drug Administration’s
(FDA) Oncologic Drugs Advisory Committee (ODAC) will review the
company's New Drug Application (NDA) for tivozanib for the treatment of
patients with advanced renal cell carcinoma (RCC) during the morning
session of its meeting on May 2, 2013. ODAC reviews and evaluates data
concerning the safety and effectiveness of marketed and investigational
human drug products for use in the treatment of cancer, and makes
recommendations to the Commissioner of Food and Drugs. According to the
timelines established by the Prescription Drug User Fee Act (PDUFA), the
review of the NDA is expected to be complete by July 28, 2013.
In November 2012, AVEO and Astellas announced that the FDA accepted for
filing the NDA for tivozanib with the proposed indication for the
treatment of patients with advanced RCC. The NDA includes results of the
global Phase 3 TIVO-1 (TIvozanib Versus
sOrafenib in 1st
line advanced RCC) trial, a randomized superiority-designed pivotal
trial evaluating the efficacy and safety of tivozanib compared to
sorafenib, an approved targeted agent, in 517 patients with advanced
RCC, as well as data from 16 additional AVEO-sponsored studies involving
over 1,000 subjects who received tivozanib. Tivozanib is an
investigational medicine and is not currently approved in any country.
About Tivozanib
Tivozanib is an oral, once-daily, investigational tyrosine kinase
inhibitor for which positive results from a Phase 3 clinical study in
advanced RCC have been reported, and is being evaluated in other tumors.
About Kidney Cancer
Advanced RCC, or kidney cancer, 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 accounts
for more than 90 percent of all kidney cancers.3
About the AVEO/Astellas Collaboration
In February 2011, AVEO and Astellas entered into a worldwide agreement
to develop and commercialize tivozanib outside of Asia for the treatment
of a broad range of cancers. Subject to regulatory approval, AVEO will
lead commercialization of tivozanib in North America and Astellas will
lead commercialization of tivozanib in the European Union (EU).
About Astellas
Astellas Pharma Global Development, Inc., located in Northbrook,
Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc.
Astellas is a pharmaceutical company dedicated to improving the health
of people around the world through the provision of innovative and
reliable pharmaceutical products. The organization is committed to
becoming a global category leader in oncology, and has several oncology
products on the market and compounds in development. Astellas is proud
to be an award recipient of the CEO Gold Standard Accreditation from the
CEO Roundtable on Cancer. For more information on Astellas Pharma Inc.,
please visit our website at www.astellas.us.
About AVEO
AVEO Oncology (NASDAQ: AVEO) is a cancer therapeutics company committed
to discovering, developing and commercializing targeted therapies to
impact patients' lives. AVEO's proprietary Human Response PlatformTM
provides the company unique insights into cancer biology and is being
leveraged in the discovery and clinical development of its cancer
therapeutics. 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 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: the planned launch and
commercialization of tivozanib; the potential approval by the FDA of
tivozanib in advanced RCC; the targeted dates for the FDA’s ODAC meeting
to review the NDA and the completion of the FDA’s review of the NDA;
tivozanib’s safety and efficacy profile and its potential in treating
patients with kidney cancer; and AVEO’s plans to leverage its Human
Response Platform™. 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: whether the results of AVEO’s
Phase 3 TIVO-1 trial are sufficient to obtain marketing approval for
tivozanib, which turns on the ability of AVEO to demonstrate to the
satisfaction of the FDA or comparable foreign regulatory authorities the
safety and efficacy of tivozanib based upon the findings of TIVO-1,
including its data with respect to PFS, the rate of adverse events,
overall survival and other information that the FDA may determine to be
relevant to approvability; AVEO’s ability to demonstrate in subsequent
trials any safety and efficacy it demonstrated in earlier trials of
tivozanib; ongoing regulatory requirements with respect to the approval
of tivozanib, including the risk that the FDA or any comparable foreign
regulatory agency could require additional positive clinical trials as
the basis for product approval; AVEO’s ability to obtain and maintain
adequate protection for intellectual property rights relating to its
product candidates and technologies; unplanned operating expenses;
AVEO’s ability to raise the substantial additional funds required to
achieve its goals; adverse general economic and industry conditions;
competitive factors; AVEO’s ability to maintain its collaboration with
Astellas; AVEO’s and Astellas’ ability to successfully launch and
commercialize tivozanib if and when it may be approved for
commercialization; and those risks discussed in the section titled “Risk
Factors” and elsewhere in AVEO’s current report on Form 8-K filed with
the SEC on January 16, 2013 and in its other filings with the Securities
and Exchange Commission. 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.
1U.S. Cancer Statistics Working Group. United States Cancer
Statistics: 1999–2009 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; 2013. 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
3American 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
AVEO Oncology
Investor Contact:
Monique Allaire,
617-299-5810
or
Media Contacts:
AVEO Oncology
Rob
Kloppenburg, 617-930-5595
or
Astellas US LLC
Jenny Kite,
224-205-5405
