AVEO and Astellas Report FDA Oncologic Drug Advisory Committee Votes Tivozanib Application Did Not Demonstrate Favorable Benefit

  AVEO and Astellas Report FDA Oncologic Drug Advisory Committee Votes
  Tivozanib Application Did Not Demonstrate Favorable Benefit-to-Risk
  Evaluation in Treatment of Advanced Renal Cell Carcinoma

Business Wire

CAMBRIDGE, Mass. & TOKYO -- May 2, 2013

AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Inc. (TSE: 4503) today
reported that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs
Advisory Committee (ODAC) voted that the application for investigational agent
tivozanib did not demonstrate a favorable benefit-to-risk evaluation for the
treatment of advanced renal cell carcinoma (RCC) in an adequate and
well-controlled trial (13 to 1, 0 abstentions).

“While we are disappointed with the outcome of the ODAC vote, we remain
confident in the efficacy, safety and tolerability of tivozanib in RCC
patients,” said Tuan Ha-Ngoc, president and chief executive officer of AVEO.
“We are committed to the RCC patient community and will work closely with the
FDA to address the issues discussed by the panel today as the Agency continues
its ongoing review of the New Drug Application for tivozanib.”

The ODAC provides the FDA with independent expert advice and recommendations.
The FDA is not bound by the Committee's guidance, but its input will be
considered by the Agency in its review of the tivozanib New Drug Application
(NDA), which was submitted by AVEO on September 28, 2012. 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.

The ODAC reviewed findings from a total of 17 trials involving more than 1,000
patients, including 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. In TIVO-1,
tivozanib demonstrated a statistically significant improvement in
progression-free survival, the primary endpoint of the study, and a favorable
tolerability profile when compared to sorafenib.

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 Tivozanib

Tivozanib is an oral, once-daily, investigational vascular endothelial growth
factor (VEGF) 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 the AVEO/Astellas Collaboration

In February 2011, AVEO and Astellas entered into an 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 Inc., located in Tokyo, Japan, is a pharmaceutical company
dedicated to improving the health of people around the world through the
provision of innovative and reliable pharmaceuticals. Astellas has
approximately 17,000 employees worldwide. The organization is committed to
becoming a global category leader in Urology, Immunology (including
Transplantation) and Infectious Diseases, Oncology, Neuroscience and DM
Complications and Kidney Diseases. For more information on Astellas Pharma
Inc., please visit the company website at www.astellas.com/en.

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 Platform^TM 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 date
for the completion of the FDA’s review of the tivozanib NDA; tivozanib’s
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 the TIVO-1 trial, including its data with respect
to progression-free survival, 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 the safety and efficacy
levels 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’s 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 most recent annual report on Form 10-K 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.

^1 U.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^.

^2 ^Cancer 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

^3 ^American Cancer Society. Available at:
^http://www.cancer.org/Cancer/KidneyCancer/OverviewGuide/kidney-cancer--adult^--
renal-cell-carcinoma-overview-what-is-kidney-cancer.

Contact:

Pure Communications
Investor Contact:
Caton Morris, 910-232-7166
or
AVEO Oncology
Media Contacts:
Rob Kloppenburg, 617-930-5595
or
Astellas US LLC
Maribeth Landwehr, 847-962-6507
 
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