AVEO and Astellas Announce FDA Acceptance of NDA Filing for Tivozanib for the Treatment of Advanced Renal Cell Carcinoma

  AVEO and Astellas Announce FDA Acceptance of NDA Filing for Tivozanib for
  the Treatment of Advanced Renal Cell Carcinoma

Business Wire

CAMBRIDGE, Mass. & TOKYO -- November 28, 2012

AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Inc. (TSE: 4503) today
announced that the U.S. Food and Drug Administration (FDA) has accepted for
filing the New Drug Application (NDA) for tivozanib with the proposed
indication for the treatment of patients with advanced renal cell carcinoma
(RCC). Tivozanib is an investigational medicine and is not currently approved
in any country. 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 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. Results of TIVO-1 were presented at the 2012
Annual Meeting of the American Society for Clinical Oncology (ASCO).

The proposed brand name for tivozanib is TIVOPATH™, which is a trademark of
AVEO Pharmaceuticals, Inc.This name has received conditional acceptance from
the FDA and the European Medicines Agency (EMA), but final approval by the FDA
and EMA is pending. Tivozanib is an investigational compound. Its safety and
efficacy have not yet been fully established.

The FDA’s acceptance of the NDA triggers a $15 million milestone payment to
AVEO under its development and commercialization agreement with Astellas.

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
Currently available therapies provide less than one year of median PFS in
treatment naive patients and are associated with significant toxicities.^4
These toxicities not only lead to high rates of dose reductions and
interruptions (potentially compromising efficacy), but also can impact a
patient’s quality of daily living.^5

About Tivozanib

Tivozanib is a potent, selective, long half-life inhibitor of all three
vascular endothelial growth factor (VEGF) receptors that is designed to
optimize VEGF blockade while minimizing off target toxicities. Tivozanib is an
oral, once-daily, investigational tyrosine kinase inhibitor for which positive
results from a Phase 3 clinical study in advanced renal cell carcinoma have
been reported. Tivozanib is also under evaluation across a broad range of
solid tumors, including metastatic colorectal cancer and metastatic breast
cancer.

About Astellas

Astellas Pharma Inc., headquartered 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 Oncology, Urology, Immunology (including
Transplantation) and Infectious Diseases, Neuroscience and DM Complications
and Kidney Diseases. For more information on Astellas Pharma Inc., please
visit the company’s 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™ 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 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: the targeted date for the completion of the
FDA’s review of the 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 TIVO-1 are sufficient to obtain marketing approval for tivozanib in
the U.S. and abroad, 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 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 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 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 most recent Quarterly Report on Form 10-Q 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:
1999–2007 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

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

^4Bhargava, P., Robinson, M. Curr Oncol Rep (2011) 13:103–111

^5Ravaud, A. Annals of Oncology 20 (Supplement 1): i7–i12, 2009

Contact:

AVEO
Investor Contact:
Monique Allaire, AVEO Oncology, 617-299-5810
or
Media Contacts:
Rob Kloppenburg, AVEO Oncology, 617-930-5595
or
Astellas Pharma Inc.
Jenny Kite, Astellas US LLC, 224-205-5405