AVEO Announces Complete Response Letter Received for Tivozanib New Drug Application in Renal Cell Carcinoma

  AVEO Announces Complete Response Letter Received for Tivozanib New Drug
  Application in Renal Cell Carcinoma

Business Wire

CAMBRIDGE, Mass. -- June 10, 2013

AVEO Oncology (NASDAQ: AVEO) today announced that it has received a Complete
Response letter from the U.S. Food and Drug Administration (FDA) informing the
company that the FDA will not approve in its present form the New Drug
Application (NDA) for AVEO’s investigational agent tivozanib for the treatment
of patients with advanced renal cell carcinoma (RCC).

In the letter, the FDA stated that the inconsistent progression-free survival
and overall survival results and imbalance in post-study treatments make the
TIVO-1 results uninterpretable and inconclusive when making a risk-benefit
assessment necessary for drug approval, and recommended that AVEO conduct an
additional clinical study to support approval of tivozanib for the treatment
of advanced RCC. The FDA also stated that the proposed dissolution acceptance
criterion was not supported by the provided dissolution data, and would need
to be updated and resubmitted.

“In follow up to our conference call last week regarding AVEO’s restructuring,
we will convene a conference call tomorrow to discuss the Complete Response
letter and recent ODAC meeting,” said Tuan Ha-Ngoc, president and chief
executive of AVEO. “We hope this will be an opportunity to address questions
our investors may have about the FDA’s review of the tivozanib NDA in RCC.”

AVEO Conference Call Tuesday, June 11 at 8:00 a.m. ET

The AVEO management team will host a conference call on Tuesday, June 11, 2013
at 8:00 a.m. ET. The call can be accessed by dialing 1-877-299-4454 (domestic)
or 1-617-597-5447 (international) five minutes prior to the start of the call
and providing the passcode 15119983. A replay of the call will be available
approximately two hours after the completion of the call and can be accessed
by dialing 1-888-286-8010 (domestic) or 1-617-801-6888 (international),
providing the passcode 90604841. The replay will be available for two weeks
from the date of the call.

A webcast of the conference call can also be accessed by visiting the
investors section of the AVEO website at investor.aveooncology.com. A replay
of the webcast will be archived on the company’s website for two weeks
following the call.

About the AVEO/Astellas Collaboration

In February 2011, AVEO and Astellas Pharma Inc. entered into an agreement to
develop and commercialize tivozanib outside of Asia for the treatment of a
broad range of cancers.

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. 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 those risks
discussed in the section titled “Risk Factors” and elsewhere in AVEO’s
quarterly report on Form 10-Q for the quarter ended March 31, 2013 as filed
with the SEC, and in other filings it makes with the Securities and Exchange
Commission from time to time. 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.

Contact:

Pure Communications
Dan Budwick, 973-271-6085
or
AVEO Oncology
Rob Kloppenburg, 617-930-5595
 
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