AVEO Oncology Announces Receipt of Payments from EUSA Pharma and CANbridge
September 13 2017 - 7:00AM
Business Wire
AVEO Oncology (NASDAQ:AVEO) today announced the receipt of a $4
million research and development payment from EUSA Pharma related
to the approval of FOTIVDA® (tivozanib) for the treatment of adult
patients with advanced renal cell carcinoma in Europe, and a $0.5
million milestone payment from CANbridge related to manufacturing
development activities for AV-203, AVEO’s clinical-stage ErbB3
(HER3) inhibitory antibody candidate.
“These payments further strengthen our balance sheet while
demonstrating the value of our partnerships in advancing AVEO’s
pipeline,” said Michael Bailey, president and chief executive
officer of AVEO. “Additionally, these payments add to our current
cash on hand, which was expected to fund operations into the fourth
quarter of 2018. We look forward to several additional key
milestones in the coming quarters, including the expected
presentation of tivozanib-nivolumab combination Phase 1 TiNivo
study results this fall, and the anticipated readout of our pivotal
Phase 3 TIVO-3 trial in the first quarter of 2018.”
Under the terms of their December 2015 agreement, EUSA Pharma
has agreed to pay AVEO up to $390 million in future milestone
payments and research and development funding, assuming successful
achievement of specified development, regulatory and
commercialization objectives. In addition, a tiered royalty will be
due to AVEO ranging from a low double-digit up to mid-twenty
percent on net sales of tivozanib in the agreement’s territories.
With European approval, AVEO will be eligible for up to $12 million
in milestones from EUSA based on reimbursement and regulatory
approvals. In the territories licensed to EUSA, thirty percent of
milestone and royalty payments received by AVEO, excluding research
and development payments such as the one announced today, are due
to Kyowa Hakko Kirin (KHK) as a sublicensing fee. In the
territories retained by AVEO, the royalty obligation to KHK ranges
from the low- to mid-teens on net sales.
In March 2016, AVEO announced an exclusive collaboration and
license agreement, granting CANbridge worldwide rights to AV-203,
excluding the United States, Canada, and Mexico. Under the terms of
the collaboration and license agreement, AVEO is eligible to
receive up to $132 million in future reimbursement and milestone
payments, assuming the successful achievement of specified
development, regulatory and commercialization objectives, as well
as a tiered royalty, with a percentage range in the low double
digits, on net sales of AV-203 in the partnered territories.
AVEO has retained North American rights to tivozanib and
AV-203.
About AVEO
AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to
advancing a broad portfolio of targeted therapeutics for oncology
and other areas of unmet medical need. The Company is focused on
seeking to develop and commercialize its lead candidate tivozanib,
a potent, selective, long half-life inhibitor of vascular
endothelial growth factor 1, 2 and 3 receptors, in North
America as a treatment for renal cell carcinoma and other
cancers. AVEO is leveraging multiple partnerships aimed
at developing and commercializing tivozanib in oncology indications
outside of North America, and at progressing its pipeline of
novel therapeutic candidates in cancer and cachexia (wasting
syndrome). Tivozanib (FOTIVDA®) is approved by the European
Commission for the treatment of adult patients with advanced
renal cell carcinoma (RCC) in the European
Union plus Norway and Iceland. 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
that involve substantial risks and uncertainties. All statements,
other than statements of historical fact, contained in this press
release are forward-looking statements. The words “anticipate,”
“believe,” “expect,” “intend,” “may,” “plan,” “potential,” “could,”
“should,” “would,” “seek,” “look forward,” “advance,” “goal,”
“strategy,” 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 value of AVEO's partnerships in
advancing its pipeline; AVEO's cash runway; the expected
presentation of TiNivo results this fall; the anticipated readout
of TIVO-3 in the first quarter of 2018; expectations about the
potential for additional payments by EUSA Pharma and CANbridge;
plans to progress pipeline programs; the expected benefits of
tivozanib; and AVEO’s strategy, prospects, plans and objectives,
including as they pertain specifically to tivozanib and AV-203.
AVEO has based its expectations and estimates on assumptions that
may prove to be incorrect. As a result, readers are cautioned not
to place undue reliance on these expectations and estimates. 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 enter into and
maintain its third party collaboration agreements, and its ability,
and the ability of its licensees and other partners, to achieve
development and commercialization objectives under these
arrangements; AVEO’s ability, and the ability of its licensees, to
demonstrate to the satisfaction of applicable regulatory agencies
the safety, efficacy and clinically meaningful benefit of AVEO’s
product candidates, including without limitation risks relating to
the ability of EUSA to successfully obtain reimbursement approval
of tivozanib in the countries within its territory. AVEO faces
other risks relating to its business as well, including risks
relating to its ability to successfully enroll and complete
clinical trials, including the TIVO-3 and TiNivo studies; 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, expenses and outcomes related to AVEO’s
ongoing shareholder litigation; AVEO’s ability to successfully
implement its strategic plans; AVEO’s ability to raise the
substantial additional funds required to achieve its goals,
including those goals pertaining to the development and
commercialization of tivozanib; unplanned capital requirements;
adverse general economic and industry conditions; competitive
factors; and those risks discussed in the section titled “Risk
Factors” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations—Liquidity and Capital
Resources” included in AVEO’s Annual Report on Form 10-K for the
year ended December 31, 2016, its quarterly reports on Form 10-Q
and in other filings that AVEO may make with the SEC in the future.
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 may cause its views to
change. 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 other than the date of this press release.
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version on businesswire.com: http://www.businesswire.com/news/home/20170913005216/en/
AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
AVEO Pharmaceuticals (NASDAQ:AVEO)
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