Exercise of Option Triggers $2.0 Million
Research and Development Payment to AVEO
AVEO Oncology (NASDAQ:AVEO) and EUSA Pharma today announced that
EUSA Pharma, under its multi-territory licensing agreement with
AVEO for FOTIVDA® (tivozanib), has opted into the Phase 1/2 TiNivo
study. Under terms of the agreement, EUSA may utilize data from the
study for regulatory or commercial purposes in exchange for a
research and development funding payment totaling $2.0 million.
EUSA’s decision follows approval in August of tivozanib by the
European Commission for the treatment of adult patients with
advanced renal cell carcinoma (RCC) in the European Union plus
Norway and Iceland.
The TiNivo trial is a Phase 1/2 trial of tivozanib in
combination with Bristol-Myers Squibb’s OPDIVO® (nivolumab),
an immune checkpoint, or PD-1, inhibitor, for the treatment of
RCC. The TiNivo trial is being led by the Institut Gustave Roussy
in Paris under the direction of Bernard Escudier, MD, Chairman of
the Genitourinary Oncology Committee. In June, AVEO announced the
advancement of the trial into the Phase 2 expansion portion
following successful completion of the Phase 1 dose escalation
portion. The combination was well tolerated to the full dose and
schedule of single agent tivozanib, with no dose limiting
toxicities. The expansion portion of the trial is expected to
enroll an additional 20 subjects. Phase 1 results from the ongoing
study have been submitted for presentation at a scientific meeting
taking place in the fourth quarter.
“We look forward to working with EUSA in helping shape the
future direction of FOTIVDA® in an evolving treatment landscape for
advanced RCC,” said Michael Bailey, president and chief
executive officer of AVEO. “Immunotherapy is defining an important
role as an early treatment option for this disease, creating an
opportunity to investigate the role of TKIs following immunotherapy
or in combination with immunotherapy. Having already demonstrated
superior PFS and an improved side effect profile compared to
sorafenib in the pivotal TIVO-1 study, FOTIVDA® is currently being
evaluated in an ongoing third line pivotal trial stratifying for
prior immunotherapy, and is well positioned to play a role in this
evolving treatment landscape.”
Lee Morley, EUSA Pharma’s Chief Executive Officer said,
“Following the recent European approval of FOTIVDA® for the
first-line treatment of patients with advanced RCC, emerging data
from the TiNivo study indicates the potential for FOTIVDA® in this
setting. With our partner AVEO and the RCC community, we are
committed to the ongoing development of FOTIVDA® and look forward
to investigating new and innovative treatment options for patients
with advanced RCC."
Under the terms of their December 2015 agreement, EUSA Pharma
has agreed to pay AVEO up to $388 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.
About Tivozanib (FOTIVDA®)
An over-expression of VEGF protein, and a resulting increase in
tumour blood supply (angiogenesis), is a common feature of
RCC.1 VEGFR-TKIs reduce the supply of blood to the tumour
and are the recommended first-line treatment for advanced RCC in
Europe, however, patients often experience significant side
effects, including fatigue, diarrhoea, and hand-foot syndrome.
In the global Phase III trial (TIVO-1)1 of over 500 patients
with advanced RCC, tivozanib demonstrated a significant PFS benefit
versus sorafenib (11.9 vs. 9.1 months in the overall patient
population [HR, 0.797; 95% CI, 0.639 to 0.993; P =.042], and 12.7
vs. 9.1 months in treatment-naïve patients [HR, 0.756; 95% CI,
0.580 to 0.985; P =.037]).1 There was also an improved side-effect
profile versus sorafenib, with significantly fewer patients on
tivozanib (14% versus 43%) requiring a dose reduction due to AEs;
and less than 5% of patients experiencing severe side effects
(grade 3&4, such as diarrhoea, asthenia (physical weakness) and
hand-foot syndrome. Hypertension (44%) and dysphonia (21%) were the
most commonly reported AEs on tivozanib.1
Under EUSA Pharma’s license agreement with AVEO, announced in
December 2015, the company holds exclusive commercialization rights
to tivozanib in RCC in Europe and in a number of other territories
outside North America, including South America and South Africa.
Under the terms of the agreement, EUSA Pharma will undertake and
fund the commercialization of the product in its territories,
assuming licensing. AVEO retains the rights to commercialize the
product in North America. Tivozanib was discovered by Kyowa Hakko
Kirin.
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), with the ultimate goal of creating high-value medicines
for the patients we serve. For more information, please visit the
company’s website at www.aveooncology.com.
About EUSA Pharma
Founded in March 2015, EUSA Pharma is a specialty pharmaceutical
company with a focus on oncology and oncology supportive care. The
company has commercial operations in the US and Europe, and a wider
distribution network in approximately 40 countries around the
world. EUSA Pharma is led by an experienced management team with a
strong record of building successful specialty pharmaceutical
companies, and is supported by significant funding raised from
leading life science investor EW Healthcare Partners.
For more information visit www.eusapharma.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: clinical, regulatory and commercial plans
of AVEO and its partner EUSA Pharma to progress the development of
FOTIVDA® (tivozanib); the role and expected benefits of tivozanib
and other TKIs on a stand-alone basis, or in combination with or
following immunotherapy; the expected enrollment of the TiNivo
trial and presentation of TiNivo results; expectations about the
potential for additional payments by EUSA Pharma; the value of
AVEO\'s partnerships in advancing its pipeline; and AVEO’s
strategy, prospects, plans and objectives, including as they
pertain specifically to tivozanib. 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 tivozanib. 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.
References
_________________
1 Motzer R.J; Nosov D et al. Tivozanib Versus Sorafenib As
Initial Targeted Therapy for Patients With Metastatic Renal Cell
Carcinoma: Results From a Phase III Trial. Journal of Clinical
Oncology. Volume 31. 2013: 30:3791
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version on businesswire.com: http://www.businesswire.com/news/home/20170920005638/en/
AVEO Contact:Argot PartnersDavid Pitts, (212)
600-1902aveo@argotpartners.comorEUSA Contacts:EUSA PharmaLee
MorleyChief ExecutiveTel: +44 (0)330 5001140orRJB CommunicationsRob
BudgeTel: +44 (0)1865 760969Mobile: +44 (0)7710 741241
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