EUSA Pharma and AVEO Oncology (NASDAQ:AVEO) today announced the
first commercial launch of FOTIVDA® (tivozanib) with the initiation
of product sales in Germany. In the European Union, Norway and
Iceland, tivozanib is indicated for the first line treatment of
adult patients with advanced renal cell carcinoma (aRCC) and for
adult patients who are vascular endothelial growth factor receptor
(VEGFR) and mTOR pathway inhibitor-naïve following disease
progression after one prior treatment with cytokine therapy for
aRCC.i Tivozanib is an oral, once-daily, potent and
highly-selective vascular endothelial growth factor receptor
tyrosine kinase inhibitor (VEGFR-TKI). EUSA Pharma is the licensee
for tivozanib in Europe, North and South Africa, Latin America and
Australasia.
Lee Morley, EUSA Pharma’s Chief Executive Officer said, “We are
delighted that we have been able to grant access to FOTIVDA for
patients in one of Europe’s key markets so soon after our
regulatory approval. We look forward to working with physicians in
Germany to ensure the profile and benefits of FOTIVDA are known and
understood. We will of course continue to work with health
authorities across all European markets to ensure early access to
FOTIVDA as a therapeutic option in the ongoing fight against
aRCC.”
“The first-ever commercial launch of FOTIVDA is a tremendous
accomplishment for AVEO, our partner EUSA Pharma, and, most
importantly, patients with aRCC who now have access to a new and
differentiated therapeutic option,” said Michael Bailey, president
and chief executive officer of AVEO. “Over the course of its
development, FOTIVDA’s efficacy and tolerability profile among VEGF
TKIs has been recognized by investigators as an important potential
option for their patients, making this long-anticipated milestone a
gratifying achievement. We continue to leverage this profile as we
work towards exploring the full extent of FOTIVDA’s use in the
emerging aRCC market. We also look forward to continuing to expand
its availability in Europe, through our partner, EUSA, and
potentially in North America, where we plan to file for FDA
approval pending the results of our pivotal study, TIVO-3.”
FOTIVDA® was approved by the European Commission in August 2017.
Approval was primarily based on data from a global, open-label,
randomized, multi-center Phase 3 trial (TIVO-1)i,ii which evaluated
the efficacy and tolerability of tivozanib compared to a currently
available comparator VEGFR-TKI treatment (sorafenib) in 517
patients with advanced RCC. Patients treated with tivozanib
experienced superior PFS (11.9 vs. 9.1 months in the overall
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]) versus sorafenib.ii There was also an
improved side effect profile with tivozanib, with only 14% (versus
43% with sorafenib) requiring a dose reduction due to adverse
events (AEs). In addition, fewer people on tivozanib experienced
burdensome side effects, such as diarrhea (23% vs 33%) and
hand-foot syndrome (14% vs 54%).ii
About RCC in Europe
RCC is the most common form of kidney cancer,iii which accounts
for an estimated 49,000 deaths in Europe each year.iv It is
expected to be one of the fastest increasing cancers over the next
ten years.v Tyrosine Kinase Inhibitor (TKI) vascular endothelial
growth factor (VEGF) inhibitors are the standard of care treatment
for advanced RCC in Europe, however, patients on current treatments
can often experience significant side effects.ii,vi
About Tivozanib (FOTIVDA®)
Tivozanib (FOTIVDA®) is an oral, once-daily, vascular
endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)
discovered by Kyowa Hakko Kirin and approved for the
treatment of adult patients with advanced renal cell carcinoma in
the European
Union plus Norway and Iceland. It is a potent,
selective and long half-life inhibitor of all three VEGF receptors
and is designed to optimize VEGF blockade while minimizing
off-target toxicities, potentially resulting in improved efficacy
and minimal dose modifications.i,ii Tivozanib has been investigated
in several tumors types, including renal cell, colorectal and
breast cancers.
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.
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 and
commercialization 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; 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 in AVEO’s Annual Report on Form 10-K for the year
ended December 31, 2016 and in other periodic filings that AVEO
makes 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, except
as required by law. 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
i Fotivda (Tivozanib) SmPC, August 2017ii Motzer RJ, Nosov D,
Eisen T, et al. J Clin Oncol 2013; 31(30): 3791-9.iii Cancer
Research UK. Kidney Cancer, Types and Grades, May 2017.iv Cancer
Research UK. Kidney Cancer Statistics, May 2017.v Cancer Research
UK. Kidney cancer rates are increasing, so what’s fuelling the
surge? May 2017.vi Wong MKK, Mohamed AF et al. J Clin Oncol 30:
303s, 2012 (suppl; abstr 4608)
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version on businesswire.com: http://www.businesswire.com/news/home/20171115005382/en/
AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.comorEUSA:EUSA PharmaLee
Morley, +44 (0)330 5001140Chief Executive
AVEO Pharmaceuticals (NASDAQ:AVEO)
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