AVEO Oncology (NASDAQ: AVEO) today announced that the European
Commission (EC) has approved FOTIVDA® (tivozanib) for the treatment
of adult patients with advanced renal cell carcinoma (RCC) in the
European Union plus Norway and Iceland. Tivozanib is indicated for
the first line treatment of adult patients with advanced RCC 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
advanced RCC.i EUSA Pharma, a specialty pharmaceutical company with
a focus on oncology and oncology supportive care, is the European
licensee for tivozanib. Tivozanib is an oral, once-daily, potent
and highly-selective vascular endothelial growth factor receptor
tyrosine kinase inhibitor (VEGFR-TKI).
Dr. Bernard Escudier, Medical Oncologist and member of the
Genitourinary Tumour Board of Gustave Roussy, France, commented
“This is excellent news for patients with metastatic RCC. Outcomes
in this disease have greatly improved with the introduction of
targeted therapies, meaning that patients are living for longer.
However, we are still in need of effective and well tolerated new
treatments in metastatic RCC and thus, tivozanib is a welcomed
addition.”
The approval from the EC follows the recommendation from the
Committee for Medical Products for Human Use (CHMP).i1 The decision
was primarily based on data from a global, open-label, randomized,
multi-center Phase 3 trial (TIVO-1)i,iii 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.iii 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%).iii
EUSA Pharma has indicated that it intends to now work with the
necessary health authorities to make tivozanib available to
advanced RCC patients across Europe as quickly as possible.
“The European Commission’s decision is the first regulatory
approval of tivozanib globally, and a tremendous accomplishment for
AVEO and its partner, EUSA Pharma. We are very pleased that
tivozanib is now available to patients in Europe,” said Michael
Bailey, president and chief executive officer of AVEO. “We also
continue to make progress on the next two pillars in our tivozanib
strategy: U.S. registration, driven by the pivotal Phase 3 TIVO-3
trial, which is expected to read out in the first quarter of 2018;
and immunotherapy combination trials, starting with the TiNivo
trial, our Opdivo® combination trial. European approval further
strengthens our balance sheet by triggering an R&D payment to
AVEO and provides AVEO the opportunity to achieve multiple
potential commercial milestone payments, as well as royalty
payments on sales, that would support our execution of the
tivozanib strategy.”
Under the terms of their December 2015 agreement, EUSA Pharma
has agreed to pay AVEO up to $394 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.
European marketing approval for tivozanib triggers a $4 million
research and development payment from EUSA, and AVEO will also be
eligible for up to $12 million in additional 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 funding, 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 RCC in Europe
RCC is the most common form of kidney cancer,iv which accounts
for an estimated 49,000 deaths in Europe each year.v It is expected
to be one of the fastest increasing cancers over the next ten
years.vi 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.iii,vii
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. 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.
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 anticipated readout of TIVO-3 in the
first quarter of 2018; expectations about the potential for
additional payments by EUSA Pharma; 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. 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.
i
http://ec.europa.eu/health/documents/community-register/index_en.htmii
CHMP summary of opinion. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004131/WC500229916.pdfiii
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: 30:3791iv Cancer Research UK. Kidney Cancer, Types
and Grades. Available at:
http://www.cancerresearchuk.org/about-cancer/kidney-cancer/stages-types-grades/types-grades.
Last accessed May 2017.v Cancer Research UK. Kidney Cancer
Statistics. Available at:
http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/kidney-cancer/mortality#heading-Five.
Last accessed May 2017.vi Cancer Research UK. Kidney cancer rates
are increasing, so what’s fuelling the surge? Available at:
http://scienceblog.cancerresearchuk.org/2017/04/24/kidney-cancer-rates-are-increasing-so-whats-fuelling-the-surge/.
Last accessed May 2017.vii Wong MKK, Mohamed AF et al. Selecting
renal cell carcinoma therapy: Ranking of patient perspective on
toxicities. J Clin Oncol 30: 303s, 2012 (suppl; abstr 4608)
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170828005408/en/
AVEO:Argot PartnersDavid Pitts,
212-600-1902aveo@argotpartners.com
AVEO Pharmaceuticals (NASDAQ:AVEO)
Historical Stock Chart
From Aug 2024 to Sep 2024
AVEO Pharmaceuticals (NASDAQ:AVEO)
Historical Stock Chart
From Sep 2023 to Sep 2024