EUSA to Submit Marketing Authorization Application for Tivozanib
in Advanced RCC in Q1 2016
AVEO to Host Conference Call Today, December 21, 2015 at 9:00 AM ET
CAMBRIDGE, Mass. & HEMEL HEMPSTEAD, England--(BUSINESS WIRE)--Dec. 21, 2015--
AVEO Oncology (NASDAQ:AVEO) and EUSA Pharma, a newly-established
specialty pharmaceutical business with global reach, today announced an
exclusive license agreement in which AVEO has granted EUSA Pharma
European rights to tivozanib for the treatment of advanced renal cell
carcinoma (“RCC”). The agreement also includes a number of additional
territories outside North America, including South America and South
Africa, and additional potential indications.
Under the terms of the agreement, EUSA Pharma will pay AVEO an upfront
research and development funding payment of $2.5 million, and up to $394
million in potential payments and milestones, assuming successful
achievement of specified development, regulatory and commercialization
objectives, as well as a tiered royalty ranging from a low double-digit
up to mid-twenty percent on net sales of tivozanib in the agreement’s
territories. A percentage of milestone and royalty payments received by
AVEO are due to Kyowa Hakko Kirin as a sublicensing fee.
EUSA Pharma plans to submit a Marketing Authorization Application for
tivozanib as a first line treatment for advanced RCC to the European
Medicines Agency in the first quarter of 2016. Under the terms of the
agreement, EUSA Pharma will undertake and fund future regulatory and
commercial activities to bring tivozanib to market and commercialize the
product within the agreement’s territories.
“Tivozanib has the potential to become an important new first line
treatment for advanced renal cell carcinoma in Europe, and we look
forward to submitting a Marketing Authorization Application in the
coming months,” said Lee Morley, chief executive officer of EUSA Pharma.
“As a recently established specialty pharma company, we have ambitious
growth plans, and tivozanib is a strong strategic fit with our portfolio
of marketed specialty products, as we increase our focus on oncology.”
“Our agreement with EUSA Pharma marks a critical step in the execution
of our company strategy. Between our partnership with EUSA and our
previous agreements with Ophthotech and Pharmstandard, we have a solid
foundation to potentially generate near-term capital and long-term value
for this important asset while retaining commercial rights to tivozanib
in oncology in North America,” said Michael Bailey, president and chief
executive officer of AVEO. “These tivozanib partnerships collectively
amount to over $35 million in potential payments over the next 18 months
in addition to potential payments from our other licensed pipeline
assets, which could provide substantial additional funding to support
our tivozanib development strategy for North America. We look forward to
working with the experienced commercial and regulatory team at EUSA
Pharma as they seek to successfully commercialize tivozanib in Europe.”
Today’s Conference Call Information
AVEO will host a conference call today, December 21, at 9:00 am (ET).
The call can be accessed by dialing (866) 428-2694 (domestic) or (704)
908-0403 (international) five minutes prior to the start time and
providing the conference ID 13985653. A live webcast of the conference
call can be accessed by visiting the investors section of
the AVEO website at www.aveooncology.com.
A replay of the webcast will be archived on the AVEO website for two
weeks following the call.
About Tivozanib
Tivozanib is an oral, once-daily, investigational vascular endothelial
growth factor (VEGF) tyrosine kinase inhibitor (TKI). 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 evaluated in several tumors types,
including renal cell, colorectal and breast cancers.
About EUSA Pharma
Founded in March 2015, EUSA Pharma is a specialty pharmaceutical
company. The company has commercial operations in the US and Europe, and
a wider distribution network in approximately 40 countries around the
world. Currently, EUSA has a portfolio of five approved and several
named-patient specialty hospital products, and the company has ambitious
plans to expand this through acquisition and in-licensing. EUSA 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 Essex
Woodlands.
EUSA Pharma’s products include: Caphosol® for the treatment of oral
mucositis, a common and debilitating side-effect of radiation therapy
and high-dose chemotherapy; Collatamp®, a gentamicin-collagen implant
licensed either in haemostasis or for the prevention and treatment of
surgical site infection; Custodiol® solution for use in the preservation
of organs for transplantation; Fomepizole® for the treatment of ethylene
glycol poisoning; and Xenazine® for the treatment of movement disorders
associated with Huntington's chorea.
For more information please visit www.eusapharma.com.
About AVEO
AVEO Oncology (AVEO) is a biopharmaceutical company committed to
developing targeted therapies through biomarker-driven insights to
provide improvements in patient outcomes where significant unmet medical
needs exist. AVEO’s proprietary Human Response Platform™ has delivered
unique insights into cancer and related disease biology that AVEO is
seeking to leverage in the clinical development strategy of its
therapeutic candidates. For more information, please visit the company’s
website at www.aveooncology.com.
AVEO Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of AVEO 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 fact, contained in this press release are
forward-looking statements. The words “anticipate,” “believe,” “expect,”
“intend,” “may,” “plan,” “could,” “should,” “seek,” “would” “look
forward,” 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
expected benefits of AVEO’s agreement with EUSA Pharma; the amount,
timing and potential receipt of payments under the EUSA agreement;
AVEO’s development plans for tivozanib; AVEO’s beliefs about its ability
to execute on its strategies for tivozanib; AVEO’s ability to generate
near-term capital and long-term value for tivozanib; and AVEO’s
expectations that its tivozanib partnerships could provide over $35
million in potential payments in the next 18 months, and that its
receipt of this and other potential payments from other licensed
pipeline assets could provide substantial additional funding to support
its tivozanib development strategy for North America. 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 maintain its agreement with EUSA Pharma and its other
licensees, and its ability, and the ability of its licensees, 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; AVEO’s
ability to successfully implement its strategic plans; AVEO’s ability to
successfully enroll and complete clinical trials of its product
candidates; 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 and SEC investigation; AVEO’s ability to raise
the substantial additional funds required to achieve its goals;
unplanned capital requirements; adverse general economic and industry
conditions; competitive factors; and those risks discussed in the
section titled “Risk Factors” in AVEO’s most recent Annual Report on
Form 10-K, its quarterly reports on Form 10-Q and its other filings with
the SEC. 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151221005110/en/
Source: Aveo Pharmaceuticals, Inc.
For AVEO:
Argot Partners
David Pitts, 212-600-1902
aveo@argotpartners.com
or
For
EUSA:
EUSA Pharma
Lee Morley, +44 (0)330 5001140
Chief
Executive
or
RJB Communications
Rob Budge, +44 (0)1865
760969
Mobile: +44 (0)7710 741241
