Aeterna Zentaris and Orient EuroPharma Co., Ltd. Sign Exclusive License Agreement for Zoptrex™ in Taiwan and Southeast Asia
July 01 2016 - 8:30AM
Business Wire
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”)
and Orient EuroPharma Co., Ltd. (“OEP”) today announced the signing
of an exclusive license agreement between the Company and Cyntec
Co., Ltd., an affiliate of OEP (“Cyntec”), for the Company’s lead
anti-cancer compound, Zoptrex™ (zoptarelin doxorubicin), for the
initial indication of endometrial cancer, for Taiwan and nine
countries in Southeast Asia (the “Territory”). Zoptrex™, a novel
synthetic peptide carrier linked to doxorubicin as a New Chemical
Entity (NCE), is currently in a fully-enrolled Phase 3 clinical
trial in endometrial cancer. The Company expects to complete the
Phase 3 clinical trial in the third quarter of 2016 and, if the
results of the trial warrant doing so, to file a new drug
application for Zoptrex™ in the first half of 2017.
Under the terms of the License Agreement, Aeterna Zentaris will
be entitled to receive a non-refundable upfront payment in
consideration for the license to Cyntec of the Company’s
intellectual property related to Zoptrex™ and the grant to Cyntec
of the right to commercialize Zoptrex™ in the Territory. Cyntec has
also agreed to make additional payments to the Company upon
achieving certain pre-established regulatory and commercial
milestones. Furthermore, the Company will receive royalties on
future net sales of Zoptrex™ in the Territory. Cyntec will be
responsible for the development, registration, reimbursement and
commercialization of the product in the Territory.
David Dodd, President and CEO of the Company, stated, “We are
very excited about this arrangement with OEP. It is an important
step in our strategy of leveraging our pipeline to secure future
revenues with strategic development and commercial licensees for
specific regions of the world. We are very pleased that OEP’s
affiliates will commercialize Zoptrex™ in the Territory, providing
women with advanced endometrial cancer a significant treatment
option. Their experience and commitment to ensuring the success of
Zoptrex™ in their Territory is most assuring. We look forward to
similar, additional agreements as we progress towards the
completion of the pivotal Phase 3 trial and the subsequent
reporting of top-line results later this year.”
Commenting on the signing of the agreement, Peter Tsai, Chairman
and CEO of OEP stated, “With our advantage of the comprehensive
sales network and operation over Southeast Asia market which we
have cultivated for years, we successfully signed the partnership
with Aeterna Zentaris and the outstanding endometrial cancer
treatment. The exclusive license agreement gives us more confidence
in exploring the Asian market with a stronger product
portfolio.”
About Zoptrex™
Zoptrex™ is a complex molecule that combines a synthetic peptide
carrier with doxorubicin, a well-known chemotherapy agent. The
synthetic peptide carrier is [D-Lys6]-LHRH, a modified natural
hormone believed to have a strong affinity for the LHRH receptor.
The design of the compound allows for the specific binding and
selective uptake of the cytotoxic conjugate by LHRH
receptor-positive tumors. Potential benefits of this targeted
approach include enhanced efficacy and a more favorable safety
profile with lower incidence and severity of side effects as
compared to doxorubicin.
About Orient EuroPharma Co., Ltd.
Founded in 1982, Orient EuroPharma Co., Ltd (OEP) was officially
listed in the Gre-Tai Securities market in 2003, and consolidated
net sales exceeded $5 billion in the 2014 financial year.
Currently, OEP has more than 800 staffs worldwide, in which over
40% are overseas employees. OEP’s products include pharmaceuticals,
cancer drugs, cosmeceutical, infant & adult nutrition and
healthcare products. OEP also established a subsidiary company
focused on developing and manufacturing new drugs. OEP is one of
multinational pharmaceutical companies able to integrate
pharmaceutical research & development, clinical trial,
manufacture and marketing in Taiwan.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing novel treatments in
oncology, endocrinology and women’s health. We are engaged in drug
development activities and in the promotion of products for others.
We are now conducting Phase 3 studies of two internally developed
compounds. The focus of our business development efforts is the
acquisition or license of products that are relevant to our
therapeutic areas of focus. We also intend to license out certain
commercial rights of internally developed products to licensees in
territories where such out-licensing would enable us to ensure
development, registration and launch of our product candidates. Our
goal is to become a growth-oriented specialty biopharmaceutical
company by pursuing successful development and commercialization of
our product portfolio, achieving successful commercial presence and
growth, while consistently delivering value to our shareholders,
employees and the medical providers and patients who will benefit
from our products. For more information,
visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbor provisions of the US Securities
Litigation Reform Act of 1995. Forward-looking statements may
include, but are not limited to statements preceded by, followed
by, or that include the words “expects,” “believes,” “intends,”
“anticipates,” and similar terms that relate to future events,
performance, or our results. Forward-looking statements involve
known and unknown risks and uncertainties that could cause the
Company's actual results to differ materially from those in the
forward-looking statements. Such risks and uncertainties include,
among others, the availability of funds and resources to pursue
R&D projects and clinical trials, the successful and timely
completion of clinical studies, the risk that safety and efficacy
data from any of our Phase 3 trials may not coincide with the data
analyses from previously reported Phase 1 and/or Phase 2 clinical
trials, the rejection or non-acceptance of any new drug application
by one or more regulatory authorities and, more generally,
uncertainties related to the regulatory process, the ability of the
Company to efficiently commercialize one or more of its products or
product candidates, the degree of market acceptance once our
products are approved for commercialization, the ability of the
Company to take advantage of business opportunities in the
pharmaceutical industry, the ability to protect our intellectual
property, the potential of liability arising from shareholder
lawsuits and general changes in economic conditions. Investors
should consult the Company's quarterly and annual filings with the
Canadian and US securities commissions for additional information
on risks and uncertainties relating to forward-looking statements.
Investors are cautioned not to place undue reliance on these
forward-looking statements. The Company does not undertake to
update these forward-looking statements. We disclaim any obligation
to update any such factors or to publicly announce the result of
any revisions to any of the forward-looking statements contained
herein to reflect future results, events or developments, except if
required to do so.
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Aeterna Zentaris Inc.Philip A. Theodore, 843-900-3223Senior Vice
PresidentIR@aezsinc.com
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