Aeterna Zentaris & Specialised Therapeutics Asia Sign Exclusive License Agreement for the Potential Marketing of Zoptrex™ i...
October 12 2016 - 8:00AM
Business Wire
Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the “Company”)
and Specialised Therapeutics Asia (“STA”) today announced the
signing of an exclusive license agreement for the Company’s lead
investigational anti-cancer compound, Zoptrex™ (zoptarelin
doxorubicin), for the territories of Australia and New Zealand (the
“Territory”). Zoptrex™, a novel synthetic peptide carrier linked to
doxorubicin, is currently undergoing a fully-enrolled Phase 3
clinical trial to evaluate the compound in endometrial cancer. The
Company expects to complete the Phase 3 clinical trial in 2016 and,
if the results of the trial warrant doing so, to submit a new drug
application for Zoptrex™ to the United States Food and Drug
Administration (FDA) in the first half of 2017. Zoptrex™ is the
Company’s proposed tradename for zoptarelin doxorubicin. The
proposed tradename is subject to approval by the FDA.
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 STA of the Company’s intellectual
property related to Zoptrex™ and the grant to STA of the right to
commercialize Zoptrex™ in the Territory. STA has also agreed to
make additional payments to the Company upon achieving certain
pre-established regulatory and commercial milestones, as well as
double-digit royalties on future net sales of Zoptrex™ in the
Territory. STA will be responsible for the development,
registration, reimbursement and commercialization of the product in
the Territory. The Company and STA have also entered into a supply
agreement, pursuant to which the Company will supply Zoptrex™ to
STA for the duration of the license agreement.
David Dodd, President and CEO of the Company, stated, “I am very
pleased that we have now concluded four agreements for the
commercial rights to Zoptrex™, if approved, outside the United
States. We believe that the interest in Zoptrex expressed by our
licensees supports our view that Zoptrex™, if it is approved by the
FDA for its initial indication, could be an important treatment
option for women with the most severe form of endometrial cancer.
We are particularly pleased to have a company of the caliber of STA
as a licensee. STA enjoys the highest reputation in its markets
and, with its existing portfolio of oncology products, it has the
capability to position Zoptrex™ very well in the market.”
STA Chief Executive Officer Mr. Carlo Montagner said Zoptrex™
had demonstrated great potential and was poised to add further
value to the company’s expanding oncology portfolio. “All results
to date suggest Zoptrex™ is a potent new compound and we look
forward to collaborating closely with Aeterna Zentaris to maximise
its full potential in our key markets,” he said.
About Zoptrex™
Zoptrex™ (zoptarelin doxorubicin) 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 Specialised Therapeutics Asia
Specialised Therapeutics Asia Pte Ltd (“STA”) is an
international biopharmaceutical company established to provide
pioneering healthcare solutions to patients throughout South East
Asia, as well as in Australia and New Zealand. The company is a
close affiliate of Specialised Therapeutics Australia, which also
collaborates with leading global pharmaceutical and diagnostic
companies to bring novel, innovative and life changing healthcare
solutions to patients affected by a range of diseases. STA is
committed to making new and novel therapies available to patients
around the world, with a broad therapeutic portfolio spanning
oncology, hematology, urology and ophthalmology. Additional
information can be found at www.specialisedtherapeutics.com.au.
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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version on businesswire.com: http://www.businesswire.com/news/home/20161012005199/en/
Aeterna Zentaris Inc.Philip A. Theodore, Senior Vice
PresidentIR@aezsinc.com843-900-3223orSpecialised Therapeutics
AsiaEmma Power, Communications Managerepower@stabiopharma.com+61
419 149 525
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