Aeterna Zentaris and Rafa Laboratories Sign Exclusive License Agreement for Zoptrex™ in Israel
August 01 2016 - 8:30AM
Business Wire
Aeterna Zentaris Inc. (NASDAQ: AEZS)(TSX: AEZ) (the “Company”)
and Rafa Laboratories, Ltd. (“Rafa”) today announced the signing of
an exclusive license agreement for the Company’s lead anti-cancer
compound, Zoptrex™ (zoptarelin doxorubicin), for the initial
indication of endometrial cancer, for Israel and the Palestinian
Territories (the “Territory”). Zoptrex™, a novel synthetic peptide
carrier linked to doxorubicin, 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 Rafa of the Company’s intellectual
property related to Zoptrex™ and the grant to Rafa of the right to
commercialize Zoptrex™ in the Territory. Rafa has also agreed to
make additional payments to the Company upon achieving certain
pre-established regulatory and commercial milestones. Furthermore,
the Company will receive double-digit royalties on future net sales
of Zoptrex™ in the Territory. Rafa will be responsible for the
development, registration, reimbursement and commercialization of
the product in the Territory. The Company and Rafa have also
entered into a supply agreement, pursuant to which the Company will
supply Zoptrex™ to Rafa for the duration of the license
agreement.
David Dodd, President and CEO of the Company, stated, “We are
very excited about this agreement for Zoptrex™ with Rafa
Laboratories. Women with advanced endometrial cancer are in need of
such additional treatments, and Zoptrex™ could prove to be a
significant treatment option for them. This agreement is also
consistent with 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 to have Rafa
Laboratories as our licensee for the Territory. Their experience
and commitment to ensuring the success of Zoptrex™ in their
Territory is most assuring.”
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 Rafa Laboratories, Ltd.
Rafa is a pharmaceutical company in Israel that markets,
manufactures and distributes prescription (Rx) and over-the-counter
(OTC) medicines, mainly proprietary formulations, as well as
generic formulations, and consumer health products. With a history
of over 75 years, Rafa is a trusted partner of some of the leading
pharmaceutical companies, such as Mundipharma, Purdue, United
Therapeutics, Napp, Ony, Galderma, Dr. Falk Pharma, Zambon and
more. Rafa's wide range of products portfolio is complemented by
world-class manufacturing facilities and a distribution network
that maintains the quality and integrity of our partners’ products.
The combination of its marketing expertise in market access and its
extensive local presence, gives Rafa a competitive advantage that
sets it apart from the competition. Rafa is part of a privately
owned international group of independent associated pharmaceutical
companies - the Purdue/Mundipharma/Napp group. These international
companies develop and market a broad range of pharmaceutical
solutions in key therapeutic areas, such as pain management,
respiratory and oncology.
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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