Aeterna Zentaris Files International Patent Application for Novel Method of Manufacturing Zoptrex™
January 26 2016 - 8:30AM
Business Wire
Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the “Company”)
today announced that it has filed an international patent
application as well as national patent applications in selected
countries including the US, China, Taiwan, Japan and India. These
applications seek to protect the novel method of manufacturing
Zoptrex™ (zoptarelin doxorubicin), and were filed in addition to a
European patent application filed last year. The Company decided to
file patent applications in additional territories after the
European Patent Office issued a search report for the European
patent application that the Company considers to be favorable.
Dr. Richard Sachse, Senior Vice President and Chief Scientific
Officer/Chief Medical Officer of the Company stated, “Zoptrex™
passed a significant hurdle last fall when the independent Data and
Safety Monitoring Board recommended that we continue with our
pivotal ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase
3 clinical study of the compound in women with advanced, recurrent
or metastatic endometrial cancer who have progressed and who have
received one chemotherapeutic regimen with platinum and taxane
(either as adjuvant or first-line treatment). We expect to complete
the ZoptEC trial in Q3 of 2016 and, if the results of the trial
warrant doing so, to file the NDA and MAA for Zoptrex™ in
2017.”
Jude Dinges, Senior Vice President and Chief Commercial Officer
of the Company added, “We are now moving forward with our planning
to commercialize Zoptrex™, looking toward commercial launch of the
product in 2018, if our NDA and MAA are granted. The claimed
manufacturing process is expected to result in a significant
reduction in our cost of manufacturing Zoptrex™, providing what
should be a stronger competitive position for the Company and
discouraging competition from generic manufacturers after our
five-year period of data exclusivity expires.”
Zoptarelin doxorubicin is a complex molecule that combines a
synthetic peptide carrier with doxorubicin, a well-known
chemotherapy agent. The synthetic peptide carrier is a Luteinizing
Hormone Releasing Hormone (“LHRH”) agonist, a modified natural
hormone with high affinity for the LHRH receptor. The design of the
compound allows for the specific binding to the LHRH receptor and
is believed to facilitate the selective and targeted uptake of the
cytotoxic agent by LHRH receptor-positive tumors.
David A. Dodd, Chairman, President and Chief Executive Officer
of the Company explained the significance of the new synthesis
process: “We believe that Zoptrex™ has the potential to become the
first approved therapy in the U.S. for treating women within the
endometrial indication targeted in the ZoptEC trial, as well as
additional cancers that we might evaluate in the future. Our
commitment is to do our best such that patients and their
physicians have such therapies that can potentially improve and
extend the quality of lives. Zoptrex™ could be a very important
oncology tool if our ZoptEC Phase 3 study achieves its endpoints.
By reducing the complexity of production and the cost of the
compound, we will have greater flexibility in potentially ensuring
that patients on a worldwide basis have access to and can benefit
from this therapy. We believe this patent family, if granted, could
provide that advantage by giving us what should be a significant
production and cost advantage in support of further development in
additional indications. Along with our existing partner, Sinopharm
A-Think in China, Hong Kong and Macau, as well as other parties
currently evaluating the licensing of Zoptrex™ for other geographic
territories, we look forward to the possibility of successful
commercialization of this product and the benefits it might deliver
to patients and their health care providers.”
About Zoptrex™
Zoptrex™ represents a new targeting concept in oncology using a
hybrid molecule composed of a synthetic peptide carrier and a
well-known chemotherapy agent, doxorubicin. Zoptrex™ is the first
intravenous drug in advanced clinical development that is
considered to direct the chemotherapy agent specifically to
LHRH-receptor expressing tumors, which then could result in a more
targeted treatment with less damage to healthy tissue. Potential
benefits of this targeted approach include better efficacy and a
more favorable safety profile with lower incidence and severity of
side effects as compared to doxorubicin alone. Aeterna Zentaris
owns the worldwide rights to this compound except in China.
On December 1, 2014, the Company entered into a Master
Collaboration Agreement, a Technology Transfer and Technical
Assistance Agreement and a License Agreement with Sinopharm A-Think
Pharmaceuticals Co., Ltd for the development, manufacture and
commercialization of Zoptrex™ in all human uses in the Peoples
Republic of China, including Hong Kong and Macau. Sinopharm A-Think
is a subsidiary of Sinopharm, the largest medical and healthcare
group in China and on Fortune's Global 500 list.
About Aeterna Zentaris
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 of licenses to 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 ability of the Company to efficiently commercialize one
or more of its products or product candidates, the ability of the
Company to take advantage of business opportunities in the
pharmaceutical industry, uncertainties related to the regulatory
process, 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, unless required
to do so by a governmental authority or by applicable law.
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Aeterna Zentaris Inc.Philip A. Theodore, 843-900-3223Senior Vice
Presidentir@aezsinc.com
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