QUÉBEC CITY, April 16, 2015 /CNW
Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the
"Company") today announced that it has filed an application for a
patent (European Patent Office priority application: EP15000132) on
a novel method of manufacturing zoptarelin doxorubicin, its hybrid
cytotoxic molecule that is the subject of a pivotal ZoptEC
(Zoptarelin doxorubicin in Endometrial Cancer)
Phase 3 clinical study 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). The claimed
manufacturing process is expected to result in a significant
reduction in the cost of goods sold, providing a stronger
competitive position for the Company.
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 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 a better efficacy and a
more favorable safety profile with lower incidence and severity of
side effects as compared to doxorubicin alone.
Because zoptarelin doxorubicin is a complex molecule, it is
expensive to synthesize. The patent application, which is entitled
"Enzymatic process for the regioselective manufacturing
of N-Fmoc-doxorubicin-14-O-dicarboxylic acid mono esters", may,
if granted, make it difficult for generic manufacturers to produce
the compound on a financially feasible basis after the Company's
composition‑of-matter patent on zoptarelin doxorubicin
expires.
David A. Dodd, Chairman and Chief
Executive Officer of the Company explained the significance of the
patent application for the new synthesis process: "We believe that
zoptarelin doxorubicin has the potential to become the first
approved therapy in the U.S. for treating women within the targeted
Phase 3 indication, as well as additional cancers that we might
evaluate in the future. Our commitment is to ensure that patients
and their physicians have such therapies that can potentially
improve and extend the quality of lives. With the 2015 expiration
date of the U.S. composition-of-matter patent on the horizon, we
sought a means to maintain our advantage for this compound beyond
the five-year period of exclusivity granted to new chemical
entities, which we expect to apply to zoptarelin doxorubicin. The
compound could be a very important oncology tool if our ZoptEC
Phase 3 study achieves its endpoints. By reducing the complexity of
production and cost of the compound, we will have greater
flexibility in potentially ensuring that patients on a worldwide
basis have access and can benefit from this therapy. We believe
this patent, if granted, could provide that advantage by giving us
a significant production and cost advantage in support of further
development in additional indications. Finally, we are most proud
that this manufacturing process was invented by our colleagues
within the Company's Frankfurt-based research and development
staff."
The Company owns all rights to the new process. The Company
intends to file a PCT patent application in January 2016, claiming priority of the filed EP
patent application.
About Zoptarelin Doxorubicin
Zoptarelin doxorubicin represents a new targeting concept in
oncology using a hybrid molecule composed of a synthetic peptide
carrier and a well-known chemotherapy agent, doxorubicin.
Zoptarelin doxorubicin is the first intravenous drug in advanced
clinical development that directs the chemotherapy agent
specifically to LHRH-receptor expressing tumors, resulting in a
more targeted treatment with less damage to healthy tissue. The
Company is currently conducting a ZoptEC (Zoptarelin
doxorubicin in Endometrial Cancer) Phase 3 trial in
women with advanced, recurrent or metastatic endometrial cancer,
while zoptarelin doxorubicin is also in an investigator-initiated
Phase 2 trial in prostate cancer. 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 zoptarelin doxorubicin 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 Endometrial Cancer
Endometrial cancer is the most common gynecologic malignancy in
developed countries and develops when abnormal cells amass to form
a tumor in the lining of the uterus. It largely affects women over
the age of 50 with a higher prevalence in Caucasians and a higher
mortality rate among African Americans. According to the American
Cancer Society, there will be more than 54,000 new cases of
endometrial cancer in the U.S. alone in 2015, with about 20% of
recurring disease.
About Aeterna Zentaris
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing novel treatments in
oncology, endocrinology and women's health. 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. Specifically, the statement of our
expectation that zoptarelin doxorubicin is a new chemical entity
that will receive a five-year period of exclusivity is a
forward-looking statement that was based on a review of the
applicable law and FDA written guidance, and communications from
the agency itself on this compound. However, the status of
zoptarelin doxorubicin as a new chemical entity will be determined
by the FDA during the new-drug-application process. 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.
SOURCE Aeterna Zentaris Inc.