Aeterna Zentaris to Participate in 18th Annual BIO CEO & Investor Conference Seeking Partnering Opportunities
February 01 2016 - 5:33PM
Business Wire
Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the “Company”)
today announced that Chairman, President and Chief Executive
Officer David A. Dodd will participate in the 18th Annual BIO CEO
& Investor Conference, on February 8 & 9, 2016 in New York
City. Mr. Dodd will update participants on the status of the
Company’s two Phase 3 clinical trials and will continue the
Company’s efforts to secure additional partners for the development
of Zoptrex™, which if approved by the FDA, would be the first
systemic therapy for the treatment of advanced and recurrent
endometrial cancer, and for Macrilen™, which if approved by the
FDA, would be the first orally administered drug indicated for the
evaluation of adult growth hormone deficiency (“AGHD”). The Company
continues to actively seek opportunities to in-license and acquire
products for US commercialization, consistent with its goal of
becoming a growth-oriented specialty biopharmaceutical company by
pursuing successful development and commercialization of its
product portfolio.
Commenting on the BIO CEO & Investor Conference, Mr. Dodd
stated, “This conference is an excellent opportunity to meet with a
number of potentially interested commercial and strategic partners
because it brings the key decision-makers together in one place.
With the expected completion of our Phase 3 clinical trials of
Zoptrex™ and Macrilen™ by the end of 2016, we are seeing increased
interest from potential development partners for both compounds. We
intend to pursue this interest aggressively.”
About Zoptrex™
Zoptrex™ (zoptarelin doxyrubicin) represents a new concept in
oncology whereby a “targeting” peptide is conjugated to a cytotoxic
drug in order to facilitate targeted delivery of the cytotoxic
agent to cancer cells expressing the corresponding target peptide
receptor. 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 the cytotoxic
agent alone. The Zoptrex™ Phase 3 clinical program, which is
fully-enrolled, is being conducted under a Special Protocol
Assessment with the US FDA and, in October 2015, received
endorsement and support for trial continuation to completion from
the independent Data and Safety Monitoring Board. Completion of the
clinical trial is expected by the end of Q3 2016.
The Company intends to commercialize Zoptrex™, if approved, in
the U.S. market. Zoptrex™ has been out-licensed to Sinopharm
A-Think, the largest China-based pharmaceutical company, for the
development, manufacturing and commercialization for all human
indications, in the territories of China, Hong Kong and Macao.
Discussions are underway with potential additional partners
relative to the development and commercialization rights in other
geographic territories. Zoptrex™ has also demonstrated encouraging
results in Phase 2 clinical programs completed in both ovarian and
prostate cancer therapy.
About Macrilen™
Macrilen™ (macimorelin acetate) is an orally-active ghrelin
receptor agonist that induces a fasting patient’s Growth Hormone
(GH) secretion. A single oral dose of Macrilen™ causes a rapid
increase in GH levels in individuals with an intact
hypothalamic-pituitary axis. It is in Phase 3 development for the
evaluation of adult growth hormone deficiency (AGHD) and is
expected to be completed in 2016. The Company intends to
commercialize Macrilen™, once approved in the U.S. market.
Discussions relative to non-US geographic rights for Macrilen™ are
underway with various interested parties.
Macrilen™ (macimorelin acetate) is an orally-active ghrelin
receptor agonist that induces a fasting patient’s Growth Hormone
(GH) secretion. A single oral dose of Macrilen™ causes a rapid
increase in GH levels in individuals with an intact
hypothalamic-pituitary axis. It is in Phase 3 development for the
evaluation of adult growth hormone deficiency (AGHD) and is
expected to be completed in 2016. The Company intends to
commercialize Macrilen™, once approved in the U.S. market.
Discussions relative to non-US geographic rights for Macrilen™ are
underway with various interested parties.
Co-Promoted Products
The Company currently co-promotes three products: EstroGel®
(estradiol gel), a leading gel application of estrogen therapy,
from Ascend Therapeutics; Saizen® [somatropin (rDNA origin) for
injection], a recombinant human growth hormone supplement from EMD
Serono; and APIFINY®, the first non-PSA blood test for use in
evaluating and managing the risk of prostate cancer, from Armune
Bioscience. During the conference, the Company will pursue
opportunities to in-license or to acquire products that will
compliment this portfolio.
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 or 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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version on businesswire.com: http://www.businesswire.com/news/home/20160201006383/en/
Aeterna Zentaris Inc.Philip A. Theodore, Senior Vice
President843-900-3223ir@aezsinc.com
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