Aeterna Zentaris to Present at Upcoming Aegis Capital Corp. 2016 Growth Conference in Las Vegas, Nevada
September 12 2016 - 8:30AM
Business Wire
Company to Provide Updates regarding
Completion of Pivotal, Phase III Trials for Macrilen™ and Zoptrex™
and Potential NDA Submission Timelines
Aeterna Zentaris Inc. (NASDAQ: AEZS)(TSX: AEZ) (the “Company”)
today announced that the Company's President and Chief Executive
Officer, David Dodd, will present a corporate overview at the Aegis
Capital Corp. 2016 Growth Conference on Thursday, September 22,
2016 at 1:00 p.m. (Pacific Daylight Time) in Room 1, Life Science
in The Encore at Wynn Las Vegas, Las Vegas, Nevada.
During the presentation, the Company will provide updates on the
impending completion of the pivotal, Phase III trials for Macrilen™
and Zoptrex™, as well as potential timing of NDA submissions, if
the results of the trials warrant doing so.
About Macrilen™ (macimorelin)
Macimorelin, a ghrelin agonist, is an orally-active small
molecule that stimulates the secretion of growth hormone.
Macimorelin, under the trade name Macrilen™, has been granted
orphan drug designation by the FDA for diagnosis of Adult Growth
Hormone Deficiency (“AGHD”). The Company owns the worldwide rights
to this patented compound and has significant patent protection
left. The Company’s U.S. composition of matter patent expires in
2022 and its U.S. utility patent runs through 2027. If approved,
Macrilen™ will be the only FDA-approved drug indicated for use in
assessing AGHD.
The Company believes that, in the US alone, approximately 36,000
confirmatory tests for AGHD are conducted each year, which
represents the target market at commercialization. Furthermore, the
Company believes that Macrilen™, if it is approved, is likely to be
rapidly adopted by physicians as the preferred means of evaluating
AGHD for the following reasons:
- Unlike the insulin tolerance test
(“ITT”), currently the most often means of evaluating AGHD, the
evaluation of AGHD using Macrile™ does not require the patient to
become hypoglycemic;
- Macrilen™ is administered orally, while
the ITT requires an intravenous infusion of insulin;
- the evaluation of AGHD using Macrilen™
is much less time consuming and labor intensive than the ITT and,
therefore, it is less expensive to conduct; and
- the evaluation can be conducted in the
physician’s office rather than in a hospital setting.
The Company intends to commercialize the product in the United
States and is considering out-licensing the commercial rights in
non-US territories.
About Zoptrex™ (zoptarelin doxorubicin)
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. Zoptarelin doxorubicin, under the
tradename, Zoptrex™, provides potential benefits of this targeted
approach, including enhanced efficacy and a more favorable safety
profile with lower incidence and severity of side effects as
compared to doxorubicin. To date, the Company has entered into
out-licensing agreements for Zoptrex™ with: Sinopharm A-Think
Pharmaceuticals Co., Ltd. for China, Hong Kong and Macau;
affiliates of Orient EuroPharma Co., Ltd. for Taiwan and Southeast
Asia; and Rafa Laboratories, Ltd. for Israel and Palestine.
Agreements for other non-US territories are in discussion.
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, Macrilen™ and Zoptrex™. 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160912005400/en/
Aeterna Zentaris Inc.Philip A. Theodore, 843-900-3223Senior Vice
PresidentIR@aezsinc.com
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