Aeterna Zentaris to Present at Upcoming Rodman & Renshaw Annual Global Investment Conference in New York
06 September 2016 - 10:30PM
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
Rodman & Renshaw 18th Annual Global Investment Conference on
Monday, September 12, 2016 at 9:35 a.m. (Eastern) in conference
room Kennedy I (4th Floor) in the Lotte New York Palace Hotel in
New York City.
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 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 Adult Growth Hormone
Deficiency.
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:
- it is safer than the ITT because it
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. 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/20160906005310/en/
Aeterna Zentaris Inc.Philip A. Theodore, 843-900-3223Senior Vice
PresidentIR@aezsinc.com
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