Aeterna Zentaris to Present at Upcoming Rodman & Renshaw Annual Global Investment Conference in New York
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.
Aeterna Zentaris Inc.
Philip A. Theodore, 843-900-3223
Senior Vice President
IR@aezsinc.com
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