CHARLESTON, S.C.--(BUSINESS WIRE)--
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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