All amounts are in US dollars
QUÉBEC CITY, May 26, 2015 /CNW Telbec/ – Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”) today announced that it has received written scientific advice from the European Medicines Agency (“EMA”) regarding the further development plan, including the study design, for the new confirmatory Phase 3 clinical study of Macrilen™ (macimorelin) for use in evaluating adult growth hormone deficiency (“AGHD”), following a Scientific Advice Meeting that was held earlier this month. As a result of the advice, the Company believes that the confirmatory Phase 3 study that was discussed with the U.S. Food & Drug Administration (“FDA”) last March, meets the EMA’s study-design expectations.
Dr. Richard Sachse, Chief Scientific Officer and Chief Medical Officer of the Company stated, “We are very pleased with the EMA’s advice as we continue to believe that our trial will confirm the efficacy and safety of this product. In principle, the EMA agreed with our proposed protocol design in the evaluation of the product. In addition, it proposed that we consider additional aspects regarding the demonstration of reproducibility of a diagnosis made using Macrilen™, which will further enhance the profile of our compound. We believe we will be able to provide the information that EMA requires in a timely and cost‑effective manner.”
David A. Dodd, Chairman and Chief Executive Officer of the Company commented on the future development of Macrilen ™, “We are committed to moving forward swiftly with the development of Macrilen ™ in AGHD. We believe that completion of the confirmatory Phase 3 study and the QT study will take 15 to18 months and will require a combined expenditure of between $5 million and $6 million. We have the resources necessary to bring this product to market and intend to do so as rapidly as possible, pending regulatory approvals.”
The multinational confirmatory efficacy Phase 3 clinical study with Macrilen™ for the evaluation of AGHD will be conducted as a two-way crossover study with the insulin tolerance test as the benchmark comparator. The study population will consist of patients with a medical history documenting risk factors for AGHD and will include a spectrum of patients from those with a low risk of having AGHD to those with a high risk of having the condition. The Company will submit a proposed final protocol to the FDA for their review prior to commencing the confirmatory efficacy Phase 3 study. A dedicated thorough Phase 3 QT study to evaluate the effect of Macrilen™ on myocardial repolarization is expected to be initiated in early 2016.
About Macrilen ™ (macimorelin)
Macimorelin, a ghrelin agonist, is a novel 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 novel patented compound.
About Adult Growth Hormone Deficiency (AGHD)
AGHD affects approximately 75,000 adults across the U.S., Canada and Europe. Growth hormone not only plays an important role in growth from childhood to adulthood, but also helps promote a hormonally-balanced health status. AGHD mostly results from damage to the pituitary gland. It is usually characterized by a reduction in bone mineral density, lean body mass, exercise capacity, and overall quality of life.
About Aeterna Zentaris
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health. For more information, visit www.aezsinc.com.
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 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.
SOURCE Aeterna Zentaris Inc.