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Guildford, UK – 25 June 2015: Ergomed plc, (LSE: ERGO or ‘Ergomed’) a profitable UK-based company, dedicated to the provision of specialised services to the pharmaceutical industry and the development of new drugs is pleased to announce that it has been selected by Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) to manage the new, confirmatory Phase 3 clinical study to demonstrate the efficacy of Macrilen™ (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency (“AGHD”).
Miroslav Reljanovic, Chief Executive Officer of Ergomed said: “We are delighted that Aeterna Zentaris has selected us to manage their confirmatory study of Macrilen™. We have a strong and deep working relationship the Aeterna Zentaris scientific staff and hold them in the highest regard. Ergomed is committed to developing orphan drugs, and we believe that Macrilen™ has the potential to provide a much needed tool for the evaluation of AGHD. We look forward to progressing this study with Aeterna Zentaris.”
David A. Dodd, Chairman, President and Chief Executive Officer of Aeterna Zentaris remarked regarding the selection of Ergomed: “We have great confidence in Ergomed’s ability to conduct our confirmatory clinical study of Macrilen™ on schedule and within budget. Ergomed’s performance as our clinical research organization supporting our pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer has been excellent. We are committed to Macrilen™ because of our confidence in its efficacy and safety and the medical need for such a convenient test in the absence of an FDA-approved diagnostic test for AGHD.”
The confirmatory Phase 3 clinical study of Macrilen™ 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. Based on meetings with the US FDA as well as the European Medicines Agency (the “EMA”) and subsequent written scientific advice, the Aeterna Zentaris believes that the study meets FDA’s and EMA’s study-design expectations allowing US and European approval, if successful.
For further information, please contact:
Mary Clark, Supriya Mathur and Hollie Vile
Tel: + 44 203 440 5654
Stifel Nicolaus Europe Limited
NOMAD/Broker to the Company
Jonathan Senior, Giles Balleny
Tel: + 44 207 710 7600
Ergomed Plc is a profitable UK-based company, providing drug development services to the pharmaceutical industry and has a growing portfolio of co-development partnerships. It operates in over 40 countries.
Ergomed provides clinical development, trial management and pharmacovigilance services to over 60 clients ranging from top 10 pharmaceutical companies to small and mid-sized drug development companies. Ergomed successfully manages clinical development from Phase I through to late phase programmes.
Ergomed has a wide therapeutic focus, with a particular expertise in oncology, neurology and immunology and the development of orphan drugs. Ergomed believes its approach to clinical trials is differentiated from that of other providers by its innovative Study Site Management model and the use of Study Physician Teams, resulting in a close relationship between Ergomed and the physicians involved in clinical trials.
As well as providing high quality clinical development services, Ergomed is building a portfolio of co-development partnerships with pharma and biotech companies which share the risks and rewards of drug development. Ergomed leverages its expertise and services in return for carried interest in the drugs under development. For further information, visit: http://www.ergomedplc.com
About MacrilenTM (macimorelin)
Macimorelin, a ghrelin agonist, is a novel orally-active small molecule that stimulates the secretion of growth hormone. Macimorelin, under the trade name MacrilenTM, has been granted orphan drug designation by the FDA for diagnosis of AGHD. Aeterna Zentaris 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 Inc.
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
Forward Looking Statements
Certain statements contained within the announcement are forward looking statements and are based on current expectations, estimates and projections about the potential returns of Ergomed plc (“Ergomed”) and industry and markets in which Ergomed operates, the Directors’ beliefs and assumptions made by the Directors. Words such as “expects”, “anticipates”, “should”, “intends”, “plans”, “believes”, “seeks”, “estimates”, “projects”, “pipeline” and variations of such words and similar expressions are intended to identify such forward looking statements and expectations. These statements are not guarantees of future performance or the ability to identify and consummate investments and involve certain risks, uncertainties, outcomes of negotiations and due diligence and assumptions that are difficult to predict, qualify or quantify. Therefore, actual outcomes and results may differ materially from what is expressed in such forward looking statements or expectations. Among the factors that could cause actual results to differ materially are: the general economic climate, competition, interest rate levels, loss of key personnel, the result of legal and commercial due diligence, the availability of financing on acceptable terms and changes in the legal or regulatory environment.
These forward-looking statements speak only as of the date of this announcement. Ergomed expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in Ergomed’s expectations with regard thereto, any new information or any change in events, conditions or circumstances on which any such statements are based, unless required to do so by law or any appropriate regulatory authority.