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