AEterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the "Company"), a global biopharmaceutical company focused on endocrinology and oncology, today reported financial and operating results as at and for the three-month and nine-month periods ended September 30, 2009.
Third Quarter 2009 Highlights - July 7, 2009. Publication in Proceedings of the National Academy of Sciences, of new data supporting the use of AEZS-123 for the treatment of alcohol dependence that involves
ghrelin. - August 3, 2009. The Company's licensee partner for perifosine in North America, Keryx Biopharmaceuticals ("Keryx"), disclosed that it had reached an agreement with the FDA regarding a Special Protocol Assessment on the design of a Phase 3 trial for
multiple myeloma. - August 17, 2009. Disclosure of results for two Phase 3 studies with cetrorelix in benign prostatic hyperplasia ("BPH"). The
efficacy study Z-033 did not achieve its primary endpoint. Results from the safety study Z-041 were positive and exhibited a similar level of efficacy as the previously disclosed Phase 2 study results. - September 16, 2009. Disclosure that Keryx received Orphan Drug designation from the FDA for perifosine for multiple myeloma. - September 21, 2009. Disclosure of Phase 1 study results with AEZS-112 in advanced solid tumors or
lymphoma showed prolonged courses of stable disease, excellent tolerability and potential for long-term use as a combination treatment for
cancer. - September 30, 2009. Disclosure of results for the Thorough QT Z-043 ("TQT") study, which is part of the cetrorelix pamoate clinical development in BPH. The study met its primary endpoint. Subsequent to Quarter-End - October 19, 2009. Disclosure of the initiation of activities to complete a Phase 3 trial with macimorelin (AEZS-130) as a first approved oral diagnostic test for
Growth Hormone Deficiency. - October 23, 2009. Completion of a $5.5 million registered direct offering. - November 2, 2009. Disclosure of positive preliminary results for the Phase 2 study with AEZS-108 in
ovarian cancer.
Juergen Engel, Ph.D., AEterna Zentaris President and Chief Executive Officer, commented, "During this quarter, we disclosed results for the first of two efficacy trials of our Phase 3 program in BPH with cetrorelix. The first efficacy trial did not reach its primary endpoint, while results for the safety and TQT trials were positive. We remain committed to this program and are working towards receiving the results of the second efficacy study next month. Furthermore, we made significant progress with other innovative late-stage compounds such as perifosine and AEZS-108 in oncology, as well as AEZS-130 in endocrinology, which are further proof of the breadth of our pipeline."
Dennis Turpin, the Company's Senior Vice President and Chief Financial Officer, added, "Our financial position enables us to pursue our business and drug development activities, as planned."