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Aeterna Zentaris Reports First Quarter 2013 Financial and Operating Results
All amounts are in U.S. dollars (unless otherwise noted) QUEBEC CITY, May 7, 2013 /CNW ...
About this update from Cosciens Biopharma Inc.
[{"type":"text","content":"\n\n\n\n\n\nAll amounts are in U.S. dollars (unless otherwise noted)\n\n\nQUEBEC CITY, May 7, 2013 /CNW Telbec/ - Aeterna Zentaris Inc.\n (NASDAQ: AEZS) (TSX: AEZ) (the \"Company\"), a late‑stage drug\n development company specializing in oncology and endocrinology, today\n reported financial and operating results as at and for the first\n quarter ended March 31, 2013.\n\n\nKey Drug Developments\n\n\nAEZS-108 (Doxorubicin Peptide Conjugate) \n\n\n\nFirst patient treated for Phase 2 trial in triple-negative breast\n cancer. Alberto J. Montero, MD, Assistant Professor, Department of\n Medicine, Division of Hematology/Oncology, Sylvester Comprehensive\n Cancer Center at the University of Miami Miller School of Medicine, is\n the lead investigator of this trial which also includes sites at the\n Universities of Regensburg and Goettingen in Germany.\n\n\n\n\nSubsequent to quarter-end, a co-development and profit-sharing agreement\n was signed with Ergomed Clinical Research Ltd. (\"Ergomed\") as the\n contract clinical development organization for the upcoming Phase 3\n trial for AEZS‑108 in endometrial cancer. Under the terms of the\n agreement, Ergomed will assume 30% (up to $10 million) of the clinical\n and regulatory costs for this trial, which are estimated at\n approximately $30 million over the course of the study. Ergomed will be\n entitled to receive an agreed upon single-digit percentage of any net\n income received by the Company for AEZS-108 in this indication, up to a\n specified maximum amount. This is an open-label, randomized,\n multicenter trial to be conducted in North America, Europe, Israel and\n other countries under a Special Protocol Assessment (\"SPA\"). The trial\n will compare AEZS-108 with doxorubicin as second line therapy for\n locally-advanced, recurrent or metastatic endometrial cancer. The trial\n will involve approximately 500 patients and the primary efficacy\n endpoint is improvement in median Overall Survival (\"OS\").\n\n\n\n\n\n\nAEZS-130 (Oral Ghrelin Agonist)\n\n\n\nOngoing preparation of a New Drug Application (\"NDA\") submission to the\n U.S. Food and Drug Administration (\"FDA\") for AEZS‑130 as an oral\n diagnostic test for Adult Growth Hormone Deficiency (\"AGHD\"). Phase 3\n data have demonstrated that the compound has the potential to become\n the fir...