Aeterna Zentaris Inc. (AEZS, AEZ.TO) announced that it signed co-development and profit sharing agreement with Ergomed Clinical Research Ltd. for AEZS-108 in endometrial cancer. Ergomed was selected as the contract clinical development organization to conduct the multicenter, multinational, randomized Phase 3 trial with AEZS-108 in endometrial cancer.
As per the terms of the agreement, Ergomed will assume 30% (up to $10 million) of the clinical and regulatory costs for the Phase 3 trial with AEZS-108 in endometrial cancer, which are estimated at approximately $30 million over the course of the study.
Ergomed will receive its return on investment based on an agreed single digit percentage of any net income received by Aeterna Zentaris for AEZS-108 in this indication, up to a specified maximum amount.
The study will be an open-label, randomized, multicenter Phase 3 trial conducted in North America, Europe, Israel and other countries under a Special Protocol Assessment, comparing AEZS-108 with doxorubicin as second line therapy for locally-advanced, recurrent or metastatic endometrial cancer. The trial will involve approximately 500 patients and the primary efficacy endpoint is improvement in median Overall Survival.
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