CHARLESTON, S.C.--(BUSINESS WIRE)--Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) (the “Company”), a specialty biopharmaceutical company engaged in developing and commercializing novel pharmaceutical therapies, today reported financial and operating results for the first quarter ended March 31, 2017.
“Our focus has now shifted entirely to filing our new drug application (“NDA”
Commenting on recent key developments, David A. Dodd, President and Chief Executive Officer of the Company, stated, “On May 1, we reported that the ZoptEC (zoptarelin doxorubicin in endometrial cancer) Phase 3 study of Zoptrex™ in women with locally advanced, recurrent or metastatic endometrial cancer did not achieve its primary endpoint of demonstrating a statistically significant increase in the median period of overall survival of patients treated with Zoptrex™ as compared to patients treated with doxorubicin. Therefore, the results of the study do not support regulatory approval of Zoptrex™. Based on this outcome, we do not anticipate conducting clinical trials of Zoptrex™ with respect to any other indications.” Regarding the Company’s plans, Mr. Dodd continued, “Our focus has now shifted entirely to filing our new drug application (“NDA”) for Macrilen™ and, if the product is approved, to its commercial launch as soon as possible. We will also optimize our resources to be consistent with our focus on Macrilen™-related efforts. Consequently, we now expect that our monthly average use of cash in operations during the remainder of 2017 will be between $1.7 million and $1.9 million, a decrease of approximately 22%, compared to the first quarter. We continue to believe in the potential that Macrilen™ provides for us to become a successful specialty pharmaceutical company. Our intention is to submit the Macrilen™ NDA in the third quarter of 2017 and, if the product receives approval from the U.S. Food and Drug Administration (the “FDA”), to commercially launching the product in the first quarter of 2018.”
