NEW RESEARCH: 52-page Report Available on Aeterna Zentaris Inc. (AEZS-NASDAQ)

Crystal Research Associates has issued a comprehensive, 52-page Executive Informational Overview (EIO) on Aeterna Zentaris Inc. (AEZS-NASDAQ; AEZ-TSX). 

Company Snapshot

Aeterna Zentaris (“Aeterna” or “the Company”) is transitioning into a specialty biopharmaceutical company in oncology, endocrinology, and women’s health. With a focus on establishing revenues and profitability while optimizing resources to reduce its burn rate, the Company co-promotes a non-patch estrogen replacement therapy, EstroGel®, in specific U.S. markets with partner, Ascend Therapeutics (“Ascend”). As well, Aeterna holds a pipeline of candidates in varying stages of development and is working to acquire, in-license, or co-promote other commercial compounds.

The Company’s most advanced wholly owned clinical candidate, zoptarelin doxorubicin (doxorubicin peptide conjugate targeting LHRH receptor–expressing tumors), is in a Phase 3 trial in advanced, recurrent, or metastatic endometrial cancer—a disease for which patients typically have a poor prognosis and there is no approved systemic therapy. Aeterna’s pipeline further includes Macrilen™, a drug for the evaluation of Adult Growth Hormone Deficiency (AGHD), for which the Company intends to initiate a confirmatory Phase 3 program, as well as other compounds in oncology, as the Company works to pursue strategic initiatives consistent with becoming a commercially operating specialty biopharmaceutical company.

Key Points

• As part of Aeterna’s co-promotion agreement announced in November 2014 with Ascend, Aeterna’s sales force of 19 co-promote EstroGel® in 19 U.S. sales territories with access to sales commissions. A top-prescribed estrogen product in Europe and the leading transdermal estrogen product in Canada, EstroGel® partakes in the $3.6 billion estrogen replacement market.

• A ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer), open-label, 500-patient Phase 3 trial in advanced endometrial cancer is ongoing under a Special Protocol Assessment (SPA) with the U.S. FDA. The primary endpoint is improvement in median overall survival. The first interim analysis could occur in the first half of 2015; the second interim analysis by year-end 2015.

• The Company intends to initiate a confirmatory Phase 3 efficacy trial and a QT interval trial by year-end 2015 for the evaluation of AGHD with Macrilen™, its orally active ghrelin agonist.

• Aeterna has established the infrastructure to grow through successful licensing, acquisition, and co-promotional opportunities of commercial compounds as it leverages its current sales force and brings in products that fit synergistically within its core focus areas.

• Aeterna’s leadership has experience and established ability in building significant value in the pharmaceutical industry.

• As of December 31, 2014, Aeterna had cash and cash equivalents of $34.9 million versus $43.2 million as of December 31, 2013. The Company subsequently closed a public offering of 59,677,420 units, generating net proceeds of approximately $34.5 million.