We published a 12-page Quarterly Update on specialty biopharmaceutical company Aeterna Zentaris, Inc. this morning. The report updates readers on Aeterna's news, milestones, and clinical and commercial development status since the publication of our base report, the Executive Informational Overview from April 2015.
About Aeterna Zentaris
With a focus on establishing revenues and profitability while optimizing resources to reduce its burn rate, Aeterna co-promotes a non-patch estrogen replacement therapy, EstroGel®, in specific U.S. markets with partner, Ascend Therapeutics (“Ascend”), and has recently entered into an agreement to promote EMD Serono’s Saizen® for growth hormone deficiencies in the U.S. as well. Aeterna further 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 fully enrolled 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 also includes Macrilen, which is in preparation for a Phase 3 confirmatory trial for the evaluation of Adult Growth Hormone Deficiency (AGHD), 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 from the Quarterly Update
Entering into an agreement with biopharmaceutical company, EMD Serono, Inc., marks the second promotional services agreement for Aeterna in recent months, as the Company accelerates its transition into a commercially operating specialty biopharma by leveraging its contractual sales force. The Company’s first co-promotion agreement was with Ascend for the sale of EstroGel® in 19 U.S. territories not already covered by Ascend.
In the second quarter 2015, Aeterna reached two milestones in its Phase 3 clinical trial of zoptarelin doxorubicin in endometrial cancer (the ZoptEC study). The first interim futility analysis was completed favorably with the trial recommended to continue per an independent data safety monitoring board, and Aeterna completed its enrollment of all 500 participants into the trial. The study is on track for completion in 2016.
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 overall strategy.
The Company’s leadership has experience and established ability in building significant value in the pharmaceutical industry. After raising approximately $34.5 million in early 2015, Aeterna reported that it held cash and cash equivalents of $53.3 million as of March 31, 2015.