Veru Adds Androgen Deprivation Therapy to Prostate Cancer Pipeline

— VERU-100 Is a Proprietary Peptide Formulation Designed with Multiple Beneficial Clinical Attributes Addressing the Shortfalls of the Current Multi-Billion-Dollar Androgen Deprivation Therapy Market —

— Reached Agreement with FDA on an Expedited Regulatory Pathway and Clinical Development Strategy —

Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company developing novel medicines for prostate cancer treatment and prostate cancer supportive care, today announced that it has added to its robust prostate cancer drug development pipeline, a proprietary biologic drug candidate, VERU-100, for the treatment of hormone sensitive advanced prostate cancer, an established multi-billion-dollar global market.  VERU-100 was internally developed in collaboration with Drug Delivery Experts, LLC of San Diego, California (DDE Labs).

“The target product profile for VERU-100 is most compelling having a number of advantages over currently available androgen deprivation therapies. VERU-100 is a long-acting gonadotropin-releasing hormone (GnRH) antagonist designed to be administered as a small volume subcutaneous 3-month depot injection without a loading dose. As a GnRH antagonist, it will immediately suppress testosterone with no testosterone surge upon initial or repeated administration and no testosterone micro-increases which may adversely affect patient outcomes — a problem which potentially occurs with approved LHRH agonist drugs like LUPRON®, ZOLADEX® and ELIGARD®,” said Peter N. Schlegel, M.D., James J. Colt Professor and Chairman of the Department of Urology at Weill Cornell Medicine and Urologist-in-Chief at New York-Presbyterian / Weill Cornell Medical Center.  “Currently, there are no GnRH antagonists commercially approved beyond 1 month, making VERU-100, if approved, the only commercially available GnRH antagonist 3-month depot — an attractive choice for androgen deprivation therapy.”

The Company recently met with the FDA and received agreement that VERU-100 qualifies for an expedited regulatory pathway. Based on FDA input, the Company plans to commence a single open label, multicenter dose-finding Phase 2 clinical trial in approximately 50 men, followed by a single open label, multicenter Phase 3 clinical trial in approximately 100 men. Veru is in the process of scaling up GMP manufacturing of drug product to prepare for the clinical trials of VERU-100. The Company plans to submit an Investigational New Drug application by no later than calendar Q1 2020.

Based on current cash on hand and expected cash from current sales forecasts, along with existing sources of capital, the Company does not anticipate the need for a new equity financing until at least fiscal 2021, even with additional costs related to the VERU-100 clinical development.

https://www.globenewswire.com/news-release/2019/06/04/1863861/0/en/Veru-Adds-Breakthrough-Novel-Androgen-Deprivation-Therapy-Formulation-to-its-Advancing-Prostate-Cancer-Drug-Pipeline-Following-Successful-Meeting-with-FDA.html