Veru Submits New Drug Application for Proprietary TADFIN for BPH
--TADFIN, Tadalafil 5mg and Finasteride 5mg formulated capsule, for daily oral dosing to improve compliance--
--Administration of Tadalafil and Finasteride is more effective than Finasteride alone to treat symptoms of benign prostatic hyperplasia--
--FDA PDUFA Date is expected in December 2021--
--Plan to launch TADFIN, if approved, via telemedicine channels and to outlicense--
--TADFIN revenues will be part of Veru’s sexual health commercial business--
MIAMI, Feb. 23, 2021 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer and breast cancer, today announced that it has submitted a 505(b)(2) New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for TADFIN (tadalafil 5mg and finasteride 5mg) capsules, a novel oral daily dosing combination formulation, for the treatment of benign prostatic hyperplasia (BPH).
“The submission of TADFIN, the Company’s first NDA submission, is a significant milestone and a major step toward expanding the revenues for our sexual health commercial business—revenues we have used to substantially invest in the clinical development of our prostate and breast cancer drug candidates,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer. “We believe FDA approval of TADFIN is possible toward the end of the current calendar year, with a launch shortly thereafter via telemedicine or out-license of product to specialty pharmaceutical companies.”
Dr. Steiner further added: “Veru is focused on delivering on our deep and promising late-stage oncology pipeline.”
TADFIN combines both tadalafil 5mg and finasteride 5mg into one capsule formulation. CIALIS (tadalafil) tablets, for oral use (Eli Lily and Company) is currently approved for treatment of BPH and erectile dysfunction and PROSCAR (finasteride) tablets (Merck & Co., Inc.) is currently approved for treatment of BPH and PROPECIA (finasteride) tablets for oral use for male pattern hair loss (androgenic alopecia) in men only (Merck & Co., Inc).
As previously announced, Veru received a waiver of the FDA NDA PDUFA filing fees, worth approximately $2.4 million in cost savings, as a first-time filer. If approved, the Company currently plans to launch TADFIN through third-party telemedicine sales channels, and outlicensing opportunities thus eliminating the need for and cost of a direct sales force.