Veru Submits New Drug Application for Proprietary TADFIN for BPH

By Globe Newswire13 days ago

--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.

About Veru Inc.

Veru Inc. is an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer and breast cancer. The Veru prostate cancer pipeline includes VERU-111, VERU-100, and Zuclomiphene citrate. VERU-111 is an oral, first-in-class, new chemical entity that targets, crosslinks, and disrupts alpha and beta tubulin subunits of microtubules for the treatment of metastatic castration and androgen receptor resistant prostate cancer. VERU-100 is a novel, proprietary peptide formulation designed to address the current limitations of commercially available androgen deprivation therapies (ADT) for advanced prostate cancer. Zuclomiphene citrate is an oral nonsteroidal estrogen receptor agonist being developed to treat hot flashes, a common side effect caused by ADT in men with advanced prostate cancer. The Veru breast cancer pipeline includes enobosarm for AR+/ER+/HER2- metastatic breast cancer and VERU-111 for taxane resistant metastatic triple negative breast cancer. Enobosarm is an oral, first-in-class, new chemical entity, selective androgen receptor agonist that targets and activates the androgen receptor in AR+/ER+/HER2- metastatic breast cancer without unwanted masculinizing side effects. VERU-111 is also being advanced into Phase 3 for the treatment of hospitalized patients with COVID-19 who are at high risk for acute respiratory distress syndrome.

The Company's Sexual Health Business commercial product is the FC2 Female Condom®/ FC2 Internal Condom (“FC2“), an FDA-approved product for the dual protection against unintended pregnancy and the transmission of sexually transmitted infections. The Company's Female Health Company Division markets and sells FC2 commercially ...

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