Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company, announced today that the Company has dosed its first patient for its bioequivalence study of Tadalafil (Cialis®) and Finasteride (PROSCAR®) combination tablet for benign prostatic hyperplasia (BPH) (Tad-Fin Combination Tablet).  Tad-Fin Combination Tablet is designed for the co-administration of tadalafil and finasteride to improve patient compliance and convenience for men suffering from BPH.  Finasteride shrinks the prostate while tadalafil treats the symptoms of BPH.

The bioequivalence study will enroll 36 patients and will be completed in approximately four weeks.  Clinical results will be reported in the first calendar quarter of 2019.  In addition, the Company has initiated manufacturing of the commercial grade product through its contract manufacturer to be used for an NDA submission to the U.S. Food and Drug Administration (FDA). If successful, NDA submission target is mid-2019.

“The co-administration of tadalafil and finasteride has been clinically proven to significantly improve lower urinary tract symptoms in men with BPH and an enlarged prostate, all with attendant benefits for erectile dysfunction,” commented Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru.*  “Co-administration reduces the risk of acute urinary retention and the potential need for surgery while shrinking prostate size. We believe our Tad-Fin Combination Tablet will provide convenience which should substantially increase compliance improving the health of patients.”

About Tadalafil/Finasteride Combination Tablet 
Tad-Fin Combination Tablet is a new combination tablet containing 5 mg tadalafil and 5 mg finasteride to improve lower urinary tract symptoms in men with BPH and an enlarged prostate. Finasteride inhibits the enzyme 5-alpha-reductase, which converts testosterone to the more potent dihydrotestoserone. By doing so, it can act to shrink the prostate, prevent the progression of BPH, reduce the risk of acute urinary retention and reduce the potential need for surgery. Tadalafil is a PDE5 inhibitor that has efficacy in relieving the symptoms of BPH by relaxing the smooth muscle of the prostate and is also indicated for erectile dysfunction.  Co-administration of tadalafil and finasteride is currently FDA approved for the initial treatment of symptoms of BPH for up to 26 weeks.

About Veru Inc.
Veru Inc. is an oncology and urology biopharmaceutical company developing novel medicines for prostate cancer and prostate cancer supportive care as well as near term specialty pharmaceuticals to address significant unmet needs in urology.

The Veru prostate cancer pipeline includes zuclomiphene citrate (also known as VERU-944, cis-clomiphene) and VERU-111 (bisindole). Zuclomiphene citrate is an estrogen receptor agonist being evaluated in a Phase 2 trial to treat hot flashes, a common side effect caused by hormone treatment for men with advanced prostate cancer. VERU-111 is an oral, next-generation, first-in-class small molecule that targets and binds to alpha and beta subunits of microtubules in cells to treat metastatic prostate cancer patients whose disease is resistant to both castration and novel androgen blocking agent (abiraterone or enzalutamide) therapies. Veru expects VERU-111 to enter a Phase 1b/2 clinical trial in late 2018.

Veru is also advancing four new drug formulations in its specialty pharmaceutical pipeline addressing unmet medical needs in urology. Tamsulosin DRS granules and Tamsulosin XR capsules are formulations of tamsulosin, the active ingredient in FLOMAX®, which Veru has developed to avoid the “food effect” inherent in currently marketed formulations of the drug, allowing for potentially safer administration and improved patient compliance (NDA submission expected in 2019). Veru is also developing Tadalafil/Finasteride combination tablets for inhibition of both phosphodiesterase type 5 (PDE5) and 5-alpha-reductase to shrink an enlarged prostate, to treat symptoms of BPH and to treat erectile dysfunction (NDA submission expected in 2019). Finally, Veru is developing Solifenacin DRG granules, a formulation of a selective M3 muscarinic receptor antagonist for the treatment of overactive bladder in patients who have difficulty with swallowing tablets (NDA submission expected in 2019).

Veru’s currently marketed products are the PREBOOST^® medicated individual wipe for the prevention of premature ejaculation and the FC2 Female Condom^®. The Female Health Company Division markets the FC2 Female Condom^® in the global public health sector to improve the lives, health and well-being of women around the world. To learn more please visit www.verupharma.com.