FDA approves ENTADFI, a New Treatment for Benign Prostatic Hyperplasia

ENTADFI (finasteride and tadalafil) capsule for oral use has also been shown to be more effective to treat urinary tract symptoms caused by BPH with less potential for adverse sexual side effects compared to finasteride monotherapy. ENTADFI dosing is one capsule orally once a day, and the FDA approved indication is to initiate treatment of the signs and symptoms of benign prostatic hyperplasia in men with an enlarged prostate for up to 26 weeks.

ENTADFI will be marketed and distributed by Veru's own direct to patient telemedicine and telepharmacy services platform. Veru has also partnered with GoodRx®, a US based digital resource for healthcare, to reach their almost 20 million monthly visitors, which include both consumers and healthcare providers, and offer a unique cash price to ensure our treatment is more affordable and accessible.

"FDA approval of ENTADFI, a new treatment for BPH, is a significant execution milestone for Veru and an important step in expanding revenues from our commercial Sexual Health Division. We use these revenues to invest and advance our late clinical stage oncology drug pipeline portfolio as well as our global Phase 3 COVID clinical study," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer. "We are in the process of augmenting our marketing and sales efforts by adding commercialization partners in the US and ex-US. We expect to begin commercialization in early calendar year 2022. The treatment of BPH is an annual multi-billion dollar market with over 45 million US prescriptions filled each year and is projected to continue to grow with an aging male population."