Veru Announces FDA Approval of ENTADFI, a New Treatment for Benign Prostatic Hyperplasia
--ENTADFI (Finasteride and Tadalafil) Capsules to Treat Benign Prostatic Hyperplasia--
--Commercialization Will Start Early Calendar Year 2022--
--ENTADFI to Be Marketed and Distributed by Veru’s Direct to Patient Telemedicine and Telepharmacy Services Platform--
--Veru Partners with GoodRx, a National Healthcare Company that Operates a Telemedicine Platform that Connects Patients to Over 75,000 US Pharmacies--
MIAMI, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of breast and prostate cancer, announced today that the U.S. Food and Drug Administration (FDA) has approved ENTADFITM for the treatment of urinary tract symptoms caused by an enlarged prostate called benign prostatic hyperplasia (BPH).
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.”
The Company’s late-stage breast cancer development portfolio is comprised of enobosarm, a selective androgen receptor targeting agonist, and sabizabulin, a cytoskeleton disruptor, and includes: the ongoing Phase 3 ARTEST study of enobosarm in AR+ ER+ HER2- metastatic breast cancer with AR = 40% (3rd line metastatic setting); the planned Phase 2b study of sabizabulin in AR+ ER+ HER2- metastatic breast cancer with AR < 40% (3rd line metastatic setting); the planned Phase 3 ENABLAR-2 study of enobosarm + abemaciclib (a CDK 4/6 inhibitor) in AR+ ER+ HER2- metastatic breast cancer with AR = 40% (2nd line metastatic setting); and the planned Phase 2 study of sabizabulin + enobosarm combination therapy in metastatic triple negative breast cancer after twosystemic chemotherapies.
The Company has identified that patients who have = 40% androgen receptor nuclei staining by immunohistochemistry, which is a measure of AR expression, in their breast cancer tissue are the patients that are most likely to respond to enobosarm. Based on this observation, the Company is developing a companion diagnostic test to determine a patient’s AR expression status. Consequently, the Company has partnered with Roche/Ventana Diagnostics, a world leader in oncology companion diagnostic tests, who will develop and, if approved, commercialize the companion diagnostic AR test. The companion diagnostic test is being developed in parallel with the Phase 3 ARTEST clinical study.
The Company’s late-stage prostate cancer development portfolio is comprised of sabizabulin, VERU-100, a long-acting GnRH antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist and includes: the ongoing Phase 3 VERACITY and Phase 2 studies of sabizabulin in metastatic castration and androgen receptor targeting agent resistant prostate cancer prior to IV chemotherapy; the ongoing Phase 2 dose finding study of VERU-100 in advanced hormone sensitive prostate cancer; and the planned Phase 2b study of zuclomiphene citrate in men with advanced prostate cancer on androgen deprivation therapy who suffer from hot flashes.
One of the Company’s anticancer drugs, sabizabulin, also has dual antiviral and anti-inflammatory effects and is currently enrolling in a Phase 3 study for the potential treatment of hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS).
Veru also has a commercial Sexual Health Division which includes 2 FDA approved products: ENTADFI™ (finasteride and tadalafil) capsules for oral use, a new treatment for benign prostatic hyperplasia in the U.S., and FC2 Female Condom® (internal condom), for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections which is sold in the U.S. and globally.
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