Veru Announces FDA Approval of ENTADFI, a New Treatment for

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ENTADFI capsules (finasteride and tadalafil) to treat benign prostatic hyperplasia –

–Marketing will begin at the start of calendar year 2022–

–ENTADFI will be marketed and distributed through 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 more than 75,000 U.S. pharmacies–

MIAMI, Dec. 13 2021 (GLOBE NEWSWIRE) – Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company focused on the development of novel drugs for the management of breast and prostate cancer, today announced that the US Food and Drug The Administration (FDA) approved ENTADFIMT 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 was also found to be more effective in treating urinary tract symptoms caused by BPH with less potential for unwanted sexual side effects compared to monotherapy with finasteride. The dosage of ENTADFI is one capsule taken orally once daily, and the FDA-approved indication is to initiate treatment for the signs and symptoms of benign prostatic hyperplasia in men with hypertrophy. prostate for up to 26 weeks.

ENTADFI will be marketed and distributed through Veru’s own telemedicine and telepharmacy services platform. Veru has also partnered with GoodRx®, a United States-based digital resource for healthcare, to reach their nearly 20 million monthly visitors, which include both consumers and healthcare providers, and offer a unique spot price to guarantee that our treatment is more affordable and accessible.

“The FDA approval of ENTADFI, a new treatment for BPH, is a milestone in execution for Veru and a significant step in increasing revenues for our commercial sexual health division. We are using this revenue to invest and advance our portfolio of advanced clinical oncology drugs as well as our global phase 3 COVID clinical study, ”said Mitchell Steiner, MD, President, President and CEO. “We are in the process of increasing our marketing and sales efforts by adding marketing partners in the United States and outside of the United States. We expect to begin commercialization early in calendar year 2022. BPH treatment represents a multi-billion dollar annual market with over 45 million US prescriptions filled each year and is expected to continue to grow. with the aging of the male population.

About Veru Inc.
Veru is an oncology biopharmaceutical company primarily focused on the development of new drugs for the management of breast and prostate cancer.

The Company’s late stage breast cancer development portfolio includes enobosarm, a selective androgen receptor targeting agonist, and cytoskeletal disruptor sabizabulin, and includes: the ARTEST phase 3 study underway enobosarm in AR + ER + 40% metastatic breast cancer (3rd line metastatic setting); planned phase 2b study of sabizabulin in AR + ER + HER2- metastatic breast cancer with AR

The Company has identified that patients who have ≥ 40% staining of androgen receptor nuclei by immunohistochemistry, which is a measure of RA expression, in their breast cancer tissue are the patients most likely to respond to enobosarm. Based on this observation, the Company is developing a companion diagnostic test to determine a patient’s RA expression status. Therefore, the Company has partnered with Roche / Ventana Diagnostics, a global leader in companion oncology diagnostic tests, which will develop and, if approved, commercialize the AR companion diagnostic test. The companion diagnostic test is being developed in parallel with the ARTEST Phase 3 clinical study.

The Company’s advanced prostate cancer development portfolio includes sabizabulin, VERU-100, a long-acting GnRH antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist and includes: the studies in phase 3 VERACITY and phase 2 of sabizabulin in metastatic castration and prostate cancer resistant to agents targeting androgen receptors before 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 experience hot flashes.

One of the Company’s anti-cancer drugs, sabizabulin, also has a dual antiviral and anti-inflammatory effect and is currently in a Phase 3 study for the potential treatment of hospitalized COVID-19 patients at high risk of syndrome. acute respiratory distress (ARDS).

Veru also has a commercial sexual health division which includes 2 products approved by the FDA: ENTADFI™ (finasteride and tadalafil) capsules for oral use, a new treatment for benign prostatic hyperplasia in the United States, and the female condom FC2® (internal condom), for dual protection against unwanted pregnancy and transmission of sexually transmitted infections which is sold in the United States and around the world.

Forward-looking statements
Statements contained in this press release that are not historical facts are “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this press release include statements regarding: timing where the commercial launch of ENTADFI will take place; the magnitude of the potential income generated by ENTADFI; whether the results of the Company’s current or future clinical development program will demonstrate sufficient efficacy and safety and potential benefits to secure FDA approval of the Company’s drug candidates; and whether the companion diagnostic for enobosarm will be successfully developed or be approved by the FDA for use. These forward-looking statements are based on the Company’s current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unforeseen developments and risks related to: the development of the Company’s product portfolio and the results of clinical trials that may be unsuccessful or insufficient to meet applicable regulatory standards or justify continued development; the ability to enroll a sufficient number of subjects in clinical trials and the ability to enroll subjects according to scheduled schedules; the ability to fund planned clinical development; the timing of any submission to the FDA and any decisions made by the FDA or any other regulatory authority; the possibility that as vaccines become widely distributed, the need for new candidates for COVID-19 treatment may be reduced or eliminated; government entities possibly taking measures which, directly or indirectly, have the effect of limiting the opportunities for sabizabulin as a COVID-19 treatment, in particular by promoting other treatment alternatives or by imposing price controls on treatments COVID-19; the Company’s existing products and any future products, if approved, may not be commercially successful; the effects of the COVID-19 pandemic and measures to address it on clinical trials, the supply chain and other third-party vendors, business efforts and the Company’s business development operations; the Company’s ability to obtain sufficient financing on acceptable terms when necessary to finance development and operations; demand, market acceptance and competition for any product or product candidate of the Company; new or existing competitors with greater resources and capabilities and new approvals and / or introductions of competing products; changes in regulatory practices or policies or government-led healthcare reform efforts, including pricing pressures and changes in insurance coverage and reimbursement; the Company’s ability to successfully market any of its products, if approved; the Company’s ability to protect and enforce its intellectual property; the potential that delays in orders or shipments in connection with government tenders or the Company’s prescription activities in the United States could cause significant quarter-over-quarter variations in results of operation of the Company and adversely affect its net income and gross margin; the Company’s dependence on its international partners and on the level of spending by country governments, global donors and other public health organizations in the global public sector; the concentration of accounts receivable with our largest customers and the collection of those accounts receivable; the Company’s production capacity, efficiency and supply constraints and interruptions, including the potential interruption of production at the Company’s and third-party manufacturing facilities and / or the Company’s ability to deliver the product in a timely manner due to labor disputes or strikes, labor shortages, shortages of raw materials, physical damage to Company and third party facilities, COVID-19 (including impact of COVID-19 on key raw material suppliers), product testing, transportation delays or regulatory actions; costs and other effects of litigation, including product liability claims; the Company’s ability to identify, successfully negotiate and complete appropriate acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in Company press releases, communications to shareholders and documents filed with the Securities and Exchange Commission, including the Company’s Form 10-K for the year ended September 30, 2020 and subsequent quarterly reports on Form 10-Q. These documents are available in the “SEC Filings” section of our website at www.verupharma.com/investors. The Company disclaims any intention or obligation to update these forward-looking statements.

Investor and media contact:
Samuel Fisch
Executive Director, Investor Relations
and corporate communication
Telephone: 800-972-0538


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