Veru Provides FDA Update on Request for Emergency Use Authorization for Sabizabulin for Hospitalized COVID-19 Patients at High Risk for ARDS

MIAMI, FL, March 02, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced that the U.S. Food and Drug Administration (FDA) has declined to grant at this time the Company’s request for Emergency Use Authorization (EUA) for sabizabulin, Veru’s novel microtubule disruptor, to treat hospitalized adult patients with moderate to severe COVID-19 who are at high risk for Acute Respiratory Distress Syndrome (ARDS).

In communicating its decision, the FDA stated that despite the FDA declining to issue an EUA for sabizabulin at this time, the FDA remains committed to working with the Company for the development of sabizabulin.

Separately, the FDA also provided comments on a proposed confirmatory Phase 3 study protocol submitted by the Company for hospitalized moderate to severe COVID-19 patients at risk for ARDS and death that could support a new EUA authorization and/or NDA approval. FDA stated that in the potential confirmatory Phase 3 clinical study design: “strong consideration should be given to appropriate time frames for interim analyses so that – should a strong efficacy signal again be observed – the trial could be stopped in an efficient time frame.” Veru expects to communicate the details of the design and timing of this potential Phase 3 confirmatory study soon. It should be noted that in the U.S. Department of Health and Human Services’ (HHS) fact sheet published on February 9, 2023, HHS and FDA made clear that FDA’s ability to continue authorizing new COVID-19 therapeutics for emergency use is not impacted by the ending of the declaration of the U.S. public health emergency on May 11, 2023.

“Our team has applied its scientific rigor and clinical expertise to expeditiously investigate sabizabulin, a microtubule disruptor, for the treatment of hospitalized critically ill COVID-19 patients during the pandemic,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “We are disappointed in the FDA’s decision to decline the request for an EUA because of the possibility of unknown influences, or uncertainties that may have affected the study as FDA agreed upon its review that our Phase 3 study met its primary endpoint and could not be invalidated by any known influences¹, and we followed the unanimous recommendation of the Independent Data Monitoring Committee to stop the Phase 3 study because of clear clinical benefit. During our May 10, 2022 pre-EUA meeting with the FDA, the Agency indicated that our clinical data package was sufficient to support an EUA submission. Unfortunately, COVID-19 remains a serious threat as the third leading cause of death in the U.S. with over 250,000 lives lost in 2022. We lost 510 Americans to COVID-19 just yesterday despite existing FDA authorized and approved standard of care treatments. We reaffirm our strategy to deliver sabizabulin, a potentially life-saving treatment, to this vulnerable patient population facing inadequate therapeutic options to address the threat of ARDS and death from COVID-19. To that end, we will work closely with the FDA to gain clarity on advancing our sabizabulin program toward a potential new request for an EUA and an NDA submission.”

Sabizabulin for the treatment of hospitalized moderate to severe COVID-19 patients at high risk for ARDS is currently under regulatory review for potential emergency authorization by other regulatory agencies outside the U.S.

About Veru Inc.

Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for infectious diseases and for oncology.

The Company also has a commercial sexual health program, UREV, which has 2 FDA-approved products, including 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 and ENTADFI^® (finasteride and tadalafil) capsules for oral use, a new treatment for benign prostatic hyperplasia.

Forward-Looking Statements

The statements in this release that are not historical facts are “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include statements regarding: whether the FDA will approve the protocol for any finally proposed confirmatory Phase 3 study of sabizabulin for certain COVID-19 patients; whether any such Phase 3 study will meet its proposed primary or secondary endpoints; the proposed timing, size and scope of any such Phase 3 study; whether any potential interim analyses of such Phase 3 study will show sufficient efficacy and safety and whether any such interim results would be sufficient to support stopping the study early and submitting a new EUA or an NDA on any accelerated timeline; when the Company expects to disclose the details of the design and timing of this potential Phase 3 confirmatory study; whether the FDA will accept any results of such trial as sufficient for a new EUA or an NDA submission and, if any such application is submitted, whether the FDA will ultimately authorize or approve such application; how long the FDA will be able to continue to issue EUAs under its current emergency authorization under the U.S. Department of Health and Human Services; whether the current mortality rate of COVID-19 in the U.S. will continue, increase or decrease; whether sabizabulin will be a potentially life-saving drug for COVID-19 patients in the U.S. or elsewhere in the world; the degree to which the FDA continues to work with the Company to develop sabizabulin; whether the current and future clinical development efforts of the Company and any of their results will demonstrate sufficient efficacy and safety and potential benefits to secure FDA approval of any of the Company’s other drug candidates; whether the drug candidates will be approved for the targeted line of therapy; whether ENTADFI will be commercialized successfully, the Company will grow sales of ENTADFI or the Company will be able to successful partner with any other entity to grow sales of ENTADFI; whether the telemedicine customers for FC2 will return to historical ordering patterns or increase their purchases of FC2 at all; and whether the Company’s current cash will be sufficient to fund its planned or expected operations. These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: the development of the Company’s product portfolio and the results of clinical studies possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical studies and the ability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the possibility that as vaccines, anti-virals and other treatments become widely distributed the need for new COVID-19 treatment candidates may be reduced or eliminated; government entities possibly taking actions that directly or indirectly have the effect of limiting opportunities for sabizabulin as a COVID-19 treatment, including favoring other treatment alternatives or imposing price controls on COVID-19 treatments; the Company’s existing products, including FC2 and ENTADFI and, if authorized, sabizabulin, and any future products, if approved, possibly not being commercially successful; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company’s clinical studies, supply chain and other third-party providers, commercial efforts, and business development operations; the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; the Company’s ability to successfully commercialize any of its products, if approved; risks relating to the Company's development of its own dedicated direct to patient telemedicine and telepharmacy services platform, including the Company's lack of experience in developing such a platform, potential regulatory complexity, and development costs; the Company’s ability to protect and enforce its intellectual property; the potential that delays in orders or shipments under government tenders or the Company’s U.S. prescription business could cause significant quarter-to-quarter variations in the Company’s operating results and adversely affect its net revenues and gross profit; the Company’s reliance 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 receivables; the Company’s production capacity, efficiency and supply constraints and interruptions, including potential disruption of production at the Company’s and third party manufacturing facilities and/or of the Company’s ability to timely supply product due to labor unrest or strikes, labor shortages, raw material shortages, physical damage to the Company’s and third party facilities, COVID-19 (including the impact of COVID-19 on suppliers of key raw materials), 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 suitable 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 the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company’s Form 10-K for the fiscal year ended September 30, 2022 and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at /investors. The Company disclaims any intent or obligation to update these forward-looking statements.

1. U.S. FDA Pulmonary-Allergy Drugs Advisory Committee. (2022, November 9). Pulmonary-Allergy Drugs Advisory Committee Meeting Briefing Document.

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