VERU-944 to Advance to Phase 2 Clinical Trial; 505(b)(2) Drug Candidate Addresses $600 Million Market, Potentially the First Drug for This Indication

MIAMI, May 24, 2017 (GLOBE NEWSWIRE) -- Veru Healthcare (NASDAQ:FHCO), a pharmaceuticals company focused on developing pharmaceuticals for men’s and women’s health and oncology, today announced that following a Pre-Investigational New Drug Application meeting with the U.S. Food and Drug Administration (FDA), it plans to advance into Phase 2 clinical trial its proprietary drug candidate, VERU-944, for the treatment of hot flashes in men receiving hormone therapy for prostate cancer. 

“VERU-944 addresses a $600 million US market,” said Mitchell S. Steiner, M.D., Chief Executive Officer of Veru Healthcare.  “As a 505(b)(2) drug candidate, VERU-944 may be developed on an accelerated basis and at lower cost and lower risk.  Importantly, VERU-944 has the potential to be the first FDA approved medication for this indication.  Our plan is to commence the Phase 2 trial as soon as possible, and if successful, we expect to begin our Phase 3 trial in the second half of 2018.”

“We had a very positive meeting with FDA during which we received clarification on a path forward for the clinical development of VERU-944,” said Robert H. Getzenberg, Ph.D., Executive Vice President for Clinical Development at Veru Healthcare. “The FDA expressed enthusiasm for the development of this product, acknowledging the importance of treating the unmet medical need of hot flashes in the large number of men that are undergoing androgen deprivation therapy.”

Initially VERU-944 will be developed as a once weekly oral agent for the treatment of hot flashes that are often associated with the use of androgen deprivation therapy (ADT) in men with advanced prostate cancer.  Approximately 80% of men receiving one of the common forms of ADT, including Lupron®, Eligard® and Firmagon®, experience hot flashes. 

About Hot Flashes in Men with Prostate Cancer Undergoing Hormonal Therapy
ADT is widely used to treat men with advanced prostate cancer. Approximately, 600,000 men in the US are currently on ADT. The symptom of hot flashes is the most common side effect of ADT.  These hot flashes can range from bothersome to debilitating.  Associated symptoms may include anxiety and palpitations.  Hot flashes usually last from a few seconds to several minutes but can persist for up to 20minutes. Unlike postmenopausal hot flashes, ADT induced hot flashes do not get better or resolve over time. There are no FDA approved treatments available.

About Veru Healthcare
Veru Healthcare is a pharmaceutical company, with a focus on the development and commercialization of pharmaceuticals that qualify for FDA's 505(b)(2) accelerated regulatory approval pathway as well as the 505(b)(1) pathway.  The Company does business and is organized as follows:

  • Veru Healthcare manages the Pharmaceuticals Division, which develops and commercializes pharmaceutical products for men's and women's health and oncology.
  • Veru Healthcare manages the Consumer Health / Medical Devices Division, which is focused on commercializing sexual healthcare products and devices for the consumer market, including the Company's FC2 Female Condom® (now available by prescription) and PREBOOST® medicated individual wipe, which is a male genital desensitizing drug product that helps in the prevention of premature ejaculation.
  • The Female Health Company division of Veru Healthcare manages the Global Public Health Division, which is focused on the global public health sector FC2 business.  This division markets the Company’s Female Condom (FC2) to entities, including ministries of health, government health agencies, U.N. agencies, nonprofit organizations and commercial partners, that work to support and improve the lives, health and well-being of women around the world.

More information about the Company and its products can be found at www.PREBOOST.com and www.fc2femalecondom.com.  For corporate and investor-related information about the Company, please visit https://veruhealthcare.com/investors.

"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:
The statements in this release which are not historical fact 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 relating to the timing, cost and risk of the regulatory pathway to secure FDA approval of the Company's Veru-944 drug candidate.  These statements are based upon the Company's current plans and strategies, and reflect the Company's current assessment of the risks and uncertainties related to its business, and are made as of the date of this release.  The Company assumes no obligation to update any forward-looking statements contained in this release as a result of new information or future events, developments or circumstances. Such forward-looking statements are inherently subject to known and unknown risks and uncertainties. The Company's actual results and future developments could differ materially from the results or developments expressed in, or implied by, these forward-looking statements.  Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, the following:  product demand and market acceptance; competition in the Company's markets and the risk of new competitors and new competitive product introductions; risks relating to the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; risks related to the development of the Company's product portfolio, including clinical trials, regulatory approvals and time and cost to bring to market; many of the Company's products are at an early stage of development and the Company may fail to successfully commercialize such products; risks related to intellectual property, including licensing risks; government contracting risks, including the appropriations process and funding priorities, potential bureaucratic delays in awarding contracts, process errors, politics or other pressures, and the risk that government tenders and contracts may be subject to cancellation, delay or restructuring; a governmental tender award indicates acceptance of the bidder's price rather than an order or guarantee of the purchase of any minimum number of units, and as a result government ministries or other public sector customers may order and purchase fewer units than the full maximum tender amount; the Company's reliance on its international partners in the consumer sector and on the level of spending on the female condom by country governments, global donors and other public health organizations in the global public sector; the economic and business environment and the impact of government pressures; risks involved in doing business on an international level, including currency risks, regulatory requirements, political risks, export restrictions and other trade barriers; the Company's production capacity, efficiency and supply constraints; risks related to the costs and other effects of litigation; 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 in the Company's press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2016.  These documents are available on the "SEC Filings" section of our website at www.veruhealthcare.com/investors.

Contact:
Kevin Gilbert
Veru Healthcare
312-366-2633
KGilbert@veruhealthcare.com

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Female Health Company