The Female Health Company / Veru Healthcare Launches PREBOOST® For Premature Ejaculation

The Female Health Company / Veru Healthcare (NASDAQ:FHCO) today announced the U.S. launch of PREBOOST® (topical 4% benzocaine wipes) that helps in the prevention of premature ejaculation (PE).

PREBOOST® is a new, proprietary over-the-counter (OTC) male genital desensitizer that helps in temporarily prolonging the time until ejaculation in men with premature ejaculation.

PREBOOST® is compliant with the relevant FDA monograph and is approved for sale in the United States. PREBOOST® is the only individually packaged medicated wipe that contains a desensitizing agent (benzocaine 4.0%). Unlike currently available OTC desensitizing sprays or gels that contain lidocaine or benzocaine, PREBOOST® is an individually packaged wipe containing 4% benzocaine, which allows for discrete, direct and precise application of the correct dosage each time. It is applied topically and dries quickly which prevents the potential for transference to a partner.

The product is now available and can be purchased through the e-commerce site http://preboost.com. The site includes information about PREBOOST®, including how to apply the product, as well as frequently asked questions (FAQs) and tips for better sex with a partner.

“I invented PREBOOST® to help the millions of men who suffer from PE and for those couples that want to extend their sexual pleasure,” said Dr. Harry Fisch, the Company’s Chief Corporate Officer “We believe PREBOOST® has significant advantages over currently available therapies, especially with regard to ease of use, delivery system and convenience.”

“Premature ejaculation is a large and underserved market,” said Mitchell Steiner, M.D. President and Chief Executive Officer of The Female Health Company / Veru Healthcare. “We are using targeted digital, social media marketing and online optimization capabilities to drive traffic to the PREBOOST® e-commerce site. The next phase of launch will be to include a sampling program targeting urologists, engaging a marketing partner to co-promote PREBOOST®, introducing the product to large chain pharmacies and other OTC distribution outlets, and seeking out licensing opportunities for markets outside the U.S.”

“In my opinion, PREBOOST® is the only over-the-counter product that has the clinical data that shows that it prolongs ejaculation time based on an interim analysis of a well-designed placebo controlled study with statistically significant results,” said Ridwan Shabsigh, M.D., Professor of Urology at Weill Cornell Medical College and President of the International Society of Men’s Health.

As previously announced, the Company reported top line interim analysis of an independent, double-blind, randomized, controlled clinical study of PREBOOST®. The scientific abstract that describes the full interim analysis results has been submitted to a major urological medical conference.

The independent clinical study was conducted by Jed Kaminetsky, M.D., Medical Director at Manhattan Medical Research, Clinical Assistant Professor of Urology at New York University Medical Center, and practicing urologist with University Urology Associates; Michael Yang, Clinical Research Coordinator at Manhattan Medical Research and University Urology Associates; Michael Perelman. M.D., Clinical Professor Emeritus of Psychology in Psychiatry at Weill Cornell Medical College; and, Ridwan Shabsigh, M.D., Professor of Urology at Weill Cornell Medical College, and President of the International Society of Men’s Health. The clinical study was funded but not conducted by Veru Healthcare.

The top line results of the interim analysis from 21 men show:

After two months, men treated with PREBOOST® had statistically significant improvement in their ability to control ejaculation, with a mean increase in duration of almost four minutes, which was significantly greater than men on placebo. After treatment with PREBOOST, 80% of men were no longer considered to have PE;
Men treated with PREBOOST® reported a statistically significant better sense of ejaculation control, confidence, satisfaction, sexual pleasure, length of intercourse and reduced frustration;
PREBOOST® was well tolerated and no transference was reported; and
The interim clinical study met the primary endpoint of change in average intravaginal ejaculatory latency time (IELT) at two months and secondary outcomes of change in questionnaire assessments, such as global rating of distress, medication assessment, and Index of Premature Ejaculation (IPE).

The Company said the interim results in men with PE show that PREBOOST® prolonged time to ejaculation in men who suffer from PE.

About Premature Ejaculation (PE):PE is defined by the International Society for Sexual Medicine as persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the person wishes it. PE is the most common sexual dysfunction, even more common than erectile dysfunction, according to numerous epidemiological studies. It is a problem for couples and the most commonly observed sexual disorder in men below 40 years of age. PE is a self-reported diagnosis with a prevalence rate of 20-30 percent. The estimated prevalence of PE is 50 million men in the US and 60 million men in Europe. Total worldwide market for premature ejaculation drugs and consumer health care products is estimated to be greater than $500 million annually.

About PREBOOST®:PREBOOST® is a new, proprietary OTC male genital desensitizer used for the treatment of PE. There are no prescription products for PE approved by the FDA. Off label use of antidepressants and PDE-5 inhibitors have been used with limited success because of inconsistent efficacy and unacceptable side effects. Psychological counseling and behavioral therapy are also used with mixed results. Of the consumer health products, the topical anesthetics are administered as sprays and gels. The drawbacks of these approaches include inconsistent dosing leading to too much anesthetic and transference of the anesthetics to the partner. PREBOOST® is compliant with the relevant FDA monograph and is approved for sale in the United States. PREBOOST® is the only individually packaged medicated wipe that contains a desensitizing agent (benzocaine 4.0%). The advantages are: 1) Convenient individually wrapped wipes so it is easier to carry and to be discreet, 2) The correct dose is delivered each time, 3) The medicine is applied topically and dries quickly which prevents the potential for transference to partner, and 4) Benzocaine at 4.0% temporarily desensitizes, but does not numb, the penis.

PREBOOST® is now available and can be purchased through the e-commerce site http://preboost.com.

About The Female Health Company / Veru HealthcareThe Female Health Company / Veru Healthcare is a medical therapeutics company, with a focus on the development and commercialization of pharmaceuticals that qualify for the FDA's 505(b)(2) accelerated regulatory approval pathway as well as the 505(b)(1) pathway. The Company does business both as "Veru Healthcare" and as "The Female Health Company" 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 Female Condom (FC2), which is referred to as the FC2 Female Condom® in the consumer health products sector and as the Female Disposable Contraceptive Device (FC2) in the U.S. prescription market, and PREBOOST® medicated individual wipes which is a male genital desensitizing drug product that helps in the prevention of premature ejaculation.
The Female Health Company 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 Female Health Company and its products can be found at www.femalehealth.com, www.veruhealthcare.com and www.femalecondom.org. For corporate and investor-related information about the Company, please visit www.FHCinvestor.com.

"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. 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: demand and market acceptance of PREBOOST®; 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; the length, cost and uncertain results of the Company’s clinical trials; the potential of adverse side effects or other safety risks that could preclude the approval of the Company’s product candidates; 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 global public health 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 health sector; the economic and business environment and the impact of government pressures; the Company's reliance on its major customers and risks related to delays in payment of accounts receivable by major customers; 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 and 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.femalehealth.com/investors.