Specialty pharmaceutical and medical device company, Female Health, Co. (NASDAQ:FHCO), announces successful analysis of PREBOOST, it’s premature ejaculation management drug.
MIAMI, Nov. 17, 2016 (GLOBE NEWSWIRE) — The Female Health Company / Veru Healthcare (FHCO) today announced top line interim analysis of an independent, double-blind, randomized, controlled clinical study of the company’s novel PREBOOST® product (topical 4% benzocaine wipes) for the management of premature ejaculation (PE). The scientific abstract that describes the full interim analysis results has been submitted to a major urological medical conference. The company plans to launch PREBOOST® in the US before year-end.
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 supported 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;
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).
PREBOOST® is a new, proprietary over-the-counter (OTC) male genital desensitizer used for the treatment of PE. Unlike currently available OTC anesthetic sprays using lidocaine or gels using benzocaine, PREBOOST® is an individually packaged wipe containing 4% benzocaine, which allows for direct and precise application of the same dosage each time.
“Our interim results in men with PE show that PREBOOST® appears to prolong time to ejaculation, supporting the clinical validity of PREBOOST® for the management of PE,” said Mitchell Steiner, M.D. President and Chief Executive Officer of The Female Health Company / Veru Healthcare. “These interim analysis results show that PREBOOST® improved both objective and subjective symptoms of PE compared to placebo. We believe PREBOOST® has significant advantages over currently available therapies, especially with regard to ease of use, delivery system and convenience.”
“Our plan is to launch PREBOOST® in the US later this quarter through digital and social media marketing,” said Shiao Zhu, Vice President of Marketing of Veru Healthcare. “We look forward to being able to provide a tested medical therapy to men and couples who suffer from PE.”
For more information about PREBOOST®, please visit www.preboost.com.
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.
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 United States 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 FDA monograph and is approved 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.
The Company plans to implement a sampling program targeting urologists, co-promoting with a marketing partner, introducing the product through Walmart, CVS, Walgreens and other OTC distribution outlets, optimizing its internet ecommerce capabilities and digital marketing via www.preboost.com, as well as through out-licensing opportunities for markets outside the U.S.
About The Female Health Company
The Female Health Company is a specialty pharmaceutical and medical device company, with a focus on pharmaceutical products that qualify for the 505(b)(2) FDA regulatory pathway that can result in more rapid approval than a full new drug application. The company is organized as follows: Veru Healthcare manages the Pharmaceuticals and Medical Devices division, which develops and commercializes pharmaceutical and medical device products for men’s and women’s health and oncology, as well as the Consumer Health division, which is focused on commercializing sexual health products, including FC2 Female Condom® (FC2) and PREBOOST®, for the consumer market. The Female Health Company through its Global Public Health Division manages the global public health sector FC2 business. This division markets FC2 to entities, including ministries of health, government health agencies, non-profit organizations and commercial partners, that work to support and improve the lives, health and well-being of women around the world.
Female Health, Co. (NASDAQ:FHCO) shares are moving +19.00% on the news today and have traded in the range of $1.00 – 1.24 during the current trading session. A number of brokerage analysts have recently weighed in on the stock, providing price target projections. The covering firms currently have a consensus one-year price target of $5.40 on the stock. This is according to brokerage analysts polled by Thomson Reuters First Call. This is the average number from the individual targets provided by the firms. Analysts are projecting earnings per share of $0.00 for the next fiscal quarter. For the current year, analysts are predicting earnings of $0.15 per share according to First Call.
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In looking at where Female Health, Co. (NASDAQ:FHCO) is trading on a technical level, the stock is trading +15.57% away from its 50-day moving average of $1.03. Based on the most recent available data, the equity is -56.73% off of its 52-week high of $2.75 and +64.77% away from its 52-week low which is $0.72.
In taking a look at the company’s valuation, the firm’s price to earnings ratio stands at 13.22. Today, the stock opened at $1.00 and the last bid at the time of writing stood at $1.19. During the session thus far, the equity dipped down to $1.00 and touched $1.24 as the high point. Female Health, Co. (NASDAQ:FHCO) has a market cap of $34.57M and has seen an average daily volume of 86,877 over the past three months.
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