Veru Inc. (Nasdaq:VERU), a biopharmaceutical company focused on
urology and oncology, today announced it has signed a United States
distribution and co-promotion agreement with Timm Medical
Technologies for PREBOOST
® (4% benzocaine wipes)
for the prevention of premature ejaculation. Veru grants Timm
Medical Technologies distribution and promotion rights of
PREBOOST
® in the United States and its
territories, and Veru retains rights to also distribute and promote
PREBOOST
® sales in the US.
Timm Medical Technologies is a medical device and pharmaceutical
company specializing in marketing and sales of men’s health
products including STENDRA® (avanafil tablets) and ERECAID® to over
3,000 urology practices in US. Timm Medical Technologies has
approximately 32 sales representatives that will promote
PREBOOST® to urologists.
As reported in May 2017, Veru reported positive results from a
Phase 4 clinical study of PREBOOST®. The Phase 4
double-blind, randomized, placebo-controlled clinical study met its
primary endpoint of change in average Intravaginal Ejaculatory
Latency Time (IELT) of 5.5 minutes at two months (p<0.001), as
well as secondary outcomes of change in questionnaire assessments
including global rating of distress, medication assessment and
Index of Premature Ejaculation (IPE). After treatment with
PREBOOST®, 82 percent of men were no longer
considered to have premature ejaculation.
Timm will target urology practices as well as over the counter
(OTC) websites such as www.PREBOOST.com to develop product
awareness and to set up distribution of PREBOOST® directly to
patients from physicians’ offices.
“Timm Medical is a well-known specialty pharmaceutical company
with an impressive marketing and sales record focusing on erectile
dysfunction and men’s health. They also have an extensive database
of urology medical practitioners and independent distributors who
will increase awareness of and patient access to
PREBOOST®,” said Mitchell Steiner, MD, President
and CEO of Veru, Inc. “Both organizations target urological
markets. We are pleased to be working with Timm Medical
Technologies to significantly expand the scope of marketing and
sales activities and patient access to PREBOOST®.”
“We are excited to partner with Veru on the sale of
PREBOOST® and further our mission of providing
urologists with solutions for their patients,” said Andy
Gesek, President of Timm Medical Technologies,
Inc. "Urologists will now have the option to offer a viable
treatment to their patients who suffer from premature
ejaculation.”
About Premature Ejaculation According to
the International Society for Sexual Medicine (ISSM),
premature ejaculation (PE) is the most common sexual dysfunction in
men, even more common than erectile dysfunction. The ISSM
defines PE as persistent or recurrent ejaculation with minimal
sexual stimulation before, on, or shortly after penetration and
before the person wishes it to happen. Estimates of prevalence
range significantly; however, most experts estimate the prevalence
rate at 20-30 percent of men, as it can affect men of all ages and
it is the most commonly observed sexual disorder in men below 40
years of age. The condition is especially debilitating
because many men who suffer from PE also report a significant
impact on partners and relationships. About
PREBOOST® (4% benzocaine wipes) PREBOOST® is a
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
completely numb the penis.
The PREBOOST® Clinical Study enrolled 26 men aged 18 years or
older in a heterosexual, monogamous relationship, with PE, defined
as reported poor control over ejaculation, personal distress
related to ejaculation and average IELT of two minutes or less on
stopwatch measurement. Subjects were randomized 2:1 to treatment
with benzocaine wipes or placebo wipes, with men in the placebo
group crossed over to the treatment group one month after
randomization. The primary outcome measure for the study was
change in IELT at two months, with secondary outcomes including
change in questionnaire assessments of global rating of distress,
medication assessment and IPE. Data showed that patients
treated with benzocaine 4% wipes demonstrated a statistically
significant improvement in IELT after the first month of treatment
(2.75 minutes), with greater improvement after the second month
(5.5 minutes), compared to placebo (1.8 minutes). Men in the
treatment group also reported greater improvement in distress
relating to intercourse, control of ejaculation and satisfaction
with sexual intercourse over the study period. After
treatment with PREBOOST®, 82 percent of men were
no longer considered to have premature ejaculation. Results
showed that treatment was well tolerated. PREBOOST® is
available for sale in the U.S. at www.PREBOOST.com.
About Veru Inc. Veru Inc. (Veru) is
a biopharmaceutical company focused on urology and oncology.
Veru utilizes FDA's 505(b)(2) regulatory approval pathway to
develop and commercialize drug candidates. FDA's 505(b)(2)
regulatory approval pathway is designed to allow for potentially
expedited regulatory approval based on a previously established
safety and efficacy profile of the product. Veru is developing
products under the 505(b)(1) pathway as well, which is the
traditional new drug application (NDA) pathway. The company
is currently developing drug product candidates for benign
prostatic hyperplasia (BPH or enlarged prostate), hot flashes
associated with prostate cancer hormone treatment, male infertility
and novel oral chemotherapy (alpha & beta tubulin inhibitor)
for a variety of malignancies, including metastatic prostate,
breast and ovarian cancers. In addition, the company markets
and sells the FC2 Female Condom® (now available by prescription in
the US including through the virtual doctor smartphone app
“HeyDoctor” at www.fc2.us.com) and PREBOOST® medicated individual
wipe, which is a male genital desensitizing drug product for the
prevention of premature ejaculation.
The company’s division, The Female Health Company, 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 Veru and its products can be found at
www.veruhealthcare.com, www.PREBOOST.com and www.fc2.us.com.
For corporate and investor-related information about the Company,
please visit https://veruhealthcare.com/investors.
About Timm Medical Technologies, Inc.Timm
Medical Technologies, Inc. (Timm) is a privately held Medical
Device and Pharmaceuticals company headquartered in Fort
Washington, PA. Timm’s mission is focused on providing a
variety of men’s sexual health treatment options to Urologists and
ultimately their patients. More information about Timm and
its products can be found at www.TimmMedical.com.
"Safe Harbor" statement under the Private Securities
Litigation Reform Act of 1995: The statements in this
release that are not historical fact are "forward-looking
statements" as that term is defined in the Private Securities
Litigation Reform Act of 1995. Any forward-looking statements
in this release 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 GilbertVeru
Inc.786-322-2213KGilbert@veruhealthcare.com
Matt BeckThe Trout Group LLC646-378-2933MBeck@troutgroup.com
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