Innovus Pharma Announces Agreement with ACON Laboratories, Inc.
New FDA-Cleared Urinary Tract Infection Test to be Sold Under the UriVarx™ Brand
Innovus Pharmaceuticals, Inc. ("Innovus Pharma" or the “Company”) (OTCQB Venture Market: INNV), an emerging commercial-stage
pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve
men’s and women's health and respiratory diseases, today announced that it has entered into an agreement with ACON
Laboratories, Inc. (“ACON Labs”). ACON Labs is a San Diego-based diagnostic product manufacturer who will supply
Innovus Pharma with its U.S. Food and Drug Administration’s (“FDA”) cleared Urinary Tract Infection (“UTI”) test strips. Innovus
Pharma will offer the UTI test strips, which provide results in 2-minutes, to its customers who buy its UriVarx™ product. UriVarx™
is clinically tested in patients with overactive bladder (“OAB”) and urinary incontinence (“UI”). Innovus Pharma is expected to
launch the UTI strips under its UriVarx™ brand in Q1 2018.
According to WebMD, UTIs are the most common bacterial infections in the United States. According to a study by the
National Institutes of Health in 2007 (NIH publication 075512) by Griebling et al., the prevalence of UTI is found to be higher in
women. Nearly 20% of UTIs are found in men. Patients with OAB and UI have a higher occurrence of Urinary Tract Infections and early
detection is key in better responses to treatments.
Under the aforementioned agreement, ACON Labs will be responsible for filing the updated brand with the FDA. The process
is expected to be relatively quick, with FDA clearance of the UriVarx™ brand currently anticipated to take approximately 30 days
from the filing date.
“We are very excited about adding the FDA-cleared UTI diagnostic strips for bladder control and health to our UriVarx™ clinical
supplement offerings,” stated Dr. Bassam Damaj, President and Chief Executive Officer of Innovus Pharma. “We strongly believe
our UriVarx™ customers will be able to use our FDA cleared UTI test strips to monitor ongoing bladder infections from the
convenience of their homes. We are excited that Innovus Pharma is a pioneering company in this field. We are differentiating
ourselves by offering clinically-tested supplements and consumer care products sold in concert with FDA-cleared tests and/or FDA
OTC drugs,” he continued.
As a market leader, ACON Labs offers additional home test kits and test strips. Innovus Pharma anticipates expanding into
other areas that align with their current product line. In particular, both companies have discussed additional collaboration on
glucometers and diabetes strips as well as other possibilities.
“We view the agreement with ACON Labs on the FDA cleared UTI strips as the first phase in our burgeoning relationship. We
look forward to working with ACON Labs to provide us with quality FDA-cleared diagnostics products and test strips focused
on diabetes, and others, to help our clients optimize their healthcare outcomes within the confines of their homes,” Dr. Damaj
said.
About UriVarx™ Clinical Supplement
UriVarx™ is clinically published to reduce urinary urgency, accidents and both day and night frequency in OAB and UI
patients.
UriVarx™ has undergone two double blind and comparative trials in both male and female OAB and UI patients. The clinical results
include:
1. Reduction of ~56% in Urge Incontinence;
2. Reduction of ~66% in Stress Incontinence;
3. Reduction of ~61% in Urinary Urgency;
4. Reduction of ~33% in Urinary Frequency meaning the total average urinary frequency was in the normal/ideal range after two
months of use; and
5. Reduction of ~46% in Nocturia.
According to the U.S. National Association for Continence (“NAFC”), OAB is a medical term that describes various symptoms caused
by involuntary bladder spasms, including urinary frequency, especially at night, and urgency with or without involuntary leakage.
These symptoms may occur without obvious cause or be secondary to certain diseases of the nervous system. The NAFC estimates that
nearly 25 million Americans suffer from some form of OAB or incontinence. The condition, with frequency and urgency only, affects
men and women of all ages, although most are under age 65.
About the UriVarx™ FDA Cleared UTI Test
The UriVarx™ UTI test strips are FDA-cleared tests for the detection of leukocytes and nitrites to aid in the screening of
Urinary Tract Infection for self-testing. The test has undergone clinical trials and the results can be seen in two minutes.
According to a study by Grand View Research (April 2016), the market size for urinalysis tests in 2015 worldwide was $1.37
billion and in North America was $510 million of which UTI testing represented a large percentage of that market.
About Innovus Pharmaceuticals, Inc.
Headquartered in San Diego, Innovus Pharma is an emerging OTC consumer goods and specialty pharmaceutical company engaged in the
commercialization, licensing and development of safe and effective non-prescription medicine and consumer care products to improve
men’s and women’s health and vitality and respiratory diseases. Innovus Pharma delivers innovative and uniquely presented and
packaged health solutions through its (a) OTC medicines and consumer and health products, which we market directly, (b) commercial
partners to primary care physicians, urologists, gynecologists and therapists, and (c) directly to consumers through our
on-line channels, retailers and wholesalers. The Company is dedicated to be a leader in developing and marketing new OTC and
branded Abbreviated New Drug Application (“ANDA”) products, men’s and women’s health supplements, related diagnostics and medical
devices. The Company is actively pursuing opportunities where existing prescription drugs have recently, or are expected to, change
from prescription (or Rx) to OTC, as well as related products.
For more information, go to www.innovuspharma.com; www.zestra.com; www.ejectdelay.com; www.myvesele.com; www.urivarx.com ; www.sensumplus.com; www.myandroferti.com; www.beyondhumantestosterone.com; www.getbeyondhuman.com; www.trybeyondhuman.com; www.recalmax.com; www.prostagorx.com; www.fluticare.com; www.allervarx.com; and www.apeaz.com .
About ACON Laboratories, Inc.
ACON Laboratories Inc. is a privately-owned Diagnostics and Medical Device company, which was founded in 1995, with its
headquarters located in San Diego, California. ACON Laboratories, Inc. produces a broad range of medical diagnostic and
healthcare products that are sold in over 130 countries worldwide. The company continues to expand its product lines through
extensive research and development, with the goal of helping improve the health and well-being of patients around the world.
ACON’s manufacturing facility is a US FDA registered manufacturer of rapid diagnostic and healthcare products.
Innovus Pharma's Forward-Looking Safe Harbor:
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information
contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties
that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the
Company, including, but not limited to, projected revenues from the UriVarx™® product in the United States if approved in that
country, estimated market for its products, and statements about achieving its other development, growth, commercialization,
financial and staffing objectives. Readers are cautioned not to place undue reliance on these forward-looking statements as actual
results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors
set forth in the Company's most recent filing on Form S-1, annual report on Form 10-K, subsequent quarterly reports filed on Form
10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the
Company.
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Contact:
Emerging Markets Consulting, LLC
James S. Painter III, 407 340 0226
jamespainter@emergingmarketsllc.com
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