SAN DIEGO--(BUSINESS WIRE)--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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