Pharma Focus Asia

Innovus Pharma Announces Agreement with ACON Laboratories, Inc.

Friday, November 10, 2017

Innovus Pharmaceuticals, Inc., 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.

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