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Innovus Pharma Receives Expanded Claims for Its UriVarx® Product in Canada to Include Symptoms of Urinary Incontinence

April 4, 2019

SAN DIEGO--(BUSINESS WIRE)--Apr 4, 2019--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 its marketed product UriVarx® has received approval for an expanded claim to include “helps improve the symptoms of urinary incontinence.” Innovus Pharma currently sells this product in Canada exclusively through its distributor, Acerus Pharmaceuticals Corporation (“Acerus”).

“We are very happy to receive Health Canada’s expanded claim for improving the symptoms of urinary incontinence, which we believe is a significant market in that country,” said Dr. Bassam Damaj, the President and Chief Executive Officer of Innovus Pharma. “These claims are in addition to UriVarx®’s current claims of overactive bladder, urgency and nocturia approved in Canada. UriVarx® is a very successful product for us in the United States and also for Acerus in Canada, and the addition of the urinary incontinence claim will expand this product’s target patient population in Canada and potentially increase sales of the product there,” continued Dr. Damaj.

About UriVarx®

UriVarx® has undergone published Phase 2 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 Simon Foundation, Urinary Incontinence affects 26 million Americans with a total market size of $1.1 billion (Source: Medical Devices Inc.). The NAFC (National Association for Continence) estimated that over 33 million Americans suffer from Overactive Bladder with a market size over $2.1 billion (Source: IMS Health).

The product is commercially available in the US and Canada.

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 being a leader in developing and marketing new OTC and branded Abbreviated New Drug Application (“ANDA”) products. The Company is actively pursuing opportunities where existing prescription drugs have recently, or are expected to, change from prescription (or Rx) to OTC.

For more information, go to www.innovuspharma.com; www.zestra.com; www.ejectdelay.com; www.vesele.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.xyralid.com; www.fluticare.com; www.allervarx.com; www.apeaz.com; www.mzssleepingaid.com, www.novalere.com, www.diabasens.com and urivarx.com.

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 sale of the UriVarx® product in Canada, 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.

View source version on businesswire.com:https://www.businesswire.com/news/home/20190404005090/en/

CONTACT: Randy Berholtz

Innovus Pharma Investor Relations

Tel: +1 858 249 7865

ir@innovuspharma.com

KEYWORD: UNITED STATES NORTH AMERICA CANADA CALIFORNIA

INDUSTRY KEYWORD: SENIORS WOMEN HEALTH CLINICAL TRIALS PHARMACEUTICAL RETAIL SPECIALTY CONSUMER MEN

SOURCE: Innovus Pharmaceuticals, Inc.

Copyright Business Wire 2019.

PUB: 04/04/2019 06:00 AM/DISC: 04/04/2019 06:00 AM

http://www.businesswire.com/news/home/20190404005090/en