Innovus Pharma Files Its Product License Application In Canada For The Commercialization Of Vesele As A Natural Health Product To Help Improve Symptoms Of Sexual Dysfunction

Published: May 18, 2017

SAN DIEGO--(BUSINESS WIRE)--Innovus Pharmaceuticals, Inc. (the “Company” or “Innovus Pharma”) (OTCQB Venture Market: INNV) today announced that the Company filed its Product License Application with Health Canada as a Natural Health Product (“NPN”) to market its current best-selling product Vesele® with the indication to “Help Improve Symptoms of Sexual Dysfunction.” If accepted by Health Canada, Vesele® will be available over-the-counter (“OTC”) in 120 capsule bottles and will not require a prescription. The product if approved will not be reimbursed by the Canadian government, therefore, the Company will be able to set the retail price as it does in the United States. If approved, the Company expects to directly launch the product itself through its Beyond Human® sales and marketing platform currently being set up in Canada and through other sales channels.

“If approved by Health Canada for commercialization in Canada, Vesele® will be our fourth product on the Canadian market including Zestra®, Zestra Glide® and EjectDelay® sold under the name Uxor™ by our partner Orimed Pharma”

Based on Health Canada’s approval process, the approval process normally takes up to six (6) months in Canada for this type of product, assuming no additional information is requested by Health Canada.

“If approved by Health Canada for commercialization in Canada, Vesele® will be our fourth product on the Canadian market including Zestra®, Zestra Glide® and EjectDelay® sold under the name Uxor™ by our partner Orimed Pharma,” said Dr. Bassam Damaj, President and Chief Executive Officer of Innovus Pharma. “Having Vesele® be an NPN in Canada, bearing the indication of 'Help Improve Symptoms of Sexual Dysfunction,' would be a great value add to the product and a great accomplishment for the Company,” continued Dr. Damaj.

Vesele® is a proprietary oral formulation of L-Arginine and L-Citrulline with the natural absorption enhancer Bioperine®. Vesele® was formulated to increase blood flow and nitric oxide production.

As previously reported, a U.S. human clinical use survey was completed on Vesele® to evaluate erectile dysfunction and sexual satisfaction in men using Vesele® twice daily for up to four months with the following favorable results:

1. 49.5% increase in erection hardness
2. 44.5% increase in erection maintenance
3. 34.6% increase in desire for sexual activity
4. 34.1% increase the ability to satisfy the partner

About Innovus Pharmaceuticals, Inc.

Headquartered in San Diego, Innovus Pharma is an emerging over-the-counter (“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.

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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, receiving patent protection for any of its products, to successfully receive approval for Vesele® in Canada and commercialize this product therein, and commercialize other products in the U.S. and internationally and to achieve its other development, 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 annual report on Form 10-K, and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.

Emerging Markets Consulting, LLC
James S. Painter III

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