Innovus Pharma Files Application for the Commercialization of ProstaGorx for Benign Prostatic Hyperplasia (“BPH”) as a Natural Health Product in Canada

SAN DIEGO--(BUSINESS WIRE)-- Innovus Pharma (“Innovus Pharma” or the “Company”) (OTCQB Venture Market: INNV), 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, today announced the filing of a Natural Health Product license application (“NHP”) in Canada for its ProstaGorx® product. ProstaGorx® is a clinical strength, multi-response prostate supplement, scientifically formulated to effectively maintain good prostate health and help in preventing future prostate issues. If accepted by Health Canada, ProstaGorx® will be available as an NHP throughout that country specifically to help relieve urologic symptoms associated with Benign Prostatic Hyperplasia (“BPH”). The review process could take up to six months in Canada assuming no additional information is requested by the reviewing body, Health Canada.

“ProstaGorx® will be, if approved, an excellent complement to our fast growing portfolio of products available within the Canadian market,” said Innovus CEO Dr. Bassam Damaj. “Prostate health issues affect millions of men in Canada and we believe it is important to offer a natural, clinically tested, alternative product with a potentially approved claim for urologic symptoms of BPH. We look forward to Health Canada’s positive response to our application.”

With multiple published clinical trials, ProstaGorx® ingredients have been shown to:

1. Work with the prescription drug finasteride to reduce actual prostate weight;
2. Regulate DHT production and hormones that influence prostate volume;
3. Clinically reduce nocturia, and improve prostate symptoms in men with BPH or prostatitis;
4. Clinically reduce overall rate of progression of prostate cancer in men; and
5. Decrease serum PSA levels, suppression of tumor growth and support urinary function.

An estimated 50% of men have histologic evidence of BPH by age 50 and 75% by age 80; in 40–50% of these men, BPH becomes clinically significant^] BPH was one of the ten most common, and costly, diseases in men older than 50 years of age in a recent study in the United States.

In addition to ProstaGorx®, Innovus Pharma has previously announced the filing of a Product License Application (“PLA”) for its drug Xyralid™ with Health Canada and the filing of the NHP to market its product AllerVarx™ with that agency as well. If the above PLA and NHPs are approved, then the Company will have eight (8) products for sale within the Canadian market including Vesele® and UriVarx®, which are currently being sold by the Company directly and Zestra®, Zestra Glide® and Uxor™ (EjectDelay®`), which are currently marketed by the Company’s distribution partner there, Orimed Pharma.

For more information on ProstaGorx® and for ordering in the U.S. please visit www.prostagorx.com

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.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.

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 ProstaGorx® product in Canada 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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