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Innovus Pharma to Enter the Oncology Supportive Care Market With an Exclusive License to Two GRAS-Listed OTC Compounds for Cachexia and Muscle Growth and Repair From the University of Iowa Research Foundation


Innovus Pharmaceuticals, Inc. ("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, announced today its plans to enter the oncology supportive care OTC market with an exclusive license (“License”) to two GRAS (“generally recognized as safe” by the U.S. FDA)-listed compounds, thymol and carvacrol, for cachexia and muscle growth and repair, from the University of Iowa Research Foundation. Specifically, the License is to U.S. Patent Application No. 15/509,438 “Use of Thymol and Carvacrol (monoterpene phenols) for Induction of Increased Skeletal Muscle Endurance, lean Muscle Mass and Reduced Adiposity,” and all related foreign worldwide patent applications.

The compounds have shown in preclinical studies to induce an over 37% increase in exercise tolerance and between a 15% to a 50% increase in muscle mass of certain body muscles.

“The oncology supportive care market is a very large unmet medical market with limited choices to both physicians and patients,” said Dr. Bassam Damaj, the Chief Executive Officer of Innovus Pharma. “Companies such as Abbott have been selling several hundred million dollars of its powder medical foods such as Juven® into this market for years and we believe that products we develop utilizing thymol and carvacrol could add additional needed benefits and be more competitive in this field. The treatment of cachexia just doesn’t exist. It is a miserable frequent event, that every physician knows about and many patients experience, but there is simply little available against it and nothing to prevent it,” continued Dr. Damaj.

Thymol and carvacrol are listed as GRAS substances by the FDA, meaning that they are approved to be safely used in foods, drinks, nutritional and dietary supplements.

About Cachexia and Oncology Supportive Care Market

The prominent feature in cachexia is weight loss and muscle wasting that leads to progressive functional impairment; the loss of chest, diaphragm and abdominal muscles that eventually erodes cardiopulmonary function is often the ultimate cause of death for sufferers. It is a multifactorial syndrome with many mechanisms involved, and is associated with several chronic diseases including COPD, kidney disease, heart failure and in particular cancer.

The rate of cachexia in all cancer patients is anywhere around 40-50%, and in pancreatic cancer it’s about 80%. The National Cancer Institute quoted 20-40% of cancer death is directly caused by cachexia.

Current treatments for cachexia are essentially palliative care - nutritional support, medications like steroids to build muscle and exercise to maintain muscle function. According to Market Intel Reports published on January 31, 2016, the U.S. market for cachexia is estimated to be over $1 billion.

About Muscle Growth and Repair Market

In addition to the large cachexia market, the Company believes that the two licensed compounds may eventually provide Innovus Pharma with patented effective and safe new products in the general everyday muscle repair and growth market. According to Forbes, the VMS (Vitamins, Minerals and Supplements) market is estimated to be $60 billion by 2021.

Juven® is a trademark owned by Abbott Laboratories (ABT)

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.

For more information, go to www.innovuspharma.com, www.zestra.com; www.ejectdelay.com; www.myvesele.com; www.sensumplus.com; www.myandroferti.com; www.fluticare.com; www.beyondhumantestosterone.com; www.getbeyondhuman.com; www.trybeyondhuman.com; www.prostagorx.com; www.allervarx.com; and www.fluticare.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, receiving patent protection in the U.S. and abroad relating to its licensed patent applications from the University of Iowa Foundation and for other technologies and products, to successfully commercialize such and other products in the U.S. and throughout the world 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 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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