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Innovus Pharma’s Partner Luminarie Receives Approval for Zestra® for Female Sexual Arousal Disorder as a Medical Device I from Australia’s Therapeutic Goods Administration

2017年07月20日 PM07:00
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SAN DIEGO

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 that its partner Luminarie Pty Ltd (“Luminarie”) received approval to commercialize Innovus Pharma’s product Zestra® as a Medical Device I from Australia’s FDA equivalent Therapeutic Goods Administration (“TGA”) for the treatment of Female Sexual Arousal Disorder.

“We are pleased with the speed in which our partner Luminarie received approval for Zestra® as a medical device in Australia,” said Innovus Pharma CEO, Dr. Bassam Damaj. “We look forward to the launch of the product in Australia in the near future and look forward to Luminarie’s efforts to have the product approved and eventually launch in other countries in its territory, namely New Zealand and the Philippines,” continued Dr. Damaj.

Innovus Pharma signed in May 2017 an exclusive license and distribution agreement with Luminarie, a company based in Australia, for the commercialization of Zestra® for Female Sexual Arousal Disorder and Zestra Glide® for female lubrication in the three countries named above.

Besides Luminarie, Zestra® is currently exclusively partnered with Orimed Pharma, the OTC subsidiary of Jamp Pharma in Canada, Densmore in France and Belgium, DanaLife ApS in select European markets, Sothema Laboratories for the Middle East and North Africa, Elis Pharmaceuticals in Turkey and certain select markets, BioTask in Malaysia and J&H Co. LTD in South Korea, and non-exclusively to PT Resources in Hong Kong and certain select Asian markets.

Zestra® is currently approved to be commercialized in 34 countries in the world, namely, in Canada, the 28 countries of the European Union, Australia, India, Hong Kong, the United Arab Emirates (“UAE”), South Korea and Morocco. Innovus Pharma currently generates revenues from the following markets for Zestra®: Canada, Morocco, certain European countries, South Korea and Hong Kong in addition to the United States as its biggest market.

About Zestra® and FSI/AD

Zestra® is a patented blend of natural oils clinically-proven in double-blind placebo-controlled clinical trials in 276 women to increase in a statistical significant manner the arousal, desire and sexual satisfaction in FSI/AD women. To the Company’s knowledge, Zestra® is the first NHP product to receive approval for the indication of FSI/AD in Canada. To date, no product has been approved to treat FSI/AD, a persistent or recurring inability to attain or maintain adequate sexual excitement until the completion of a sexual activity. The diagnosis can also refer to an inadequate lubrication-swelling response normally present during arousal and sexual activity causing personal distress. Published papers on the FSI/AD market size estimate it to be equal or larger than the market for erectile dysfunction in males, and possibly larger.

Approximately 43% of women in the United States age 18 to 59, or ~50 million, experience some form of Female Sexual Dysfunction (“FSD”) according to a published study. (Laumann, E.O. et al. Sexual Dysfunction in the United States: Prevalence and Predictors. JAMA, Feb. 10, 1999. vol. 281, No. 6.537-542) and (http://www.indexmundi.com/south_korea/demographics_profile.html). The FSD market in the United States is estimated to be more than $1 billion per year. For more information on Zestra®, please visit www.zestra.com.

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; and www.allervarx.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 for any of its products, to successfully commercialize Zestra®, Zestra Glide® and other products in Australia, New Zealand and the Philippines 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 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: http://www.businesswire.com/news/home/20170720005449/en/

CONTACT

Emerging Markets Consulting, LLC
James S. Painter III, +1
321-206-6681
jamespainter@emergingmarketsllc.com

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