Innovus Pharma Announces Receipt of Notification to Commercialize Zestra® in the European Union
March 2, 2017 1:12 pm ET
Innovus Pharmaceuticals, Inc. ("Innovus Pharma") (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 it received the CPNP notification number required to commercialize Zestra® in all 28 member countries of the European Union.
“We are pleased to expand the commercialization market for Zestra® to the second largest market in the world and believe this will enhance our partnering discussions in EU member countries and eventually expand our sales into this region,” said Innovus Pharma CEO, Dr. Bassam Damaj.
Zestra® is currently exclusively partnered with Orimed Pharma in Canada, Sothema Labs for the Middle East and North Africa, Elis Pharma in Turkey and certain select markets, Oz Biogenics for Myanmar and Vietnam, Biotask in Malaysia, J&H in South Korea and non-exclusively to DanaLife in the alternative markets in select European countries and to PT Laras Bumi Resources, LTD in Hong Kong.
Zestra® is currently approved to be marketed and sold in 34 countries worldwide including the United States, Canada, Europe, India, Hong Kong, the United Arab Emirates (“UAE”), the United Kingdom, Morocco, and South Korea. In addition to the United States, the largest market for Zestra®, Innovus Pharma currently generates Zestra® revenues from the following markets: Canada, Morocco, certain European countries and Hong Kong.
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 date, to Innovus Pharma’s knowledge, 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.
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). The worldwide FSD market is estimated to be more than $500 million per year. For more information on Zestra® 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.beyondhumantestosterone.com; www.getbeyondhuman.com; www.trybeyondhuman.com; www.recalmax.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 Zestra® product in Europe, the sale of other of the Company’s products, projected online subscribers, 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.