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 the signing of an exclusive license and distribution agreement with Corporacion Pharma Solutions Peru SAC, a Peruvian company (“Pharma Solutions”) for the commercialization of Zestra®, Zestra Glide®, EjectDelay® and Sensum+® in Peru. As part of the agreement, Innovus Pharma will receive an upfront payment and minimum yearly quantity of orders.
The Company expects to ship its first commercial order to Peru within thirty (30) days of Pharma Solutions receiving regulatory approval from the Peru Health Authorities, which is currently expected to be Q1 2018.
“We are pleased to expand our global reach and commercialization market for four of our important men’s and women’s health products, which include Zestra®, Zestra Glide®, EjectDelay® and Sensum+® in Peru,” said Innovus Pharma CEO, Dr. Bassam Damaj. “Pharma Solutions is our 17th distribution partner for our products outside the United States and is our first distributor in South America, a region that we are looking forward to expanding into,” continued Dr. Damaj.
To date, Innovus Pharma has focused on expanding its worldwide footprint:
- License and distributor agreements with 17 international distributors covering 112 countries worldwide;
- The Company or its distributors have received approval from 37 countries to sell 6 of Innovus Pharma’s products in such countries - products include Zestra®, Zestra Glide®, Sensum+®, EjectDelay®, Vesele® and UriVarx®;
- The Company has filed for approval for another 2 products: Xyralid® and ProstaGorx®; and
- Innovus Pharma is currently generating revenue from the sale of its products by its distributors in 10 countries outside the U.S.
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 (in a statistical significant manner), to increase 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, which is normally present during arousal and sexual activity causing personal distress. Published papers on the FSI/AD market size estimate it is comparable and/or possibly exceeds the market for erectile dysfunction in males.
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.
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, Li USA, Co. for South Korea and Bio Task in Malaysia, and non-exclusively to PT Resources in Hong Kong and certain select Asian markets.
Zestra® is currently approved to be commercialized in 37 countries in the world namely, in Canada, the 28 countries of the European Union, Australia, New Zealand, India, Hong Kong, the United Arab Emirates, South Korea, Morocco, and Malaysia. Innovus Pharma currently generates revenue from the following markets for Zestra®: Canada, Morocco, select European countries, South Korea, and Hong Kong in addition to the United States, which is its biggest market.
About Zestra Glide® and the Lubrication Market
Zestra Glide® is a clinically tested, water-based, longer lasting lubricant. Innovus Pharma acquired Zestra Glide® in its acquisition of Semprae Laboratories, Inc. in December 2013. In a 57 patient safety clinical study, Zestra Glide® proved to be safe and caused no irritation or skin side effects during the six-week trial. Zestra Glide® appears to be the only water-based lubricant clinically tested for safety and has a viscosity of over 16000cps on the market. Increased viscosity usually translates into longer effects. The lubricant market is estimated to be around $200.0 million in the U.S. (Symphony IRI Group Study, 2012).
About EjectDelay® and Premature Ejaculation
EjectDelay® is an over-the-counter (“OTC”) U.S. Food and Drug Administration and Health Canada compliant proprietary topical treatment containing the drug benzocaine and indicated for treatment of premature ejaculation (“PE”). The drug typically works within minutes of application to the glans of the penis. In clinical trials, the application of benzocaine has been shown to delay premature ejaculation by several minutes. For more information visit www.ejectdelay.com and www.uxor.com.
Premature ejaculation is the most common sexual dysfunction reported by men, but is still under-diagnosed and under-treated. PE can occur at any age and its prevalence is consistent across all ages. In an article in The Journal of Sexual Medicine “Sex Med 2007”, D.L. Patrick, D. Rowland and M. Rothman state, “Global studies consistently report that 20-30% of men experience PE worldwide. This means that PE is experienced at similar rates across the globe.”
About Sensum+®
Sensum+® is a non-medicated cream which moisturizes the head and shaft of the penis for enhanced feelings of sensation and greater sexual satisfaction. It is a proprietary blend of essential oils and ingredients generally recognized as safe, which has been commercialized in the U.S. Innovus Pharma acquired the global ex-U.S. distribution rights to Sensum+® from Centric Research Institute. The safety and efficacy of Sensum+® was evaluated by two post-marketing survey studies in circumcised and non-circumcised men. A total of 382 men used Sensum+® twice daily for 14 consecutive days followed by once daily for eight weeks and as needed thereafter. Users reported a 50% increase in penile sensitivity with the use of Sensum+®.
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.urivarx.com; www.sensumplus.com; www.myandroferti.com; www.fluticare.com; www.beyondhumantestosterone.com; www.getbeyondhuman.com; www.trybeyondhuman.com; www.prostagorx.com; www.recalmax.com; www.apeaz.com; and www.allervarx.com.
About Pharma Solutions
Pharma Solutions is a leader in the areas of reproductive medicine, personal care and aesthetic medicine. Their products are developed by companies from the United States and Europe, leaders in pharmaceutical research and development. Their extensive product portfolio offers unique range of products promoted to physicians and pharmacies throughout Peru. For more information, go to www.pharmasolutions.com.pe.
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®, EjectDelay® and Sensum+® and other products in Peru and in other countries 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171201005200/en/
Contacts:
James S. Painter, 407 340 0226
jamespainter@emergingmarketsllc.com
