Innovus Pharma Announces Positive Regulatory Guidance From Europe to File for Zestra® as Herbal Medicine
San Diego, CA, July 23, 2015 (Newswire.com) - Innovus Pharmaceuticals, Inc., (“Innovus Pharma”) www.innovuspharma.com (OTCQB: INNV) announced today it received positive regulatory guidance from the European Medicines Evaluation Agency (“EMEA”) through its member state Sweden to file for its product Zestra® as an over the counter herbal medicine. Innovus chose Sweden as the reference member state for its guidance and will be filing its marketing application in the European Union under the decentralized procedure (“DCP”) for the temporary increase of arousal and desire in women with Female Sexual Interest Arousal Disorder (FSI/AD). The guidance received confirmed that Zestra® can be filed as a Herbal Medicine under Article 10(a) as a well-established use under Directive 2001/83/EC. The entire DCP process takes approximately 240 days. One of the major advantages of the DCP is that a company may receive identical marketing authorizations for its product in multiple- chosen European Member countries at the same time. The Company expects to file its DCP application in the Q4-2105-Q1-2016 time period.
Bassam Damaj, President and Chief Executive Officer of Innovus Pharma commented, "We are very excited about this positive guidance as it allows us to file for use of the DCP process to potentially receive marketing approval for Zestra®, for a large indication, namely FSI/AD where the market is estimated to be as large as the $5 billion dollar erectile dysfunction market. We believe that being able to market and sell Zestra® as a drug in Europe will increase the drug’s value and our ability to enter into commercial partnerships with international pharmaceutical companies."
“With what we believe is strong clinical data on hand and with over 12 million doses sold so far in other countries, we believe that Innovus will be the first to file a marketing application for the FSI/AD indication in Europe with Zestra® and if approved by the EMEA, the product would be first to be marketed in that region for this indication,” continued Dr. Damaj,
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. 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.
About Innovus Pharmaceuticals, Inc.
Headquartered in San Diego, Innovus Pharma is an emerging leader in OTC and consumer products for men's and women's health, vitality and respiratory diseases. The Company generates revenues from its lead products Zestra® for female arousal and EjectDelay® for premature ejaculation and has a total of five marketed products in this space, including Sensum+® for the indication of reduced penile sensitivity, (for sales outside the U.S. only), Zestra Glide®, Vesele® for promoting sexual and cognitive health and two products in the pipeline including, Androferti® (in the US and Canada) to support overall male reproductive health and sperm quality and FlutiCare™ OTC for Allergic Rhinitis if approved by the FDA.
For more information, go to www.innovuspharma.com, www.zestra.com; www.ejectdelay.com; www.myvesele.com; www.sensumplus.com; www.myandroferti.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 receive approval or meet the requirements of any relevant regulatory authority, to successfully file and received approval by the European authorities and commercialize Zestra® in that region. 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, 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.
Innovus Pharma Contact:
Reuven Rubinson
Vice President of Finance
ir@innovuspharma.com
T: 858-964-5123