Innovus Pharmaceuticals Announces the Filing of the Product License to Commercialize Androferti With Health Canada
(firmenpresse) - SAN DIEGO, CA -- (Marketwired) -- 03/08/16 -- (OTCQB: INNV) a company focusing on the commercialization of over-the-counter ("OTC") and consumer products for men''s and women''s health, vitality and respiratory diseases, announced today that its partner Orimed Pharma filed a Product License Application with Health Canada as a Natural Health Product (NPN) to market the Product License Fertility and Protect Sperm from Oxidative Damage.
Androferti®, a carnitine based product, has been shown in multiple published clinical trials to statistically increase seminal quality (concentration, motility, morphology and vitality) and enhances spermatozoa quality (decreases of vacuoles in the sperm nucleus, decreases DNA fragmentation, decreases the dynamics of sperm DNA fragmentation, and improvement on the inventory of mobile sperms (REM)).
To our belief, Androferti® is the only product clinically proven to increase Sperm Quality and enhance Spermatozoa Quality as compared to other products where the claims are based on an ingredient used in the products.
The approval process takes up to six months in Canada for this type of product, assuming no additional information is requested by Health Canada.
"We have had an excellent track record of receiving approval for our products by Health Canada with three products already approved and commercialized in that country including Zestra® for Female Sexual Interest Arousal Disorder (FSI/AD), Zestra Glide® as a lubricant and EjectDelay® (Uxor™) approved to treat Premature Ejaculation by our partner Orimed Pharma. If approved, Androferti® will be the fourth product Innovus Pharma has received approval for by Health Canada," said Dr. Bassam Damaj, President and Chief Executive Officer of Innovus Pharma.
"The Canadian market has been a great source of revenues for Innovus as we continue to gain more market share with our current products and introduce new ones," added Dr. Damaj.
To the Company''s knowledge, Androferti® is the only supplement product clinically proven to increase the Sperm Quality and enhance Spermatozoa Quality as compared to other products where the claims are based on an ingredient used in the products.
Androferti®, has been shown in multiple published clinical trials to statistically increase seminal quality (concentration, motility, morphology and vitality) and enhances spermatozoa quality (decreases of vacuoles in the sperm nucleus, decreases DNA fragmentation, decreases the dynamics of sperm DNA fragmentation, and improvement on the inventory of mobile sperms (REM)).
According to reports by IBIS World August 2014, the fertility market is estimate to be around $2 billion with a 2.5% yearly increase with 70% of the cases due to male infertility.
Headquartered in San Diego, Innovus Pharma is an emerging leader in OTC and consumer products for men''s and women''s health and vitality. The Company generates revenues from its lead products (a) BTH® Testosterone Booster, (b) BTH® Human Growth Agent, (c) Zestra® for female arousal and (d) EjectDelay® for premature ejaculation and has a total of thirteen marketed products in this space, including (e) Sensum+® for the indication of reduced penile sensitivity, (for sales outside the U.S. only), (f) Zestra Glide®, (g)Vesele® for promoting sexual and cognitive health, (i) Androferti® (in the US and Canada) to support overall male reproductive health and sperm quality, (j) BTH Vision Formula, (k) BTH Blood Sugar, among others and eventually FlutiCare™ OTC for Allergic Rhinitis, if its ANDA is approved by the U.S. FDA.
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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 commercialize such products and to achieve its other development, commercialization and financial goals, whether we and our distributors will continue to successfully market and sell our products such as Androferti® in Canada. 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.
Reuven Rubinson
Vice President of Finance
T: 858-964-5123
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Datum: 08.03.2016 - 09:00 Uhr
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