Innovus Pharmaceuticals Inc (OTCMKTS:INNV) has quickly become a favorite for us at Insider Financial and our subscribers. We first alerted our subscribers back in May that INNV was set up to go on a bull run. Except for a drop at the beginning of June, shares have been steadily climbing higher and have just made new highs. With the company now well capitalized, we think another bull run could just be getting started.Innovus Pharma describes itself as "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 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, Androferti (in the US and Canada) to support overall male reproductive health and sperm quality and hopefully, eventually from FlutiCare OTC for Allergic Rhinitis for which an ANDA has been submitted to the U.S. Food and Drug Administration."INNV just closed an additional $0.75 million convertible promissory note investment from institutional investors for a total of $2.25M. The convertible promissory notes have a $0.25 fixed conversion price and bear an interest rate of 10% and mature in 13 months. CEO Dr. Bassam Damaj said:
"We continue to bolster our financial position in preparation of the launch of FlutiCare in anticipation of the FDA's upcoming decision. Our ability to raise money in such a difficult market is a testimony to the strength of the Company and its pipeline. The new capital raised will increase the current growth we are experiencing in our sales, and will fast track our goal of being cash flow positive exiting 2016 and potentially profitable exiting 2017."
In February of last year, Innovus Pharma acquired the over-the-counter rights to FlutiCare, the leading nasal steroid recommended by physicians for the treatment of nasal congestion, sneezing, runny nose, and itchy nose. FlutiCare Rx form has sold more than 177 million units, making it a clear leader in the Rx nasal steroid market.The over-the-counter Abbreviated New Drug Application (ANDA) for FlutiCare was filed with the FDA during the fourth quarter of 2014. In January of 2015, the FDA accepted the ANDA for review and the application has been making its way through the lengthy approval process. The good news is that ANDA applications take less time than NDA applications, since the drug already has been approved in prescription form. Innovus expects to hear back from the FDA on the ANDA within the next two months. Once this happens and if approved, shares are off and running again.The nasal steroid market is expected to become a $1+ billion market opportunity. With a 75% market share in the prescription market, FlutiCare is expected to become the clear leader in the OTC market given its efficacy and patient satisfaction if approved by the FDA.In Europe, Innovus Pharma is seeking regulatory guidance from the United Kingdom's MHRA as a Reference Member State in Europe before submitting its European application for its FlutiCare (50mcg fluticasone propionate) 60 and 120 sprays/bottle. The guidance is expected to take 3-4 months pending the response from the MHRA in the UK.Currently trading with a market cap of $32 million, INNV is one of the most exciting stories on the OTC Markets. The company has built an impressive portfolio of over-the-counter brands that have the potential to become billion dollar revenue generators. INNV has already established distribution channels through Walmart, Target, and Walgreen’s Drugstore.com. We're expecting some major news from INNV over the next few weeks. Sign up to our free newsletter below and get our current updates on INNV!Disclosure: We have no position in INNV and have not been compensated for this article.







