Innovus Pharmaceuticals Inc. (OTCQB: INNV), an emerging commercial-stage pharmaceutical company that delivers safe, innovative, and effective over-the-counter medicine and consumer care products, plans to launch a new product into a multibillion dollar market in the near-term. After acquiring over-the-counter rights to FlutiCare™ – a leading prescription nasal steroid – in February 2015, the company expects to receive regulatory approval later this year.
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In this article, we will take a look at the company’s plans to transition FlutiCare™ from a prescription nasal steroid into an over-the-counter treatment, as well as the timeline to launch and the financial potential from the move over the coming years.
Rx to OTC Transition
FlutiCare™ is the leading nasal steroid recommended by physicians for the treatment of nasal congestion, sneezing, runny nose, and itchy nose. While GlaxoSmithKline’s (NYSE: GSK) Rx Flonase brand has sold roughly two million units, FlutiCare™ Rx form has sold more than 177 million units, making it a clear leader in the Rx nasal steroid market. Both of these products will compete against Sanofi’s (NYSE: SNY) Nasacort, which has been the only product on the market for a year.
In addition to competing with each other, nasal steroids compete with OTC allergy products that alleviate many of the same symptoms, including so-called “D” allergy pills like Bayer’s (OTC: BAYRY) Claritin and Johnson & Johnson’s (NYSE: JNJ) Zyrtec. While these products are popular among allergy sufferers, they aren’t as effective as many Rx nasal steroids at clearing nasal-specific symptoms associated with allergies, such as a runny or stuffy nose.
The nasal steroid market is expected to become a $1+ billion market opportunity as these brands transition from prescription-only to over-the-counter. With 75% market share in the prescription market, FlutiCare™ is well positioned to become a clear leader in the OTC market given its efficacy and patient satisfaction if approved by the FDA. The company will initially target these existing Rx users and expand the market to include external customers over the coming years.
Time to Market
The over-the-counter Abbreviated New Drug Application (ANDA) for the product was filed with the U.S. Food & Drug Administration 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.
According to an April 2016 investor presentation, the company anticipates approval of the new OTC ANDA during summer 2016. Should the company receive approval on the product at this time, management plans to launch the product during late Q4 2016 or early Q1 of 2017 through a variety of different channels.
It is worth noting that the FDA’s approval of the ANDA could be a significant catalyst for the stock in the near-term. The commercialization of FlutiCare™ is a significant long-term catalyst for the stock as revenues accelerate. The unique combination of a short- and long-term catalyst might make the stock appealing to investors.
Innovus plans to launch the over-the-counter version of FlutiCare™ through both traditional retailers, such as Target, Walgreens’s Drugstore, and CVS where it already has a presence in the OTC space, as well as through online channels. As the #1 nasal steroid used by Rx patients and the #1 nasal steroid prescribed by physicians, the company is well positioned to capitalize on the market opportunity and unlock significant long-term value for shareholders.
The company plans to launch a media campaign when the OTC indication is approved that will include television, sponsored field surveys, and print advertising among other channels. In addition, the company will market directly to healthcare professionals and pharmacists to encourage referrals for the product. And finally, the company has developed attractive in-store advertising to target consumers at the point of purchase.
FlutiCare™ is also ideally suited for online distribution given its potential for customer loyalty and relatively high per unit retail value that provides margin cushion. The company plans on using the FlutiCare™ brand website as a content marketing hub for allergic rhinitis sufferers, while leveraging a dynamic e-mail platform and detailed analytics to ensure a high return on investment for its marketing efforts and enable real-time improvements.
Innovus Pharmaceuticals is uniquely positioned to capitalize on the over-the-counter nasal steroid market with its leading product and existing distribution. With a market worth more than a billion dollars per year at its fingertips, the company could see significant revenue over the near-term if FlutiCare™ obtains an approval from the U.S. Food and Drug Administration later this year – a milestone that could also catalyze the stock.
For more information, visit the company’s website at www.innovuspharma.com.