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Thursday, 08/25/2016 3:34:59 AM

Thursday, August 25, 2016 3:34:59 AM

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Bayer’s ClariSpray™ Success Bodes Well for Innovus Pharmaceuticals’ FlutiCare™
By Ryan Allway · Wednesday, August 24th, 2016
Bayer AG expanded its allergy portfolio in the United States to include ClariSpray™, a 24-hour nasal spray to treat allergy symptoms, in April 2016. Though the two drugs contain different ingredients, the company was looking to play off of the already successful Claritin™ brand. Despite a weak allergy season in the United States, the company’s Claritin™ division ‘developed positively’ during the second quarter ‘due primarily’ to the launch of the nasal spray, with revenue expanding by a currency-adjusted 11% to $178 million euros.
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In this article, we will take a look at how this success could bode well for Innovus Pharmaceuticals Inc. (OTC: INNV) and its FlutiCare™ product under review by the FDA.
Blockbuster Drug
ClariSpray™ is an over-the-counter nasal spray that contains fluticasone propionate, which is the generic name of Glaxosmithkline plc’s Flonase. The new product was strongly promoted with television ads across most major networks in an effort to compete with the $45.4 million spent by Flonase and $26.3 million spent by Sanofi’s Nasacort on advertising since their respective launches in the nasal spray market.
ClariSpray’s™ success in the market shouldn’t come as a surprise to those following the nasal spray market. According to some sources, Glaxosmithkline’s Flonase peaked at around $1.3 billion in sales, which places it clearly in the ‘blockbuster’ category of drugs. The company has only a handful of competitors in the market at the moment, which has created a great opportunity for Bayer to take advantage of the gap.
The same opportunity drew Innovus Pharma to pursue its own version of the generic drug, particularly given the expansive distribution network that it has built over the years for its wellness product lines and the limited ANDAs approved in the US by the FDA for the active fluticasone propionate.
Brand Wars
While Bayer’s ClariSpray™ leverages the powerful Claritin™ brand name, Innovus Pharma hopes to capitalize on the leading prescription nasal allergy medication’s reputation in the market. The company secured the rights to market FlutiCare™ – the #1 prescription form in the nasal allergy space with over 177 million units sold – as an over-the-counter drug. The ‘prescription strength’ brand could benefit from its history as a doctor-recommended medication.
Currently, FlutiCare™’s fluticasone propionate is awaiting an ANDA decision from the FDA that’s expected over the coming month or two. With the drug’s robust safety and efficacy profile, the company doesn’t expect to meet any resistance from the FDA when making the decision. Management has also already signed a manufacturing agreement for the supply of FlutiCare™ 60 and 120 spray bottles and plans to leverage its existing distribution network that reaches over 30,000 stores in the U.S.
Innovus trades with a market capitalization of just over $40 million, according to Google Finance. Capturing just a fraction of the billion-dollar market could translate to a significant opportunity for the company given its small size.
Looking Ahead
Bayer’s success with ClariSpray™, Glaxosmithkline’s success with Flonase™, and Sanofi’s success with Nasacort™ all bode well for Innovus’ potential upcoming launch of FlutiCare™. Rather than relying on a strong consumer brand, the company purchased the rights to the leading prescription form in the space, which could be a compelling differentiator from the competition. The company’s modest market cap also creates significant room for upside for investors.
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