Market movers

Innovus Fast Tracks FlutiCare™ Commercialization with New Hikma Partnership

The nasal allergy market is worth billion of dollars per year with many different product lines on the market. Nasal sprays have become increasingly popular as a way to quickly control allergies without waiting for tablets to kick in. Fluticasone propionate nasal sprays represent a great way to manage the symptoms of seasonal and perennial allergic and non-allergic rhinitis, as evidenced by the wild success of products like Flonase®.

In this article, we will take a look at Innovus Pharmaceuticals Inc.’s (OTCQB: INNV) recent partnership with West-Ward Pharmaceuticals plc, a wholly-owned subsidiary of Hikma Pharmaceuticals PLC (Hikma) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) to fast-track the launch of Innovus’ fluticasone propionate nasal spray - FlutiCare™. 

Fast Tracking Commercialization

Innovus Pharma announced a partnership agreement with West-Ward Pharmaceuticals International on May 9, 2017 that will enable Innovus to launch FlutiCare™ under West-Ward’s recently approved ANDA application No. 207957. Under the terms of the agreement, Innovus will be the first and only nationally branded over-the-counter product under the ANDA, and one of three nationally branded products with the same formulation. 

It is worth noting that West-Ward previously granted license to Perrigo (NYSE: PRGO) for brand stores only. In other words, Perrigo can make the product for a chain such as Walgreens (for example) to sell as a Walgreens brand, but Perrigo cannot create a separate brand to be sold everywhere. The fact that Innovus Pharma is considered for the only national brand to compete with Glaxosmithkline plc’s Flonase® and Bayer AG’s Clarispray® is a testament of trust in the company’s commercial capabilities and the strength of the FlutiCare™ brand.

“Having an approved ANDA drug in our portfolio in a very large indication and being one of only three national brands in the U.S. is a great and long awaited achievement for Innovus Pharma,” said Innovus Pharma President & CEO Dr. Bassam Damaj. “We are putting significant efforts into the launch of FlutiCare™ in the U.S. in the second half of this year through our Beyond Human® sales and marketing platform, our other online channels, and select retail store[s].”

Previously, Innovus Pharma’s undisclosed partner filed an abbreviated new drug application - or ANDA - with the U.S. Food & Drug Administration (FDA) in 2014 for fluticasone propionate nasal spray. This is a separate filing and deal than the West-Ward arrangement. If approved, Innovus would have two manufacturers, ensuring that it has continuous product availability and doesn’t suffer from any production shortfalls that could arise.

The company expects to generate between $10 million and $15 million in additional revenue from the sale of FlutiCare™ in the U.S. during the first 12 months from the planned launch date later this year. 

Significant Market Demand

The long-term potential could be much larger as the FlutiCare™ brand permeates the market. FlutiCare™ will compete against national brands like Flonase® and Clarispray® - both extremely successful product lines.

According to some sources, Flonase® sales peaked at around $1.3 billion before Clarispray® was introduced as a competitor. Clarispray® has become an important revenue contributor to the Claritin™ division, which generates nearly $200 million per quarter. With few competitors in the market, Innovus Pharma has a unique opportunity to introduce a third national competing product under the trusted FlutiCare™ brand name, The Rx form of the API has sold over 177 million prescription units.

The company plans to market the nasal spray through well over 20,000 U.S. retail stores where it is well established as a vendor of record, including Walgreens, CVS, Rite Aid, Kroger, Target, and Safeway. In addition, the company plans to leverage its Beyond Human Sales & Marketing Platform, which has access to ~3,000 newspapers and magazines reaching 20-30 million consumers per month, two million current subscribers, access to over 140 of its websites, online retailers and Amazon.

Looking Ahead

Innovus Pharmaceuticals Inc. (OTCQB: INNV) represents a compelling and unique opportunity within the over-the-counter pharmaceutical space. It’s business model combining approved OTC drug with complementary clinically proven supplements in the same indication give it a unique and trusted name among consumers. Its management has been able to build an impressive pipeline of drugs and consumer care products to be positioned as a serious player competing with large pharma in large markets. By securing the rights to market FlutiCare™, the company is fast-tracking its plans to enter into the nasal allergy market in 2017. Investors may want to take a closer look at the stock given the near-term potential to add $10 million to $15 million in revenue and the long-term potential to grow that revenue.

To get a gauge of how Innovus is doing so far in 2017, interested parties are encouraged to tune in to the company’s Q1 2017 financial results conference call. Innovus will be releasing its financial results with a corporate update after market hours on Friday, May 12 and follow that with a conference call and discussion.

For more information, visit the company’s website at www.innovuspharma.com, the company’s investor presentation, or SECFilings.com’s company profile.