SOURCE: SECFilings.com

SECFilings.com

May 11, 2017 08:00 ET

Innovus Fast Tracks FlutiCare Commercialization with New Hikma Partnership -- SECFilings.com

REDONDO BEACH, CA--(Marketwired - May 11, 2017) - SECFilings.com, a leading financial news and information portal offering free real time public filing alerts, recently published an article discussing Innovus Pharmaceuticals' (OTCQB: INNV) recently announced deal to commercialize and launch FlutiCare™ in the United States as a treatment for seasonal and perennial allergic and non-allergic rhinitis.

The nasal allergy market is worth billions 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®.

Fast Tracking Commercialization

Innovus Pharma announced a partnership agreement with West-Ward Pharmaceuticals International, a wholly-owned subsidiary of Hikma Pharmaceuticals PLC, 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 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.

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.

Follow the link to read the full article: http://analysis.secfilings.com/articles/170-innovus-fast-tracks-fluticare-commercialization-with-new-hikma-partnership

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