Innovus to request regulatory guidance for FlutiCare product filing in Europe to treat allergic rhinitis

The guidance is expected to take 3-4 months pending the response from the MHRA in the UK. Under a European system called the "Decentralized Procedure" (DCP), a company files its application for marketing approval of a drug in just one European country, which is designated the Reference Member State (RMS). Innovus Pharma has chosen The United Kingdom as its RMS.

The RMS then evaluates the application and prepares an assessment report that is submitted to other chosen European Union countries for their consideration and approval. The entire process takes approximately 240 days. One of the major advantages of the DCP is that a company may receive identical marketing authorizations for its product in multiple chosen European Member countries at the same time.

"Submitting our application to the European Agency will be another major milestone for the Company as it will open for us a very large market for our product and increase our revenues dramatically if approved," said Damaj.

Fluticasone propionate nasal spray is sold under the brand name of Flixonase by GSK in Europe.

In Europe, allergy is considered a public health pandemic. It affects over 150 million people, making it the continent’s most prevalent chronic disease.

FlutiCare targets the allergic and non-allergic rhinitis – better known as "hay fever" or "stuffy nose" by the public. The company’s FlutiCare active is the #1 nasal steroid prescribed by physicians and used by patients with more than 177 million units dispensed since 2007. According to a report by Fierce Pharma, GSK’s Flonase OTC sold over $100,000MM in a short period of time from its launch, confirming the size of the market and the potential of FlutiCare if approved by the FDA.

About FlutiCare

Fluticasone propionate 50 mcg spray is the No. 1 prescribed allergy treatment ingredient for temporary relief of the symptoms of hay fever or upper respiratory allergies.

Roughly 50 million people in the United States suffer from nasal allergies, and allergies take a toll on sufferers:

-Nasal allergies can lead to fatigue, sleep disturbances, learning and attention problems and impaired function at work and/or school.

– In 2010, Americans with allergic rhinitis (AR) spent approximately $17.5 billion on health- related costs, lost more than 6 million work and school days and made more than 16 million visits to the doctor.

– 70 percent of sufferers treat their symptoms with prescription or OTC treatments; however, 50 percent of them report they are not completely satisfied with their current method of treatment.