Innovus Pharma to Request Regulatory Guidance for Filing for Its FlutiCare Product in Europe for the Treatment of Allergic Rhinitis

SAN DIEGO, CA–(Marketwired – Jun 2, 2016) – Innovus Pharmaceuticals, Inc. (“Innovus Pharma”) (OTCQB: INNV), an emerging commercial stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men and women’s health and respiratory diseases, today announced today that it will seek regulatory guidance from the United Kingdom’s MHRA as a Reference Member State in Europe before submitting its European application for its FlutiCare™ (50mcg fluticasone propionate) 60 and 120 sprays/bottle.
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 [1] for temporary relief of the symptoms of hay fever or upper respiratory allergies. [2]
Roughly 50 million people in the United States suffer from nasal allergies [3], 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. [4]
– 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. [5]
– 70 percent of sufferers treat their symptoms with prescription or OTC treatments [6]; however, 50 percent of them report they are not completely satisfied with their current method of treatment. [7]
References
[1] Sur D, et al. Treatment of Allergic Rhinitis. American Family Physician. Volume 81, Number 12, June 15, 2010.
[2] American College of Allergy, Asthma and Immunology: Allergy facts. Available at https://www.acaai.org/allergist/news/Pages/Allergy_Facts.aspx. Accessed July 2014.
[3] American College of Allergy, Asthma and Immunology: Allergic diseases and cognitive impairment. Available at https://www.acaai.org/allergist/allergies/Types/rhinitis/Pages/allergic-diseases-cognitive-impairment.aspx. Accessed July 2014.
[4] Academy of Allergy and Asthma in Primary Care: National impact of allergies. Available at https://www.aaapc.us/wp-content/uploads/2013/01/National-Impact-of-Allergies.pdf. Accessed July 2014.
[5] Scadding G, Punekar Y. EAACI 2006, Abstract 742.
[6] New Survey Reveals Many Patients Want More from Their Allergy Medication. Asthma and Allergy Foundation of America. Available at: https://www.aafa.org/display.cfm?id=7⊂=92&cont=529. Accessed April 24, 2014[7] Data on hand
About Innovus Pharmaceuticals, Inc.
Headquartered in San Diego, Innovus Pharma is an emerging leader in OTC and consumer products for men’s and women’s health and vitality. The Company generates revenues from its lead products (a) BTH® Testosterone Booster, (b) BTH® Human Growth Agent, (c) Zestra® for female arousal and (d) EjectDelay® for premature ejaculation and has an additional five marketed products in this space, including (e) Sensum+® for the indication of reduced penile sensitivity, (for sales outside the U.S. only), (f) Zestra Glide®, (g)Vesele® for promoting sexual and cognitive health, (i) Androferti® (in the US and Canada) to support overall male reproductive health and sperm quality, (j) BTH Vision Formula, (k) BTH Blood Sugar, among others and eventually FlutiCare™ OTC for Allergic Rhinitis, if its ANDA is approved by the U.S. FDA.
For more information, go to www.innovuspharma.com, www.zestra.com; www.ejectdelay.com; www.myvesele.com; www.sensumplus.com; www.myandroferti.com; www.beyondhumantestosterone.com; www.getbeyondhuman.com; www.trybeyondhuman.com.
Innovus Pharma’s Forward-Looking Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, receiving patent protection for any of its products, receiving approval of the ANDA in the U.S. or to be compliant with the requirements of any relevant regulatory authority relating to Fluticare™, to successfully commercialize this product and other products and to achieve its other development, commercialization, financial and staffing objectives. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company’s most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC’s website or without charge from the Company.