SOURCE: Innovus Pharmaceuticals, Inc.

Innovus Pharmaceuticals, Inc.

May 31, 2016 06:00 ET

Innovus Pharma Achieves Major Milestone With Securing a Manufacturing Agreement for FlutiCare in Anticipation of the FDA Decision

SAN DIEGO, CA--(Marketwired - May 31, 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 that it signed a manufacturing agreement for the supply of its FlutiCare™ 60 and 120 spray/bottles. Innovus signed the agreement in anticipation of the FDA's decision, expected between July-September of this year, on the ANDA application for the drug.

"This is a major milestone for the Company as manufacturing of a drug is one of the biggest hurdles in the ability of companies to market products," said Dr. Bassam Damaj, President & CEO of the Company.

In addition to the manufacturing of the product, the Company previously announced that it has established over 30,000 stores in the United States as Vendors of Record in addition to the major wholesale drug distributors in anticipation of the FDA's decision. 

"Innovus has successfully launched multiple products in the U.S. and we have the needed expertise and know how to make it happen for FlutiCare™ if approved by the FDA," continued Dr. Damaj.

"While the ANDA is under review, the manufacturing agreement is in place and the vendors of record are established. We await the FDA's decision and are fully prepared to go full speed with the sales and marketing if the drug is approved," said Dr. Damaj.

FlutiCare™ targets the allergic and non-allergic rhinitis -- better known as "hay fever" or "stuffy nose" by the general public. The company's FlutiCare™ active is the #1 nasal steroid prescribed by physicians and used by patients after dispensing more than 177 million units since 2007. According to a report by Fierce Pharma, GSK's Flonase OTC sold over $100,000M 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 http://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 http://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 http://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: http://www.aafa.org/display.cfm?id=7&sub=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.

Contact Information

  • Contact:
    Innovus Pharmaceuticals, Inc.
    Brokers and Analysts
    Kevin Holmes
    Chesapeake Group
    410-825-3930
    info@chesapeakegp.com