Innovus Pharma Strengthens its Respiratory Franchise with the In-Licensing of Lertal® Tablets, a Clinically Proven Supplement for the Relief of Allergic Rhinitis Symptoms from NTC for the United States and Canada

-Product to be Launched as AllerVarx™-

SAN DIEGO--()--Innovus Pharmaceuticals, Inc. ("Innovus Pharma") (OTCQB Venture Market: INNV), an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men’s and women's health and respiratory diseases, today announced the in-licensing of Lertal® tablets for the management of allergic rhinitis from NTC S.r.l. (“NTC”), an Italian company, for sale by Innovus Pharma in the United States and Canada. Under the terms of the exclusive license agreement, Innovus Pharma agreed to pay an upfront payment, transfer price and sales milestones during the term of the agreement.

“Strengthening our respiratory franchise is an important goal for us and adding more products such as Lertal® as a cross sell or potentially in a kit format with FlutiCare™, when that product is eventually approved by the FDA, will give Innovus Pharma an immense advantage over our competitors,” said Innovus Pharma Chief Executive Officer Dr. Bassam Damaj. “We continue to look at other respiratory products to in-license to further build out our respiratory franchise.”

“We are proud to be partnering with Innovus Pharma in the US and Canada so Lertal® will be available to patients who regularly suffer from allergy symptoms,” said Dr. Riccardo Carbucicchio, Chief Executive Officer of NTC. “Innovus Pharma was positively impressed with our promising clinical trial results of Lertal® which saw reductions in both nasal and ocular symptoms in allergic patients. In view of these results, we are now supporting another larger randomized, multicenter, placebo controlled study in perennial and seasonal allergy in pediatric patients. Lertal® is meant to contribute to a reduction in daily consumption of anti-allergic drugs.”

Lertal® is a patented formulation produced in bilayer tablets with a technology that allows a controlled release of the ingredients. The fast-release layer allows the rapid antihistaminic activity of Perilla. The sustained-release layer enhances Quercetin and Vitamin D3 bioavailability, thanks to its lipidic matrix, and exerts antiallergic activity spread over time.

Lertal® was studied in a clinical trial assessing the reduction of both nasal and ocular symptoms in allergic patients, and daily consumption of anti-allergic drugs, over a period of 30 days. Lertal® showed a reduction of approximately 70% in total symptom scores and a reduction of approximately 73% in the use of anti-allergic drugs. There were no side effects noted during the administration of Lertal® and all the patients enrolled finished the study with good compliance.

The World Health Organization (“WHO”) classifies allergies as the fourth most important chronic disease in the world. Allergic Rhinitis (“AR”) is the most common form of non-infectious rhinitis, affecting between 10% and 30% of all adults in the United States and as many as 40% of US children. Epidemiologic studies show that the prevalence of AR is expected to still be important in the next decades. The World Allergy Organization (“WAO”) has estimated that 400 million people in the world suffer from AR, which remains to a large extent underdiagnosed and undertreated.

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 respiratory diseases. 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, (f) Zestra Glide®, (g)Vesele® for promoting sexual and cognitive health, (h) Androferti® (in the US and Canada) to support overall male reproductive health and sperm quality, (i) BTH® Vision Formula, (j) BTH® Blood Sugar, (k) UriVarx™ for bladder health, among others and eventually FlutiCare™ OTC for Allergic Rhinitis, if its ANDA is approved by the U.S. FDA.

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About NTC s.r.l.

NTC, headquartered in Milan, Italy, is a B2B pharmaceutical company that develops pharmaceutical products, medical devices and food supplements. NTC distributes its products through third parties in more than 70 countries in the world through a large network of partners. In addition to allergy, NTC is involved in the development of products in ophthalmology, gastroenterology, and women’s health.

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About LERTAL ®

Lertal® tablets are a food supplement produced with a proprietary bilayer technology allowing a controlled release of the ingredients.

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, projected revenues from the AllerVarx™ product in the U.S. and Canada, projected online subscribers, estimated market for its products, and statements about achieving its other development, growth, commercialization, financial and staffing objectives and statements regarding any eventual approval by the U.S. FDA of FlutiCare™. 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.


Chesapeake Group
Kevin Holmes, 410-825-3930

Release Summary

Innovus Pharma Strengthens Respiratory Franchise with the In-licensing of Lertal for Relief of Allergy Symptoms


Chesapeake Group
Kevin Holmes, 410-825-3930