Innovus Pharma Files Product License Application for the Commercialization of Its Seasonal Allergic Rhinitis
Product in Canada
The Company looks to add AllerVarx™ to its growing portfolio of approved drugs and products in
Canada
Innovus Pharmaceuticals, Inc. ("Innovus Pharma" or the “Company”) (OTCQB Venture Market: INNV), an emerging commercial-stage
pharmaceutical company, today announced the filing of a Natural Health Product License Application (“NHP”) in Canada for its
product AllerVarx™, which is a clinically-proven, patented supplement, formulated to help reduce nasal and/or eye symptoms in
subjects with seasonal allergic rhinitis. If accepted by Health Canada, AllerVarx™ will be available as an NHP and can be
prescribed by physicians to help reduce nasal and/or eye symptoms for seasonal allergic rhinitis. The review process is
approximately seven months in Canada assuming no additional information is requested by Health Canada.
“We are very excited about filing the NHP for our AllerVarx™ product in Canada,” said Dr. Bassam Damaj, the President and Chief
Executive Officer of Innovus Pharma. “We look forward to adding this important product to our growing portfolio of approved drugs
and products in Canada once it is approved by Health Canada for marketing and sales in that country.”
In addition to AllerVarx™, Innovus Pharma has previously announced the filing of a PLA for its drug Xyralid™ with Health Canada,
the filing of the NHP to market its leading product Vesele® with that agency and is awaiting approval decision for its NHP
application to market UriVarx™. If all of the above PLAs are approved, then the Company will have seven products for sale on the
Canadian market including Zestra®, Zestra Glide® and Uxor™ (EjectDelay™), which are currently marketed by the Company’s
distribution partner there, Orimed Pharma.
AllerVarx™ was studied in a published 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. AllerVarx™ 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 AllerVarx™ 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 U.S. children. Epidemiological 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 AllerVarx™
AllerVarx™ 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 anti-allergic activity spread
over time. For more information on the product please visit www.allervarx.com.
About Innovus Pharmaceuticals, Inc.
Headquartered in San Diego, Innovus Pharma is an emerging OTC consumer goods and specialty pharmaceutical company engaged in the
commercialization, licensing and development of safe and effective non-prescription medicine and consumer care products to improve
men’s and women’s health and vitality and respiratory diseases. Innovus Pharma delivers innovative and uniquely presented and
packaged health solutions through its (a) OTC medicines and consumer and health products, which we market directly, (b) commercial
partners to primary care physicians, urologists, gynecologists and therapists, and (c) directly to consumers through our
on-line channels, retailers and wholesalers. The Company is dedicated to being a leader in developing and marketing new OTC and
branded Abbreviated New Drug Application (“ANDA”) products. The Company is actively pursuing opportunities where existing
prescription drugs have recently, or are expected to, change from prescription (or Rx) to OTC.
For more information, go to www.innovuspharma.com; www.zestra.com; www.ejectdelay.com; www.myvesele.com; www.urivarx.com ; www.sensumplus.com; www.myandroferti.com; www.beyondhumantestosterone.com; www.getbeyondhuman.com; www.trybeyondhuman.com; www.recalmax.com; www.prostagorx.com; www.fluticare.com; www.allervarx.com; and www.apeaz.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, projected revenues from the AllerVarx™ product in Canada if approved in that country,
estimated market for its products, and statements about achieving its other development, growth, 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 filing on Form S-1, 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.
Emerging Markets Consulting, LLC
James S. Painter III, 407 340 0226
jamespainter@emergingmarketsllc.com
or
Chesapeake Group
410-825-3930
info@chesapeakegp.com
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