Innovus Pharma Announces the Approval of the Product Licenses for Zestra®, Zestra Glide®, EjectDelay® and Sensum+® by the Indian FDA (Directorate General of Health Services) through its Partner Khandelwal Laboratories

SAN DIEGO–(BUSINESS WIRE)–Innovus Pharmaceuticals, Inc. (“Innovus Pharma”) (OTCQB Venture Market:
INNV), an emerging commercial stage cash flow positive 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 its partner
Khandelwal Laboratories received the approval of the product licenses
for Zestra®, Zestra Glide®, EjectDelay® and Sensum+® from the Indian
FDA, The Drugs Controller General (India), and the Directorate General
of Health Services to commercialize the products in India.

“We are thrilled to have received the approval to commercialize our
products from the Indian FDA in a very short time due to the strength of
the dossier and the clinical trials. India is our seventh country where
we have our products approved and we look forward to start the
commercial launch by our partner Khandelwal Labs in the very near
future,” said Dr. Bassam Damaj, President and CEO of Innovus
Pharmaceuticals, Inc.

On September 10, 2015 Innovus Pharma entered into an exclusive marketing
and distribution agreement with Khandelwal Laboratories based in India
(“KLab”) under which Innovus Pharma has granted to KLab an exclusive
ten-year license and distribution rights to market and sell Innovus
Pharma’s products. These products include Zestra® to increase Female
Sexual Arousal and Desire and Satisfaction, EjectDelay® for treating
premature ejaculation, Sensum+® to increase penile sensitivity
and Zestra Glide®, the high-viscosity water-based lubricant. If KLabs
exceeds its minimum yearly orders, the agreement has two five-year term
extensions. Under the agreement, the minimum orders for the first term
of the agreement are over two million and six hundred thousand ($2.6M)
US dollars annually.

About Zestra® and Female Sexual Interest/Arousal Disorder (FSI/AD)

Zestra® is a patented blend of natural oils clinically-proven
in double-blind placebo-controlled clinical trials in 276 women to
increase in a statistical significant manner the arousal, desire and
sexual satisfaction in FSI/AD women. Zestra® is the first Natural Health
Product (NHP) to receive approval for the indication of FSI/AD in Canada
as an NHP. To date, the Company believes that no product has been
approved to treat FSI/AD, a persistent or recurring inability to attain
or maintain adequate sexual excitement until the completion of a sexual
activity. The diagnosis can also refer to an inadequate
lubrication-swelling response normally present during arousal and sexual
activity causing personal distress. Published papers on the FSI/AD
market size estimate it to be equal or larger than the market for
erectile dysfunction in males, and possibly larger. Zestra® is currently
available in the United States, Canada and Morocco. For more information

About EjectDelay® and Premature Ejaculation

EjectDelay® is an over-the-counter (“OTC”) U.S. Food and Drug
Administration and Health Canada compliant proprietary topical treatment
containing the drug benzocaine and indicated for treatment of premature
ejaculation. The drug typically works within minutes of application to
the glans of the penis.

In clinical trials, the application of benzocaine has been shown to
delay premature ejaculation by several minutes. For more information

Premature ejaculation (“PE”) is the most common sexual dysfunction
reported by men but is still under-diagnosed and under-treated. PE can
happen at any age and its prevalence is consistent across all ages. In
an article in The Journal of Sexual Medicine in 2007 Sex Med 2007, D.L.
Patrick, D. Rowland and M. Rothman stated, “Global studies consistently
report that 20-30% of men experience PE worldwide.”

About Sensum+® and Reduced Penile Sensitivity (RPS)

Sensum+® is a patented blend of essential oils and natural botanicals
including rose oil, sweet almond oil, cinnamon bark oil, and other
extracts. The main ingredient of Sensum+® (cinnamon oil) works by
activating the Transient Receptor Potential A1 (TRPA-1) channels
responsible for the heat and cold sensation of the skin and results in
an increase of sensation that current users welcome and appreciate. The
safety and efficacy of Sensum+® was evaluated in 2 post marketing survey
studies in circumcised and non-circumcised men. A total of 382 men used
Sensum+® twice daily for fourteen consecutive days followed by once
daily for 8 weeks and as needed thereafter.

Reduced penile sensitivity is a major problem associated with many
diseases such as hernia surgery, the use of anti-depressants,
circumcision, multiple sclerosis and others. There are no approved
products to treat RPS.

For more information visit

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,;;;;;;;

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 product licenses in India. or to be compliant with the
requirements of any relevant regulatory authority relating to its
Products 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.


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