SAN DIEGO, CA--(Marketwired - Jun 7, 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 its partner Khandelwal
Laboratories filed the product licenses for Zestra®, Zestra Glide®, EjectDelay® and Sensum+® with the Indian FDA, The Drugs
Controller General (India) and the Directorate General of Health Services to commercialize the products in India.
The process is expected to take between 120 to 180 days pending any questions from the Indian government.
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 some of Innovus Pharma's products including: 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 KLab 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."
"We are seeing the benefits of our signed commercial partnerships for our products and we look forward to the potential
approval of our four products in India. We are determined to enter yet another large market for our products to continue to boost
our revenues," said Damaj.
About Zestra® and 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
NHP product 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 visit www.zestra.com.
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 visit www.ejectdelay.com.
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 www.sensumplus.com.
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 U.S. 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
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.