Innovus Pharma Announces Positive Pre-Clinical Synergistic Effects Of Vesele In Combination With Sildenafil (Viagra) On Nitric Oxide Production

SAN DIEGO--(BUSINESS WIRE)--Innovus Pharmaceuticals, Inc. ("Innovus Pharma" or the “Company”) (OTCQB Venture Market: INNV), an emerging over-the-counter (“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, announced today the first set of its pre-clinical results on the combination use of its dietary supplement Vesele® for sexual health with Sildenafil (sold as Viagra® in the U.S. by Pfizer) on the nitric oxide (“NO”) production in rats. Inducing nitric oxide production is necessary and a pre-requisite to causing more blood flow to the penis therefore inducing an erection.

In this first set of studies, Vesele® synergistically increased the Sildenafil NO production levels in blood by over 35% as compared to animals receiving 100mg/70kg of Sildenafil alone. The results reported in this release are the first set of a number of ongoing experiments, which also will include Tadalafil (Cialis®), and which we currently believe will lead to our first projected human clinical trial evaluating the effects of Sildenafil (Viagra®) and/or Tadalafil (Cialis®) with Vesele®.

“The synergistic effect of Vesele® on Sildenafil was a great and unexpected finding as we would normally expect only an additive effect between the two products. This finding prompted us to file a provisional patent application in the U.S. covering the use of our product Vesele® with all PDE5 inhibitors,” said Innovus Pharma CEO, Dr. Bassam Damaj. “We are very happy with the results and if these results eventually translate into humans, it means that Vesele® could potentially augment the Sildenafil response proportionately,” continued Dr. Damaj.

The Company is currently expanding its studies to include the low dose Cialis® (Tadalafil) marketed by Eli Lilly as it is expected, pending FDA approval, that Cialis® low dose would potentially be the first OTC drug for erectile dysfunction (“ED”) on the market once patents expire in 2018.

On May 28, 2014, Sanofi and Eli Lilly announced a licensing agreement for Cialis® (Tadalafil) OTC under which Sanofi will pursue regulatory approval for nonprescription Cialis® (Tadalafil) in the U.S., Canada and Australia following patent expiration.

According to Eli Lilly’s May 28, 2014 press release, Cialis® was first approved by the European Medicines Agency in 2002, then by the U.S. Food and Drug Administration in 2003, for the treatment of ED. Ultimately, Cialis® has received approval in more than 120 countries for indications that vary by country, including ED and the signs and symptoms of benign prostatic hyperplasia (“BPH”). Cialis® reached $2.16 billion in worldwide sales in 2013 and has recorded total global sales of more than $14 billion since launch. As of that date, more than 45 million men worldwide had been treated with Cialis®.

About Erectile Dysfunction

ED is a medical condition in which a man has trouble getting or keeping an erection. It is very common: more than half of men over 40 years old have ED.^[1]

About Vesele®

Vesele® is a proprietary oral formulation of L-Arginine and L-Citrulline with the natural absorption enhancer Bioperine®. Vesele® was formulated to increase blood flow and nitric oxide production. As previously reported, a four-month U.S. human clinical use survey study was completed on Vesele® to evaluate erectile dysfunction and sexual satisfaction in men using Vesele® twice daily for up to four months with the following favorable results:

1. 49.5% increase in erection hardness;
2. 44.5% increase in erection maintenance;
3. 34.6% increase in desire for sexual activity; and
4. 34.1% increase the ability to satisfy the partner.

About Innovus Pharmaceuticals, Inc.

Headquartered in San Diego, Innovus Pharma is an emerging over-the-counter (“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.sensumplus.com; www.myandroferti.com; www.fluticare.com; www.beyondhumantestosterone.com; www.getbeyondhuman.com; www.trybeyondhuman.com; www.prostagorx.com; www.allervarx.com; and www.fluticare.com

^[1] Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994;151:54-61.

Viagra® is a trademark owned by Pfizer and Cialis® is a trademark owned by Eli Lilly.

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 in the U.S. and abroad for its Vesele® product in combination with Sildenafil and for any of its other products, to successfully commercialize such and other products in the U.S. and throughout the world 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 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.