SOURCE: Innovus Pharmaceuticals Inc.

Innovus Pharmaceuticals Inc.

June 09, 2016 06:00 ET

Innovus Pharma (INNV)'s Vesele Could Be the Best Complementary Product for Viagra and Cialis's $3.2 Billion Dollar Erectile Dysfunction Market

SAN DIEGO, CA--(Marketwired - Jun 9, 2016) -  Innovus Pharma (OTCQB: INNV) -- The global erectile dysfunction drug market is expected to reach $3.2 billion USD by 2022 according to a new report by Grand View Research Inc. Male sexual dysfunction has become a multi-billion-dollar market fueled by sales of erectile dysfunction drugs like Viagra and Cialis. In fact, Pfizer Inc.'s Viagra surpassed $1 billion in sales during its first year despite having lower than usual third-party coverage. The drug has consistently surpassed $1 billion per year in sales since its launch and even briefly reached above the $2 billion mark back in 2012 despite growing competition.

To view the Pfizer's Viagra Revenue - Source: Statista chart please click here.

According to IMS data, Viagra accounted for over 47.0% of the total revenue in 2014. It is generally considered as the first line of treatment for erectile dysfunction. Brand loyalty and initial effectiveness are the major factors attributing for its large market share. Cialis (tadalafil) from Eli Lilly & Co. and Levitra (vardenafil) from Bayer AG are known to be the competitors for Viagra globally. Cialis (tadalafil) was approved in 2003 by the United States Food and Drug Administration as a prescription drug. Cialis is also known as "The Weekend Pill" owing to its 36-hour effectiveness.

North America constituted the largest share of approximately 55.0% in 2013 of the total erectile dysfunction market. Extension of patent exclusivity rights for Viagra (sildenafil citrate) in the U.S. till 2019 along with introduction of new erectile dysfunction drugs such as Zydena (udenafil) and Stendra/Spedra (avanafil) will be the major factors responsible for market growth during the forecast period.

Viagra and Cialis fall into the Phosphodiesterase type 5 inhibitors (PDE5) class of drugs and are currently the first line treatment for erectile dysfunction (ED), among others. PDE5 inhibitors work by increasing the blood flow to the penis through nitric oxide (NO) conversion therefore allowing a natural erection to take place. However, several published research shows that PDE5 treatments have high discontinuation rates. The study published by Carvalheira AA et al. in the highly reviewed Journal of Sexual Medicine shows that close to 40% of men on PDE5 inhibitors stop using the drugs due to loss of efficacy.

Innovus Pharmaceuticals' (OTCQB: INNV) Vesele®, currently on the U.S. market, is designed to maximize the benefits of NO. The product contains two amino acids: L-Citrulline and L-Arginine, plus a patented piperine extract called BioPerine®, that helps the body absorb these amino acids and results in higher NO production. Nitric Oxide relaxes blood vessels to allow for healthy blood flow throughout the body.

Innovus ran a 72 patient U.S. human survey use clinical trial over 16 weeks in people with low erectile dysfunction accompanying endpoints including: 1) erection hardness; 2) erection maintenance; 3) frequency of sexual encounters; and 4) desire for sexual encounters. The results announced by the company show that Vesele® use resulted in the following:

1. 49.5% increase in erection hardness
2. 44.5% increase in erection maintenance
3. 34.6% increase in desire for sexual activity
4. 34.1% increase the ability to satisfy the partner
5. 44% increase in overall satisfaction

Based on the results from Innovus' study and the similar mechanism of action of the PDE5 inhibitors and Vesele® it is conceivable that the combination of the two products might result in a higher blood flow and therefore better erections and clinical responses.

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.

Looking Ahead
Innovus Pharmaceuticals plans to capitalize on the enormous market for erectile dysfunction with a clinically proven product with widespread distribution. Investors may want to keep an eye on the stock over the coming quarters as it expands awareness of Vesele and works to build out its other pipeline products. As it transitions to profitability, the company will likely attract the interest of a growing number of institutional investors.

For more information, visit the company's website at www.innovuspharma.com.

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