San Diego, CA / ACCESSWIRE / June 25, 2014 / Innovus Pharmaceuticals, Inc. ("Innovus Pharma" or the "Company") (OTCBB: INNV) (http://www.innovuspharma.com/) announced today a corporate mid-year update covering Company activities, expected near-term events and comments on recent market conditions, as follows:
“2014 has been a transformative year for Innovus Pharma as we evolved into our commercial stage and revenue generating mode,” said Dr. Bassam Damaj, President & CEO of the Company. “The continued execution on our business model and global strategy has resulted in revenue generation from our four products on the market. We have also expanded our management team, and secured additional financing for the company. Our focus will be to continue to build and expand our global pipeline and grow our revenues to achieve profitability”.
The Company main corporate objectives for 2014 are as follows:
1) Strengthen our global product pipeline in large markets with the acquisition of additional revenue generating products or companies;
2) Expand our global presence with commercial partnerships for our existing products in territories where we do not have any commercial infrastructure;
3) Initiate physician detailing in support of our products in the US;
4) Continue to expand the management team; and
5) Secure financing for our on-going operations.
Strengthen our Global Product Pipeline
Building a strong and global pipeline continues to be an important priority in 2014. We will continue focusing our efforts on being a leader in the OTC and consumer care products in the field of male and female sexual health and vitality, adding to our product pipeline globally.
Innovus Pharma Commercial Pipeline:
The Product: The Company acquired Semprae Laboratories, Inc. and its valuable consumer care product Zestra(r) in late 2013. Zestra(r) is the only OTC natural product clinically proven in two U.S. double-blind, placebo controlled trials in 276 women to increase arousal, desire and satisfaction during sexual intercourse. Zestra(r) is recommended by many top therapists and gynecologists and is currently commercialized in the U.S. and Canada and has sold millions of units since its launch in 2007. Zestra(r) is currently sold in retail stores in the United States and Canada with Walmart being the largest retail chain, through wholesale drug distributors such as Cardinal Health and McKesson and online through the Company and product websites and many online pharmacies and distributors.
The Use: Zestra(r) is clinically proven to enhance arousal, desire and satisfaction in women.
The Potential Market: To date, no product has been approved in the U.S. to treat Female Sexual Interest/Arousal Disorder (“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.
The Drug: EjectDelay(tm) is Innovus’ proprietary, clinically proven, over-the-counter 7.5% benzocaine gel for premature ejaculation. Benzocaine acts to inhibit the voltage-dependent sodium channels on the nerve membrane, stopping the propagation of the action potential and causes temporary numbing of the application site. EjectDelay(tm) is applied to the head of the penis ten to fifteen minutes before sexual intercourse.
The Indication: Male genital desensitizer for the delay of premature ejaculation.
The Disease: Premature Ejaculation, or PE, is the absence of voluntary control over ejaculation resulting in ejaculation either preceding vaginal entry or occurring immediately upon vaginal entry, and is defined as an ejaculation latency time of less than 1 minute.
The Market: It is estimated that over 30% of males suffer from PE at some point in their lives.
The Product: The Company acquired the ex-US rights to the patented CIRCUMserum(tm) in 2012. CIRCUMserum(tm) is a proprietary consumer healthcare product to help in alleviating Reduced Penile Sensitivity (RPS) that contains essential oils and natural botanical extracts. Listed as FDA-GRAS (generally recognized as safe by the US FDA) the cream is applied to the head and shaft of the penis to increase the sensation of the skin in order to improve feelings of sensation to the nerves underlying the skin of the glans.
The Use: Alleviate Reduced Penile Sensitivity.
The Disease: Reduced Penile Sensitivity, or RPS, refers to the condition of decreased sensation in the penis during sexual activity, including difficulty in stimulating the penis, maintaining erection, and/or achieving an orgasm. RPS is commonly associated with circumcision, age, diabetes, and alcoholism, whereby exposure of the glans of the penis over a period of years leads to excessive keratinization and decreased sexual stimulation and neuropathy associated with diabetes.
The Market: Innovus acquired the ex-US rights to CIRCUMserum(tm) in April 2013. RPS is a large market as it is the result or associated with circumcision, diabetic neuropathy, ilioinguinal nerve entrapment resulting from hernia surgery, multiple sclerosis and side effect from the use of monoamine oxidase inhibitors.
The Product: Zestra Glide(r) is a water-based lubricant with high viscosity. The product is natural containing Vitamin A and Aloe Vera and is preservative free. The product was designed to last longer due to its higher viscosity.
The Use: Female lubricant.
The Disease: According to the Mayo Clinic website, vaginal dryness is unfortunately a very common part of the transition into menopause. In fact, some studies report that 40 to 60% of women develop this symptom at some point during the menopausal transition.
The Market: According to the Mass Market Retailer 08/08 the lubricant market in the US is estimated to be around $200M a year and over $400M on a worldwide basis.
The Company is actively looking for additional products to complement its sexual dysfunction health and vitality franchise.
Expand Management Team
The Company has put together a very seasoned and experienced management team with an excellent track record of product development, partnering, commercial operations and growth.
On February 11, 2014, Lynnette Dillen C.P.A., joined Innovus as Executive Vice President and Chief Financial Officer with responsibility for finance, accounting, human resources, information technology and investor relations. Ms. Dillen is a seasoned financial executive with 20 years of experience encompassing multiple industries with private and NASDAQ listed companies. She has held key financial positions for both large public corporations including Blockbuster and Chart House Enterprises as well as medium to smaller venture capital or investment-backed companies, such as Wireless Knowledge, Inc. (a QUALCOMM and Microsoft joint venture), and Catalina Restaurant Group, Inc. Most recently, she has been working as a CFO with both public and private equity backed companies in the process of raising equity either for start-up or next stage growth.
On July 22, 2013, Innovus added Mr. Randy Berholtz, Esq. as its Acting General Counsel and Secretary. Mr. Berholtz has an impressive resume, working most recently as Executive Vice President, General Counsel, and Secretary at Apricus Biosciences, Inc. (NASDAQ: APRI). Mr. Berholtz has served in many leadership roles with various life science companies, including ACON Laboratories, Inc., IngleWood Ventures, L.P., and Nanogen, Inc. The Company looks forward to having his expertise available to assist with complex legal issues and corporate governance.
On March 1, 2014, Innovus added Dr. Mohamad Hachicha as its Vice President of Research and Development. Dr. Hachicha has extensive experience in drug safety, pharmacology and development with senior level experience in companies such as Apricus Biosciences, Forest Laboratories and Perdue Pharma. He holds a Ph.D. in Microbiology and Immunology from Laval University and post-doctoral fellowships from University of British Columbia and Harvard University.
Secure Financing for its On-Going Operations and Increase Cash Reserves
During the first six months of 2014, the Company worked hard to secure financing for its growth and ongoing operations. To date, we have secured close to $1.7M in notes mainly from our President & CEO with some additional outside investment. The Company is also in discussion to secure non-dilutive funding from on-going commercial and distribution partnerships for its products.
Expand Our Global Presence
The Company is pursuing an aggressive commercial partnering and distribution strategy ex-US. In 2013 the Company signed two commercial agreements with Ovation Pharma to distribute and sell EjectDelay(tm) for PE and CIRCUMserum(tm) for RPS in Morocco totaling over $62M in potential license fees, regulatory milestones and sales milestones. The Moroccan partnerships are the first of many distribution agreements the Company is currently negotiating. The Company is focusing its efforts in the largest markets for EjectDelay(tm) and CIRCUMserum(tm), namely the Middle East/North Africa (MENA), Europe and Canada. In addition, the Company launched a comprehensive commercial partnership effort for Zestra(r) for Canada, Europe and the MENA region and expects to start announcing its partners the third quarter of this year. Our standard licensing agreement will include upfront payments, sales milestones and two digit royalties on sales.
In summary, we are committed to driving topline performance with growth products in key geographies, advancing and augmenting our pipeline and aggressively managing our cost base. By doing these things well, we will preserve the ability to invest in our future, potentially start to generate strong cash flow and drive shareholder value and return over both the short and long term. Our main goal remains to continue our growth and achieve profitability in the near future.
About Innovus Pharmaceuticals, Inc.
Headquartered in San Diego, Innovus Pharma is an emerging leader in the OTC male and female sexual dysfunction products. The Company generates revenues from its lead products Zestra(r) for female arousal, and EjectDelay(tm) for premature ejaculation, and has a total of four marketed products in this space including CIRCUMSerum(tm) (for sales outside the U.S. only) and Zestra(r) Glide.
For more information, go to http://www.innovuspharma.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 or to be compliant with the requirements of any relevant regulatory authority relating to such products such as Zestra(r), Zestra Glide(r), EjectDelay(tm) and CIRCUMSerum(tm) to successfully commercialize such 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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Source: Innovus Pharmaceuticals, Inc.