Awaiting Official Announcement of FDA Approval for FlutiCare
FlutiCare™ Approval could bring a BILLION DOLLARS in sales annually
REDONDO BEACH, CA--(Marketwired - Jul 12, 2016) - SECFilings.com, a leading financial news and information portal offering free real time public company filing alerts, discusses the potential impact of the anticipated FDA ruling on Innovus Pharmaceuticals' (OTCQB: INNV) ANDA filing for FlutiCare™, the company's over-the-counter treatment for allergic rhinitis.
FlutiCare™ is designed to treat non-allergic rhinitis -- better known as "hay fever" or "stuffy nose" -- which affects roughly 50 million Americans each year. While 70% of these individuals use over-the-counter products, more than half are not satisfied with the treatment option, according to an Asthma and Allergy Foundation of America survey, which suggests there's an opportunity for a prescription-strength OTC treatment option to capture market share from category leaders.
As the #1 prescription nasal steroid with over 177 million units sold since 2007, Innovus believes that the over-the-counter version of FlutiCare™ could be worth up to $1 billion per year by addressing a much wider over-the-counter market. The FDA decision is expected in the next several weeks.
The CEO has already signed an agreement for the manufacturing of FlutiCare
Innovus Pharma Achieves Major Milestone With Securing a Manufacturing Agreement for FlutiCare in Anticipation of the FDA Decision
SAN DIEGO, CA--(Marketwired - May 31, 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 that it signed a manufacturing agreement for the supply of its FlutiCare™ 60 and 120 spray/bottles. Innovus signed the agreement in anticipation of the FDA's decision, expected between July-September of this year, on the ANDA application for the drug.
Prior to joining Innovus Pharma,
Dr. Damaj served as President and Chief Executive Officer of Apricus Biosciences, Inc.
where he helped move the company's stock price from
19 Cents to $6.00 !!!
(Uplisted from OTC to NASDAQ)
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.
Innovus Pharmaceuticals, Inc., a pharmaceutical company, engages in the commercialization, licensing, and development of non-prescription medicine and consumer care products in the United States. Its products include Zestra, a non-medicated patented consumer care product to enhance desire, arousal, and satisfaction in women; EjectDelay, an over-the-counter monograph-compliant benzocaine-based topical gel for treating premature ejaculation; Sensum+, a non-medicated consumer care cream that enhances penile sensitivity; Zestra Glide, a high viscosity and low osmolality water-based lubricant; Vesele, a proprietary oral dietary supplement to enhance nitric oxide beneficial clinical effects on sexual functions and brain health; and Androferti to support overall male reproductive health and sperm quality. The company?s pipeline products includes FlutiCare, an over the counter drug for Rhinitis; Urocis for urinary tract infection; and AndroVit, a proprietary supplement to support overall prostate and male sexual health. The company markets and sells its products through commercial partners to primary care physicians, urologists, gynecologists, and therapists; and directly to consumers through online channels, retailers, and wholesalers. Innovus Pharmaceuticals, Inc. was incorporated in 2011 and is based in San Diego, California.
Bassam Damaj, Ph.D.
President and Chief Executive Officer:
Dr. Bassam Damaj was appointed to serve as our President and Chief Executive Officer in January 2013. Prior to joining Innovus Pharma, Dr. Damaj served as President and Chief Executive Officer of Apricus Biosciences, Inc. (NASDAQ: APRI), a specialty pharmaceutical company, from December 2009 until November 2012. At Apricus Bio, Dr. Damaj was responsible for the approval of its lead drug Vitaros, a treatment for erectile dysfunction. Dr. Damaj also signed multimillion dollar partnerships between Apricus Bio and leading pharmaceutical companies such as Abbott, Novartis-Sandoz and Takeda. Before Apricus Bio, Dr. Damaj was a co-founder of Bio-Quant, Inc. and served as the Chief Executive Officer and Chief Scientific Officer and a Director of Bio-Quant's board of directors from its inception in June 2000 until its acquisition by Apricus Biosciences in December 2009. In addition, Dr. Damaj was the founder, Chairman, President and Chief Executive Officer of R&D Healthcare, and the co-founder of Celltek Biotechnologies. He also served as a Director of the Board of Directors at CreAgri, Inc. and was a Member of the Scientific Advisory Board of MicroIslet, Inc. He is the author of the Immunological Reagents and Solutions reference book, the inventor of many patents and author of numerous peer reviewed scientific publications. Dr. Damaj won a US Congressional award for the Anthrax Multiplex Diagnostic Test in 2003. Dr. Damaj holds a Ph.D. degree in Immunology/Microbiology from Laval University and completed a postdoctoral fellowship in molecular oncology from McGill University.
Robert E. Hoffman
Executive Vice President and Chief Financial Officer:
Mr. Hoffman was appointed as our Executive Vice President and Chief Financial Officer on September 6, 2016. Prior to Innovus Pharma, Mr. Hoffman was Chief Financial Officer of AnaptysBio, Inc., a clinical stage biopharmaceutical company. He was part of the founding management team of Arena Pharmaceuticals, Inc. (NASDAQ:ARNA), a biopharmaceutical company, in 1997, serving as Senior Vice President, Finance and Chief Financial Officer until 2015. He also served as Chief Financial Officer for Polaris Group, a biopharmaceutical drug company, from March 2011 to August 2011. Mr. Hoffman is a member of the board of directors of CombiMatrix Corporation (NASDAQ:CBMX), a molecular diagnostics company, Kura Oncology, Inc. (NASDAQ:KURA), a biotechnology company, and MabVax Therapeutics Holdings, Inc. (NASDAQ:MBVX), a biopharmaceutical company. He also was a member of the Financial Accounting Standards Board’s Small Business Advisory Committee until 2015 and is a member of the steering committee of the Association of Bioscience Financial Officers. Mr. Hoffman received his B.B.A. from St. Bonaventure University, and is licensed as a C.P.A. (inactive) in the State of California.
Who are the major players at Innovus Pharma?
Shares Outstanding: ~ 122 Million (as of 1/6/17) Dr. Damaj owns $23+M shares alone
- Current cash on-hand is enough to fund operations through Q3 of 2017. Profitability expected around that time !
- 2017 Projected Revenue of $15M (NOT counting FlutiCare), which would be approximately 3x GREATER than 2016.
Innovus Pharma CEO Provides Shareholder Update and Conference Call
Corporate Presentation November 2016 (8-K 11/1/2016)
Upcoming PDUFA and ANDA Approval Dates Could Catalyze Innovus Pharma (INNV) and Lipocine (LPCN)
Innovus Pharma (INNV): Targeting $3+ Billion Markets With 13 Commercial Products
Major 2016 Accomplishments:
Where can INNV products be seen?
Existing Product Lines @ Innovus Pharma: