Upcoming PDUFA and ANDA Approval Dates Could Catalyze Innovus Pharma (INNV) and Lipocine (LPCN)
(firmenpresse) - SAN DIEGO, CA -- (Marketwired) -- 05/16/16 -- Innovus Pharmaceutical, Inc. (OTCQB: INNV) and Lipocine Inc. are two specialty pharmaceutical companies focused on men and women's health that have PDUFA and ANDA dates scheduled over the next few months that could significantly alter their future prospects.
Upcoming catalysts drive the stock prices of many biotech and pharmaceutical companies, such as Prescription Drug User Fee Act (PDUFA) dates or Abbreviated New Drug Application (ANDA) actions. These are scheduled dates are when the FDA makes a decision on whether or not to approve a new or a generic drug candidate.
Innovus Pharma and Lipocine each have very interesting products addressing large markets that could soon be introduced to the U.S. market following potential FDA approvals.
(OTCQB: INNV) 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.
The company's FlutiCare™ product candidate has an ANDA filed with the FDA and has an expected response date of July to august of 2016. With over 40 million units of nasal spray sold in the U.S. during 2014, management estimates the global market for FlutiCare™ to be $1 billion per year as it transitions Fluticasone propionate nasal spray into the over-the-counter markets.
Lipocine Inc. is a specialty pharmaceutical company which develops pharmaceutical products using its oral drug delivery technology in the area of men's and women's health. The company offers a portfolio of proprietary product candidates designed to produce pharmacokinetic characteristics and facilitate low dosing requirements, bypass first-pass metabolism, reduce side effects, and eliminate gastrointestinal interactions that limit bioavailability, its lead product candidate, LPCN 1021, an oral testosterone replacement therapy designed for twice-a-day dosing, is under FDA review. Lipocine's pipeline candidates also include LPCN 1111, a next generation oral testosterone therapy product with once daily dosing that is in Phase II clinical study. LPCN 1107 is in Phase I clinical study for the prevention of recurrent preterm birth.
The company's LPCN 1021 product candidate expects potential PDUFA approval on June 28, 2016. As an oral testosterone agent that's designed to replace existing therapies -- typically topical creams or injections -- the product could see widespread adoption as consumers look for more convenience delivery methods.
These two companies may have unrelated products under review by the FDA (Innovus Pharma's Fluticare™ is for allergic rhinitis and Lipocine's LPCN 1021 is an oral testosterone replacement), but the two companies also have a lot of commonalities:
1. Lipocine CFO Morgan Brown came out of Innovus Pharma.
2. Both companies target the testosterone market through different products with Innovus Pharma's BTH natural testosterone booster and Lipocine LPCN 1021 oral testosterone booster.
3. Management is known to turn around companies with great success.
Investors may want to keep a close eye on both of these companies as key FDA response dates approach and PDUFA and ANDA decisions could serve as key catalysts for the stock price.
For more information, visit Innovus Pharmaceuticals' website at and Lipocine's website at .
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.
For more information, go to , ; ; ; ; ; ; ; .
For additional information on INNV please visit
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, to receive approval or meet the requirements of any relevant regulatory authority, to successfully commercialize such products and to achieve its other development, commercialization and financial goals, whether we and our distributors will continue to successfully market and sell our products.. 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
Reuven Rubinson
Vice President of Finance
858.964.5123
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Datum: 16.05.2016 - 14:00 Uhr
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