Upcoming PDUFA and ANDA Approval Dates Could Catalyze Innovus Pharma (INNV) and Lipocine (LPCN)
Published Monday, May 16, 2016 by Ryan Allway
Innovus Pharmaceutical, Inc. (OTCQB: INNV) and Lipocine Inc. (NASDAQ: LPCN) 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.

Innovus Pharmaceuticals, Inc. (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. (NASDAQ: LPCN) - 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

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