PLx Pharma (PLXP) is a specialty pharmaceutical company which received FDA approval in early March for its key drug VAZALORE (aspirin capsules) in 325mg and 81mg doses, notes John McCamant, biotech sector specialist and editor of The Medical Technology Stock Letter.
The FDA approval was achieved during one of the agency’s worst stretches in recent memory and is a testament to management’s experience with regulators and the strength of the data package.
With FDA approval in hand the focus has shifted to U.S. commercialization and the launch timeline for the OTC drug, which is on target for August. VAZALORE is the first and only FDA approved, liquid-filled aspirin capsule with a unique mechanism of lipid encapsulated delivery, PLxGuard.
The drug — a potential super aspirin — is a highly differentiated formulation with proven advantages over current offerings on both safety and efficacy parameters including achievement of 99% platelet inhibition significantly faster than standard-of-care enteric coated (EC) aspirin.
PLXP announced that three stock-keeping units (SKUs) of VAZALORE will be available in over 4,500 Walmart stores across the United States in mid-August. This is a huge deal for PLXP because Walmart’s broad reach and millions of customers translate into patients having easy access to VAZALORE in most of their stores nationwide.
In addition to creating retail/OTC partnerships, management’s current marketing strategy will continue to focus on raising awareness of VAZALORE within the medical community at major medical conferences such as the American Heart Association (AHA) meeting.
The company will also target cardiologists broadly with the message that VAZALORE has significant potential in platelet inhibition, with nearly twice as many patients achieving a complete antiplatelet effect compared to EC aspirin.
While VAZALORE is PLXP’s first FDA approved product, we believe the company has a deep bench of talented managers who are seasoned at launching blockbuster products to the market including household names such as Mucinex, Lipitor, Zantac, and Zicam.
Regarding Mucinex, Chairman Mike Valentino led the team that launched Mucinex and was key in turning it into a $500 million OTC drug before being acquired. Mucinex currently generates over $1 billion in sales in its various formulations.
Entry into the U.S. aspirin market is potentially a high-value proposition as the OTC aspirin market is worth over $10 billion. Currently available products have limited differentiation on efficacy and safety with enteric coated (EC) formulations.
The key to VAZOLORE’s superior activity is the PLxGuard technology, which allows the active drug to be released in the optimal place in the GI tract for absorption.
After a patient swallows a capsule of VAZALORE the gel coating dissolves releasing aspirin-filled liposomes into the stomach. These liposomes are stable in the low pH of the stomach, protecting the lining of the stomach from interactions with the aspirin.
When the liposomes move to the higher pH environment of the duodenum they release their payload and it is readily absorbed. If the materials reflux back into the stomach, the liposome re-forms, offering continued protection.
The action of liposomes is very similar to dishwashing detergent — VAZALORE stores aspirin in the same way that dish soap surrounds grease and allows it to be washed down the drain with water.
VAZALORE was approved based on bioequivalence data that showed from a pharmacological perspective it behaves very similarly to EC aspirin once it is absorbed, meaning that previously generated efficacy and safety data for aspirin can be applied to VAZALORE.
However, because of the improved delivery system VAZALORE leads to less agitation of the gastric system and improved platelet inhibition.
The company also showed that VAZALORE is more readily absorbed by diabetic patients, who often experience reduced bioavailability when using immediate-release aspirin.
From our perspective, the improved safety profile and OTC availability of VAZALORE alone make it a better option for most patients who take daily aspirin regimens for a variety of indications.
We are recommending PLXP based on a combination of VAZALORE’s market potential and management’s demonstrated ability to execute.
Additional upside for the stock lies in VAZALORE’s potential to be a pipeline in a pill and PLxGuard’s potential to become a multi-drug delivery platform. PLXP is a buy under $22 with a target price of $35.