PLx Pharmais a late-stage specialty pharmaceutical company initially focused on developing our clinically validated and patent-protected PLxGuard™ delivery system to provide safer and more effective aspirin products. Our PLxGuard™ delivery system works by releasing active pharmaceutical ingredients into the duodenum, the first part of the small intestine immediately below the stomach, rather than in the stomach itself. We believe this improves the absorption of many drugs currently on the market or in development, and reduces acute gastrointestinal (GI) side effects—including erosions, ulcers and bleeding—associated with aspirin and ibuprofen, and potentially other drugs.
INVESTMENT HIGHLIGHTS
•PL2200 Aspirin Professional:Best-in-Class aspirin for Acute Coronary Syndrome
•Provides Complete Antiplatelet Efficacy
•Predictable and reliable pharmacokinetics and pharmacodynamics
•3-5x greater chance of complete antiplatelet benefit
•Reduced Risk of Gastric Erosions and Acute Gastric Ulcers
•PL2200 has clinically demonstrated a 65% lower risk of acute gastric ulceration
•Enteric Coated (EC) aspirin hasthe same upper GI riskas regular aspirin
•Rapid and Complete Absorption without Significant Food Effects
•Patent Protected (until 2032) Formulation Selectively Releases Aspirin in the Duodenum
•Expected to be the Only OTC Aspirin Product Marketed with FDA Approved NDA
•Potential for 100% Reimbursement for all Age-Related Risk Patients
One of the most widely used drugs in the world
Used to treat and prevent the leading cause of death – cardiovascular disease
§>200 studies supporting aspirin benefit; global standard of care
• EC aspirin dominates the aspirin market with > 90% of US sales due to the perception that it is equally antiplatelet efficacious and GI safer than regular aspirin --it is not
•EVERYimportant clinical study supporting the cardiovascular benefit of aspirin was conducted using immediate release (regular) aspirinNOTEC aspirin, except one which used regular aspirin for first dose then EC aspirin thereafter
• Dec 2014JAMA, Japanese study with >14,000 high risk primary prevention subjects comparing 100 mg EC aspirin with no aspirin stopped after 5 years with no benefit for EC aspirin
• Many misconceptions among physicians and consumers about the efficacy of EC aspirin
The information contained herein was obtained from PLx Pharma management and other sources LHA believes to be reliable. This does not constitute the solicitation of the purchase or sale of securities. LHA has been engaged by PLx Pharma as its investor relations firm. Except for historical information contained herein, matters discussed in this document are forward-looking statements, the accuracy of which is subject to risks and uncertainties. Please see PLx Pharma’s most recent SEC filings for additional information about the Company and related risks.
Dec. 2015
Single dose pharmacokinetics and thromboxane depletion in non-insulin dependent diabetics
•Two independent studies in 92 subjects (PL-ASA-004 and PL-ASA-006 – clinical studies not yet published)
•Complete aspirin response is clinically defined as >99.9% inhibition of ex-vivo platelet thromboxane generation over baseline