TAHO Pharmaceuticals Announces Positive Results for TAH3311 Oral Anticoagulant Study

TAHO Pharmaceuticals has reported promising initial results from the critical study of TAH3311, the first oral dissolving film (ODF) form of Apixaban. This study demonstrates that TAH3311 is bioequivalent to the Apixaban tablets available in the United States and Europe, known as Eliquis®, when taken on an empty stomach. The Cmax and AUC values of TAH3311 were found to be within the 80-125% regulatory acceptance range. In the study, conducted with 60 healthy participants, 48 completed the trial successfully. The outcomes align with the guidelines previously discussed with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), setting the stage for TAHO Pharmaceuticals to submit a New Drug Application (NDA) and a Marketing Authorization Application (MAA). This achievement marks a crucial step in the regulatory progression.

Currently, approximately 15 million individuals worldwide suffer from strokes each year. Nearly 50% of stroke patients admitted to hospitals encounter swallowing difficulties, and around 13% develop long-term dysphagia. Traditional anticoagulant therapies often necessitate crushing tablets and mixing them with liquids for patients with such difficulties, which can result in dosage inaccuracies and inconvenience. TAH3311 offers a solution by dissolving swiftly in the mouth without requiring water, thereby providing a more convenient alternative. Dr. Howard Lee, Chairman and CEO of TAHO Pharmaceuticals, emphasized that the pivotal study reflects the company's dedication to patient-focused innovation. TAH3311 is particularly advantageous for stroke patients, the elderly, children, or others who struggle with swallowing and need anticoagulant treatment twice daily. The innovative formulation aims to enhance patient outcomes and decrease the risk of aspiration pneumonia, which can occur from choking on medication taken with water.

In 2024, sales of Apixaban in the U.S. reached $26.1 billion, and the global market for anticoagulants is steadily growing. In light of these trends, TAH3311 is strategically positioned as a safer and more accessible treatment option. TAHO Pharmaceuticals plans to submit regulatory filings in both the U.S. and Europe by the third quarter of 2025. Concurrently, the company is actively seeking strategic partnerships with international companies to expedite the worldwide introduction of TAH3311.

Apixaban, co-developed by Bristol-Myers Squibb (BMS) and Pfizer under the Eliquis® brand, is a direct factor Xa inhibitor approved for use in several thromboembolic disorders. These include stroke prevention in patients with non-valvular atrial fibrillation, thromboprophylaxis after hip or knee replacement surgeries, and the treatment and prevention of deep vein thrombosis or pulmonary embolism. Apixaban is recognized for its substantial safety advantages and is currently the leading novel oral anticoagulant (NOAC).

TAHO Pharmaceuticals Ltd., founded in 2010, employs its proprietary Transepithelial Delivery System (TDS) to address existing drug limitations and create innovative dosage forms for niche markets. The TDS platform integrates advanced transdermal and transmucosal delivery technologies, enabling the development of unique dosage forms such as transdermal patches, ODF, and buccal films. TAHO's diverse product lineup covers various therapeutic areas, including antithrombotic agents, opioid overdose antidotes, addiction treatments, pediatric ADHD, and chemotherapy-induced antiemetics. One of its significant accomplishments is TAH4411, an ODF for chemotherapy-induced nausea and vomiting, which became the first of its kind to gain regulatory approval and be commercialized in Japan.