TAHO Pharmaceuticals, a biotech company listed on the emerging stock market, announced on the 17th that its anti-thrombosis oral dissolving film (ODF) TAH3311 has successfully met its pivotal study endpoint in the United States. The preliminary trial data analysis confirms that this novel formulation is highly comparable in efficacy to the reference drug. The company plans to release the full trial report in April and submit new drug applications (NDA) for the U.S. and European markets in Q3 2024.
TAHO Pharmaceuticals’ Chairman, Howard Lee, stated that TAH3311 demonstrated bioequivalence (BE) to Apixaban tablets (brand name Eliquis) marketed in the U.S. and Europe. Under fasting conditions, the key pharmacokinetic (PK) parameters, including Cmax (maximum plasma concentration) and AUC (area under the concentration-time curve), fell within the geometric mean ratio range of 80-125%, meeting the regulatory standards set by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This marks a critical milestone toward obtaining regulatory approval.
TAH3311 is the world’s first Apixaban oral dissolving film (ODF) formulation, developed under the 505(b)(2) regulatory pathway as a novel dosage form. The pivotal study, conducted in accordance with FDA and EMA regulatory guidelines, was initiated in November 2024 and completed patient dosing on January 16, 2025. A total of 60 healthy volunteers were enrolled, with 48 successfully completing the study.
Howard Lee noted that while the full clinical trial report is expected by April, the interim data has already confirmed TAH3311’s efficacy equivalence to the reference drug. TAHO Pharmaceuticals plans to submit NDAs in the U.S. and Europe in Q3 2024 while simultaneously seeking licensing partners to accelerate its global market expansion.
TAHO Pharmaceuticals highlighted that 15 million new stroke cases occur worldwide each year, with approximately 50% of hospitalized patients experiencing swallowing difficulties. Long-term dysphagia affects around 13% of patients. Currently, Apixaban is only available in tablet form, requiring twice-daily crushing and mixing with water for dysphagic patients, making dose control challenging and lifelong treatment burdensome.
The oral dissolving film (ODF) formulation of TAH3311 dissolves instantly on the tongue without the need for water, reducing the risk of choking. This innovation provides a safer and more convenient treatment option, particularly for elderly patients, children, stroke survivors, and individuals with chronic swallowing difficulties. According to Taiwan’s National Health Insurance data, the mortality rate for aspiration pneumonia caused by choking in the elderly reaches 47.3%, with 38.7% of these patients suffering from swallowing disorders. Switching to an ODF formulation could help reduce the risk of aspiration pneumonia triggered by water-assisted drug administration.
According to IQVIA, Apixaban’s U.S. sales reached $26.1 billion in 2024, making it the world’s top-selling small-molecule drug. The global anti-thrombosis market continues to expand, with a compound annual growth rate (CAGR) of 9.5% from 2023 to 2032. While patent litigation between Apixaban’s originator and generic drug manufacturers has mostly resulted in victories for the originator, settlements have been reached with a few generic companies, allowing them to launch generics as early as April 2028. If TAH3311 secures regulatory approval as planned, it could enter the market before generics, competing directly with the branded tablet formulation and offering patients a more convenient and safer anticoagulation therapy.
Resource: 泰合抗血栓口溶膜新藥樞紐試驗結果達標 拚第3季申請上市
