TAHO Pharmaceuticals announced on November 19 that its new antithrombotic drug TAH3311, developed as an Oral Dissolving Film (ODF), has entered Phase III clinical trials in the United States. The first group of participants has already received the treatment. Additionally, TAHO plans to re-list on the Emerging Stock Board by late December, marking a significant milestone for the biotech capital market this year.
TAHO Chairman Howard Lee revealed that in late July 2023, the company conducted an End-of-Phase I Meeting with the U.S. Food and Drug Administration (FDA) to discuss the Phase III trial plan. The FDA approved a bioequivalence (BE) study design, comparing blood concentration levels of the ODF to the original tablet formulation. The Phase III trial aims to recruit 60 healthy participants, with completion expected by Q1 2025, followed by applications for drug approval in the U.S. and Europe.
TAH3311 reformulates Apixaban, a first-line antithrombotic drug (marketed as Eliquis by Bristol Myers Squibb and Pfizer), into a rapidly dissolving film that can be taken without water. This innovation addresses the needs of patients with swallowing difficulties, which affect 50% of stroke patients during hospitalization, with 13% experiencing long-term dysphagia.
Howard Lee explained that while Apixaban is the standard therapy for stroke prevention and thrombosis, its tablet-only format poses challenges for elderly patients, children, and those with dysphagia. Caregivers often have to crush tablets and mix them with water, a time-consuming process that can result in dosage inaccuracies.
The ODF formulation dissolves on the tongue without water, features a pleasant strawberry flavor, and reduces the risk of choking. This enhances patient compliance, lightens the caregiver's burden, and mitigates the risk of aspiration pneumonia—a leading cause of death in elderly patients. According to Taiwan's National Health Insurance data, aspiration pneumonia has a mortality rate of 47.3%, with 38.7% of cases linked to swallowing disorders.
The market for Apixaban has shown robust growth, reaching $22.1 billion in the U.S. in 2023, a 16.4% increase from $18.9 billion in 2022, according to IQVIA. Globally, Apixaban ranks as the second-largest drug by sales after Keytruda, and it is the leading small-molecule drug. As a Factor Xa inhibitor, Apixaban offers advantages such as lower dosing requirements and reduced gastrointestinal bleeding risks, making it a prime candidate for TAHO’s ODF innovation.
With the original drug’s active ingredient patent set to expire in November 2026, generic drugmakers are preparing to enter the market. However, tablets remain the only available dosage form. TAHO’s ODF differentiates itself by addressing clinical needs for patients with swallowing difficulties, creating a unique competitive edge.
Under the 505(b)(2) regulatory pathway, TAH3311 qualifies as a new dosage form drug, giving TAHO the opportunity to enter the market ahead of generics, which are expected to launch in April 2028. This timing allows TAH3311 to compete directly with the original drug and establish itself in the global market.
TAHO Pharmaceuticals plans to accelerate the international expansion of TAH3311, leveraging its innovative ODF formulation to enhance patient care, reduce caregiver challenges, and seize a significant share of the growing anticoagulant market.
Resource: 泰合生技12月重登興櫃 抗血栓口溶膜啟動美三期臨床
