Summary

KEY INSIGHTS
TLC599 is a proprietary formulation of dexamethasone sodium phosphate (DSP) utilizing the BioSeizer technology, designed to deliver up to 24 weeks of continuous pain relief. TLC599 offers the benefit of locally delivering a powerful, clinically validated steroid that typically has a short half-life, providing both immediate and sustained effects. This emerging therapy presents several advantages, including rapid pain relief, prolonged maintenance of up to 24 weeks, reduced risk of cartilage damage and toxicity, enhanced drug retention within the joints, and flexible needle size options, making it suitable for use in small joints.
BioSeizer, developed by the Taiwan Liposome Company, is a proprietary technology used in pharmaceutical product development. It utilizes multilayer lipid membranes to encapsulate active therapeutic molecules, ensuring a prolonged duration of drug release.
The BioSeizer nanoparticles are engineered to release their payload steadily as each lipid layer gradually collapses over time, which is particularly advantageous in NSAIDs in osteoarthritis treatment. This technology is adaptable for both small molecules and larger biologics, allowing for extended therapeutic effects, which can be beneficial for osteoarthritis patients seeking longer-lasting relief from osteoarthritis medication.
The drug is developed by the Taiwan Liposome Company, founded in the year 1997 and is headquartered in Taipei City, Taiwan. Taiwan Liposome Company Ltd is a biopharmaceutical firm specializing in drug delivery technology and new drug research. The company focuses on developing lipid-based formulations, parenteral drugs, and various other pharmaceutical products. Additionally, Taiwan Liposome Company provides a range of services related to the advancement of drug delivery technologies and the development of innovative therapeutics.
MARKET POTENTIAL AND POSITIONING
TLC599 is a liposomal formulation of dexamethasone developed for controlled and extended release to manage knee osteoarthritis pain. Unlike conventional intra-articular anti-inflammatory treatments, which can have toxic side effects and damage cartilage proteins, TLC599 offers a novel approach with potentially fewer adverse effects. Currently, in Phase III clinical trials, TLC599 is being evaluated for its safety and effectiveness in treating knee osteoarthritis.
In June 2022, Taiwan Liposome Company (TLC) and Endo International, through its subsidiary Endo Ventures Limited (EVL), formed a partnership. Under this agreement, TLC is responsible for developing TLC599, while EVL will manage regulatory approval and commercialization in the United States.
Upon obtaining regulatory approval, Endo will exclusively manufacture, market, and distribute TLC599 in the United States. This collaboration positions TLC599 as a promising new option in the US market for managing knee osteoarthritis pain, offering a potentially safer and more effective alternative to existing treatments with long-term pain relief benefits.
REGIONAL ANALYSIS
Inkwood Research offers an analysis of eight key markets:
• United States
• Germany
• France
o France’s healthcare landscape is characterized by a robust and well-developed system that combines public and private sectors. These investments are directed toward improving patient outcomes, managing chronic diseases, and supporting advanced therapeutic research, including regenerative medicine and innovative drug development.
o Osteoarthritis is a major public health concern in France, affecting millions of people, particularly among the elderly population. As the population ages, the prevalence of osteoarthritis is expected to rise, driving demand for new and effective treatment options.
• United Kingdom
• Italy
• Spain
• Canada
• Korea

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Table of Contents

TABLE OF CONTENTS
1. INTRODUCTION TO THE REPORT
2. TLC599 OVERVIEW
2.1. PRODUCT DETAIL
2.2. CLINICAL DEVELOPMENT
2.2.1. CLINICAL STUDIES
2.2.2. CLINICAL TRIALS INFORMATION
2.2.3. SAFETY AND EFFICACY
2.3. OTHER DEVELOPMENTAL ACTIVITIES
2.4. PRODUCT PROFILE
3. COMPETITIVE LANDSCAPE
3.1. MARKETED THERAPIES
3.2. LATE-STAGE EMERGING THERAPIES
4. TLC599 MARKET ASSESSMENT
4.1. MARKET OUTLOOK OF TLC599 IN OSTEOARTHRITIS
5. 8 MAJOR MARKET’S ANALYSIS
5.1. MARKET SIZE OF TLC599 IN THE 8 MAJOR MARKETS FOR OSTEOARTHRITIS
5.2. 8 COUNTRY ANALYSIS
5.2.1. MARKET SIZE OF TLC599 IN UNITED STATES FOR OSTEOARTHRITIS
5.2.2. MARKET SIZE OF TLC599 IN GERMANY FOR OSTEOARTHRITIS
5.2.3. MARKET SIZE OF TLC599 IN FRANCE FOR OSTEOARTHRITIS
5.2.4. MARKET SIZE OF TLC599 IN ITALY FOR OSTEOARTHRITIS
5.2.5. MARKET SIZE OF TLC599 IN SPAIN FOR OSTEOARTHRITIS
5.2.6. MARKET SIZE OF TLC599 IN UNITED KINGDOM FOR OSTEOARTHRITIS
5.2.7. MARKET SIZE OF TLC599 IN CANADA FOR OSTEOARTHRITIS
5.2.8. MARKET SIZE OF TLC599 IN KOREA FOR OSTEOARTHRITIS
6. SWOT ANALYSIS
7. ANALYST PERSPECTIVE