Formosa Pharmaceuticals, Inc. (TPE: 6838) announced an exclusive licensing agreement with Rxilient Medical Pte. Ltd., granting exclusive rights to commercialize clobetasol propionate ophthalmic suspension 0.05% (APP13007) in key ASEAN regions: Indonesia, Philippines, Singapore, and Thailand.

Licensing Agreement & Territory

ComponentDetails
LicensorFormosa Pharmaceuticals, Inc. (TPE: 6838)
LicenseeRxilient Medical Pte. Ltd.
ProductAPP13007 (clobetasol propionate ophthalmic suspension 0.05%)
TerritoryIndonesia, Philippines, Singapore, Thailand (ASEAN)
RightsExclusive commercialization rights
TechnologyAPNT nanoparticle formulation platform

Product Profile & Clinical Advantages

Active Ingredient:

  • Clobetasol propionate: Superpotent corticosteroid for rapid anti-inflammatory action

APNT Nanoparticle Platform:

  • Enables superior ocular penetration and sustained drug release
  • Reduces dosing frequency while maintaining efficacy

Dosing Regimen:

  • Twice daily for 14 days (vs. competitive products requiring more frequent administration)
  • Patient convenience: Simple, short course of therapy

Clinical Benefits:

  • Rapid relief: Onset of action within 24-48 hours
  • Sustained effect: Continued anti-inflammatory action post-treatment
  • Approved: US FDA approval in 2024 validates safety and efficacy

Market Context & Commercial Opportunity

MarketPopulationOphthalmic Inflammation PrevalenceMarket Potential
Indonesia275 millionHigh (tropical climate, infection rates)$15-20M peak sales
Philippines110 millionModerate-high$8-12M peak sales
Singapore5.5 millionDeveloped market, premium pricing$5-8M peak sales
Thailand70 millionGrowing ophthalmology sector$10-15M peak sales

Total ASEAN Opportunity: $38-55 million peak sales potential for APP13007

Strategic Outlook & Competitive Position

  • First-Mover Advantage: First superpotent corticosteroid with 14-day, BID regimen in ASEAN
  • Rxilient’s Edge: Established ophthalmology distribution network across Southeast Asia
  • Formosa’s Strategy: Capitalizes on US FDA approval to accelerate ex-US partnerships
  • Revenue Model: Upfront payment + milestones + double-digit royalties; Formosa retains manufacturing

Forward‑Looking Statements
This brief contains forward‑looking statements regarding commercial launch timelines, market penetration, and revenue projections for APP13007 in ASEAN markets. Actual results may differ due to regulatory, competitive, and reimbursement uncertainties.-Fineline Info & Tech