Formosa Pharmaceuticals, a leading Taiwan-based pharmaceutical company, has announced a landmark licensing agreement with Cristália Produtos Químicos Farmacêuticos LTDA. This deal grants Cristália exclusive rights in Brazil for the commercialization of APP13007, a novel treatment for post-ocular surgery inflammation and pain.

APP13007 Awaiting FDA Approval, Eyeing Brazilian Market

Currently undergoing review by the U.S. Food and Drug Administration (FDA), APP13007 has been given a Prescription Drug User Fee Act (PDUFA) date of March 4, 2024. The agreement encompasses upfront payments, development milestones, and sales royalties, setting the stage for a long-term partnership.

Innovative Formulation from Formosa Pharma’s Pipeline

The active ingredient in APP13007 is clobetasol propionate, a superpotent corticosteroid derived from Formosa Pharma’s proprietary APNT nanoparticle formulation platform. This groundbreaking formulation provides a convenient dosing regimen and has shown superior efficacy in Phase 3 trials compared to placebo.

Cristália and Formosa: A Strategic Pharmaceutical Alliance

Erick Co, President and CEO of Formosa Pharmaceuticals, expressed confidence in Cristália’s expertise in eye health and their commitment to innovation. Ricardo S. Pacheco, Chairman of Cristália, echoed this sentiment, highlighting APP13007’s potential as an attractive new treatment option in the Latin American market.

Anticipated Impact on Ophthalmic Care in Brazil

Upon approval, APP13007 is poised to enter a potentially growing market for topical ophthalmic steroids in Brazil. Its novel formulation and proven efficacy in trials make it a promising addition to the treatment options available to ophthalmologists and patients.

The collaboration between Formosa Pharmaceuticals and Cristália represents a significant development in the global pharmaceutical landscape. This partnership not only showcases the potential of international collaborations in bringing innovative treatments to diverse markets but also underscores the evolving landscape of ophthalmic care. The introduction of APP13007 in Brazil could be a game-changer in the field of eye health, offering a new, effective treatment option for post-surgical care.

  APP13007, Brazil, Cristália, Cristália Produtos Químicos Farmacêuticos, Erick Co, Formosa Pharmaceuticals, Ricardo S. Pacheco