Formosa and Cristália Partner for Exclusive Rights to APP13007 in Brazil
Formosa Pharmaceuticals announced a strategic licensing agreement with Cristália Produtos Químicos Farmacêuticos to secure exclusive commercialization rights for APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) in Brazil.
APP13007 is designed for the treatment of inflammation and pain following ocular surgery and is currently undergoing review by the FDA, with a Prescription Drug User Fee Act (PDUFA) date set for March 4, 2024.
The comprehensive licensing deal includes upfront payments, development milestones, and sales royalties, along with additional considerations throughout the agreement's duration.
APP13007, formulated with Formosa Pharma's proprietary APNT™ nanoparticle formulation platform, features the superpotent corticosteroid clobetasol propionate as its active ingredient. The innovative formulation facilitates a convenient dosing regimen (twice daily for 14 days), delivering rapid and sustained relief of inflammation and pain.
Phase 3 trials demonstrated that APP13007 was statistically and clinically superior to its placebo counterpart (p<0.001). If granted FDA approval, APP13007 is poised to enter the expanding market for topical ophthalmic steroids in Brazil.
Erick Co, President, and CEO of Formosa Pharmaceuticals expressed optimism about the collaboration, stating, "We are honored to establish this partnership with Cristália, with its storied history in Brazilian pharmaceuticals and expertise in eye health. Given their dedication to bringing innovation to the market, we are confident APP13007 will reach its potential in providing ophthalmologists and patients a powerful option in recovering from ocular surgery."
Ricardo S. Pacheco, Chairman of Cristália, commented on the agreement, saying, "We are pleased to have entered into this agreement with our development partner, Formosa Pharmaceuticals. If approved, APP13007 will be an attractive new treatment option to ophthalmic surgeons and their patients in Latin America with a convenient posology. Once approved, Cristália will go full steam ahead with commercialization."
