Taiwan-based Formosa Pharmaceuticals has inked a licensing agreement with Cristália Produtos Químicos Farmacêuticos (Cristália) to obtain exclusive rights in Brazil for the commercialisation of APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%).
The medication is designed to treat inflammation and pain post-ocular surgery. Currently undergoing evaluation by the US Food and Drug Administration (FDA), APP13007 has a scheduled Prescription Drug User Fee Act (PDUFA) date set for 4 March 2024.
The licensing arrangement encompasses upfront payments, development milestones, and sales royalties, with additional considerations integrated throughout the agreement’s duration.
Formulated with the superpotent corticosteroid clobetasol propionate, APP13007 uses Formosa Pharma’s proprietary APNT nanoparticle formulation platform.
Distinguished by its innovative formulation, APP13007 offers a user-friendly dosing regimen (twice daily for 14 days) and delivers swift and sustained relief from inflammation and pain.
Phase 3 trials demonstrated statistical and clinical superiority over the corresponding placebo (p<0.001).
Pending approval, APP13007 is poised to enter Brazil’s expanding market for topical ophthalmic steroids.
Formosa Pharmaceuticals president and CEO Erick Co said: “We are honoured 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.”
Cristália chairman Ricardo Pacheco said: “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 for ophthalmic surgeons and their patients in Latin America with a convenient posology. Once approved, Cristália will go full steam ahead with commercialisation.”
Formosa Pharmaceuticals is a clinical-stage biotechnology company specialising in ophthalmology and oncology.
The company’s nanoparticle formulation technology (APNT), through which APP13007 was developed, enhances the dissolution and bioavailability of APIs for topical, oral, and inhaler administration.
