Taiwan-based Formosa Pharmaceuticals (TPE: 6838) has announced the signing of a licensing agreement with Brazil-based Cristália Produtos Quimicos Farmaceuticos Ltda. According to the agreement, Formosa will grant Cristália the commercialization rights for its product candidate APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) in Brazil, which is being developed as a potential treatment for pain following ocular surgery. Financial details of the deal were not disclosed.
APP13007 contains the active ingredient clobetasol propionate, a corticosteroid derived from Formosa’s proprietary APNT nanoparticle formulation platform. This technology allows for a dosing regimen of twice daily for 14 days. The product candidate, currently in Phase III, has demonstrated rapid and sustained relief of inflammation and pain, showing clinical superiority over its matching placebo (p<0.001). The US Food and Drug Administration (FDA) is anticipated to complete its regulatory review for the molecule in March 2024.- Flcube.com