Taiwan-based Formosa Pharmaceuticals (Formosa) announced that the company has entered into a licensing agreement with Cristália Produtos Químicos Farmacêuticos Ltda (Cristália), for exclusive Brazilian rights to the commercialization of APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) for the treatment of inflammation and pain following ocular surgery. APP13007 is currently under review by the US Food and Drug Administration (FDA) and has been assigned a Prescription Drug User Fee Act (PDUFA) date of March 4, 2024. The licensing deal includes upfront, development milestones, and sales royalties, with additional considerations throughout the term of the agreement.
APP13007’s active ingredient is the superpotent corticosteroid, clobetasol propionate, and is derived from Formosa Pharma’s proprietary APNT nanoparticle formulation platform. The novel formulation enables a convenient and straightforward dosing regimen (twice daily for 14 days) while providing rapid and sustained relief of inflammation and pain, which in phase 3 trials proved statistically and clinically superior to its matching placebo (p<0.001). If approved, APP13007 will join in a potential and growing market in Brazil for topical ophthalmic steroids.
“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,” said Erick Co, president and CEO of Formosa Pharmaceuticals.
Ricardo S. Pacheco, chairman of Cristália stated: “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 is approved, Cristália will go full steam ahead with commercialization.”
Formosa Pharmaceuticals, Inc. is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology. The company’s proprietary nanoparticle formulation technology (APNT), through which APP13007 was developed, improves the dissolution and bioavailability of APIs for topical, oral, and inhaler administration.
Established 51 years ago, Cristália Laboratory is a 100% Brazilian pharmaceutical, pharmochemical, biotechnological, research/development/innovation-based industrial complex. It is a pioneer in thoroughly executing a drug production chain, from its molecule design to the finished product.