The licensing deal includes upfront, development milestones, and sales royalties, with additional considerations throughout the term of the agreement.
Formosa Pharmaceuticals announced it has entered into a licensing agreement with Cristália Products Químicos Farmacêuticos LTDA 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 FDA and has been assigned a 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.
According to a news release,1 APP13007's active ingredient is the corticosteroid, clobetasol propionate, and is derived from Formosa Pharma's proprietary APNT nanoparticle formulation platform.
The company noted 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.1
Erick Co, president and CEO of Formosa Pharmaceuticals, said the company was honored to establish the 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," Co said in the news release.
Ricardo S Pacheco, chairman of Cristália said the company was pleased to have entered into this agreement with its 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,” he said in the news release. “Once is approved, Cristália will go full steam ahead with commercialization."