Cristália Produtos Químicos Farmacéuticos has signed an agreement to license exclusive rights to market Taiwanese company Formosa Pharmaceuticals’ APP13007  (clobetasol propionate ophthalmic nanosuspension, 0.05%) in Brazil.

APP13007 is intended to treat inflammation and pain following ocular surgery.

The agreement covers the Brazilian market and includes upfront development milestones and sales-based royalty payments other than further deal-associated payments.

APP13007 is under review by the US Food and Drug Administration with a decision on the approach under the Prescription Drug User Fee Act expected on 4 March 2024.

The active ingredient in the drug is a superpotent corticosteroid known as clobetasol propionate. It is based on Formosa Pharma’s APNT nanoparticle formulation platform.

The new formulation of APP13007 allows for a suitable dosing regimen of twice daily for 14 days. It has demonstrated quick and lasting inflammation and pain relief in Phase III clinical trials, showing statistical and clinical superiority versus placebo.

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APP13007 will enter the Brazilian market for topical ophthalmic steroids.

Cristália chairman Ricardo Pacheco 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 [determination of appropriate dosage]. Once it is approved, Cristália will go full steam ahead with commercialisation.”

Formosa’s APNT technology enhances the dissolution and bioavailability of active pharmaceutical ingredients across a range of administration methods including topical, oral and inhalation.

The platform ensures increased uniformity, purity and stability in formulations, enabling the use of poorly soluble or highly potent drug agents that may otherwise encounter significant challenges in delivery and penetration to target tissues.

Formosa Pharmaceuticals president and CEO Erick Co stated: “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.”