Taiwan-based Formosa Pharmaceuticals (TW:6838) announced on Friday that the company has entered into an exclusive licensing agreement with Laboratorios Saval, a Chilean pharmaceutical company operating in Central and South America, for exclusive rights to the commercialisation of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a marketed innovative treatment for post-operative inflammation and pain following ocular surgery.
The product was approved by the US Food and Drug Administration (FDA) in March 2024, and was launched in the United States in September. The licensing agreement includes upfront payment and milestones, with additional consideration throughout the term of the agreement.
APP13007's active ingredient is a superpotent corticosteroid, clobetasol propionate, and is derived from Formosa Pharma's proprietary APNT nanoparticle formulation platform. APP13007 is anticipated to have significant potential in Saval's territories, whose ophthalmic corticosteroid market is estimated at almost USD7.5m, currently led by treatments with a less convenient dosing regimen (4 to 6 times daily).
"We are pleased that Saval has identified APP13007 as a worthy therapy to include in their ophthalmology core business unit. Saval's vast network throughout Latin America will guarantee that patients recovering from ocular surgery will have access to APP13007," said Erick Co, of Formosa Pharmaceuticals president and CEO.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval