Formosa Pharmaceuticals announced that it has entered into an exclusive licensing agreement with Laboratorios Saval, a pharmaceutical company headquartered in Chile, granting Saval the exclusive commercialization rights for APP13007 (clobetasol propionate ophthalmic nanosuspension 0.05%) in nine countries across Central and South America. The drug is indicated for inflammation and pain relief following ocular surgery.
Formosa noted that Saval, founded in 1938, is a family-owned pharmaceutical company with its own R&D capabilities and GMP-compliant manufacturing facilities, and has maintained long-term collaborations with international strategic partners. APP13007 received U.S. FDA approval in March 2024 and was launched in the U.S. market in September of the same year. The licensing deal includes upfront payments, milestone payments, royalties, and other consideration over the term of the agreement.
APP13007 is a novel formulation developed using Formosa’s proprietary APNT nano-micronization platform, with ultra-potent corticosteroid clobetasol propionate as the active ingredient. This innovative formulation provides rapid and sustained relief of inflammation and pain with a convenient dosing regimen of twice daily for 14 days.
A recent survey of 100 U.S. ophthalmic surgeons revealed that the primary factors influencing their decision to prescribe APP13007 were its rapid and complete elimination of ocular pain (approximately 80% of patients were pain-free within four days post-surgery) and its low incidence of adverse events (less than 2%).
The ophthalmic corticosteroid market within Saval’s covered region is estimated to be worth nearly USD 7.5 million and is currently dominated by products requiring administration four to six times daily. APP13007 is expected to have strong market potential due to its more convenient dosing schedule.
Erick Co, CEO of Formosa Pharmaceuticals, expressed his pleasure in Saval recognizing APP13007 as an important addition to its core ophthalmology portfolio. He noted that Saval’s extensive network across Latin America will help ensure patients undergoing eye surgery have access to this therapy.
Nicolás Donoso, CEO of Saval, stated that the company is committed to providing affordable, high-quality products across multiple therapeutic areas for patients in Latin America, with ophthalmology being one of its core specialties. APP13007 will offer physicians and patients an innovative and valuable treatment option. “We are very pleased to collaborate with Formosa Pharmaceuticals and look forward to working together to bring more benefits to physicians and patients in the region.”
Since 2021, Formosa Pharmaceuticals has completed ten licensing agreements for APP13007, covering key markets including the United States, Canada, mainland China, India, the Middle East, and parts of the EU and Latin America. The company remains committed to actively pursuing global partnerships to improve post-operative ophthalmic care and enhance the quality of life for patients worldwide through new drugs developed with its APNT nano-micronization technology.
Resource: 台新藥攜手智利Saval 推動眼科新藥中南美洲市場上市
