Taiwan-based Formosa Pharmaceuticals (“Formosa”, 6838.TW) announced that the company has entered into an exclusive licensing agreement with Medvisis Switzerland AG (“Medvisis”) in Switzerland and Liechtenstein, for exclusive rights to the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a marketed innovative treatment of post-operative inflammation and pain following ocular surgery. Medvisis, led by industry veterans with experience in multi-national pharma such as Novartis and GSK, holds close ties with Swissmedic, Switzerland’s independent registration authority. Clobetasol propionate ophthalmic suspension, 0.05% (APP13007), approved by the U.S. Food and Drug Administration (FDA) in March, 2024, was recently launched in the United States in September, 2024. The licensing agreement includes upfront payment and sales milestones, 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. In a recent US survey of 100 ophthalmic surgeons, rapid resolution of pain (~80% pain-free four days post-surgery) and low incidence of adverse events (<2%) were highlighted as key drivers to prescribing APP13007. In a Medvisis-led KOL survey, ophthalmologists collectively appreciated APP13007’s convenient posology and remarkable safety profile. APP13007 anticipates having significant potential in Switzerland, which reports greater than 100,000 cataract surgeries, annually. These surgical rates have driven a single-agent corticosteroid market of greater than USD $2.1 million, utilizing treatments with a less convenient dosing regimen (4 to 6 times daily).

“We are pleased to partner with Medvisis, marking our second foothold in Europe. Medvisis’ strong connections with their national regulatory agency and rich KOL network give us great confidence that the Swiss public will benefit from this novel and effective treatment for ocular surgery recovery.” said Erick Co, President and CEO of Formosa Pharmaceuticals.

Manuel Ackermann, CEO of Medvisis Switzerland, stated, ” We are pleased to provide patients with post-operative inflammation and pain following ocular surgery a new, best-in-class treatment option that leads to faster symptom relief. APP13007 is of great value to Swiss patients while it sets the foundation for Medvisis to build a strong portfolio of innovative ophthalmology solutions.”

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