Formosa Pharma and DÁVI Farmacêutica License Clobetasol Propionate for Post-Op Inflammation and Pain

Formosa Pharmaceuticals, based in Taiwan, has announced an exclusive licensing agreement with Portuguese company DÁVI Farmacêutica. This agreement grants DÁVI the rights to commercialize clobetasol propionate ophthalmic suspension, 0.05% (APP13007) in Portugal. This innovative medicine treats inflammation and pain following ocular surgery. DÁVI has a strong presence in the Portuguese market, known for distributing and promoting ophthalmology products for over a century. The company is also a trusted partner of well-known pharmaceutical companies like Pharmathen Global Holding B.v., AZAD Pharma AG, NTC S.r.l., and Pfizer, notably marketing Xalacom© and Xalatan© for over 12 years.

Clobetasol propionate ophthalmic suspension, 0.05% (APP13007) was approved by the U.S. Food and Drug Administration (FDA) in March 2024 and launched in the United States in September 2024. The agreement between Formosa and DÁVI includes upfront payments, milestone payments related to commercialization and sales, and additional considerations throughout the agreement's term.

APP13007 features the superpotent corticosteroid clobetasol propionate, utilizing Formosa Pharmaceuticals' proprietary APNT® nanoparticle formulation platform. This formulation allows for a convenient twice-daily dosing regimen over 14 days, offering rapid and sustained relief from inflammation and pain. In a recent survey of 100 ophthalmic surgeons, the drug’s rapid pain resolution (~80% pain-free four days post-surgery) and low incidence of adverse events (<2%) were key factors for prescribing it. The potential market in Portugal is significant, with approximately 90,000 cataract surgeries performed annually, according to Eurostat.

Erick Co, President and CEO of Formosa Pharmaceuticals, highlighted the strategic importance of this partnership as it marks their entry into the competitive European Union market. He emphasized DÁVI's experience and commitment to novel ophthalmic therapies and expressed appreciation for their recognition of APP13007’s value for patients recovering from ocular surgery.

Rui Alves, Business Development Manager of DÁVI Farmacêutica, expressed excitement about the partnership, emphasizing the opportunity to introduce this advanced drug and technology to Portuguese ophthalmologists and patients. He noted that this collaboration would strengthen DÁVI's market position and enhance their commitment to improving patient well-being.

Formosa Pharmaceuticals (6838.TW) is a clinical-stage biotechnology firm focusing on ophthalmology and oncology. Their proprietary APNT® nanoparticle formulation technology, which facilitated the development of APP13007, enhances the dissolution and bioavailability of active pharmaceutical ingredients for various types of administration, including topical, oral, and inhaler. This technology ensures high uniformity, purity, and stability of formulations, enabling the use of poorly soluble or highly potent drug agents that might otherwise face significant safety, delivery, and penetration challenges.

DÁVI Farmacêutica is a well-established company in the Portuguese market, specializing in ophthalmology and ENT segments. With a history spanning over 100 years, DÁVI is dedicated to distributing and promoting branded medicines. The company maintains significant partnerships with major multinational pharmaceutical firms and is committed to providing the best options available, aiming to enhance the quality of life for their patients.