Formosa Pharmaceuticals has signed an exclusive licensing agreement with DÁVI Farmacêutica (DÁVI) in Portugal, for exclusive rights to the commercialization of clobetasol propionate ophthalmic suspension, 0.05 percent (APP13007), a marketed innovative medicine for the treatment of inflammation and pain following ocular surgery.

DÁVI is a trusted partner of Pharmathen Global Holding B.v., AZAD Pharma AG, NTC S.r.l. and Pfizer through the marketing and promotion of Xalacom (Latanoprost + Timolol) and Xalatan (Latanoprost) for more than 12 years. DÁVI is one of the key players in the Portuguese Market, with over 100 years' history in the distribution and promotion of branded ophthalmology products.

Clobetasol propionate ophthalmic suspension, 0.05 percent (APP13007), approved by the US Food and Drug Administration (FDA) in March 2024, was recently launched in the United States in September 2024. The DÁVI licensing agreement includes upfront, commercialization milestones, 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 survey of 100 ophthalmic surgeons, rapid resolution of pain (~80 percent pain-free four days post-surgery) and low incidence of adverse events (<2 percent) were highlighted as key drivers to prescribing APP13007. APP13007 anticipates significant potential in Portugal, which has around 90,000 cataract surgeries, annually, as reported by Eurostat.

"This partnership with DÁVI Farmacêutica, marks our first entry into a competitive EU market, opening the door for growth into other EU territories. DÁVI's experience and commitment to novel ophthalmic therapies is steadily apparent and Formosa Pharma appreciates their recognition of APP13007 as a worthy offering to patients recovering from ocular surgery," said Erick Co, President and CEO, Formosa Pharmaceuticals.

Rui Alves, Business Development Manager of DÁVI Farmacêutica, stated, "We are excited at DÁVI to be partnering with Formosa and have the opportunity to offer this cutting-edge drug and technology to our ophthalmologists and patients, reinforcing our strong position in the market and the commitment to enhance the well-being of our people."