Formosa Pharmaceuticals and DÁVI Farmacêutica Announce Licensing Agreement for Clobetasol Propionate Ophthalmic Suspension for the Treatment of Post-Operative Inflammation and Pain

TAIPEI, Oct. 31, 2024 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TW) announced today that the company has entered into an exclusive licensing agreement with DÁVI Farmacêutica ("DÁVI") in Portugal, for exclusive rights to the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (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 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% (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 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% pain-free four days post-surgery) and low incidence of adverse events (<2%) 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 of 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."

About Formosa Pharmaceuticals, Inc.
Formosa Pharmaceuticals, Inc. (6838.TW) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology. The company's proprietary nanoparticle formulation technology (APNT^®), through which APP13007 was developed, improves the dissolution and bioavailability of APIs for topical, oral, and inhaler administration. Resulting formulations have high uniformity, purity, and stability, thereby allowing the utilization of poorly soluble or extremely potent drug agents which otherwise may face insurmountable challenges in safety, delivery, and penetration to target tissues. For more details about Formosa Pharma and APNT^®, visit www.formosapharma.com.

About DÁVI Farmacêutica
DÁVI Farmacêutica, is a century-old company and one of the key players in ophthalmology and ENT segments in Portugal. The company's core activities are the distribution & promotion of branded medicines with significant partnerships with major multinational pharmaceutical companies. Our daily mission is to give our patients the best option available in the market, making their lives better. To know more about DÁVI Farmacêutica, visit www.davi.pt/en.

SOURCE Formosa Pharmaceuticals Inc.,