Formosa Pharmaceuticals Announces Licensing Agreement with Apotex Inc., for Commercialization of Clobetasol Propionate Ophthalmic Suspension for Post-Ocular Surgery Inflammation and Pain for Mexico

TAIPEI, May 6, 2025 /PRNewswire/ -- Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TW) announced today that the company has entered into an exclusive licensing agreement with Apotex Inc. ("Apotex"), for exclusive rights in Mexico for the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a patented innovative medicine for the treatment of inflammation and pain following ocular surgery. Clobetasol propionate ophthalmic suspension, 0.05% (APP13007) was approved by the U.S. Food and Drug Administration (FDA) in 2024. 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, while providing rapid and sustained relief of inflammation and pain, which in Phase 3 trials proved statistically and clinically superior to its matching placebo (p<0.001).

"Having started our journey together in 2024, Formosa Pharma is pleased to expand the partnership with Apotex to include Mexico." said Erick Co, President and CEO of Formosa Pharmaceuticals. "Our experience with Apotex's Canadian team underscored their commitment to branded and differentiated ophthalmology products, giving us full confidence that APP13007 will reach ophthalmologists and patients in Mexico as swiftly as possible."

"At Apotex, we are committed to delivering access to medicines and health products, and unlocking new possibilities for patients through partnerships. We are pleased to bring access to APP13007 (clobetasol propionate ophthalmic suspension, 0.05%) to the Mexican market upon regulatory approval. Our agreement with Formosa Pharmaceuticals further demonstrates Apotex's leading position as partner of choice in the Americas for pharmaceutical licensing and product acquisitions as we continue to execute our Journey of Heath growth strategy," said Alok Kanti, President, Apotex International.

About Formosa Pharmaceuticals, Inc.

Formosa Pharmaceuticals, Inc. (6838.TWO) 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 delivery and penetration to target tissues.  For more details about Formosa Pharma and APNT^®, visit www.formosapharma.com.

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, and innovative pharmaceutical and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. Learn more about us at www.apotex.com.

SOURCE Formosa Pharmaceuticals Inc.,