Apotex announces expansion of licensing agreement with Formosa Pharmaceuticals to Mexico for commercialization of clobetasol propionate ophthalmic suspension for the treatment of inflammation and pain following ocular surgery
May 7, 2025Mexico City, Mexico – May 06, 2025 – Apotex Inc. (referred to as "Apotex" or "the Company") today announced it has entered into an exclusive licensing agreement with Formosa Pharmaceuticals ("Formosa", 6838.TW), 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, upon regulatory approval.
APP13007 was approved by the U.S. Food and Drug Administration (FDA) in 2024. APP13007’s active ingredient is the corticosteroid clobetasol propionate, and it is derived from Formosa Pharma's proprietary APNT® nanoparticle formulation platform. This novel formulation proved statistically and clinically superior to its matching placebo in Phase 3 trials in the United States (p<0.001).
This license agreement for the Mexican market adds to Apotex's existing exclusive rights to this product in Canada.
"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 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.
"Having started our journey together in 2024, Formosa Pharma is pleased to expand the partnership with Apotex to include the Mexico territory," 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 soon as possible."
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, innovative branded pharmaceuticals 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.
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.
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