Formosa Pharmaceuticals announced yesterday (7th) that it has signed an exclusive licensing agreement with its Canadian partner, Apotex Inc., granting Apotex the exclusive commercialization rights of the new ophthalmic drug APP13007 (clobetasol propionate ophthalmic suspension 0.05%) for postoperative inflammation and pain management in Mexico. The collaboration aims to expand the commercialization of APP13007 for postoperative inflammation and pain treatment in Mexico.
Formosa Pharmaceuticals stated that APP13007 is a new formulation developed using its proprietary APNT nanomicronized drug delivery platform, with clobetasol propionate, a potent steroid, as its active ingredient. The drug was approved by the U.S. Food and Drug Administration (FDA) in March 2024. APP13007 offers a convenient and simple dosing regimen (twice daily for 14 days) and provides fast and sustained relief of inflammation and pain. In phase III clinical trials, APP13007 demonstrated significant statistical and clinical advantages over the placebo group.
The company further noted that ophthalmic care is one of the most dynamic and fastest-growing therapeutic fields in Mexico, with an annual compound growth rate of about 10%. APP13007 will enter a market for ophthalmic anti-inflammatory drugs valued at approximately $80 million. Apotex, in addition to being the largest domestic pharmaceutical company in Canada, is currently the number one generic drug company in Mexico and Latin America, with over 25 years of experience in these markets.
Formosa Pharmaceuticals’ CEO Erick Co stated, “We are thrilled to further expand our partnership with Apotex, following the commercialization of APP13007 in Canada in 2024, to extend the collaboration to the Mexican market. Our experience working with Apotex’s Canadian team has demonstrated their commitment to branding and differentiating ophthalmic products, which gives us full confidence in successfully commercializing APP13007 and making it a better treatment option for ophthalmologists and patients in Mexico.”
Alok Kanti, President of Apotex International, said, “At Apotex, we are committed to providing accessibility to medicines and health products, and opening new possibilities for patients through partnerships. We are excited to introduce APP13007 (clobetasol propionate ophthalmic suspension 0.05%) to the Mexican market after receiving regulatory approval. This collaboration with Formosa Pharmaceuticals further demonstrates Apotex’s leadership in drug licensing and product acquisition in the Americas and is an important step in advancing our ‘Healthy Growth Journey’ strategy.”
Formosa Pharmaceuticals also highlighted that Latin America, as one of the fastest-growing pharmaceutical markets in recent years, has a total pharmaceutical market size of $56 billion and is expected to continue growing rapidly at a compound annual growth rate of 6.2% from 2024 to 2028. Through its commercialization partnerships with several renowned ophthalmic pharmaceutical companies, Formosa Pharmaceuticals has secured licensing coverage for most of the Latin American market.
Resource: 台新藥攜手Apotex 推動眼科新藥於墨西哥商業化
