Formosa inks licensing deal with Apotex for clobetasol propionate ophthalmic suspension for Mexico
Taiwan-based Formosa Pharmaceuticals has entered into an exclusive licensing agreement with Apotex for exclusive rights in Mexico for the commercialization of clobetasol propionate ophthalmic suspension, 0.05%, a medicine for the treatment of inflammation and pain following ocular surgery.
Clobetasol propionate ophthalmic suspension, 0.05% (APP13007) was approved by the Food and Drug Administration 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), the company said.
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"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.
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