TAIPEI, Taiwan – Formosa Pharmaceuticals has inked an exclusive licensing agreement with Apotex to commercialize clobetasol propionate ophthalmic suspension 0.05% (APP13007) for post-ocular surgery relief and recovery.
Under this agreement, Apotex secures the rights to market the ophthalmic suspension in Canada. APP13007 is designed to alleviate inflammation and pain following eye surgery.
The U.S. Food and Drug Administration (FDA) granted approval for APP13007 in March 2024.
The agreement includes upfront and milestone payments contingent on regulatory and sales milestones in Canada.
“Formosa Pharma is honored to partner with Apotex, given its storied history and reputation for success,” said Erick Co, president and CEO of Formosa Pharmaceuticals. “Their commitment to branded ophthalmology products gives us full confidence that APP13007 will flourish in the Canadian market. We look forward to working with the Apotex team in providing this differentiated therapy to Canadian physicians and patients.”
APP13007’s active ingredient, clobetasol propionate, is a corticosteroid formulated using Formosa Pharma’s APNT nanoparticle technology. This formulation supports a convenient twice-daily dosing regimen for 14 days, offering rapid and sustained relief from inflammation and pain, as evidenced by its superior performance in Phase III trials compared to a placebo.
Allan Oberman, president and CEO of Apotex, expressed enthusiasm for the partnership: “We are pleased to provide Canadian patients with APP13007, a new treatment option for post-operative inflammation and pain following ocular surgery. Expanding our portfolio of innovative medicines, including our ophthalmic portfolio, along with our commercial infrastructure, enables us to support more patients along their journey to health.”
This partnership follows Formosa’s previous agreement with Tabuk Pharmaceuticals, granting Tabuk exclusive rights to commercialize APP13007 in key regions of the Middle East and North Africa.
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