Formosa Pharmaceuticals and Apotex Inc. announce licensing agreement of APP13007 in Canada

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Formosa Pharmaceuticals has entered into an agreement with Apotex Inc. for exclusive rights in Canada for the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007).

APP13007 was approved by the FDA in March of 2024 for the relief of pain and inflammation following ocular surgery. Eyenovia acquired exclusive US rights to distribute and sell the drug in August of 2023 from Formosa.

The licensing deal between Formosa and Apotex will include “certain payments,” including an upfront payment of an undisclosed amount and milestone payments upon achievement of certain regulatory and sales milestones.

The CEOs of the 2 companies commented on the agreement in a press release from Formosa Pharmaceuticals.¹

“[Apotex’s] 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,” said Erick Co, president and CEO of Formosa Pharmaceuticals.

"We are pleased to provide Canadian patients with APP13007, a new treatment option for post-operative inflammation and pain following ocular surgery," said Allan Oberman, president and CEO of Apotex.

The active ingredient in APP13007 is a superpotent corticosteroid, clobetasol propionate, derived from Formosa Pharma's proprietary APNT nanoparticle formulation platform. According to the company, this novel formulation enables a “convenient and straightforward dosing regimen (twice daily for 14 days) while providing rapid and sustained relief of inflammation and pain.”

References:

1. Formosa Pharmaceuticals Announces Licensing Agreement with Apotex Inc., for Commercialization of Clobetasol Propionate Ophthalmic Suspension for Ocular Surgery Relief and Recovery. Formosa. Press Release. Released August 5, 2024. Accessed August 7, 2024. https://www.formosapharma.com/formosa-pharmaceuticals-announces-licensing-agreement-with-apotex-inc-for-commercialization-of-clobetasol-propionate-ophthalmic-suspension-for-the-treatment-of-inflammation-and-pain-following-ocular/