Formosa Pharma and Apotex Partner on New Eye Surgery Medication

Formosa Pharmaceuticals, a Taiwanese company, has announced today that it has signed an exclusive licensing agreement with Apotex for the exclusive rights to market clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a patented novel medication intended to relieve pain and inflammation after eye surgery, in Canada. The U.S. Food and Drug Administration (FDA) approved clobetasol propionate ophthalmic suspension, 0.05% (APP13007) on March 4, 2024. A milestone payment upon reaching specific sales and regulatory milestones, as well as an upfront payment, are all part of the license agreement. Clobetasol propionate, a powerful corticosteroid, is the active component of APP13007 and is made using Formosa Pharma's own APNT® nanoparticle formulation platform.

In Phase 3 studies, the innovative formulation showed statistically and clinically superior to its matched placebo (p<0.001), allowing for a practical and uncomplicated dosage regimen of twice daily for 14 days, while also delivering quick and prolonged relief from inflammation and pain. With an estimated ~500,000 ocular procedures performed yearly in Canada, APP13007 will join a ~$C50M market for topical ophthalmic steroids and steroid combinations, which is expected to expand at a rate of 5% annually.

Formosa Pharmaceuticals President and CEO Erick Co. stated, "Formosa Pharma is honoured to partner with Apotex, given its storied history and reputation for success." With their dedication to branded ophthalmology goods, we have no doubts about APP13007's success in the Canadian market. We are excited to collaborate with the Apotex team to deliver this tailored treatment.

Allan Oberman, President & CEO of Apotex, stated, "We are happy to offer APP13007, a new treatment option for post-operative inflammation and pain following ocular surgery, to Canadian patients." "We can help more patients on their road to health by growing our portfolio of novel medicines, which includes our ophthalmology portfolio, and our commercial infrastructure.”