Formosa Pharmaceuticals has announced an exclusive licensing agreement with Tabuk Pharmaceuticals, granting the latter exclusive rights to commercialise the clobetasol propionate ophthalmic suspension, 0.05% (APP13007) to treat inflammation and pain after ocular surgery.

APP13007 will be commercialised in key Middle East and North Africa (MENA) regions.

The deal comes after the ophthalmic suspension obtained approval from the US Food and Drug Administration (FDA) in March 2024.

The agreement includes upfront payments and milestone payments on meeting commercialisation and sales-based goals, other than additional considerations, throughout the deal’s term.

APP13007 utilises Formosa Pharma’s APNT nanoparticle formulation platform and contains clobetasol propionate, a superpotent corticosteroid.

This formulation offers a convenient dosing regimen, requiring administration only twice daily for 14 days, while offering quick and lasting inflammation and pain relief.

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Tabuk Pharmaceuticals CEO Ismail Shehada stated: “We are excited at Tabuk to be partnering with Formosa to introduce this innovative drug for our patients in Saudi Arabia and remaining MENA countries, which reinforces our leading position in the region and our role to deliver unique health solutions and enhance the well-being of people.”

In Phase III clinical trials, APP13007 demonstrated statistical and clinical superiority over its matching placebo.

Formosa Pharmaceuticals president and CEO Erick Co stated: “We are pleased to establish this partnership with Tabuk Pharmaceuticals, the largest private Saudi company and one of the most prominent pharmaceutical corporations in the MENA region.

“We are confident Tabuk’s experience, vast network, and commitment to value-added and innovative medicines will deliver APP13007 to patients recovering from ocular surgery.”

In August 2023, Formosa granted the exclusive licensing and commercialisation rights for its APP13007 (clobetasol steroid) to Eyenovia in the US for $86m.

The deal between Formosa and Eyenovia is based on their existing partnership to develop new eye therapies.