Clobetasol propionate ophthalmic suspension, 0.05% (APP13007) was approved by the U.S. Food and Drug Administration (FDA) on March 4, 2024. The licensing agreement includes upfront, commercialization milestones, and sales milestones, with additional considerations throughout the term of the agreement.
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 (twice daily for 14 days) 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). APP13007 will have significant potential in the MENA region for the ocular surgery market.
"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," said Erick Co, President and CEO of Formosa Pharmaceuticals.
Ismail Shehada, CEO of Tabuk Pharmaceuticals, stated, "We are excited at Tabuk to be partnering with Formosa to introduce this innovative drug for 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."
About Formosa Pharmaceuticals, Inc.
Formosa Pharmaceuticals, Inc. (6838.TWO) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology. The company's proprietary nanoparticle formulation technology (APNT™), through which APP13007 was developed, improves the dissolution and bioavailability of APIs for topical, oral, and inhaler administration. Resulting formulations have high uniformity, purity, and stability, thereby allowing the utilization of poorly soluble or extremely potent drug agents which otherwise may face insurmountable challenges in delivery and penetration to target tissues.
For more information please visit www.formosapharma.com.
