Formosa Pharmaceuticals announced on the 9th of May that it has signed a licensing agreement with Tabuk Pharmaceuticals Manufacturing Company, the largest private pharmaceutical company in Saudi Arabia, on April 30th. Tabuk Pharmaceuticals will obtain exclusive rights to commercialize the patented new drug APP13007 for post-operative inflammation and pain in the eye in the major markets of the Middle East and North Africa.
Formosa Pharmaceuticals's APP13007 (0.05% loteprednol etabonate ophthalmic suspension) was approved by the U.S. Food and Drug Administration (FDA) for marketing on March 4th of this year. The licensing agreement with Tabuk Pharmaceuticals includes signing fees, development milestones, sales milestone payments, and other considerations during the term of the contract.
APP13007 is developed based on the potent steroid loteprednol etabonate, using Formosa Pharmaceuticals's proprietary APNT nano-microparticle formulation platform. This new formulation eye medicine achieves rapid and sustained relief of inflammation and pain with a simple and convenient dosing regimen (twice daily for 14 days), as demonstrated in phase III clinical trials where APP13007 showed statistically significant superiority over placebo (p<0.001). APP13007 holds significant growth potential in the stable-growing ophthalmic surgery and pharmaceutical market in the Middle East and North Africa.
Formosa Pharmaceuticals's General Manager and CEO, Dr. Erick Co, expressed great honor in establishing a partnership with Tabuk, the largest private enterprise in Saudi Arabia and one of the most well-known pharmaceutical companies in the Middle East and North Africa region. He believes that Tabuk's experience, extensive sales network, and commitment to introducing value-added innovative drugs will bring APP13007 to patients recovering from ophthalmic surgery.
Ismail Shehada, CEO of Tabuk Pharmaceuticals, expressed his pleasure in collaborating with Formosa Pharmaceuticals to introduce this innovative drug to patients in Saudi Arabia and other Middle Eastern and North African countries, further consolidating their leading position in this region. Through this collaboration, they have not only expanded their product portfolio but also taken the first step and strategically expanded into the potential therapeutic area of ophthalmology.
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