Formosa Pharma Licenses Clobetasol Ophthalmic Suspension to Tabuk Pharma

TAIPEI, May 9, 2024 – Formosa Pharmaceuticals, a Taiwan-based biotechnology company, has announced a significant licensing agreement with Tabuk Pharmaceuticals Manufacturing Company. This deal grants Tabuk exclusive rights to commercialize clobetasol propionate ophthalmic suspension, 0.05% (APP13007) in key areas of the Middle East and North Africa (MENA). This innovative medication, designed to alleviate inflammation and pain after ocular surgery, received approval from the U.S. Food and Drug Administration (FDA) on March 4, 2024.

The licensing agreement between Formosa and Tabuk encompasses upfront payments, commercialization milestone payments, and sales milestone payments. There are also additional considerations included throughout the term of the agreement.

APP13007 utilizes a superpotent corticosteroid, clobetasol propionate, formulated through Formosa's proprietary APNT™ nanoparticle technology. This unique formulation allows for a convenient dosing schedule of twice daily over a 14-day period, offering rapid and sustained relief from inflammation and pain. In Phase 3 clinical trials, APP13007 demonstrated statistically and clinically significant superiority over its placebo counterpart (p<0.001). The medication is expected to have a considerable impact on the ocular surgery market in the MENA region.

Erick Co, President and CEO of Formosa Pharmaceuticals, expressed enthusiasm about the partnership with Tabuk Pharmaceuticals, noting that Tabuk is the largest private pharmaceutical company in Saudi Arabia and holds a prominent position in the MENA region. Co emphasized confidence in Tabuk's extensive experience, network, and dedication to innovative medicines, which will help deliver APP13007 to patients recovering from ocular surgery.

Ismail Shehada, CEO of Tabuk Pharmaceuticals, also highlighted the excitement of collaborating with Formosa. He pointed out that this partnership aligns with Tabuk's mission to provide unique health solutions and enhance the well-being of people in Saudi Arabia and other MENA countries. The introduction of this innovative drug reinforces Tabuk's leading role in the region.

Formosa Pharmaceuticals, Inc. (6838.TWO) is a clinical-stage biotechnology company focusing on ophthalmology and oncology. Their APNT™ nanoparticle formulation technology enhances the dissolution and bioavailability of active pharmaceutical ingredients (APIs) for topical, oral, and inhaler use. This technology ensures high uniformity, purity, and stability in formulations, overcoming challenges associated with the delivery and penetration of poorly soluble or extremely potent drug agents to target tissues.

Established in 1994, Tabuk Pharmaceuticals is a leading Saudi pharmaceutical company with a strong regional presence in the MENA region. Tabuk develops, manufactures, markets, and distributes a range of branded generics and manufactures pharmaceutical products for renowned international partners at its manufacturing sites in Saudi Arabia. With four state-of-the-art manufacturing sites located in Tabuk and Dammam in Saudi Arabia, as well as in Sudan and Algeria, Tabuk Pharmaceuticals employs over 2,400 people. The company reaches patients in 17 countries across the MENA region and plans to further expand its presence.

The collaboration between Formosa Pharmaceuticals and Tabuk Pharmaceuticals marks a significant step forward in providing innovative ocular treatments to the MENA region, improving patient outcomes and enhancing the quality of healthcare services in these key markets.