Riyadh – Tabuk Pharmaceutical Manufacturing Company (a fully owned subsidiary of Astra Industrial Group), a leading Saudi pharmaceuticals company, announced today an exclusive license agreement
with Formosa Pharmaceuticals for the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a patented innovative medicine for the treatment of inflammation and
pain following ocular surgery in the Middle East and North Africa (MENA). Clobetasol propionate
ophthalmic suspension, 0.05% (APP13007) was approved by the U.S. Food and Drug Administration
(FDA) on March 4, 2024. The licensing deal 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 APNTTM 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 a 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 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.”
About Tabuk
Established in 1994, Tabuk Pharmaceuticals is a leading Saudi pharmaceutical company with a regional
presence in the Middle East and North Africa (MENA). Tabuk Pharmaceuticals develops, manufactures,
markets, and distributes various branded generics, in addition to manufacturing pharmaceutical
products for renowned international partners at its manufacturing sites in Saudi Arabia, as part of its
continuous efforts to cover the needs of patients by providing high quality medicines. Tabuk
Pharmaceuticals is a major player in the pharmaceutical sector thanks to its four state-of-the-art
manufacturing sites located in Tabuk and Dammam in the Kingdom, as well as in Sudan and Algeria,
orchestrated by a team of more than 2,400 employees. Tabuk Pharmaceuticals reaches patients in 17
countries across the Middle East and North Africa, with future plans to expand its presence in the region.
https://www.tabukpharmaceuticals.com
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 (APNTTM), 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 details about Formosa Pharma and APNTTM, visit www.formosapharma.com.
Tabuk Pharmaceuticals Contact:
Wisam Al-Khatib
Chief Business Development Officer
Wisam.AlKhatib@tabukpharmaceuticals.com
Formosa Pharmaceuticals Contact:
Wayne Wei
Chief Strategy & Business Officer
waynewei@formosapharma.com