Formosa Pharmaceuticals Licensing Agreement Grants Arrotex Exclusive Rights to Clobetasol Propionate Ophthalmic Suspension in Australia and New Zealand
Taiwan-headquartered Formosa Pharmaceuticals (6838.TW) announced an exclusive licensing agreement with Arrotex Pharmaceuticals Pty Ltd, an Australian pharmaceutical company, for the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007) in Australia and New Zealand. APP13007 is a topical corticosteroid eyedrop formulated using Formosa's proprietary APNT nanoparticle platform for the treatment of inflammation and pain following ocular surgery. The Formosa Pharmaceuticals licensing agreement grants Arrotex exclusive rights to ophthalmic drug commercialization across both territories and includes upfront payments, regulatory milestone payments, sales milestone payments, and royalty considerations throughout the term of the agreement. Specific financial figures for any component of the deal were not disclosed.
Arrotex, formed in 2019 through the merger of Arrow Pharmaceuticals and Apotex Australia, is jointly owned by Dennis Bastas and Apotex Inc. of Canada. The company states that it supplies approximately 50% of Australia's total prescription medicine volume and maintains a commercial presence in ophthalmology. No equity investment or profit-sharing arrangement was referenced in the announcement. The deal follows a standard regional licensing structure consistent with Formosa's other APP13007 out-licensing transactions, with Formosa expected to serve as product supplier given its role as the APNT platform originator and manufacturer.
Deal Context
APP13007's active ingredient, clobetasol propionate, is a corticosteroid that acts via the glucocorticoid receptor (NR3C1) to suppress inflammatory mediator transcription, reduce vascular permeability, and inhibit cellular infiltration. Clobetasol is classified as a superpotent (Class I) corticosteroid in dermatological use; the APNT nanoparticle formulation is designed to improve dissolution and bioavailability of the active ingredient in the ocular environment, enabling a twice-daily dosing regimen over 14 days. The US FDA approved APP13007 in 2024 for ocular surgery treatment involving post-operative inflammation and pain. Formosa has cited survey data from 100 US ophthalmic surgeons indicating approximately 80% of patients were pain-free four days post-surgery, with adverse event incidence below 2%.
APP13007 completed Phase 3 clinical trials prior to its NDA submission to the US FDA. The US FDA had previously issued a Complete Response Letter, which Formosa addressed ahead of the 2024 approval. No new interventional clinical trials for APP13007 appear to be active. The Australian market for cataract surgery alone is estimated at approximately 250,000 procedures annually, and regulatory submission to Australia's Therapeutic Goods Administration (TGA) is expected to draw on the existing US clinical and regulatory dossier.
The Formosa Pharmaceuticals Arrotex agreement is the third licensing deal between Formosa and the broader Apotex corporate group for the same product. Formosa first licensed APP13007 to Apotex Inc. for Canada in August 2024, then expanded the relationship to Mexico in May 2025. The progression from Canada to Mexico to Australia and New Zealand within approximately 18 months reflects a territory-by-territory rollout through a single corporate family. All three deals target the same product and indication and follow a similar contractual framework of upfront payments plus regulatory and sales milestones.
Beyond the Apotex/Arrotex group, Formosa has assembled a broad network of regional partners for APP13007. Harrow, Inc. (formerly Eyenovia) holds US commercial rights under an August 2023 deal reported by trade press as valued at up to USD 86 million in upfront and milestone payments. China Grand Pharmaceutical holds rights for China, Hong Kong, and Macau. Tabuk Pharmaceuticals holds rights for the MENA region under a 2024 agreement. Adalvo Limited secured European and Brazilian rights in May 2025. Rxilient holds ASEAN rights under a December 2025 agreement, and Samil Pharmaceuticals secured South Korean rights in January 2026. Additional partners include Cipla (India and 10 emerging markets), Cristália (Brazil), Saval Corporation (Chile and eight Latin American markets), Medvisis Switzerland AG, Tzamal Biomedical (Israel), and DÁVI Farmacêutica (Portugal). Financial terms for the majority of these regional deals have not been publicly disclosed.