Specialised Therapeutics announced the extension of its 2021 partnership with Incyte Biosciences International to bring the topical Janus kinase inhibitor ruxolitinib cream, marketed as Opzelura in the United States and the European Union, to the Australian market. The Singapore‑based firm will assume responsibility for regulatory submissions, medical affairs, marketing and distribution in Australia, while Incyte will continue to develop and manufacture the product.
The agreement covers Australia, New Zealand and Southeast Asia, regions where Specialised Therapeutics already operates. The company said its immediate priority is to navigate local regulatory and reimbursement pathways to ensure eligible Australian patients can access the treatment.
Ruxolitinib cream holds approvals for non‑segmental vitiligo in patients aged 12 and older, and for mild to moderate atopic dermatitis in patients as young as two years in the United States. In the European Union, it is approved for vitiligo with facial involvement in adolescents and adults, and for moderate atopic dermatitis in adults when topical steroids or calcineurin inhibitors are unsuitable.
"The expanded agreement reinforces operational alignment between the two organisations," said Lee Heeson, executive vice‑president and head of Incyte International. Carlo Montagner, chief executive officer of Specialised Therapeutics, added that the firm will focus on securing regulatory clearance and reimbursement to bring the therapy to Australian patients.
The partnership, originally formed in 2021, follows Specialised Therapeutics' broader strategy to commercialise innovative therapies across its regional footprint. The company was founded in 2007 and has previously secured commercial rights for other Incyte products in the Asia‑Pacific region.
