Specialised Therapeutics  announced an expansion of its existing partnership with Incyte Biosciences International, an affiliate of Incyte (NASDAQ: INCY), to commercialise, distribute, and register ruxolitinib cream (registered as Opzelura® in the U.S. and European Union) in Australia.

Ruxolitinib (1.5%) cream is a novel, topical Janus kinase (JAK) inhibitor.^[1]  In the U.S., OPZELURA is indicated for the topical treatment of non-segmental vitiligo in adults and pediatric patients 12 years of age and older, as well as for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.^[2]

Under the terms of the expanded agreement, Incyte will remain responsible for the development and manufacturing of ruxolitinib cream, while ST will manage regulatory submissions, medical affairs, marketing, and distribution across Australia.

ST Chief Executive Officer, Mr Carlo Montagner, welcomed the addition of ruxolitinib cream to ST's portfolio, marking a key expansion into inflammatory dermatology.

"Our partnership with Incyte began in 2021, and we are pleased to extend this collaboration into dermatology," said Mr Montagner. "Atopic dermatitis and vitiligo are chronic skin conditions that carry a significant physical and psychosocial burden for patients.^[3],[4] Bringing ruxolitinib cream to the Australian market aligns with our ongoing commitment to providing innovative therapies for conditions where substantial unmet medical needs remain."

"Our immediate priority will be navigating the local regulatory and reimbursement pathways to ensure eligible Australian patients gain equitable and timely access to this topical treatment," Mr Montagner added.

Incyte Head of International, Lee Heeson, noted that the expanded agreement reinforces the strong operational alignment between the two organisations.

"We are pleased to expand our partnership with Specialised Therapeutics as we work to make ruxolitinib cream available to eligible patients in Australia," said Lee Heeson, Executive Vice President and Head of Incyte International. "ST's proven experience navigating regulatory, medical and commercial pathways across the region makes them a valued partner as we continue to broaden access to our portfolio globally."

ST anticipates progressing regulatory and reimbursement submissions for OPZELURA with Australian healthcare authorities in due course.