Specialised Therapeutics (ST) announced an expansion of its partnership with Incyte Biosciences International, an affiliate of Incyte (NASDAQ: INCY), to commercialize, distribute, and register ruxolitinib cream — marketed as Opzelura — in Australia.

Under the expanded agreement, Incyte will retain responsibility for the development and manufacturing of ruxolitinib cream, while ST will manage regulatory submissions, medical affairs, marketing, and distribution in Australia. The two companies have been partners since 2021.

Ruxolitinib cream is a topical JAK1/JAK2 inhibitor approved in the U.S. for the treatment of non-segmental vitiligo in patients 12 years of age and older, and for mild to moderate atopic dermatitis in patients 2 years and older. In the European Union, it is approved for non-segmental vitiligo with facial involvement and moderate atopic dermatitis in certain adult patients. More than one million patients globally have been treated with Opzelura, according to Incyte.

ST Chief Executive Officer Carlo Montagner said the company's immediate priority will be navigating local regulatory and reimbursement pathways in Australia. "Atopic dermatitis and vitiligo are chronic skin conditions that carry a significant physical and psychosocial burden for patients," Montagner said.

Lee Heeson, Executive Vice President and Head of Incyte International, said ST's experience across regulatory and commercial pathways in the region makes it a suitable partner for broadening access to Opzelura.

ST said it anticipates progressing regulatory and reimbursement submissions with Australian healthcare authorities. The Singapore-headquartered company operates across Australia, New Zealand, and Southeast Asia.