Specialised Therapeutics Expands Partnership with Incyte to Include Ruxolitinib Cream (Opzelura®) in Australia - Specialised Therapeutics

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Singapore, 21 September 2026:

Independent biopharmaceutical company Specialised Therapeutics (ST) today 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.

Ends.

 

Further Enquiries: Kellie Penrose kpenrose@stbiopharma.com +61 3 9859 1493

 

About Specialised Therapeutics

Founded in 2007, Specialised Therapeutics is an independent specialty pharmaceutical company, providing novel therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. Headquartered in Singapore, ST partners with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. ST has built a strong track record of success, navigating complex regulatory, reimbursement and commercialisation environments in its diverse regions across multiple therapeutic areas. The ST mission is to provide specialty therapies where there is an unmet need to communities that would otherwise not have ready access to such therapies. The company’s broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and dermatology, although it is not confined to these areas.  Additional information can be found at www.stbiopharma.com.

 

About Ruxolitinib Cream (OPZELURA)

Ruxolitinib cream (OPZELURA) a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. FDA for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. OPZELURA is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.²

In Europe, OPZELURA (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age and in adult patients with moderate atopic dermatitis (AD) for whom topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) are inadequate or inappropriate.⁵

Incyte has worldwide rights for the development and commercialisation of OPZELURA. To date, more than one million patients globally have been treated with OPZELURA.

OPZELURA is a registered trademark of Incyte.

 

References

1. Ryguła I, Pikiewicz W, Kaminiów K. Novel Janus Kinase Inhibitors in the Treatment of Dermatologic Conditions. Molecules. 2023 Dec 13;28(24):8064
2. U.S. Food and Drug Administration (FDA). Opzelura (ruxolitinib) cream: Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215309s001lbl.pdf
3. Australasian College of Dermatologists. A-Z of Skin: Atopic Dermatitis / Eczema. Available at: https://www.dermcoll.edu.au/atoz/atopic-dermatitis/
4. Vitiligo Association of Australia. Understanding Vitiligo and Its Psychological Impact. Available at: https://www.vitiligo.org.au/
5. European Medicines Agency (EMA). Opzelura (ruxolitinib) EPAR summary for the public. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/opzelura