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

- Link: https://www.thailand-business-news.com/pr-news/specialised-therapeutics-expands-partnership-with-incyte-to-include-ruxolitinib-cream-opzelura-in-australia
- Published: 2026-09-21T03:00:00+07:00
- Author: PR Newswire

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SINGAPORE, Sept. 21, 2026 /PRNewswire/ — 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 –**

**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](https://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:**

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[1]. Ryguła I, Pikiewicz W, Kaminiów K. Novel Janus Kinase Inhibitors in the Treatment of Dermatologic Conditions. Molecules. 2023 Dec 13;28(24):8064     

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[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](https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215309s001lbl.pdf)

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[3]. Australasian College of Dermatologists. A-Z of Skin: Atopic Dermatitis / Eczema. Available at: [https://www.dermcoll.edu.au/atoz/atopic-dermatitis/](https://www.dermcoll.edu.au/atoz/atopic-dermatitis/) 

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[4]. Vitiligo Association of Australia. Understanding Vitiligo and Its Psychological Impact. Available at: [https://www.vitiligo.org.au/](https://www.vitiligo.org.au/) 

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[5]. European Medicines Agency (EMA). Opzelura (ruxolitinib) EPAR summary for the public. Available at: [https://www.ema.europa.eu/en/medicines/human/EPAR/opzelura](https://www.ema.europa.eu/en/medicines/human/EPAR/opzelura) 

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