First skin lymphoma therapy PBS listed through Arrotex and Juniper Biologics partnership

Pharma News: The first ever treatment for Australians living with early-stage mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) is now listed on the Pharmaceutical Benefits Scheme (PBS). MF accounts for nearly 50% of all primary cutaneous lymphomas, a type of non-Hodgkin’s lymphoma.

Topical Ledaga (chlormethine gel) has become available locally through a partnership between Arrotex Pharmaceuticals, the largest Australian-owned pharmaceutical company, and Singapore-based Juniper Biologics. In 2022, Juniper Biologics secured an exclusive distribution license and supply agreement to register, distribute, promote, market, and sell Ledaga across Australia, Asia, and the Middle East.

Professor Miles Prince AM, a leading haematologist and Director of Molecular Oncology and Cancer Immunology at Epworth Healthcare, has been a strong advocate for the approval of Ledaga.

“Sadly, this condition is incurable, and patients suffer from pain, constant itch, and often the cosmetic impact of the disease involving their skin,” he remarked. “Something that can be easily applied and one that is so effective is life-changing for my patients.”

While the cause of MF remains unknown, it is characterised by an indolent clinical course, gradually progressing from patches to thicker plaques and, eventually, to tumours over years or even decades.

Caroline Guerbet, Marketing Director at Juniper Biologics, emphasised the significance of the partnership with Arrotex.

“This finally offers hope for those Australians who have this lifelong, painful disease. We believe in developing game-changing medicines, such as Ledaga, to help treat some of the most complex and pressing illnesses of our time,” Guerbet stated.

The European Organisation for Research and Treatment of Cancer (EORTC) recommends Ledaga as a first-line treatment for early-stage disease. The pivotal 201 study, the largest randomised controlled trial ever conducted for early-stage MF-CTCL, involved 260 patients.

Results revealed that 77% of those treated for at least six months with Ledaga achieved a clinical response according to the Composite Assessment of Index Lesion Severity (CAILS) score, compared to 59% in the control group. Furthermore, a complete response was achieved in 19% of patients receiving Ledaga versus 15% in the control group, with reductions in mean CAILS scores observed as early as four weeks into the study.

Ledaga is also the inaugural therapy launched under the new ‘Arrotex Innovation Hub,’ aimed at delivering hard-to-access, cutting-edge treatments to Australians in need.

Monique Jonson, the new Head of Innovation at Arrotex, described the partnership with Juniper Biologics as a testament to Arrotex’s commitment to addressing the unmet clinical needs of vulnerable patients.

Dr Jillian Wells from the Cutaneous Lymphoma Clinic at Westmead Hospital echoed this sentiment, stating, “This is great news for the 2,000 or so Australians living with MF-CTCL. The dermatologists and haematologists who treat patients with this terrible disease can now finally offer an effective and convenient treatment option.”

Sharon Winton, CEO of the patient advocacy group Lymphoma Australia, expressed optimism about the treatment’s potential impact.

“Ledaga will give MF patients the hope of a symptom-free, relatively normal life,” she said.

As part of its Innovation Hub, Arrotex is actively exploring further opportunities, both independently and in collaboration with global partners, to introduce vital therapies currently unavailable in Australia.

Hayley Tamborini, Chief Commercial Officer of Arrotex, emphasised the company’s mission, saying “Taking on complex challenges is in Arrotex’s DNA. We are an Australian company focused on ensuring Australians have timely, sustainable, and affordable access to world-class treatments.”

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