Independent pharmaceutical company Specialised Therapeutics Asia (STA) has signed a new license deal, enabling it to provide a global advanced sarcoma therapy to patients in Australia, New Zealand and throughout SE Asia.
Under the terms of the agreement, STA will provide the marine-derived compound YONDELIS (trabectedin) to patients throughout Australia, New Zealand and in South East Asia under exclusive license from Spanish company PharmaMar.
YONDELIS – which has been shown to improve progression-free survival when used as second-line therapy for patients with unresectable or metastatic liposarcoma (LPS) or leiomyosarcoma (LMS) 1 – is already approved and has been available to patients in the United States since 2015,2 and in Europe since 2007.3
Until now, it has not been available in Australia and New Zealand, although it is currently provided to patients in Singapore, Malaysia and Brunei via a previous pharmaceutical arrangement. Former product licensee Janssen will continue to distribute YONDELIS in Singapore, Malaysia and Brunei until marketing authorisation is formally transferred to STA.
Announcing the new deal, STA Chief Executive Officer Mr Carlo Montagner said some Australian patients and their doctors had previously sought to access YONDELIS from international sources, at great difficulty and expense.
"We are delighted to provide this important therapy to patients in Australia, New Zealand and in South-East Asia," he said.
"We will be immediately seeking approval from the Therapeutic Goods Administration (TGA) and in the interim, will ensure YONDELIS is available to appropriate patients via a Special Access Program."
Associate Professor Jayesh Desai, Medical Oncologist at the Peter MacCallum Cancer Centre in Melbourne, Australia, and Deputy-Chair of the Australia New Zealand Sarcoma Association (ANZSA) said the availability of YONDELIS in Australia would be greatly appreciated by the sarcoma community.
"Sarcoma is a relatively rare cancer and treatment options are limited for Australian patients with advanced disease," Associate Professor Desai said.
"YONDELIS has been shown to provide a 45% reduction in the risk of disease progression or death versus dacarbazine in patients who have failed prior therapies,1 and has been a global standard of care. We welcome news that Australian patients will soon be provided access to this therapy that is already providing benefit to sarcoma patients around the world."
Specialised Therapeutics will now seek formal regulatory approval to market YONDELIS in Australia from the Therapeutic Goods Administration (TGA) and subsequent reimbursement via the Pharmaceutical Benefits Scheme (PBS).
In the interim, a Special Access Program will be opened on November 1 to ensure YONDELIS is available at the earliest opportunity to eligible patients.
PharmaMar President, José María Fernández Sousa-Faro, commented: "This new license arrangement is the third we have struck with STA, and is a strong endorsement of their capabilities in these key marketing regions of Australia, New Zealand and South-East Asia.
"Patients and the medical community will now be provided the opportunity to readily access YONDELIS, which is already recognised as a global standard of care. We look forward to seeing sarcoma patients benefit with improved outcomes."
About Specialised Therapeutics Asia
Headquartered in Singapore, Specialised Therapeutics Asia Pte Ltd (STA) is an international biopharmaceutical company established to commercialise new therapies and technologies to patients throughout South East Asia, as well as in Australia and New Zealand. STA and its regional affiliates collaborate with leading global pharmaceutical and diagnostic companies to bring novel, innovative and life-changing healthcare solutions to patients affected by a range of diseases. Its mission is to provide therapies where there is an unmet need. The company's broad therapeutic portfolio currently includes novel agents in oncology, haematology, neurology, ophthalmology and supportive care.
About PharmaMar
Headquartered in Madrid, PharmaMar is a biopharmaceutical company focused on oncology and committed to research and development, taking its in...
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