Specialised Therapeutics to license brain tumor visualisation drug Gliolan in Australia and New Zealand
A new drug which aids neurosurgeons to better visualise and operate on brain tumours that have a poor prognosis, high grade gliomas, will be available in Australia under a special access program later this year. Specialised Therapeutics Australia Ltd has signed a binding term sheet with German company photonamic GmbH and Co. KG to in-license the drug Gliolan, which is used in brain tumour surgery.
The drug - which selectively induces fluorescence in brain tumour cells to assist surgeons in defining and resecting gliomas – will be available to Australian neurosurgeons from September this year under the Federal Government’s Special Access Scheme.
An article published in The Lancet Oncology medical journal indicated complete resection of the malignant brain tumour tissue was achieved in 65% of patients receiving Gliolan, compared to 36% of patients in the control arm. Additionally, 6-month progression-free survival was achieved in 41% of patients receiving Gliolan compared to 21.1% of patients who received surgery without the use of the drug.
The drug is already approved for use in 27 countries, including the United Kingdom, France and Germany. STA will lodge an application with the Therapeutic Goods Administration to have the drug formally approved for widespread use in Australia.
Announcing the plan, STA chief executive officer Mr Carlo Montagner said STA would be responsible for marketing and clinical/regulatory development of the product in Australia and NZ. Photonamic would receive a confidential upfront payment, as well as milestone and royalty payments.
The active substance in Gliolan is 5-aminolevulinic acid, a natural biochemical precursor of heme, which is absorbed by cells in the body, where it is converted by enzymes into fluorescent chemicals, particularly protoporphyrin IX (PPIX).
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