Australian company QBiotics has announced the commercialisation of the first product for its lead compound, tigilanol tiglate, with the launch of STELFONTA in Europe.
The company said STELFONTA (tigilanol tiglate) is now available as the first pharmaceutical treatment for all grades of canine non-metastatic mast cell tumours (MCT). MCTs are the second most frequent cancer diagnosed in dogs and the most common skin cancer, accounting for up to 21 per cent of skin cancer cases.
QBiotics has partnered with the global veterinary pharmaceutical company, Virbac, for marketing and distribution of STELFONTA in the US and Europe.
According to QBiotics veterinary oncologist, Dr Pamela Jones, “Tigilanol tiglate is a novel approach to treating cancer that is administered by injection directly into the tumour mass. It works largely through specific protein kinase C (PKC) activation, in which it locally stimulates the immune system. This results in destruction of the tumour mass and the tumour’s blood supply, usually within 7 days, followed by rapid healing of the site with minimal scarring.”
“We are delighted to announce that STELFONTA will be commercially available, with product being distributed in Europe through our Virbac partners. This major milestone creates a repeatable revenue stream for QBiotics and validates the company’s ability to develop, register and commercialise a pharmaceutical addressing significant medical problems,” said QBiotics’ CEO and managing director, Dr Victoria Gordon.
“It has been an exciting time for the company, having received approval from both the European Medicines Agency (EMA) and Veterinary Medicines Directorate (VMD) for STELFONTA earlier this year. This regulatory approval triggered our second milestone payment and revenue initiated by the first shipment of product to Virbac for distribution to veterinary clinics across the European continent.” said Dr Gordon.
QBiotics said it anticipates first launches to veterinary clinics across Europe from May 2020, with details and timings to be coordinated locally amidst country-specific COVID-19 requirements. STELFONTA will also be launched in the US and Australia, pending approvals.
“Applications are currently under review by the US Food & Drug Administration – Center for Veterinary Medicines (FDA-CVM) and the Australian Pesticides and Veterinary Medicines Authority (APVMA). Our objective is for tigilanol tiglate to be available globally to primary care and specialist veterinarians for the treatment of MCT in dogs,” said Dr Gordon.