April 28, 2020

QBiotics Group Debuts New Canine Tumor Treatment in Europe, US Approvals Pending

Australian life sciences company QBiotics Group Limited (QBiotics) has launched tumor treatment STELFONTA for dogs, the first product for its lead compound, tigilanol tiglate, in the European markets at the Virbac Oncology Summit webinar event that took place April 24.

STELFONTA is now available as the first pharmaceutical treatment for all grades of canine non-metastatic mast cell tumors (MCT). MCTs are the second most frequent cancer diagnosed in dogs and the most common skin cancer, accounting for up to 21 percent of skin cancer cases.

QBiotics has partnered with global veterinary pharmaceutical company, Virbac for marketing and distribution of STELFONTA in the US and Europe.

The exclusive online Oncology Summit attracted more than 300 veterinary oncologists and global opinion leaders. An expert panel presented on the use of tigilanol tiglate as an innovative and unique approach to MCT management.

QBiotics veterinary oncologist Pamela Jones said, “Tigilanol tiglate is a novel approach to treating cancer that is administered by injection directly into the tumor 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 tumor mass and the tumor’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 commercialize a pharmaceutical addressing significant medical problems,” said QBiotics’ CEO and Managing Director, 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 Gordon.

QBiotics 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 Gordon.

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