QBiotics commercialises first tigilanol tiglate pharmaceutical product with launch of STELFONTA®

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Apr 28, 2020, 02:43 ET

BRISBANE, Australia, April 28, 2020 /PRNewswire/ -- Australian life sciences company, QBiotics Group Limited (QBiotics) has commercialised the first product for its lead compound, tigilanol tiglate, with the launch of STELFONTA® in the European markets at the Virbac Oncology Summit Webinar Event (24 April 2020).

STELFONTA® (tigilanol tiglate) is now available as the first pharmaceutical treatment for all grades of canine non-metastatic mast cell tumours (MCT).^[1]MCTs are the second most frequent cancer diagnosed in dogs and the most common skin cancer, accounting for up to 21% of skin cancer cases.^[2]

QBiotics have partnered with global veterinary pharmaceutical company, Virbac for marketing and distribution of STELFONTA® in the USA and Europe. The exclusive online Oncology Summit attracted over 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, Dr Pamela Jones said, "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.^[3]"

"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 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.

ISSUED BY QBIOTICS GROUP LIMITED – https://qbiotics.com

ABOUT QBIOTICS

QBiotics is a public unlisted Australian life sciences company which discovers, develops and commercialises novel anticancer and wound healing products for human and veterinary markets.

The Company's lead product, tigilanol tiglate, is an anticancer pharmaceutical targeting a range of solid tumours across multiple species.

QBiotics' business model is to develop products that have application in both human and veterinary markets. Success in the veterinary programs validates QBiotics technology and de-risks human development, while generating early, non-diluting revenues.

REFERENCES:

1. QBiotics Group Ltd., Data on file. 2020.

2. Garrett, LD. 2014. Canine mast cell tumors: diagnosis, treatment, and prognosis. Veterinary Medicine: Research and Reports, Vol 5. https://doi.org/10.2147/VMRR.S41005

3. Boyle G et al. 2014. Intra-lesional Injection of the Novel PKC Activator EBC-46 Rapidly Ablates Tumors in Mouse Models, PLOS ONE, Vol 9, Issue 10

SOURCE QBiotics Group Limited