AusCann begins Australian product registration with first regulatory filing for DermaCann®

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Highlights

  • AusCann submitted its first module to the Australian Pesticides and Veterinary Drugs Association (APVMA) to begin submitting its dossier for the registration of DermaCann®, in development for anti-inflammatory and immune support in dogs with dermatological diseases;
  • There are about 1 million dogs in Australia who suffer from dermatological diseases, and the global skin and canine dermatitis market is worth an estimate US $ 1.5 billion worldwide ;
  • Subject to approval, DermaCann® would be the first and only APVMA-approved veterinary cannabinoid product to be legally provided on prescription by Australian veterinarians;
  • The DermaCann® submission in Australia compliments the previously announced submission for approval in South Africa and marketing plans for United States where some state law allows animal health products containing CBD to be sold without registration.

SYDNEY, July 20, 2021 / PRNewswire / – AusCann Group Holdings Limited (ASX: AC8) (“AusCann” or “the Company”) is pleased to announce that it has submitted its first module to the Australian Pesticides and Veterinary Medicines Association (APVMA) to begin submitting its dossier for the registration of DermaCann®, under development for anti-inflammatory and immune support in dogs with dermatological diseases.

The toxicology module was submitted following a positive response to a pre-requisition assistance (PAA) request from the APVMA, outlining a project plan with agreed milestones for off-line application that allows staged submission of supporting datasets for longer module evaluations. (such as toxicology) while other supporting datasets are being prepared for submission.

Subject to approval, DermaCann® will become a veterinary oral cannabinoid product approved by Global Dog Skin Health Regulations, and the first and only APVMA approved drug containing cannabinoids to be dispensed on prescription by Australian veterinarians.

The safety and toxicology evaluation of DermaCann® was led by Dr. Marguerite Curtis, head of research and development for AusCann, and Dr Jeffery Sherman, a Board-certified toxicologist who began consulting on the dossier in 2018. It includes nearly 2,000 pages of data and supporting literature and is the result of over 3 years of research and dossier preparation , including 8 independent in vitro and in vivo GLP toxicology studies (good laboratory practice) carried out in Hungary, Germany and United States.

The Global Canine Skin and Dermatitis Market Is Worth An Estimate US $ 1.5 billion globally, and the approval of DermaCann® will provide veterinarians with a safe and clinically validated veterinary cannabinoid product for use as a beneficial therapy in a canine atopic dermatitis management regimen.

Reduction of symptoms of atopic dermatitis in dogs

The unique property of DermaCann® is a proprietary combination of herbal ingredients, including high purity cannabidiol (CBD), to help strengthen natural immune and inflammatory responses in dogs through activation of the endocannabinoid system .

In a randomized, placebo-controlled, double-blind study, DermaCann® was found to be safe and effective in reducing inflammatory skin lesions in dogs diagnosed with atopic dermatitis.

Treatment with DermaCann® resulted in a substantial improvement in CADESI-4 scores, with an average reduction of 51% for dogs on treatment, compared to a slight increase observed in the placebo group between days 0 and 56. CADESI-4 (Canine Atopic Dermatitis Extent and Severity Index) is a benchmark method used to assess the impact of treatments in dogs with atopic dermatitis.

AusCann is currently undertaking further studies, including a 90-day animal safety goal in the United States, and ex vivo search for biomarkers with the University of Melbourne to provide supporting data on the anti-inflammatory mechanism of action of DermaCann®, to add to the growing body of evidence for the product.

The Company also advanced preparations for the commercialization of DermaCann® by United States, where some state laws allow animal health products containing CBD to be sold without registration.

Layton Mills, CEO of AusCann: “Entering the formal registration pathway with APVMA is in line with AusCann’s goal of providing safe, clinically developed and tested medicines for human and animal health to meet the unmet health needs of patients. We look forward to bringing this world-first product to veterinarians of Australia and other global markets

ABOUT AUSCANN

AusCann Group Holdings Limited (ASX: AC8) is an Australian company focused on the development and commercialization of cannabinoid-derived therapeutics to address the unmet needs of humans and animals within Australia and internationally. Our main difference is the commitment to rigorous product development, focused on providing reliable, stable and standardized cannabinoid-derived therapeutics, while generating strong safety, quality assurance and efficacy data to support market access in various regulatory environments around the world.

SOURCE AusCann Group Holdings


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