ANTG second Australian company to bring domestically cultivated products to market
ANTG, a NSW-based medicinal cannabis company, has announced that their first product is ready for Australian patients. The news, published on the company’s website, highlighted the registration of the product as an export-only medicine, listed on the Australian Register of Therapeutic Goods (ARTG). This is one of two regulatory permissions required by the Australian government prior to exporting. The company must also obtain an ODC export license and subsequent permits per consignment, before products can be shipped to international markets.
The Office of Drug Control that issues cultivation, manufacture and export licenses, requires all exporters to make their products available for local supply to patients via medical prescription and clinical trials. So although the company has only announced their ability to export, this means they are also able to supply their product to meet local demand.
“‘Listing’ on the ARTG is very different to having a product ‘registered’ on the ARTG. Product registration follows clinical trials demonstrating safety and efficacy in a particular clinical indication. The only registered cannabis product in Australia is Nabixomols (Sativex) registered for MS-related spasticity”, said Rhys Cohen, Principal Consultant at FreshLeaf Analytics.
This is a milestone for the Australian cannabis industry as only one other company, Little Green Pharma, has so far brought an Australian-cultivated product to market. And it’s a sign that Australia’s industry is finally getting up to speed.
Dr John Barlow, principal researcher at Applied Cannabis Research commented, “Australian cultivated and manufactured medicinal cannabis products are GMP-certified by our national regulator, the TGA making them unique in the global marketplace and highly suitable for clinical and research purposes”.
The product listed by ANTG is a dried cannabis plant material in a 10 gram jar. Dried plant material is currently available in Australia via medical prescription and at the time of the most recent FreshLeaf Analytics Q3 2019 market report, there were 15 dried plant material products available in the Australian market at a price of $17 – $28 per gram (price to pharmacy).
FreshLeaf is forecasting price of dried plant material to reduce substantially in 2020 as more products become available and prices fall in-line with global pricing for these products.