Little Green Pharma Ltd (ASX: LGP) has been granted a product registration for its 16% THC “Billinol LGP” cannabis flower medicine by the Danish Medicines Agency.
The grant represents the culmination of a 2.5-year application process, with Billinol LGP being the first locally produced cannabis medicine in Denmark to receive product registration.
Billinol LGP will be cultivated and produced at LGP’s Denmark Facility, with the Group expecting to distribute its first products to patients before the end of the calendar year.
Currently, Bedrocan is the only other medicinal cannabis manufacturer supplying cannabis flower into Denmark, with no other cannabis-based medicines available other than Sativex, Epidiolex and compounded formulations.
The registration aligns with LGP’s highly successful strategy of being first to market in key territories, enabling it to rapidly build a brand reputation for quality products and service with new market participants.
LGP has successfully employed this strategy previously in Australia and France and expects to repeat it in Poland and now Denmark in the future.
Under its registration, LGP is entitled to promote Billinol LGP in Denmark in the same manner as other registered medicines. Billinol LGP will be sold in 5-gram alubag pouches. Based on current publicly available data, cannabis flower medicines typically retail in Denmark for between DKK140 – 160 (A$29 – $32) per gram, compared to A$13 – $22 per gram in Australia.
The registration also gives the Group significant access to the 27 million people living in the Nordic region. Under mutual recognition agreements with Sweden, Norway and Finland, as well as through direct prescription by Danish prescribers, patients prescribed medicinal cannabis from these countries can access registered Danish cannabis medicines supplied by Danish distributors.