Medicinal cannabis in Germany - Business Report

178 Confidential __________________________________________________________________________________ 11.9.4 Epidyolex® (Cannabidiol-CBD) The product is currently only available in "Compassionate Use Procedure". The price is carefully guarded but is probably very high for an anti-epileptic. Since the price of Epidyolex® in the USA is set very high at 34,000 US dollars per patient, GW Pharmaceuticals will try to achieve a similar price level in Europe in order to avoid or at least minimize re-imports between the two markets. The distribution channel also serves this purpose, as the product is not yet available through wholesalers. This strategy will only be successful, if GW Pharmaceuticals is able to control the distribution channels. As the approved indications for Epidyolex®, Dravet and Lenneux-Gastaut Syndrome are orphan in- dications , there are only a few patients for whom Epidyolex® is the drug of choice. Experts estimate that there are approximately 1,000 patients for Epidyolex® in Germany. Assuming the current US price in euros (EUR 30,856), the market potential for Epidyolex® could be a maximum of EUR 30 million in the future. In addition, GW Pharmaceuticals is currently undertaking a broad Phase III study program to achieve potential indication expansion 11.9.5 CannEpil® (CBD) This product of the Australian company MGC Pharmaceuticals has so far only been approved in Australia under a highly regulated access route. However, the indication for CannEpil®, therapy-re- sistant epilepsy, is anything but a niche indication. Experts assume that more than one third of all epilepsy patients belong to this target group. That is then already a large market. At present, about 500,000 people in Germany are undergoing GP or specialist treatment for epilepsy. This corresponds to a population share of about 0.6%. On average, 47 out of every 100,000 new epilepsy cases occur each year. This corresponds to a number of about 38,000 new cases annually. Pharma-resistant epilepsies led to considerable medical problems. Injuries, accidents, but also comorbidities such as depression, anxiety and suicidal tendencies, and contribute to the fact that peo- ple with epilepsy have a mortality rate three times higher than that of the general population. How- ever, up to one third of patients do not respond or do not respond sufficiently to the available thera- pies - an enormous number considering the number of people affected, namely around 200,000 peo- ple in Germany alone. If CannEpil® succeeds in obtaining drug approval for the German market in this indication, the prod- uct has " blockbuster " potential, even at a not very aggressive price.