Medicinal cannabis in Germany - Business Report

177 Confidential __________________________________________________________________________________ Unfortunately, up to now there are only data for the prescription market, so a valid forecast is only possible for this segment. We estimate the market for CBD-containing drugs such as Epidyolex® and CannEpil® in Germany to have a volume of approximately EUR 80 million by 2023. 11.9 Prognosis of the sub-market Cannabis finished medicinal products Regarding the market for medicinal Cannabis, it is clear that the future belongs to finished medicinal products based on defined active ingredients (APIs). However, the market for these ready-to-use Can- nabis products with APIs, a regular drug approval based on high-quality clinical trials (RCTs), will be slow to develop, as the relevant studies are only just starting. The number of available ready-to-use drugs in the Cannabis market will grow from 3 today to 5 to 10 in the next few years. 11.9.1 Sativex® (Nabiximols) The first finished drug approved in Germany has been provided with a reimbursement price through the AMNOG procedure, at which it is reimbursed by the health insurance companies. Internationally Sativex® is now available in more than 15 countries. The administration form as oro-mucosal spray is a weak point of Sativex because of the variability of the resorption conditions. Nevertheless, the prod- uct is making its way and is currently growing by 9%. Sativex® is increasingly used off-label in Germany to offer Cannabis patients a rational therapy. The product will continue to establish itself in the market with an annual growth rate of around 10% until 2023 and will then be able to achieve sales of around 30 million euros. The probably consistent international pricing policy of Sativex® has not led to any reimports in Germany so far. 11.9.2 Canemes® (Nabilone) The product remains clearly below its potential. Even after three years in the market, there is hardly any growth to be seen and overall, the turnover in the outpatient sector is certainly not satisfactory at well under 1 million euros. It is not known how high the turnover in the hospital sub-market is. In contrast to Sativex®, we see an increasing number of reimports of Canemes® in the German market. Whether Canemes® can be put on a growth path through better marketing and/or an optimized pricing policy remains an open question. In the next five years, Canemes® will hardly be able to grow above the 3 million Euro threshold as annual sales. Canemes® is developing rather into a niche product at a low level. 11.9.3 Marinol® (Dronabinol) Imports of Marinol® have already fallen to almost zero by 2019. One reason for this is the compli- cated and time-consuming import procedure according to § 73a AMG. On the other hand, Dronabinol is available as a prescription drug in various dosage forms and doctors are making increasing use of it. This means that Marinol® will develop into an absolute niche product in the future. Whether and when the BfArMwill approve a generic version of Marinol® in the future is speculative and will only have a real market chance if a "fighting price" is paid.