Israeli medical cannabis giant Panaxia announced in a press release on Wednesday that they have become the first company to receive regulatory approval to market an inhalable cannabis solution in Europe - Germany, more specifically - along with their strategic partner, the German pharmaceutical company Neuraxpharm.
According to an analysis of market trends in 2018-2019, inhalable cannabis solutions for vaporizers are the most common medical cannabis product in the US, representing over 50% of the market.
Furthermore, inhalation of medical cannabis through a vaporizer is often regarded as a healthier form of consumption when compared to smoking, due to the reduced damage caused to the mouth, throat and lungs.
The approval allows Neuraxpharm to import Panaxia's products, distribute them to pharmacies, and market them to physicians authorized to issue prescriptions for medical cannabis products to patients for a wide range of medical conditions, such as chronic pain, spasticity, anorexia, depression and more.
In addition, as part of the strategic collaboration with Neuraxpharm, applications will later be submitted for the registration and marketing of other advanced products developed by Panaxia, including cannabis capsules.
Panaxia is the only company in Israel with an EU-GMP approval from the European Health Authority, which allows the export of all types of medical cannabis products to most European countries.They have so far used their special approval status to set up export agreements in Germany, France, Cyprus and Australia - leading the company to grow larger in a time when many other companies have struggled.
The company says that at the moment, the Israeli Health Ministry still does not allow cannabis products to be exported from Israel for inhalation. Therefore, as long as this position does not change in the coming months, the company will have to manufacture the products outside of Israel and export them to Germany from another country.
The company is currently exploring options for exporting the products through the controlling owner's plant in Malta, or alternatively from other countries, in order to prepare for the launch and first sales in Germany of these products during the second half of 2021, in parallel with applying for an export permit from the Health Ministry.
Dr. Dadi Segal, Founder and CEO of Panaxia, said in a statement that "We are excited to be the first and only company in Europe to receive a marketing permit for inhaled medical cannabis extracts."
"This is an unprecedented commercial and regulatory achievement, and a significant line for patients in Germany, who will, for the first time, be able to consume a clean product without harmful by-products and combustion products associated with smoking medical cannabis flowers, especially when combined with tobacco," he said.
"We look forward to making our quality inhalable extracts accessible to patients in other European countries as well and are working to register them in the appropriate regulatory pathways," Segal said.