A European pharmaceutical company – which focuses on drugs for the central nervous system (CNS) – has been selected to supply cannabis medicines for France’s landmark pilot study.
Neuraxpharm France announced this week it has been selected as one of winners for the participation in the programme, which has been issued by The French National Agency for the Safety of Medicines and Health Products (ANSM) and is due to start in March 2021.
The company emerged as one of the first European pharmaceutical companies to include medical cannabis products in its portfolio, with a business collaboration starting last year in Germany, the largest cannabis market outside the USA.
As part of its strategic collaboration with Panaxia Labs – Israel’s largest medical cannabis manufacturer – to enter the French market, the companies submitted a joint application for the pilot study.
The programme is based upon strict and demanding compliance specifications, with good cultivation and manufacturing practices, the quality of the drugs and the safety of the distribution channel.
France is the fifth largest pharmaceutical and CNS market in the world and is known to have the strictest regulation in the western world with regard to medical cannabis use.
With a population of about 67 million, recent estimates expect about 700,000 patients in France may be eligible for a medical cannabis prescription.
The prestigious medical cannabis pilot programme will last two years and intends to provide free products to 3,000 patients who meet the criteria.
Selected doctors, nurses and pharmacists participating in this program will undergo special training in registering and issuing medical cannabis prescriptions to patients.
At the end of the study, a decision will be made by the French Authorities regarding a license for the use and sale of medical cannabis products in France.
Along with Neuraxpharm and Panaxia, three of the world’s leading medical cannabis companies were selected as main suppliers for this pilot program, emphasizing Neuraxpharm’s status as a leading player in the European medical cannabis market.
As part of the programme, four finished products were selected that have successfully met the stringent ANSM requirements in relation to finished products.
They include the oral formulations in both the THC and CBD dominant forms together with the balanced THC / CBD formulations.
The list of indications compiled by the ANSM includes diseases such as cancer, certain types of epilepsy, multiple sclerosis, palliative care and pain, where conventional treatments don’t work.
“We are excited to have been awarded and selected to participate in this pilot program for the medical cannabis use in France, a significant market in the fast-growing international medical cannabis sector,” said Dr Jörg-Thomas Dierks, CEO of Neuraxpharm.
“As one of the first pharmaceutical companies to distribute medical cannabis products in Europe, we are ideally positioned, in partnership with Panaxia, to responsibly introduce medical cannabis products to new markets, in line with our corporate mission to offer ground-breaking therapeutic CNS solutions to patients with unmet medical needs.
“We are confident that France will lead the way for other countries to embrace the use of medical cannabis in the coming years.”
Dr Dadi Segal, CEO of Panaxia Israel, added: “Our collaboration with Neuraxpharm positions us as a leading player in the medical cannabis market in France, which is poised to experience accelerated growth. Our extensive combined experience in manufacturing and commercializing processed and advanced cannabis products will provide the program’s patients with state-of-the-art, high-quality medical cannabis products to meet the growing demand for conditions that don’t respond to conventional treatment.”