MGC Pharmaceuticals Ltd (‘MGC Pharma’ or ‘the Company’), a European-based bio-pharma company specializing in the production and development of phytocannabinoid-derived medicines, is pleased to announce that CannEpil+, a biosimilar effect-identical product of CannEpilTM, which is a phytocannabinoid treatment for refractory (or drug-resistant) epilepsy, has been approved for U.K. import by the Medicine and Healthcare products Regulatory Agency (MHRA), which was facilitated by its U.K. distribution and clinical access partner, Elite Pharmaco. As part of this process, CannEpil+ has been approved for prescription for patients in the U.K.
CannEpil+ will initially be used to treat 10 patients in the U.K. who suffer from refractory epilepsy. MGC Pharma will be providing CannEpil+ free of charge to these patients on compassionate grounds for six months. This is the first time that the U.K. authorities have approved an epilepsy treatment that is on a clinical pathway (Phase IIB) containing THC. The approval to import CannEpil+ into the U.K. is in response to the urgent need of some patients to have access to a clinical product that has demonstrated its efficacy at treating refractory epilepsy, as well as its safety.
Once the patients have commenced their treatment, CannEpil+ will undergo an observational trial with data being entered into a data collection app designed to establish a central platform to monitor the safety of treatment in patients globally.
MGC Pharma expects that the results from the observational data collection program, together with the fact that CannEpilTM has historical clinical safety and efficacy data, and a Phase IIb Clinical Trial that is currently under negotiation with a U.K. NHS facility, will provide specialist neurologists and general practitioners with the confidence to prescribe CannEpilTM and CannEpil+ to patients in urgent need of treatment.
MHRA Approval and Prescription Approval
Now officially approved for import into the U.K., a doctor can issue a prescription for CannEpil+ for both adults and children. There are currently 10 patients who will have access to CannEpil+ on compassionate grounds, who will be the first to be prescribed the treatment.
CannEpil+ is a biosimilar effect-identical product of CannEpil™, manufactured under strict EU-GMP conditions, and can be provided to patients in countries which allow cannabis-based medical products. This distinction allows MGC to offer CannEpil+ at more affordable price to patients globally, as the Company moves through the Clinical Trial pipeline with CannEpil™.
CannEpil™ is MGC's IMP (Investigational Medical Product) formulation, currently undergoing Phase IIb trials and pipelined for Central Market Authorisation in the next 2 years. This product can only be manufactured in specific facilities, for the purpose of either clinical trials or early access schemes.
Data Collection App
MGC and Alta Flora have together created a bespoke version of the Eva app, a healthcare data platform, which enables researchers and the medical establishment to determine how plant-based therapies improve patient quality of life. The system captures patient-reported outcome measures that can be used by regulators, manufacturers and clinicians to assess the safety and efficacy of new medicines.
The functionality of the app will enable the adjustment of measurement protocols to meet clinical standards, and to incorporate other conditions and future observational trials for their treatment.
Refractory or drug-resistant epilepsy affects approximately 33% of adults and 20-25% of children suffering from epilepsy. In the U.K., there is a national prevalence of treated epilepsy of 1 in 100 people, and around 87 people are diagnosed with epilepsy in the U.K. every day.
Further Phase IIb randomized, double blind, placebo-controlled clinical studies are to begin in Q3 and Q4 2021. This will take place at the Schneider Hospital in Israel and within the NHS in the U.K. It will focus on the safety and efficacy of CannEpil+ as a supplementary treatment in children and adolescents with refractory epilepsy.
Roby Zomer, co-founder and managing director of MGC Pharma, commented: “The approval for the import of CannEpil+ to the U.K. and the associated compassionate prescriptions is an important step towards our global roll out of the treatment, and our continued commitment to patients. Achieving MHRA approval has been an ongoing process for some time with our U.K. partner Elite Pharmaco, and we expect the first patients in the U.K. to begin treat with CannEpil+ in the coming months.
“The development of our data collection app will optimise our understanding of both CannEpil™, CannEpil+ and other future treatments, and ultimately provide patients with a better treatment for refractory epilepsy, and therefore improving their quality of life. It is also a vitally important foundation for building strong relationships with U.K. medical regulators and health organisations which will benefit MGC Pharma going forward, as we look to roll out further clinical trials and products in the U.K.”
Robin Emerson, COO of Elite Growth Ltd, commented: “This is a huge step forward for cannabis-based medications in the U.K. As a father of a 5-year-old girl I have witnessed first-hand how Jorja’s life has been transformed by the use of a Cannabis based medication that contains THC. With this product approval patients that have tried everything else how have a product with some level of safety and efficacy for the treatment of epilepsy that can be prescribed by their physician. With the ongoing clinical trial portfolio that MGC Pharma have developed, including a near term U.K. NHS based trial, we are answering the call of clinicians in the U.K. who are asking for safety and efficacy data. The CannEpil+ program we are executing will go a long way to moving cannabis-based medications toward greater adoption and acceptance, opening up much needed access for patients in the U.K.”
Gavin Sathianathan, CEO of Alta Flora said: “MGC Pharma have stepped up to the challenge to provide access to life-changing medicine for ten trial patients, and Alta Flora is proud to support the effort to gather data in order to demonstrate that CannEpil+ has the potential to transform the quality of life of families struggling to deal with the consequences of childhood epilepsy syndromes”