MGC Pharma's CannEpil® Now Accessible to UK Patients on Named Patient Request Basis

Rhea-AI Summary

MGC Pharmaceuticals Ltd. has announced that its investigational medicinal product, CannEpil®, is now available to patients in the UK through Named Patient Request. This decision follows the success of Epidiolex, which generated $296 million in sales in 2019, highlighting the potential market for CannEpil® in treating refractory epilepsy. CannEpil®, a high-CBD and low-THC formulation, is currently in clinical development and has already been prescribed to hundreds of patients in Australia and the Republic of Ireland. The company aims to evaluate the safety and efficacy of CannEpil® through data collected from ongoing patient use, supporting future marketing authorization submissions. This expansion into the UK market represents a significant step for MGC Pharma and offers new treatment options for patients with unmet medical needs.

Positive

• CannEpil® is now available in the UK, expanding market access.
• Potential for CannEpil® highlighted by the success of Epidiolex.
• CannEpil® has already been prescribed to hundreds of patients in Australia and the Republic of Ireland.
• Data collection from CannEpil® usage will inform future marketing authorization.

Negative

• None.

European pharmaceutical company offers its investigational medicinal product to a wide range of specialist medical practitioners in the United Kingdom

Epidiolex's Success Highlights Potential for MGC Pharma's CannEpil®

The recent success of Epidiolex, a CBD-based epilepsy treatment that generated $296 million in sales in 2019, highlights the potential for MGC Pharma's CannEpil® in the UK market. This underlines the potential of CannEpil®, an investigational medicinal product for patients suffering from refractory epilepsy, to make a significant impact in the UK market.

LONDON, April 11, 2023 /PRNewswire/ -- MGC Pharmaceuticals Ltd. (LSE: MXC), (ASX: MXC), (OTC: MGCLF), a European based pharmaceutical company specializing in the development and supply of affordable, ethically produced plant-inspired medicines, announces that its proprietary product CannEpil® is now available to patients in the UK by Named Patient Request.

MGC Pharma's CannEpil® is an investigational medicinal product (IMP) designed for patients suffering from refractory epilepsy, also known as drug-resistant epilepsy. The high-CBD, low-THC formulation is administered via an oral mucosal solution and is currently undergoing a clinical development program. The availability of CannEpil® in the UK follows the company's announcement that it is providing the product for an observational trial supported by the I am Billy Foundation.

With this development, clinicians in the UK listed on the General Medical Council (GMC) Specialist Register can now prescribe CannEpil®. This is a significant milestone for MGC Pharma and patients with unmet medical needs, as it expands the company's reach within the healthcare and life science sectors as an innovative plant-inspired pharmaceutical company.

CannEpil® has already been prescribed to hundreds of patients across Australia and the Republic of Ireland over the past three years. In 2019, it became the first product to be available with coverage in the Republic of Ireland under the Long Term Illness and General Medical Services schemes.

The data collected from patients using CannEpil® will be used to further evaluate the safety and efficacy of the drug, supporting future submissions for marketing authorization.

Epilepsy affects approximately 50 million people worldwide, with 33% of adults and 20-25% of children suffering from refractory epilepsy. CBD has been proven effective in reducing seizure frequency and severity, as supported by open-label studies, observational studies, randomized clinical trials (RCTs), and large-scale systematic reviews.

Roby Zomer, Managing Director and CEO of MGC Pharmaceuticals, commented: "The availability of CannEpil® by Named Patient Request marks a momentous breakthrough for MGC Pharma. The product will now be available to a wide cohort of specialist medical practitioners in the UK, which is testament to the progress we are making."

"We are extremely proud of the progress we have achieved thus far, and we are pleased that CannEpil® has been selected as a treatment within an observational patient trial in association with the I am Billy Foundation. We look forward to updating the market on the results of this trial in due course."

HTTP://MGCpharma.eu
Twitter: @MGC_Pharma
Facebook: @mgcpharmaceuticals

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SOURCE MGC Pharmaceuticals Ltd.

FAQ

What is CannEpil® and how is it used?

CannEpil® is an investigational medicinal product designed for patients with refractory epilepsy, administered as an oral mucosal solution.

When was CannEpil® made available in the UK?

CannEpil® became available in the UK on April 11, 2023, for patients via Named Patient Request.

What are the sales figures for Epidiolex?

Epidiolex generated $296 million in sales in 2019, indicating a strong market potential for similar products like CannEpil®.

How many patients have used CannEpil® in other regions?

CannEpil® has been prescribed to hundreds of patients across Australia and the Republic of Ireland over the past three years.

What is the purpose of the observational trial for CannEpil®?

The observational trial aims to evaluate the safety and efficacy of CannEpil® in real-world settings, supporting future marketing authorization.