MGC Pharma’s cannabis-based epilepsy treatment approved for Australian patient sales

Special Report: Australians suffering from drug-resistant epilepsy will soon have a new treatment option.

Medical cannabis biopharma company MGC Pharma announced today a number of prescribing specialist neurologists have received formal authorisation to prescribe its product CannEpil in Australia under the Authorised Prescriber Scheme.

CannEpil is an orally-administered medical cannabis treatment for drug-resistant (or refractory) epilepsy, which accounts for about 30 per cent of all epilepsy cases.

The product has undergone years of rigorous testing and now, MGC (ASX:MXC) has the all-important tick of approval from the Therapeutic Goods Administration (TGA) which will make the product available in Australia through specialist prescribers.

The authorisation by the TGA of these specialist neurologists follows approval from the Human Research Ethics Committee from St Vincent’s Hospital Melbourne for the use of CannEpil in adult patients.

It’s expected to be available to patients prescribed by these specialist neurologists by December and will be distributed via HL Pharma, a specialist Australian pharmaceutical distributor.

A significant milestone, in more ways than one

The approval is welcome news for both patients and shareholders.

MGC expects to generate in excess of $1 million in annualised revenue from the estimated starting base of under 100 patients but health experts see an even bigger opportunity.

One of MGC’s medical advisory board members, Associate Professor Wendyl D’Souza, is an Authorised Prescriber of medicinal cannabis  in Australia and has treated over 3,000 patients with drug-resistant epilepsy with currently available treatments.

Dr D’Souza is a leading neurologist and epileptologist and is driving further development of CannEpil and the next generation of medical cannabis medicines for MGC Pharma.

Up to 25,000 Australians are diagnosed with epilepsy each year and some 240,000 are living with epilepsy, according to Epilepsy Action Australia (EAA).

EEA chief Carol Ireland is a member of the federal government’s medicinal cannabis advisory council and said the approval marked an important milestone for epilepsy patients.

“It is another important step in improving access to potentially life changing medications, and part of a global trend to recognize the valid medical benefits of cannabis.

“As advocates of patient rights, we are pleased to see progress, and a sign that patient needs and wants are heard and respected.”

MGC’s co-founder and managing director Roby Zomer said it was equally important to the business and its seed-to-pharma strategy.

“This is a significant achievement for us and we are very excited at the prospect of ramping up production to a commercial scale and bringing CannEpil to Australia,” he said.

MGC says it will now also commence with commercial-scale production of CannEpil from its GMP-certified facility in Slovenia.

The company secured a formal manufacturing licence for the facility earlier this year which also enables it to produce additional medicinal cannabis-based pharmaceutical products for use in the clinical studies, research pipelines and product development.

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