MGC Pharmaceuticals receives TGA approval to market its CannEpil medicinal cannabis product in Australia

Aspiring bio-pharmaceutical company MGC Pharmaceuticals (ASX: MXC) has received formal authorisation to supply its CannEpil product through specialist prescribers under the ‘Authorised Prescriber Scheme’ as regulated by the Therapeutic Goods Administration (TGA).

The TGA authorisation follows Human Research Ethics Committee endorsement from St Vincent’s Hospital Melbourne earlier this year for CannEpil to be used in the treatment of drug-resistant epilepsy in adults.

Carol Ireland, CEO of Epilepsy Action Australia hailed today’s news as a “significant milestone for epilepsy patients” that would help Australia “lead the way in a global shift” towards patients having greater access to life-changing medications.

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

Ms Ireland added that “as advocates of patient rights, we are pleased to see progress and a sign that patient needs and wants are heard and respected. We believe that Australia has a chance to lead the way in this global shift and we are proud that the epilepsy community and ‘Epilepsy Action’ have played a significant part in bringing this about.”

MGC has said that it is working with several Australian-based specialist doctors and neurologists, who will operate under the Ethics Committee approval and have applied to the TGA for specific approval to prescribe CannEpil to their patients who suffer from drug-resistant epilepsy.

Being approved under the authorised prescriber scheme means that MGC’s CannEpil will potentially be offered to scores of patients across Australia in the coming months.

Onwards and upwards

MGC said that this development represents a major milestone that directly helps the company’s progress towards becoming a world-leading bio-pharma company, with more than 10 years’ clinical experience and a leading Scientific Advisory Board already in place.

The news also means that MGC has the green light to commence commercial-scale production of CannEpil at MGC’s GMP-certified facility in Slovenia and would also mean the “start of revenue generation” as part of the company’s intended “core pharma activity”.

MGC has been gradually assembling its path to growing medicinal cannabis and manufacturing high-value API products that it intends to distribute globally.

The biopharma company received its GMP certification and formal manufacturing licence to produce Good Manufacturing Practice (GMP) grade medical cannabis medicines containing tetrahydrocannabinol (THC) and cannabidiol (CBD) APIs at its European production and compounding facility, earlier this year.

As an immediate follow-up and to ensure it has an ample supply of raw material, MGC has also boosted its operational future by securing access to a modern state-of-the-art production facility in Malta, in April 2018.

Moving closer to sales revenues

MGC has confirmed that the first batch of CannEpil products is expected to be available for sale in Australia by December 2018, at which point the company will hand over to its specialist Australian pharmaceutical distributor, HL Pharma – the company responsible for distributing CannEpil across Australia under a previously-arranged agreement between the two companies.

“We are delighted to announce the availability of our first product CannEpil for supply under the Authorised Prescriber Scheme. 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,” said Mr Roby Zomer, co-founder and managing director of MGC Pharmaceuticals.

Mr Zomer added that “this important step validates MXC’s seed-to-pharma strategy with the start of commercial revenues from our first Investigational Medicinal Product offering.”

This morning’s news helped MGC shares to add almost 20%, trading at $0.061 per share.