MGC Pharmaceuticals (ASX:MXC) the biopharma company that manufacturers cannabinoid-based products for sale throughout Europe and Australia, has received the first import of its Investigational Medicinal Product (IMP), CannEpilTM.
The product has been approved by the Therapeutic Goods Agency (TGA) as an Investigational Medicinal Product (IMP) under the Authorised Prescriber Scheme in Australia and can be prescribed to patients with drug-resistant epilepsy.
An IMP is a pharmaceutical product that is still being tested or used as a reference in a clinical trial.
The product has been independently tested and certified as complying with product quality guidelines and strict European Good Manufacturing Practice standards. It will be available throughout Australia via a network of doctors registered as authorised prescribers.
CannEpil will be distributed nationwide by specialist Australian pharmaceutical distributer HL Pharma, under an agreement signed between the two companies in 2017.
Roby Zomer, CEO of MGC Pharmaceuticals said the arrival of the product in Australia was a key milestone for the company.
“The arrival of CannEpil in Australia is a great achievement for us on our pathway to growing and commercialising MXC as a European-based biopharma company,” Mr Zomer said.
“The team has been working extremely hard to get to this stage and we are all very excited that CannEpil is now available for supply to patients in Australia.”
This authorisation of the product as an IMP followed the endorsement from the Human Ethics Committee at St Vincent’s Hospital Melbourne for the use of CannEpil in the treatment of adult patients with drug-resistant epilepsy. This form of epilepsy accounts for 30 percent of all epilepsy cases.
There are more than a quarter of a million patients in Australia suffering from epilepsy. Carol Ireland, Chief Executive Officer of Epilepsy Action Australia, said: “This is a significant milestone for epilepsy patients and other patient communities. 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.”
Revenue for the product is expected to come from an initial customer base of approximately 100 patients that have registered interest through a number of Australian-based specialist doctors and neurologists that operate under the Ethics Committee approval.
Zomer said that “this is a significant achievement, and we are very excited at the prospect of ramping up production to a commercial scale and bringing CannEpil to Australia.”
“This important step validates MGC’s seed-to-pharma strategy, with the start of commercial revenues from our first Investigational Medicinal Product offering.”
The CannEpil product is manufactured at MGC’s GMP-certified manufacturing facility in Slovenia. It will also begin the construction of its medical cannabis cultivation and production facility in Malta this year.
Once established, MGC will cultivate all its strains of medical cannabis at the new facility, allowing the business to ramp up its strategy in Europe.
The Company continues to focus on research, development and production of further medicinal cannabis-based products to bring them to market in Australia and internationally.
This content is produced by Star Investing in commercial partnership with MGC Pharmaceuticals. This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
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