A month into the new year and MGC Pharmaceuticals (ASX: MXC) has already kicked it off with a number of key achievements.
Even though MXC have every right to still be reflective of the momentous year that 2018 was for them it has commenced 2019 with a number of regulatory milestones and the completion of the sale of its Derma division.
Permit approvals, certifications and qualifications
The Company released an announcement on January 22, highlighting the business’ list of milestones that includes its government approval for an API (active pharmaceutical ingredient) extraction permit that will allow it to develop its own THC (tetrahydrocannabinol), CBD (cannabidiol) and other phytocannabinoids as API’s at its facility in Slovenia.
The permit will also allow it to manufacture its formulations for its proprietary medical cannabis products CannEpilTM and CogniCannTM.
CogniCann is expected to enter into a phase 2b clinical trial later this year in dementia and Alzheimer’s patients and CannEpil has been authorised for sale as an Investigational Medicinal Product (IMP) under the Authorised Prescriber Scheme in Australia. The first import of the product arrived in Australia late last year.
SME certification was also issued to the company by the European Medicines Agency (EMA) and MXC was the first Australian medical cannabis company to receive the certification.
The certification gives MXC access to the EMA’s guides and support in research and development initiatives. It will also allow the company to register its CannEpil and CogniCann products and be eligible for fee reductions during the evaluation and registration process.
Furthering the achievements in the regulatory approval space, the Therapeutic Goods Administration (TGA) provided formal approval of its application to initiate the planned phase 2b clinical trial on dementia and Alzheimer patients. The trial will be conducted with University of Notre Dame in Western Australia using MXC’s GMP certified IMP (investigational medicinal product), CogniCann.
Sale completion of derma division
On January 29, four weeks in to the new year, MXC completed the sale of its subsidiary cosmetics brand, MGC Derma, to Canadian cannabis investor CannaGlobal. MGC Derma sells European-made cosmetic and anti-inflammatory products using CBD extract.
MXC now holds a 10% stake of CannaGlobal, maintaining its exposure to the future growth and success of the Derma brand and allowing it to focus solely on becoming a true seed to pharma business.
Possessing a stake in CannaGlobal also means that MXC will also benefit from CannaGlobal’s other investments as they begin to bear fruit.
A lot still to come in 2019
Remaining on MXC’s to do list for 2019 is building a manufacturing and cultivation facility in Malta to complement its facility in Ljubljana, Slovenia.
All architectural plans have been complete and MXC is working towards securing a long-term lease agreement.
MXC is also focused on growing awareness in the Australian market of medical cannabis and its benefits through its partnership and initiatives with Epilepsy Action Australia and its international research hub, dubbed Cannahub.
Reflecting on its achievements of 2018, Executive Chairman Brett Mitchell declared, ‘We are now one of the leaders in Europe in our sector. The progress within our pharma business is evidence of the dedicated work behind the scenes from the entire MXC team and we expect 2019 to deliver significantly more growth and ongoing development’.
If the first month of 2019 and the last few months of 2018 are anything to go by, this year is shaping up to be an exciting year for MXC.
This content is produced by Star Investing in commercial partnership with MGC Pharmaceuticals. This content does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
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