MGC Accomplishes Major Regulatory Milestones For Pharma Business

MGC Pharmaceuticals Ltd (ASX:MXC) has announced several important milestones in Pharma Business for the European and Australian manufacturing and research operations in the last few weeks, that materially advances the Company towards commercialization and delivering on its seed-to-pharma business strategy. These results provide real outcomes and significant milestones from the excellent work of the Company’s management and its employees and executing the vision of building a leading European bio-pharma company for all MXC shareholders. MGC is an EU based Bio-Pharma company with several years of technical clinical and commercial experience in the medical cannabis industry.Â

In a significant achievement for its product development pipeline, the Company got a formal approval by the TGA for the TGO93 Declaration Form, informing that their CTN (Clinical Trial Notification) is processed and has availability in the Clinical Trials Repository. The approval enables MGC to commence its Phase IIB Clinical Trial on Dementia and Alzheimer patients with UNDA in WA, and start the recruitment of patients, using its second GMP certified IMP (investigative medicinal product) CogniCann.

The government approval for API Extraction at MXC’s European Facility which is one of the first EU facilities to be given a full API extraction permit, is issued by the Slovenian Ministry of Health.

The receipt of TGA approval signals the commencement of patient recruitment and the 16-week trial remains on track to commence in H1 2019. During the trial, CogniCann particularly formulated by MXC, will be tested on a total of 50 patients aged 65 and over, alongside a series of pre and post-treatment surveys and focus groups that will be used to assess the effects of the product.

The government approved the European Manufacturing Facility for Extraction of Phytocannabinoid API, in a significant operational milestone for the Company in the EU currently. MXC has received a permit from the Slovenian Ministry of Health granting it with permission to operate its Phyto cannabinoid extraction at its Manufacturing Facility in Ljubljana.

MXC also received the SME qualification from European Medicines Agency in a recent international achievement. SME certification issued by the European Medicines Agency (EMA) provides access to scientific advice, drug evaluation and registration of CannEpil, CogniCann and other Phytomedicines that the Company is developing. It also gives MXC the opportunity to obtain fee reductions up to 100% in the development and registration of priority medicines (PRIME).

Receipt of this qualification represents a milestone for the Company’s European operations and strengthens its GMP certified Phytomedicines product pipeline, demonstrating the Company’s ability to commercialize and deliver on its European based, seed-to-pharma strategy.

MXC’s Scientific Advisory Board is going to present at CannaPaed Symposium 2019 to be held on the 25th January 2019 in Ljubljana, Slovenia.

Post the regulatory achievement, the shares of MXC closed the day’s session at A$0.041, up by 2.5 % or 0.001 points as compared to the previous day close of A$0.040.

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