MGC Pharmaceuticals | 22 October 2018
Company description: End-to-end cannabinoids from
greenhouse to pharmacy
MGC Pharmaceuticals (MGC, ASX:MXC) is an Australian Securities Exchange-listed company,
headquartered in Perth and with its principal operations in the Czech Republic, Slovenia and Malta.
Its main product lines are cannabis-based active pharmaceutical ingredients and cannabis-based
finished medicines, including CannEpil for the treatment of severe refractory epilepsy.
A number of the key personnel at MGC have extensive experience in producing and prescribing
medicinal cannabis products in Israel. MGC has drawn on this experience in the selection of the
formulation of its lead products, the cannabis extracts CannEpil and CogniCann. CannEpil’s
formulation is supported by the results of a retrospective study of 74 patients with refractory
epilepsy, which reported that 51% of children with refractory epilepsy experienced at least a 50%
reduction in seizures when they were treated with a cannabis oil containing the same 20:1
CBD/THC ratio as CannEpil.
MGC listed on the ASX in February 2016 via a reverse takeover of the mining exploration company
Erin Resources. At the time of listing, its business strategy was to develop and supply high-quality,
non-psychoactive cannabidiol (CBD) to the growing European and international cosmetics and
medical market; the CBD resin was to be manufactured from hemp crops (low THC cannabis sativa
strains) grown outdoors in Slovenia. However, in order to access wider market opportunities, it has
revised the business strategy to include growing cannabis that contains high levels of the
psychoactive compound tetrahydrocannabinol (THC) in secure greenhouse facilities in the Czech
Republic and Malta, establishing a GMP-certified cannabis resin extraction and separation facility
for API production, and developing finished cannabis-based medicines. As part of this revised
strategy it intends to seek approval for its cannabis-based CannEpil formulation for the treatment of
refractory epilepsy, initially for children and young adults in Europe and Australia, with the option to
pursue US approval later. It also intends to seek approval for CogniCann in dementia patients.
The strategy of producing cannabis-based medicines from seed to finished registered medical
products, as well as being a supplier of cannabis-based APIs, differentiates MGC from the majority
of companies operating in the medical cannabis market. One key differentiator is that few
companies are seeking to achieve regulatory approval for their cannabis-based medicines as
registered pharmaceutical drugs.
In addition to its strategy of seeking registration of CannEpil and CogniCann as pharmaceutical
products, the company plans to generate near-term revenues from the sale of CannEpil and other
medical cannabis products in markets where regulations allow their sale without obtaining
registration. As part of this strategy, it has entered into a supply and distribution agreement with
Lenis covering 12 European countries, and has signed a definitive exclusive supply agreement for
the distribution of CannEpil under an import licence in Australia. MGC recently obtained
authorisation from the TGA for CannEpil to be available for prescription in Australia as an
Investigational Medicinal Product through specialist prescribers under the Authorised Prescriber
Scheme. It expects sales in Australia to commence by December.
Brief introduction to medicinal cannabis
Cannabis, also known as marijuana, is usually recognised by two main types, cannabis sativa,
which originated in the western hemisphere and cannabis indica, which originated in central and
south Asia.
Tzadok et al. Seizure 35 (2016) 41–44