MGC Pharmaceuticals | 22 October 2018
Separately, the company has entered into a five-year supply and distribution agreement with the
European pharmaceutical distribution company Lenis in eight countries in central and eastern
Europe; in addition, Lenis and MGC will jointly market the products into Germany, Croatia, Greece
and Italy. Lenis will distribute MGC’s medicinal products, which include cannabis flower products
and its CannEpil epilepsy medicine. The flower products will be available in pharmacies in select
countries for use in a variety of medical conditions such as nausea, vomiting, pain, Tourette’s
syndrome, multiple sclerosis, severe uncontrollable epilepsy and inflammatory bowel diseases. In
addition, the agreement covers the future supply of MGC’s finished pharmaceutical products once
they have been registered in the EU for sale.
Furthermore, in November 2017 MGC signed a definitive exclusive supply agreement with HL
Pharma, a specialist Australian pharmaceutical distributor, to bring CannEpil to the Australian
market for treating epilepsy patients. The company plans to sell CannEpil in Australia as a 50ml
bottle containing 100mg/ml of CBD, 5mg/ml of THC (ie a total of 5,000mg CBD and 250mg THC)
plus small amounts of other cannabidiols. A 50ml bottle will retail for less than A$800, which is
significantly lower on a price per mg basis than the most similar current competing product in the
market, which is supplied by the privately owned Canadian company, Tilray.
In Australia, certain cannabis-based Investigational Medicinal Products can be dispensed by
pharmacies for treatments prescribed by doctors who are registered under the Authorised
Prescriber Scheme (APS). The TGA has approved an initial group of doctors as authorised
prescribers of CannEpil, who will provide access to a pool of more than 100 patients. The formal
TGA authorisation follows endorsement from the St Vincent’s Hospital Melbourne Human Research
Ethics Committee for the use of CannEpil in the treatment of adults with drug-resistant epilepsy.
The company has already established links with the patient support group, Epilepsy Action Australia
(EAA). The EAA estimates that up to 240,000 people are currently living with epilepsy in Australia.
However, we base our forecasts on an estimate of 154,000 Australians with active epilepsy, based
on the estimated global prevalence of active epilepsy of 6.4 cases per 1,000 people (see pages 8-9
MGC anticipates the initial base of 100 patients generating revenues of A$1m; we conservatively
model a more modest uptake, with sales of CannEpil as an investigational product in Australia
assumed to reach A$1.0m in FY21. We will look to revise our forecasts as MGC establishes a track
record of sales in Australia.
Phase II clinical trial in treatment-resistant epilepsy awaiting
final regulatory approval
MGC has announced that it intends to undertake a Phase II safety and efficacy study of six weeks
of treatment with the company’s CannEpil medicinal cannabis formulation in children and
adolescents with treatment-resistant epilepsy at the University Children’s Hospital Ljubljana,
Slovenia. CannEpil is a whole plant extract-based medicinal cannabis formulation with a high (20:1)
CBD/THC ratio. Over 65 volunteers have been identified to participate in the study, which aims to
recruit over 100 subjects. The Phase IIa crossover study will compare the response to six weeks of
treatment with CannEpil to treatment of the same individuals with a pure synthetic CBD that has
already been studied at the hospital. The primary endpoint of the study will be a reduction in the
frequency of seizures. The company has received ethics approval for the study, but it is awaiting
final sign-off from the regulators in Slovenia before the trial can commence.
A positive outcome to the study would potentially lead to a Phase III pivotal study to support an
application to register the product in the EU and Australia.