George Frangeskides, Chairman at ALBA, explains why the Pilbara Lithium option ‘was too good to miss’. Watch the video here.
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PART 2
Pricing strategy
The price of Epidiolex is at present approximately US$32,500 (£26,000/AUD$47,000) per patient, per year. However,
this is to treat rare and potentially fatal conditions, such as Dravet syndrome and Lennox Gastaut syndrome.
Given CannEpil® will be treating patients who have no other options,
the Directors have assumed lower pricing of CannEpil® compared to Epidiolex, if marketed in the USA. Given this,
the Directors are targeting an estimated price for CannEpil® in the EU, following both CMA and TGA approval,
of £6,000 – £8,000 (AUD$10,800 – AUD$15,000) per patient, per year34.
https://mgcpharma.com.au/wp-content/uploads/2021/02/MGC-Pharmaceuticals-Prospectus.pdf
PART 1
CannEpil® is currently only being made available to patients in Australia, through the SAS, and in the United Kingdom, as an
unlicensed medicine or “special”, in accordance with the requirements of the MHRA17.
The Group has recently received ethics committee approval from Schneider Children’s Medical Centre of Israel to commence a Phase IIb clinical trial for the Company’s proprietary epilepsy treatment, CannEpil®, with recruitment expected to begin shortly.
Access to patient populations through early access schemes prior to regulatory authorisation represents a unique position
for the Group to observe how the medication might be received post-approval and to establish a market presence. This has
included establishing relationships with leading pharmaceutical distributors to ensure stable product distribution upon CMA in the EU, and approval by the TGA in Australia, being obtained.
The Group intends to continue to leverage this position to generate immediate revenues, establish viable distribution networks, and ensure it remains a leader on price, access and product improvements.
The Group compared a paediatric study of a formulation similar to CannEpil® in 46 drug-resistant epilepsy patients next to
the Epidiolex study conducted by GW Pharma in over 300 patients. In the former, 62% of patients experienced a reduction
of 50% or more in the number of seizures (clinical significance measure), while in the GW Pharma study only 47% of patients
experienced this. However, only 4% were seizure-free versus 9% in the GW Pharma study. This result was also achieved with
a lower average dose than the Epidiolex study27.
Market opportunity
In the United Kingdom, there are over 480,000 people with epilepsy and approximately 25% suffer from drug-resistant epilepsy28.
Since 2001, deaths from epilepsy have risen 70%, and people with the condition now die on average eight years earlier than the rest of the population29.
Globally, over 50 million people suffer from epilepsy, with 1.9 million across Europe and over 200,000 in Australia30, with the statistic of 25% suffering from drug-resistant epilepsy continuing globally. The estimated population at the launch of CMA is over 200,000 people with drug-resistant epilepsy31.
The Directors anticipate that CannEpil® will obtain CMA within the next 4 years.
At present, access to medicinal cannabis products in certain regions is highly restricted and the Group’s projected patient
numbers have assumed a scenario without regulatory hurdles.
The Directors’ believe that peak sales of CannEpil® could reach £1.43 billion (AUD$2.57b) (excluding off-label revenue, which
could be significant during this time) within the EU5, Australia, MENA and Thailand regions32 over the next 4 years, if
extended to paediatric and adult use.
Given there are no other therapy options, CannEpil® could theoretically access 100% of the available patient population. The Group would expect a potential