Cannabis-based epilepsy drug coming in 2018

MGC Pharmaceuticals has executed a binding definitive exclusive supply agreement with specialist pharmaceutical wholesaler and distributor HL Pharma to bring its adult epilepsy product, CannEpil, to the Australian market in 2018.

Signed on 20 November, the definitive agreement provides a clear pathway for the delivery of the first MGC medical cannabis products to Australian epilepsy patients, once HL Pharma has obtained all necessary approvals for the importation of the product. HL Pharma has over 20 years of experience as a supplier of unregistered pharmaceuticals (pharmaceuticals that are not registered with the TGA, but are registered with other recognised pharmaceutical regulators) products in Australia.

CannEpil is suitable for the relief of drug-resistant epilepsy (DRE), also known as refractory epilepsy, which accounts for around 30% of all epilepsy cases (approximately 70,000 persons in Australia). It will be sold as a 50 mL bottle containing 100 mg/mL of CBD and cannabinoids, which is administered orally, and made available to patients with an authorised doctor’s prescription.

MGC has been working closely with Epilepsy Action Australia (EAA) and its scientific board of advisors to build its Australian patient market through the registration of authorised prescribing doctors. An initial group of at least five doctors have already formally registered interest in prescribing the product — which will provide access to a starting pool of more than 50 patients — and are currently in the process of applying for their authorised prescriber status.

Under the agreement, both parties will form a collaborative relationship to import and distribute CannEpil. HL Pharma plans to wholesale distribute the product to hospitals and pharmacies across Australia. HL Pharma will also be responsible for ensuring TGA and Office of Drug Control approval to import and supply the product in Australia; obtaining an import permit for each import shipment; and marketing the product, with the support of MGC for larger wholesale orders.

MGC is currently manufacturing the first batch of CannEpil and expects to be able to commence shipping to Australia within four months, making it available for patients from early 2018.

“Across Australia, patients are struggling to access this vital medicinal cannabis medicine,” said HL Pharma CEO Matt Hayward. “Sometimes it is prohibitively expensive for families. That’s why we are so delighted to be working with MGC Pharmaceuticals to bring this much-needed medicinal cannabis product to Australian epilepsy patients.”

“I welcome news of this agreement,” added EAA CEO Carol Ireland. “So much more is needed in terms of patients having access to authorised prescribers and a range of quality, legal, medicinal cannabis products, and this is a great step forward. There is significant potential for cannabinoid therapies as a treatment option for people with epilepsy and many other conditions.”

“This agreement is pivotal for MGC Pharmaceuticals,” concluded Roby Zomer, co-founder and CEO of MGC Pharmaceuticals. “It sets in place the timeline for bringing our first medical cannabis products to Australian patients, in the form of our affordable epilepsy product, CannEpil, and sees us commencing sales in the Australian market. HL Pharma has a strong profile in the specialty pharma space and we are excited to be working towards the delivery of our first order in the coming months.”