MGC Pharmaceuticals Ltd (ASX:MXC) (OTCMKTS:MGCLF) has signed a binding term sheet with one of Israel’s leading cannabis brands for the exclusive wholesale import, sales and distribution of CannEpil® in Israel.
Phase IIb clinical trial upcoming
It will also see CannEpil® imported for a phase IIb clinical trial, which is due to begin next quarter following Israel Ministry of Health final approvals.
MGC Pharma's co-founder and managing director Roby Somer said: “We are very pleased to have our first Israeli commercial distribution agreement for CannEpil® in place with one of the leading companies of medical cannabis in Israel.
"There is a strong need for epilepsy medication in Israel and the agreement with IMC has the potential to be transformational for MGC following successful clinical trials.”
Access to distribution network
Through IMC’s exclusive commercial agreement with Focus Medical Herbs Ltd it has access to the existing distribution network in place with Super Pharm, Israel’s largest pharmacy chain, in addition to other pharmacies in Israel.
MGC Pharma is in discussions with the Israeli Ministry of Health for clinical trial approval and for an early access scheme approval to sell CannEpil® through registered doctors in Israel.
This would replicate what is already in place in Australia, the United Kingdom, Ireland and Brazil for this product.
There are now more than 82,000 people in Israel suffering from epilepsy and approximately 30% are unbalanced pharmacologically and experience seizures with different frequency and intensity, making it difficult for their daily functioning and routine.
Term sheet details
The term sheet will see IMC appointed as exclusive wholesale importer of CannEpil® in Israel for five years with exclusivity subject to IMC’s compliance with the minimum annual level of sales agreed to by both parties.
IMC will be responsible for the registration of CannEpil® in Israel and the procurement of all permits and licences required for importation and commercialisation of the product in accordance with the general regulatory procedure and, if practicable, under any early access scheme.
It will also be responsible for the promotional activity and distribution of CannEpil®.
Under the term sheet each purchase order is to be a minimum €50,000.
The potential financial impact of sales and revenues generated under the agreement will only be determined in the future following the company receiving purchase orders from IMC.
MGC Pharma will continue to own all the intellectual property rights associated with CannEpil® and be responsible for the products continued development.
The distribution agreement with IMC follows the recent announcement regarding the Ethics Committee approval for the Phase IIb clinical trial of CannEpil® in Israel.
“New era of cannabis-based products”
IMC CEO Oren Shuster said: “We are embarking on a new era of cannabis-based products around the world.
“The next generation of medical cannabis products will be driven by evidence-based research and IMC plans to remain at the cutting edge of cannabis medicine which aligns with its vision for leadership in the global medical cannabis industry.
“As investment in research, development and commercialisation of treatments like CannEpil® advances over time, IMC will seek to enter into similar agreements for the distribution of innovative products in all the markets in which it operates.”
Shuster added: “We have great respect for MGC’s commitment to innovation and its ability to develop novel medical cannabis products.
“Combining MGC’s intellectual property with our local knowledge of the Israeli market is a formula for success and we look forward to working with them for the betterment of medical cannabis patients in Israel and across the world.”