pharmaceutical daily

MGC Pharmaceuticals in its first USA supply agreement for its phytocannabinoid products

MGC Pharmaceuticals, a specialist in phytocannabinoid-derived medicines, has signed a binding US Market Supply and Distribution Agreement with US-based AMC Holdings, with minimum orders of $24 million for MGC products including CannEpil®, CogniCann® and CimetrA over the initial 3 year period.

This is the first dedicated supply agreement executed by MGC Pharma for the supply of MGC Pharma pharmaceutical products into the USA, the largest healthcare market in the world. The Agreement with AMC is also an important step in expediting the clinical trials process for both CannEpil® and CogniCann®, as well as providing access to these medicines to more patients.

As the licensed distributor of MGC Pharma products in the USA, AMC will undertake all marketing activities in the US, as well as managing the import and warehousing of the products. To assist with product development activities, AMC will also collect data from the end users of the products for analysis by MGC Pharma.

The US Supply Agreement includes a minimum US$3 million of sales in Year 1, subject to AMC receiving a National Clinical Trial Number (NCTN) for a MGC Pharma product by the end of September 2021. Obtaining the NCTN will enable hospitals in the USA to participate in the ongoing clinical trials for CannEpil® or CogniCann® under approval of the Global Ethics Committee. With AMC are already well advanced in this registration process.

US based clinical sites will be added to the global clinical trial program for CimetrA® in order to initiate the registration process for CimetrA® in the US. AMC and MGC will first seek approval to distribute and issue CannEpil® to patients via Florida’s Early Access Scheme.

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