Key Highlights: MGC Pharma has executed a binding, 3-year US market Supply and Distribution Agreement with US based Company, AMC Holdings Inc (AMC), with minimum orders of US$24 million of MGC phytomedicine products including CannEpil®, CogniCann® and CimetrA™. This is MGC Pharma’s first USA supply agreement dedicated to taking MGC’s pharmaceutical phytocannabinoid products into the …
- MGC Pharma has executed a binding, 3-year US market Supply and Distribution Agreement with US based Company, AMC Holdings Inc (AMC), with minimum orders of US$24 million of MGC phytomedicine products including CannEpil®, CogniCann® and CimetrA™.
- This is MGC Pharma’s first USA supply agreement dedicated to taking MGC’s pharmaceutical phytocannabinoid products into the world’s largest healthcare market.
- US$3 million order for CannEpil®, CogniCann® and CimetrA™ for Year 1 to be placed 5 days from grant of a National Clinical Trial Number, with an additional US$21m of orders over years 2 and 3.
- For the Year 1 minimum order, AMC will pay MGC Pharma US$750,000 in advance prior to the receipt of the products, followed by an irrevocable US$2.25 million Letter of Credit.
- AMC has been founded by leading US Healthcare and ex-Federal Government legislative and regulatory executives, as a specialist vehicle for the import and distribution of specialist phytomedicines into key US markets
- AMC is seeking to expand the research and growth of phytomedicinesin the USA, and view MGC Pharma as the leader in the sector
- Clinical trials in the US for CannEpil®, CogniCann® and CimetrA® will be initiated by AMC and leading research institutes in the US, subject to Global Ethics Committee approval, as additional sites to the ongoing trials in Israel and Australia
- AMC will seek US regulatory approvals for all products which they intend to distribute, including import licenses, as well as undertaking clinical trials in the US, all the way through to US Food and Drug Administration (FDA) approval
- AMC and MGC will first seek approval to distribute and issue CannEpil® to patients via Florida’s Early Access Scheme
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 part of the Supply Agreement, AMC will be responsible for negotiating and coordinating the clinical trial process in the US, including the recruitment of patients on terms agreed by MGC Pharma. 2 – 5 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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