- MGC Pharma (MXC) signs its first dedicated agreement in the US for the supply of pharmaceutical products to AMC Holdings (AMC)
- MXC will supply its CannEpil, CogniCann and CimetrA products to AMC in orders worth a minimum of US$24 million over an initial three-year term
- The deal marks an important step in expediting clinical trials of CannEpil and CogniCann in US hospitals, subject to Global Ethics Committee approval
- Bio-pharmaceutical distributor AMC will oversee importing, warehousing and marketing of the products and will ultimately seek FDA sign-off
- Shares have spiked 38.5 per cent to 5.4 cents at 11:22 am AEST
MGC Pharma (MXC) has penned its first dedicated agreement in the US for the supply of pharmaceutical products to AMC Holdings (AMC).
Based in Europe, MXC is a bio-pharmaceutical developer and producer specialising in phytocannabinoid-derived medicines.
Under an initial three-year deal, the company will supply its products, including CannEpil, CogniCann and CimetrA, to bio-pharmaceutical distributor AMC — in orders worth a minimum of US$24 million (A$33.1 million).
To this end, AMC is required to place its first year’s order within five days of being granted a national clinical trial number (NCTN).
The minimum spend on this order must total US$750,000 (A$1.03 million) and be paid in advance, followed by an irrevocable US$2.25 million (A$3.11 million) letter of credit.
As part of the agreement, AMC will assume responsibility for co-ordinating the clinical trial process in the US, including the recruitment of patients, on terms agreed by MGC Pharma.
Further, AMC will undertake all marketing activities for the products in the jurisdiction and manage importing and warehousing.
In a statement this morning, MXC said the deal was an important step forward in expediting US clinical trials for CannEpil and CogniCann.
Accordingly, granting of the NCTN by the end of September will enable hospitals across the country to participate in ongoing trials, approved by the Global Ethics Committee.
MGC’s co-founder and managing director Roby Zomer said the agreement was an important milestone for the company and provided MGC access to the largest healthcare market in the world.
“This agreement provides MGC Pharma with a pipeline for strong revenue streams over the next three years, with the possibility of larger revenues to follow, and the opportunity to be at the forefront of phytomedicines in the US,” he said.
Looking ahead, US-based clinical sites will be added to the global clinical trial program for CimetrA to initiate the US registration process for the product.
Meanwhile, the supply partners will seek approval to distribute and issue CannEpil to patients via Florida’s Early Access Scheme.
Shares spiked 38.5 per cent to 5.4 cents at 11:22 am AEST.