I hope this answers some of your questions. @PeterKing
Manufacturing
At present, all the Group’s phytocannabinoid-derived investigational medicines are produced at the Group’s Slovenia manufacturing facility, which is one of only a few in Europe with a Certificate of GMP Class D non-sterile (demonstrating compliance with the principles and guidelines of GMP laid down in Directive 2003/94/EC), as well as an EU manufacturing licence to produce GMP certified phytocannabinoid medicinal formulations. These allow the Group to formulate and compound API provided by its third-party partner and pack the Group’s phytocannabinoid-derived medicines for delivery to pharmacies and patients utilising the Group’s appointed distributors. Other companies in Europe with the capacity to manufacture API to GMP are Bionorica (THC+CBD synthetic, THC), Echo Pharmaceuticals (THC, CBD), BSPG (CBD), CBDepot (CBD), Noramco (THC Synthetic), and non-EU companies: Linea (CBD), NYSK (THC).
Currently, the Group purchases THC and CBD API from GMP certified manufacturers in Europe, which is then compounded into final dosage form products and bottled in the Slovenian facility. The Slovenian facility currently has 13 full-time staff members focused on production.
The Group was the first phytocannabinoid-derived medicines developer and producer to obtain a letter of intent from the Government of Malta, allowing the Group to commence the planning and development of a high-level high output pharmaceutical manufacturing facility to create a hub for the Group’s global distribution from Malta. The facility is also designed to allow for the possibility (and licensing) of the cultivation and processing of medicinal cannabis for use in the Group’s pharmaceutical pipeline, with a minimum commitment of the Group to invest circa £5.4 million (AUD$9.7million) in improvements to the site, plant, machinery, and equipment.
The Group has entered into a long-term emphyteutic deed with Malta Industrial Parks for 6,000m2 of land, on which site planning has been completed and construction has been authorized of the new facility. The Group planned to construct a single multi-story 15,720m2 facility, including a 10,480m2 combined use area, designed to include GMP-certified processing and production capabilities, with a 5,240m2 greenhouse on the roof for cannabis cultivation. This facility in Malta was expected to be operational in mid-2024, subject to the premises and operations being licensed by the Medicines Authority of Malta under the Production of Cannabis for Medicinal and Research Purposes Act 2018.
However, on 10 September 2020, the Group received the second letter of intent from Malta Enterprise, addressed to MGC UK, confirming that it has approved the allocation of industrial space for the setting up and operation of a facility in Malta for the provision of standard laboratory services to the medical industry in Malta, including process validation, GMP product release, contract research, quality assurance, and in-vitro research and the setting up and operation of a production line for the manufacture of ArtemiC™.
As a result, the Company has decided to delay the building of the larger single multi-story 15,720m2 facility, and instead build an alternate manufacturing facility for ArtemiC™, which will also undertake clinical research and analytics, and serve as an alternative manufacturing facility (with a faster lead time) for the Group’s phytocannabinoid-derived products. Construction of this smaller, 480m2 facility, commenced in Q4 2020 and it is anticipated that it will be completed in 2021. Following its completion, the Company will focus its resources on the construction of the larger 15,720m2 facility, which is expected to be operational in mid-2024.
The Group’s combined facilities in Malta will be significantly larger than its existing facility in Slovenia and, once complete, will be the primary hub for the Group’s manufacturing operations. The Slovenia facility will be primarily used for research and manufacturing products for use in clinical trials. At the Malta facilities, the Group expects to employ 27 full-time staff, scaling up the ability to meet the peak demand expected by the Group.
Once construction is complete and licensing and GMP certification is obtained, the 15,720m2 Maltese facility is expected to be a sizeable GMP phytocannabinoid-focused manufacturing facility, with production capacity able to satisfy any foreseeable demand. The Group will be able to utilize existing standard operating procedures and protocols developed and established in Slovenia, in this new facility in Malta. Once complete and fully operational and licensed, the 15,720m2 facility in Malta, with GMP-certified processing and production will signal the achievement of a key milestone in the Group’s goal of being an international supplier of phytocannabinoid-derived medicines.
