CANNABIS extraction and formulations specialist 113 Botanicals is in the process of securing Good manufacturing Practice (GMP) compliance for its newly-acquired 7,500sq ft production facility in Sussex, UK.
This facility will be be used to manufacture its patented, capsule-technology, cannabis products for sale into the UK, European and then global markets.
The company anticipates GMP compliance to be in place by the end of the year, and, after in-depth discussions with the UK Medicines and Healthcare Products Regulatory Agency (MHRA), is confident of securing its first commercial sales in Q3 2023.
This planned commercial debut will come four years after the company’s launch – a period during which it has developed and patented a range of sustained-release, controlled-dosage cannabis capsules in partnership with the School of Life Sciences, at the University of Sussex.
Sustained Release; Controlled Dose
Co Founder and COO Kate Cook, told BusinessCann: “Following MHRA approval our aim is to enter the cannabis Specials market in Q3 2023.
“This will include the UK, Europe – in particular Germany, with it being an already very-well established Specials market – and additionally Australia and Israel. Further international expansion is planned from Q1 2024.”
113 Botanicals is led by Chief Technical Officer Mazin Nicola, who is based at the University of Sussex.
It is here on the south coast of England that it has developed an oral cannabis capsule formulation which it believes surpasses in effectiveness more commonly used cannabis delivery mechanisms, namely; smoking and vaping flower, or other sub-lingual formulations.
Ms Cook explained: “Our sustained-release, controlled-dose capsules are designed to bypasses the stomach and to release directly into the pulmonary system via the hilum.
“They represent a uniquely effective new route of administration for cannabis derived medicines offering continuous supply of medicine over an eight-hour time period, eliminating the need for multi-dosing.”
To date 113 has invested over £1m – including £0.76m which has been successfully SEIS/EIS approved, and it is now looking to raise a further £5m to take it through to commercial production and revenue generation.
Clever Leaves And Bedrocan
113 is looking beyond the initial debut in the Specials market with a focus on the pharmaceutical market. This will be supported with the launch of a pre-clinical trials programme in Q1 2024 in preparation for clinical trials in late 2024.
Ms Cook added: “We have already established, through discussions with the Innovation Centre, University of Sussex, that when appropriate for us to embark on Phase2 clinical trials programme, we can anticipate active support from various departments including: the Sussex Drug Discovery Centre, the School of Life Sciences, School of Medicine, Chemistry Department, Pharmaceutics Science Department and the Sussex Clinical Imaging Sciences Centre.
“With the current pharmaceutical market for CBPMs dominated by Sativex, Epidiolex and dronabinol, we would be offering our alternative product with its innovative route of administration, provided by our sustained-release, controlled-dosage capsules – a format that we feel medical practitioners would be more confident prescribing.”
113 Botanicals will produce six formulations featuring various CBD to THC ratios with these based on its own full-spectrum API, produced with its bespoke and patented extraction technology.
As well as Ms Cook and Mr Nicola the co-founders include pharmaceutical expert Tim Kneen, as Non-Executive Director, CFO Simon Price; a former Merrill Lynch investment banker and CEO Leslie Maguire.
Main image : University of Sussex Life Science Building