Oxford Cannabinoid Technologies Holdings plc (OCTP), the holding company of Oxford Cannabinoid Technologies Ltd (“OCT”) (together, the “Group”), a company developing licensed prescription cannabinoid medicines for approval by regulatory agencies worldwide and targeting the U$ multi-billion pain market, is pleased to announce that on 21 September 2021 OCT signed an exclusive licensing agreement with Canopy Growth Corporation – a world-leading diversified cannabis and cannabinoid-based consumer product company and Tweed Inc, a wholly owned subsidiary of Canopy Growth.
The terms of the Agreement provide OCT with an exclusive worldwide licence to the entire cannabinoid derivative library, including 335 derivatives of cannabidiol (CBD), tetrahydrocannabinol (THC) and cannabigerol (CBG), intellectual property rights including 14 patent families and associated product research and development (“Canopy Library”).
In return, OCT will pay Canopy Growth an annual license fee plus additional payments based on developmental, regulatory and sales milestones and royalties on future sales.
Under the terms of the agreement OCT will use reasonable efforts to develop and commercialise: (i) at least one CBD derivative; (ii) at least one CBG derivative; and (iii) at least one THC derivative, as pharmaceutical drug products.
OCT is also responsible for the manufacture and supply of the compounds for development and commercialisation. Canopy Growth and OCT will establish a Development Steering Committee (“DSC”) to monitor the progress of the development and commercialisation activities OCT is undertaking in relation to the Canopy Library.
The Group currently has four drug development programmes running in parallel. Its first and most advanced programme is OCT461201, which is initially targeting indications in neuropathic and visceral pain. Phase 1 clinical trials are scheduled for Q3 2022 with Phase 2 trials expected in Q2 2023. OCT’s second programme uses inhaled phytocannabinoids to target an undisclosed orphan pain condition, with Phase 1 trials also scheduled for Q3 2022 and Phase 2 expected in Q2 2023.
The Canopy Library accelerates the timelines and reduces the risks of the Group’s third and fourth development programmes whilst keeping the budget and overall goals for both unchanged. The principal objective of Programme 3 is to identify a drug candidate(s) for neuropathic pain conditions. The principal objective of Programme 4 is to develop a “first-in-class” drug candidate that is expected to have use across multiple therapeutic areas including pain, neurology, immuno-inflammation and oncology.
Through licensing the Canopy Library, the Directors of OCTP (“Directors”) believe the probability of success for Programmes 3 and 4 is significantly increased. Canopy Growth has pioneered advanced cannabinoid research, which includes the development of a library of compounds that could be relevant to the production of future cannabinoid-based products.
As Canopy Growth remains focused on commercialisation, this agreement will grant OCT access to the Canopy Library to advance this research. The Canopy Library includes compounds that have already demonstrated activity in experimental assays, including in vivo testing in mice. This further offers the potential for accelerating development of the Group’s existing programmes and expanding its pipeline with additional drug development programmes.
The term of the agreement, on a product by product and country by country basis, is until the last to expire patent covering the relevant product or five years from first commercial sale (whichever is later) in the respective country (unless otherwise terminated); after which OCT has a perpetual, non-exclusive, fully paid-up royalty-free licence to develop, use or commercialise said product in such country.
The agreement may be terminated for a material breach, insolvency or, on a category-by-category basis, in the event that OCT has ceased development of a category of compounds (e.g., the CBD, CBG or THC compounds). Both OCT and Canopy Growth give the standard indemnities, representations and warranties expected from agreements of this nature.
Commenting on the signing of the Agreement, OCTP Chief Executive, Dr John Lucas, said: “Acquiring an exclusive licence to Canopy Growth’s pharmaceutical cannabinoid derivative library is a significant achievement for the Group and speaks volumes about our international reputation within our market.
“Not only does the Canopy Library provide us with over 330 “new” compounds that we can put to immediate use in our screens, we will also have an exclusive license to 14 patent families covering a wide-range of cannabinoid derivatives. We believe this will increase the probability of a favourable outcome from Programmes 3 and 4 and accelerate the timeframe to clinical trials. Importantly, the library offers the opportunity to develop additional drug development programmes that should expand our drug development pipeline.”
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014 (which forms part of domestic UK law pursuant to the European Union (Withdrawal) Act 2018).
The Directors of the Company accept responsibility for the content of this announcement.