Oxford Cannabinoid Technologies has signed a worldwide exclusive licence agreement with Canopy Growth Corporation to access Canopy’s cannabinoid derivative library.
The agreement will give Oxford Cannabinoid Technologies Holdings plc (OCTP), the holding company of Oxford Cannabinoid Technologies Ltd (OCT), access to Canopy Growth’s entire cannabinoid derivative library, including 335 derivatives of CBD, THC and CBG, intellectual property rights including 14 patent families and associated product research and development.
The agreement will see OCT develop and commercialise at least one CBD derivative; at least one CBG derivative; and at least one THC derivative, as pharmaceutical drug products, and will also give the company responsibility for the manufacture and supply of the compounds for development and commercialisation.
OCTP Chief Executive, Dr John Lucas, commented: “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.”
The Oxford Cannabinoid Group currently has four drug development programmes running in parallel, with its first and most advanced programme OCT461201, initially targeting indications in neuropathic and visceral pain. For this programme, Phase 1 clinical trials are scheduled for Q3 2022 with Phase 2 trials expected in Q2 2023.
The 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.
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 principal objective of Programme 3 is to identify drug candidates for neuropathic pain conditions, and for Programme 4 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.
European Medicines Agency gives cannabinoid medicine positive opinion
Tetra Bio-Pharma’s has received a positive opinion from the EMA’s Committee for Orphan Medicinal Products on its application for Orphan Drug Designation for QIXLEEF.
The European Medicines Agency (EMA) has given a positive opinion for Orphan Drug Designation (ODD) for Tetra Bio-Pharma’s QIXLEEF.
Cannabinoid-derived drug discovery company Tetra Bio-Pharma has received a positive opinion from the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) on its application for ODD for its investigational medicine QIXLEEF as a potential treatment for Complex Regional Pain Syndrome (CRPS), a chronic neuropathic pain condition.
The medicine is a botanical inhaled drug product with a fixed ratio of THC and CBD that provides fast-acting relief from pain, which the company says offers patients a viable, safer, and non-opioid option for pain management.
Tetra CEO and CRO, Dr Guy Chamberland, commented: “The positive opinion issued by the COMP is excellent news as Tetra continues to execute its regulatory strategy in Europe.
“An ODD brings several unique advantages, from a cost reduction in drug development, to an accelerated review process and market exclusivity for 10 years. Such strategy is cost and time-effective and allows the Company to easily gain market shares in a competitive free environment. If granted, this would represent QIXLEEF’s second ODD as a potential treatment for CRPS, in addition to the ODD granted by the US FDA in March 2018.
“We firmly believe that QIXLEEF will be a safe and effective medicine for pain management and an alternative to opioids.”
The positive opinion issued by the COMP will be sent to the European Commission, which is expected to grant the orphan designation within 30 days.
As the medicine will be intended to treat an orphan condition, clinical studies will be preformed with a significantly smaller number of patients and could be entitled to conditional approval through a decentralised procedure resulting in a single decision from the European Commission, valid in all EU Member States, which would shorten the time to market approval.
Agreements to advance chronic pain relief for trigeminal neuralgia
Oxford Cannabinoid Technologies has signed agreements to accelerate the development of a pain management solution using phytocannabinoids.
Oxford Cannabinoid Technologies has signed new partnership agreements to target the chronic pain condition trigeminal neuralgia (TN), which causes severe facial pain caused by compression of the trigeminal nerve.
With current treatments for TN having adverse side effects and being only partially effective, Oxford Cannabinoid Technologies Holdings plc (OCTP) is aiming to provide a drug-device combination product for people living with the condition. To facilitate this, the group has signed three service agreements that will accelerate the development of its concept – a combination of unnamed phytocannabinoids that will be administered to the lungs using a metered-dose inhaler.
The group says this type of administration should reduce onset time and the extensive first-pass metabolism associated with oral administration of cannabinoids.
“We are delighted to have further expanded our portfolio. The pain caused by TN can be extremely debilitating and we are looking forward to working towards a pain management solution with our partners,” commented OCTP CEO Dr John Lucas.
“We remain focused on developing our portfolio and increasing our growth potential as we progress our drug development programmes through preclinical and clinical trials.”
The group’s first supply agreement has been signed with Purisys, which secures ultra-high purity, cannabinoid active pharmaceutical ingredients for the current preclinical drug development and future clinical and commercial supplies for the Group’s Programme 2. A second agreement with Oz-UK Ltd, will facilitate the development of a cannabinoid metered-dose inhaler formulation, which will include studies aiming to identify and define the excipient/formulation components, as well as the selection of the canister, valve, and actuator, and a third agreement with Voisin Consulting Life Sciences will enable the development and regulatory strategy of the Group’s combination product.
OCTP aims to obtain Orphan Drug Designation which will allow it to retain market exclusivity through regulatory protections. The programme is designed for an accelerated route to first-time-in-human (FTiH) with Phase 1 clinical trials planned for Q3 2022.
Kanabo and Medocann to develop unique cannabis strains for UK and Germany
The deal will see the companies develop new products to target specific medical conditions.
Kanabo has signed a partnership agreement with Medocann Pharma to develop unique strains for the UK and German markets.
Kanabo, one of Europe’s fastest-growing medical cannabis R&D companies, has partnered with Medocann Pharma Ltd to develop new products that will target specific medical conditions.
The deal gives Kanabo exclusive distribution rights to the co-developed products into the growing German and UK cannabis markets.
The partnership agreement will focus on the co-development of new and novel products as well as on the co-development of new and unique cannabis strains.
These new strains and products will be targeted at specific medical indications through the combination of Kanabo’s preclinical data on the effect of cannabis on different illnesses and Medocann’s genetics bank, strain development expertise and innovative cultivation capabilities.
Medocann is an established medical-grade cannabis producer with an indoor, hydroponic facility located in central Israel and has a library of proprietary cannabis genetics.
According to the announcement, 1,000kg of Medocann’s precisely grown cannabis flowers and extracts will be integrated into co-branded products that will be available for sale within the first three years of the agreement, which the board estimates will generate sales of up to €9m in aggregate.
Kanabo, the first cannabis company to IPO on the London Stock Exchange this year, focuses on the distribution of cannabis-derived products for medical patients, and non-THC products for CBD consumers.
The deal will take advantage of Kanabo’s intended acquisition of Materia, which has a state-of-the-art EU GMP certified facility in Malta.
Materia imports cannabis flower from its global supply network, including non-EU GMP certified producers, and then processes it into EU GMP certified medical cannabis products for subsequent export to distributors across Europe.
Asaf Sella, CEO Medocann commented: “The genetics and the technology used to cultivate medical cannabis make a huge difference in the safety, the quality and the consistency of the medicine patients receive. We are delighted to partner with Kanabo, together we will develop new strains to treat specific indications and provide premium medical cannabis products, all originating in Medocann’s indoor, hi-tech facility.”
Avihu Tamir, CEO Kanabo added: “Medocann’s hydroponic, precisely-grown cannabis is considered to be the best in Israel and often sells out within days. It is the only product on the market that is cultivated without the use of pesticides or insecticides. Kanabo aims to bring these unique strains that target specific medical conditions to patients in the UK and Germany through our Materia Malta production facility.”
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