The Isle of Man government has declared it is open for business to the medical cannabis industry.
In a big to create 250 new jobs and generate £3m a year for the island, policymakers want it to become ‘a world-leading exporter’.
Applications are now open for licences to produce and distribute treatments on the island, as well as to use it as an export base.
The island’s regulator – the Gambling Supervision Commission – has set out conditions for the licensing of high-THC cannabis and hemp.
Enterprise minister Laurence Skelly said: “The growing global medicinal cannabis market provides significant opportunity for economic development in the Isle of Man, and the new regulatory framework and guidance will offer stringent and flexible licensing of a broad range of cannabis products, which ranges from outdoor grown industrial hemp to indoor grown medicinal products.
“The Isle of Man Government has every confidence that the GSC will provide a world class regulatory structure required to regulate this new and complex industry.
“I am delighted to welcome licence applications and look forward to attracting quality businesses to the Island, transforming the cannabis export sector into a key contributor to the Isle of Man’s post-Covid economic recovery.”
The self-governing British Crown Dependency, which has a population of 83,000, approved new medical cannabis laws in January.
The island’s parliament – the Tynwald – moved to attract the industry to its shores after a public consultation showed 95% of residents were in favour of the policy.
Mark Rutherford, director of policy at the island’s regulator, said: “The GSC already has a sophisticated framework for supervising gambling.
‘We have worked carefully to apply the best of that framework to the risks in the new sector and we have educated ourselves in the technical areas that are new to us.
“What we now have will ensure that all stakeholders will be competent, crime free and capable of building a sector that is safe, trusted and efficient.
“As regulators, we aspire to put our regulatory umbrella above as many consumers as possible so that they can benefit from regulations that are well thought out and properly supervised.
“Years of prohibition mean that the markets in which our licensees will be participating are still in their infancy and still contain many uncertainties.
“To address this situation, it is our aim to ensure that consumers who purchase Isle of Man products will be able to understand exactly what their product contains through accurate labelling and independent testing.
“The GSC recognises there are many stakeholders in this newly created field and intends to extend its ethos of cooperation with other government authorities into its approach to cannabis regulation.”
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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