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Isle of Man opens for business to the medical cannabis industry

The island wants to become a cannabis export base close to the UK’s shores.

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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.

The Tynwald building, home to the island’s parliament

“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.”

Medicinal

Oxford Cannabinoid Technologies secures drug development agreements

The agreements follow its post-IPO review after its £16.5m fundraise and admission to the main market on LSE in May this year.

Stephanie Price

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Oxford Cannabinoid Technologies secures drug development agreements

UK pharmaceutical company Oxford Cannabinoid Technologies has secured two commercial agreements that will contribute to the development of its lead compound and other drug development programmes. 

Focused on developing a portfolio of cannabinoid-based prescription medicines approved by medicines regulatory agencies which target the pain market, the company has secured agreements with life sciences consultancy Voisin Consulting SARL and Evotec SE subsidiary Aptuit (Verona) SRL.

The agreements follow its recent post-IPO review after its £16.5m fundraise and admission to the main market on the London Stock Exchange earlier in May this year.

Drug development programmes

Oxford Cannabinoid Technologies struck a deal with Voisin, which has over 200 professionals in the UK, US and India with expertise in medical devices, cannabinoids, neurological disorders and addictions, in June this year, which will support and advise the company on its regulatory strategy and roadmap for its drug development programmes in the US, UK and Europe. 

This will include First Time in Human clinical trials for its lead compound OCT461201 – a selective cannabinoid receptor type 2 agonist which has initial indications in post-herpetic neuralgia and visceral pain caused by irritable bowel syndrome (IBS). The trials are expected to commence in 2022. 

The deal with Aptuit (Verona) SRL, subsidiary of Evotec SE, a fully integrated drug discovery and development company based in Germany, with a market capitalisation of approximately €5.7bn, will provide access to Evotec’s technology platform to further accelerate the development of OCT461201 towards phase 1 clinical trials.

These trials will be aimed at demonstrating the compound’s safety and tolerability by utilising its INDiGO programme, which is an integrated drug development process for expediting early drug candidates to the clinical trial stage. 

This is scheduled to run for approximately 12 months and will provide manufacturing, safety and toxicology packages for regulatory submissions to the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) and in the US, The Food & Drug Administration (FDA).

Dr John Lucas, Oxford Cannabinoid Technologies CEO, said: “I am delighted with the company’s progress across all fronts. The board agrees that we are off to a great operational start as a public company with the two partnership agreements signed recently, and we remain firmly on schedule to deliver the drug development timeline set out in our prospectus dated 17 May 2021. 

“The Group will continue to develop its drug pipeline and its proprietary, unique library of cannabinoid derivative compounds. Furthermore, we have visibility over a number of exciting developments and a clear path to growth. By utilising a range of inputs, the Group is creating a drug development portfolio that is intended to maximise the therapeutic potential of cannabinoids, long-term market value and market exclusivity across its activities.”

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Supply chains urged to use authentication to protect cannabis products

The IHMA says counterfeit cannabis is an alarming development that sees criminals taking advantage of people in desperate need of products.

Stephanie Price

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Supply chains urged to use authentication protect cannabis products

International trade body, the International Hologram Manufacturers Association (IHMA), is urging supply chains to protect legitimate cannabis products and packaging with authentication technologies after it was revealed that sales of counterfeit cannabis were on the rise. 

The IHMA has emphasised that the sale of counterfeit cannabis highlights the critical need for regulated cannabis products used for pain relief, relaxation and sleeping disorders, to be fully protected and secured from the threat of criminal counterfeiters. It is now urging supply chains to use authentication technologies to protect their products.

The call follows a recent report from WediNos, a Welsh harm reduction project that analyses samples of drugs provided by the public and other participating organisations, warned of an increase in sales of synthetic cannabinoids that are being mis-sold as cannabis in the UK, posing a significant health risk to the general public.

Reducing threats to public health

An analysis of 37 samples in the UK which were believed to be THC e-liquids used in vapes found that only 26% contained THC or cannabis, while 57% contained some form of synthetic cannabinoid, and further reports have shown that cannabis edibles being sold via social media have been hospitalising UK school children.

The IHMA says that counterfeit cannabis is an alarming development that sees criminals taking advantage of people who might be in desperate need of products during the pandemic, and is now urging supply chains to review how they tackle this threat by looking at the use of authentication technologies.

Dr Paul Dunn, chair of the IHMA, said: “The rise in fake drugs is a huge global problem and cannabis counterfeits are no different. However, holograms are effective weapons in the battle to combat criminals.

“They provide a flexible, quick to deploy visual authentication device that can bolster supply chains, helping manufacturers, regulatory authorities, international law enforcement and border customs improve their anti-counterfeiting plans.”

Packaging for cannabis products must comply with stringent regulatory requirements, and the IHMA warns that in the next few years, as the race to improve production and bring down costs in the face of growing demand for legalised cannabis-derived treatments opens new opportunities for consumer goods and pharmaceuticals, the need for authentication of products will become even more critical. 

“The use of track and trace programmes featuring security devices and integrated QR codes are particularly helpful in proving the authenticity of cannabis products and packaging. This can be very reassuring for all involved as well as consumers, confirming products are genuine and safe to use,” added Dunn.

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Patent for THC as Alzheimer’s treatment granted to India Globalization 

India Globalization hopes the formula could provide relief for the potential 50 million people across the globe which are expected to be impacted by Alzheimer’s disease by 2030

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Patent for THC as Alzheimer’s treatment granted to India Globalization 

The United States Patent and Trademark Office has issued a patent to India Globalization Capital Inc. for the treatment of Alzheimer’s disease using THC. 

India Globalization, which develops cannabinoid-based therapies for indications such as Alzheimer’s disease and pain, has been issued the patent, entitled ‘Ultra-Low dose THC as a potential therapeutic and prophylactic agent for Alzheimer’s Disease‘, for the treatment.

The company, which hopes that its formula could help to provide relief for the potential 50 million people across the globe which are expected to be impacted by Alzheimer’s disease by 2030, entered into an exclusive license agreement with the University of South Florida with respect to the patent application and the associated research conducted on Alzheimer’s disease.

THC clinical trials

The original application was initiated by the University of South Florida and filed on 1 August, 2016.

The granted patent relates to India Globalization’s proprietary formulation, IGC-AD1, which is the subject of the company’s placebo-controlled Multiple Ascending Dose (MAD) Phase 1 clinical trial to establish the safety and tolerability of the formula that uses THC on patients suffering from Alzheimer’s disease.

The trial aims to obtain United States Food and Drug Administration (FDA) approval. 

The company recently announced the completion of Cohort 3 in the trial. For Cohort 1, the company administered one dose of IGC-AD1 per day, in Cohort 2 the doses were increased to two per day, and the treatment will be increased to three doses for this final Cohort 3.

Participants have been monitored daily for safety, and for particular behavioural changes using the Neuropsychiatric Inventory scale. The Phase 1 trial is currently anticipated to conclude by September 2021 and the Data and Safety Monitoring Committee (DSMC) for the clinical trial will review the data from Cohort 3. India Globalization will report its findings from all three Cohorts to the FDA.

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