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Landmark UK approval for THC refractory epilepsy treatment

The medicine will now be available on prescription for patients in the UK.

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Landmark UK approval for THC refractory epilepsy treatment

For the first time ever, an epilepsy treatment that is currently in the clinical trial process, and which contains THC, has been approved by the authorities in the UK for import.

MGC Pharmaceuticals has been granted a permit for the import of its phytocannabinoid-derived treatment for refractory epilepsy, CannEpil+, into the UK by the Medicines and Healthcare products Regulatory Agency (MHRA).

CannEpil+ is a biosimilar effect-identical product of CannEpil, which is a phytocannabinoid treatment for refractory (drug-resistant) epilepsy and will now be available on prescription for patients in the UK.

Epilepsy affects approximately 600,000 people in the UK, and around 50 million people worldwide, with near to 33 per cent of adults, and 20 to 25 per cent of children suffering from refractory epilepsy ,which cannot be controlled with traditional anti-seizure medication. The approval is a welcome move for patients and their families, which have been campaigning to improve access to cannabis-based medicinal products with demonstrated efficacy at treating refractory epilepsy as well as safety.

Landmark prescription approval

The medicine will initially be used to treat ten patients in the UK who suffer from refractory epilepsy and MGC Pharma will be providing it free of charge to these patients on compassionate grounds for six months. Once the patients have started their treatment, CannEpil+ will undergo an observational trial with data being entered into a Data Collection App designed to establish a central platform to monitor the safety of treatment in patients globally.

The company says it expects the results from the observational data collection programme together with CannEpil’s historical clinical safety and efficacy data, and its Phase IIb clinical trial that is currently under negotiation with a UK NHS facility, will provide specialist neurologists and general practitioners with the confidence to prescribe CannEpil and CannEpil+ to patients in urgent need of treatment.

“The approval for the import of CannEpil+ to the UK and the associated compassionate prescriptions is an important step towards our global roll out of the treatment, and our continued commitment to patients,” commented Roby Zomer, co-founder and managing director of MGC Pharma.

“Achieving MHRA approval has been an ongoing process for some time with our UK partner Elite Pharmaco, and we expect the first patients in the UK to begin treat with CannEpil+ in the coming months.

“The development of our Data Collection App will optimise our understanding of both CannEpil, CannEpil+ and other future treatments, and ultimately provide patients with a better treatment for refractory epilepsy, and therefore improving their quality of life. 

“It is also a vitally important foundation for building strong relationships with UK medical regulators and health organisations which will benefit MGC Pharma going forward, as we look to roll out further clinical trials and products in the UK.”

What do doctors and patients need to know?

With the approval, doctors can now issue a prescription for the medicine to both adults and children. The medicine is manufactured under strict EU-GMP conditions, and can currently be provided to patients in countries that allow cannabis based medicinal products – allowing the medicine to be offered to patients at an affordable price.

MGC has worked with Alta Flora to create a bespoke version of healthcare data platform, the Eva App, to enable researchers and the medical establishment to determine how plant-based therapies improve patient quality of life. 

The system captures Patient Reported Outcome Measures which can be used by regulators, manufacturers and clinicians to assess the safety and efficacy of new medicines, and enables the adjustment of measurement protocols in order to meet clinical standards and incorporate other conditions and future observational trials for their treatment.

Alta Flora CEO, Gavin Sathianathan, said: “MGC Pharma have stepped up to the challenge to provide access to life-changing medicine for ten trial patients, and Alta Flora is proud to support the effort to gather data in order to demonstrate that CannEpil+ has the potential to transform the quality of life of families struggling to deal with the consequences of childhood epilepsy syndromes.”

The medicine is currently undergoing Phase IIb, double blind, placebo-controlled trials, which are set to begin in Q3 and Q4 2021 at the Schneider Hospital in Israel and within the NHS in the UK, and is pipelined for Central Market Authorisation in the next two years. 

Robin Emerson COO of Elite Growth Ltd and high-profile Medical Cannabis Advocate commented: “This is a huge step forward for cannabis-based medications in the UK. As a father of a five-year-old girl I have witnessed first-hand how Jorja’s life has been transformed by the use of a Cannabis based medication that contains THC. 

“With this product approval patients that have tried everything else how have a product with some level of safety and efficacy for the treatment of epilepsy that can be prescribed by their physician. With the ongoing clinical trial portfolio that MGC Pharma have developed, including a near term UK NHS based trial, we are answering the call of clinicians in the UK who are asking for safety and efficacy data. 

“The CannEpil+ programme we are executing will go a long way to moving cannabis-based medications toward greater adoption and acceptance, opening up much needed access for patients in the UK.”

Medicinal

CBD Science launches funding round to advance cancer pain treatments

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CBD Science launches funding round to advance cancer pain treatments

CBD Science has announced the launch of a funding raise to help advance cannabis-based treatments for cancer pain.

UK-based CBD Science Group has launched an EIS-approved Series A funding round of £2m that will go toward research and development, ongoing clinical trials, working capital, as well as production and supply chain purposes.

The company, which recently received endorsement from the UK’s National Cancer Research Institute’s (NCRI) Living With and Beyond Cancer (LWBC) Executive for its Real World Evidence study into the role that cannabinoids can play in treating cancer-related pain.

The Real World Evidence study is a peer-reviewed clinical trial that seeks to quickly deliver approved therapies to patients in need.

CBD Science CEO, Dr Michael Raymont, commented: “Clinical Trial protocols have been written and peer-reviewed with highly sought-after endorsements from representative institutions, such as the National Cancer Research Institute (NCRI) as well as prominent patient groups.

“The company has consolidated partnerships with a number of leading oncology research centres across the UK, and intends to initiate patient enrolment in Q1 of 2022. Investments through this crowdfund will contribute to further R&D, ongoing clinical trial facilitation, working capital, and production/supply chain.

“Given the scale of suffering currently experienced by cancer patients, the opportunity to make an ongoing and very real difference to millions of people’s lives through this research is huge. Investment in CBD Science today provides the potential for synergistically rewarding outcomes for both investors and cancer patients.”

CBD Science has established a Clinical Advisory Board under the direction of its chief clinical advisor and former deputy medical director of NHS England, Professor Mike Bewick.

The company highlights there are an estimated three million patients suffering from cancer in the UK, with 367,000 new diagnoses per year, with pain affecting between 40 to 66 percent of those patients depending on the stage of their treatment. Alternative treatments for pain are usually opioid-based which often have harmful side effects such as dependence, addiction, and overdoses.

The negative impacts of opioids have led the National Institute for Health and Care Excellence (NICE) to recommend eliminating opioid use for people with chronic primary pain completely; however, without suitable alternatives, there are concerns of a continued UK Opioid epidemic.

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Exclusive derivative library licence for Oxford Cannabinoid Technologies 

Oxford Cannabinoid Technologies has signed a worldwide exclusive licence agreement with Canopy Growth Corporation.

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Exclusive derivative library licence for Oxford Cannabinoid Technologies 

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.

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Grow Group and Sanoid Isolates: a cannabis pan-European logistics hub

Grow and Sanoid aim to supply high quality cannabis products at an affordable price point for patients.

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Grow Group and Sanoid Isolates: a cannabis pan-European logistics hub

Grow Group and Sanoid Isolates will establish a pan-European logistics hub for medical cannabis, says Harry Wildschut, CEO and co-founder at Sanoid.

London-based biopharmaceutical company Grow Group recently acquired Spain-based premium medical cannabis producer Sanoid Isolates in a move that will help establish an entire supply chain for medical cannabis products. 

Grow Group, which aims to bring medical cannabis products to patients at an affordable price, made the acquisition as part of its expansion strategy into international markets. 

Sanoid Isolates is currently working on a high-tech greenhouse near Sevilla, Andalusia, with an ambition to grow and produce high-quality cannabinoid extracts and purified isolates, having received a production license by the Spanish authorities to grow a validation crop in 2019 to certify the extraction facility, which aims to be finished by 2022.

A budding relationship

With a background in marketing, sales and general management in manufacturing companies internationally, Wildschut joined Sanoid in 2018 – which was born out of sister company, Córdoba-based Phytoplant Research – one of the first companies to conduct research on medicinal cannabis in Spain.

“In 2018 I visited Córdoba for the first time to understand what was happening here and what kind of research they were doing – the year which was also a famous year for the cannabis industry when Canada legalised cannabis. Prior to that, in early 2018 I picked up on the idea of creating a commercial company, and so, presented the business plan to my shareholders.

“Together with the Phytoplant team we presented our licence application to the Spanish health authorities, and immediately – as confident as we were to get the licence – I started building the cultivation facilities near Seville. We got a licence in June and we did our first trial crop in the second half of 2019, and we were about to start building the extraction facility. 

“Up until the point of time where we had cultivation facilities up and running, the total investment was around five million, but in order to build the extraction facility, we would need another 10 million to get operational. 

“We decided we needed investors or potentially even new owners who could take Sanoid forward in its next step into GMP manufacturing. Altogether, it took about nine months for Grow to close a final deal two months ago – so, I’m extremely pleased with Grow as my new shareholders, and with Grow being in a position to actually fund the build of our GMP facilities.”

A unique position for cannabis cultivation

Wildschut says that Sanoid is in a unique position for its cannabis cultivation activities thanks to the ideal growing climate in Andalusia, and with Sanoid being one of a handful of companies to receive a licence from the Spanish Drug and Healthcare Products Agency (AEMPS).

“We are in a very unique position because, in Spain, only three operational licences are in place. There are two or three runners up if you like, including Sanoid, which gives us a fairly unique position, given the fact that we have one of the most ideal growing climates here in Andalusia. 

“Supporters of indoor growing will tell you it allows for four or five crops in a year and allows control of all the elements to a maximum because it is in a closed building using artificial lights. However, the single biggest downside of that, is that it is incredibly expensive and unsustainable, given the huge amount of electricity you need. 

“When I started Sanoid, my view was that, first of all, we are going to grow to extract, because, in my view, patients are not going to continue to consume plant material. Doctors are not going to be comfortable prescribing plant material as a medicine, given its inconsistency. So, sooner rather than later, there will be products available based on cannabis that will be drinks or pills or creams – which will be much more comfortable for doctors to prescribe – so that is how I started Sanoid. 

“And, that’s why we grow with the natural sun, predominantly for extraction. If you grow for extraction, the size of the bud and the smell and flavour is not that important, and we already see that trend growing very quickly already in Germany, which is one of the biggest medical markets. The good thing about our setup in Andalusia, is that the typical cost of one gramme of indoor material is around one euro and, for that one gramme of material here in Seville, it is 10 cents.

“I’m a very strong believer that we are now in a position with Grow Group to reduce the end price for patients, make it a lot more affordable and reach a much larger audience of people who will benefit from cannabis medicines.”

Cost-effective medicines for European patients

Grow’s relationship with Sanoid gives the company the ability to control its own supply chain, and, Wildschut highlights, once further markets open up across Europe, the pair will be able to move into those markets at a fast pace, with the confidence of supplying high quality products at an affordable price point for patients.

“Hopefully, we will be one of those few, inspiring examples of cannabis companies serving patients European or globally,” says Wildschut.

“The reason why we have this unique licensing in Spain is because of, first of all, our Phytoplant legacy – the fact that we have European registered varieties – which is mandatory to get a licence in the first place. But secondly, a cultivation licence as such, is not being granted in Spain – there are allegedly over 100 applications here in Spain for people who want to grow, legitimately, but the Spanish government only allows cultivation for GMP processing. So you need to have GMP processing facilities in order to cultivate. But we have this tremendous ideal climate here in Andalusia where we can grow very cost efficiently. 

“Our next step is to actually get those GMP facilities. We’re going to take a two-step approach. The first one is that we’re currently applying for a cultivation licence to grow validation material for a GMP flower facility – we are going to build our extraction factory, but also a dedicated GMP drying processing and packaging area for flower. 

“Seeing how there is still an urgent need for good GMP flower, we do believe it’s worth the investment to be able to deliver that. That’s something we are looking to put in place in the first quarter next year, so that from next year onwards, we will be in a position to provide smaller quantities of GMP flower for the German and UK markets. 

“At the same time, we will start a phase two, which is the build out of our extraction and purification facility, which involves heavy equipment and machinery. By the end of next year we will be in a position to certify our extraction facility and that means that in 2023 we should be in a position to grow our first commercial crop in our greenhouses and start producing our first products from our factory to go to markets, whether it be GMP flower or extracts for products with the famous entourage effect, or whether it be isolates as API’s to be used in producing pills or lotions, for example.

“There are two further steps we are now seriously looking into. The first step, is to actually produce those pills and creams ourselves, and the other part is that Grow is now considering putting all of their logistic manufacturing facilities here in the south of Spain where we will turn out to be the pan-European logistics hub to supply all the future Grow companies – in Germany, the UK, and France, for example. 

“So, that is already where our strategic model is emerging on how we could serve the whole of Europe, with sales offices all around Europe by Grow with our logistic manufacturing down here in Spain, in a very very cost effective manner.

“What we are of course hoping for is a continuous momentum, or perhaps even acceleration of legislation around Europe. What we see now is the inconsistency of legislation – in the UK for instance they allow to some extent sales to patients, but they don’t allow manufacturing or cultivation. In Spain it’s the other way around – we don’t have legislation to consume cannabis in Spain legally, medicinally or recreationally, but, there are a few companies who are allowed to produce an export only. 

“I believe that Grow now is in a very privileged position, because I don’t believe cultivation in Germany or in Holland, or in Denmark or in Canada, is not sustainable. So I believe that, apart from politics, economics will drive to the model Grow actually incorporated today, with cultivation production in cost efficient locations and patient access locally. 

“The whole regulatory environment is very important to further increase the acceptance and the availability of cannabis medicines. 

“I have a hard time finding insurance for my cultivation facilities because cannabis is not recognised as an official crop yet. So insurance companies are reluctant to step into this, but also banks – although luckily we see some movement with banks that are willing to give credit lines to cannabis companies. The UK has now allowed cannabis companies to be listed as is the case in Canada, so, legislation, once that opens up, there will be much more ancillary businesses supporting our industry and ultimately with surprises coming down that really open the market to the many hundreds of thousands or even millions of patients will benefit from using medicinal cannabis.”

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