Roby Zomer, co-founder and Managing Director of MGC Pharma, discusses the acceptance of its Patent Application for its drug delivery innovation – SNEDDS.
Accepted by the Slovenian Intellectual Property Office, MGC Pharma expects the patent for its drug delivery innovation, the ‘Self-nano emulsifying drug delivery system (SNEDDS) of Cannabinoids-Ionic Complex Concentrate’, to be issued within the next 12 months.
Co-founder and CEO of MGC Pharmaceuticals, a European-based biopharma company specialising in the production and development of phytocannabinoid-derived medicines, Roby Zomer, describes the SNEDDS system as a “new frontier in medicine”.
A new frontier in medicine
MGC Pharma’s Self-nano emulsifying Cannabinoids-Ionic Complex Concentrate utilises Graft Polymer’s proprietary GraftBioTM SNEDDS technology, which is a unique platform to deliver active ingredients more effectively in higher concentrations to the cells, improving the bioavailability and synergy of natural active ingredients.
“The whole idea of drug delivery systems is to get the medicine to its target in the body in the best way. In some cases, when we are looking at neurological disorders and our target is the brain or nervous system, or when we are dealing with inflammatories and inflamed areas, this can be topical, or it can be systematic in our bodies. So, we are trying to identify the right mechanism or the right carrier that is the best way of delivering the drug to its target,” says Zomer.
“Until now, most of the drugs around cannabis or cannabinoids were oil-based carriers, which has its flaws such as using too much oil. If you imagine children taking CBD dissolved in oil eventually, they are drinking 100 to 150ml of oil every month. Think about a healthy person with no disorder – even without the cannabis inside, just drinking oil in this quantity will create a lot of side effects and problems.
“We are reducing the amount of the active substance that the patient needs, who will therefore consume less oil, and therefore experience less adverse events. We are changing the carrier into powders or water using SNEDDS. It is one of the newest platforms in the biotech industry that allows us to transfer the active substance from the oral mucosa to the blood plasma.
“When we are dealing with the blood-brain barrier and bioavailability, we try to go below 100 nanometres and, by making the SNEDDS effective, we can go to 50 nanometres which means we are bypassing much better from the oral mucosa to the blood plasma – we are getting a much more efficient active substance, better bioavailability, and better absorption into the plasma.
“The other element is transforming from an oil carrier into liquid and solid so, we are reducing the harm, side effects, or toxicity of overusing oil in our body which has its own problems regardless of the active substance.
“From our perspective, we see there are different types of SNEDDS and each one needs to be adjusted according to the treatment we want to achieve. For example, a while ago, we updated the patent on CimetrA, a nano-emulsifying drug carrier. We are now using an ionic liquid, so it is a different method which is salt in room temperature liquid, and therefore dissolves in water and creates our cannabinoid-type programme – it is the new frontier of active substances, not just in the cannabinoid sector but in the biopharma sector in general.”
Improving medicine for patients
Zomer says MGC Pharma aims to improve medicines by identifying and discovering new drugs and active substances to provide patients with safer, more effective, and affordable treatments.
“We are working on a two vector platform. First of all, we are trying to identify a new active substance – the same as we did in our brain cancer research, and also improving the drug carrier. We are creating a new API that will transform better in the body, have better pharmacokinetic data and bioavailability, and eventually, will be able to provide the patient with more effective and safe treatment that is also more affordable,” says Zomer. “This is a big transformation from what we see in the industry and from phytocannabinoid and phytomedicine in general.
“We are working with a company who are providing us with the platform for the medicines CannEpilTM and CogniCannTM, and running Phase 2 studies, however, we are not using this platform. We will introduce this platform to the medicine in the next study. CimetrA, which has entered into Phase 3 studies, is using the same bio-platform as the SNEDDS.
“Our brain cancer treatment is using a slightly different platform that can provide brain treatment but in a non-invasive manner – so, it will be able to take the medicine through the mucosa and the active substance will reach the brain stem cells and the tumour through the blood, without the need to do brain surgery or needling into the brain. The result we have seen so far is a very dramatic improvement and we have been able to achieve amazing results on CBG and CBD in targeting the stem cells. The next step is to complete another round of tests, then to move to an animal model and then to patients.”
Drug delivery innovation
The SNEDDS platform will be protected by the patent for the next 20 years – allowing MGC Pharma the freedom to operate and to discover new formulations to bring products to market.
Zomer said: “For the company, this patent means that we are now in the area of the bigger players – the platform will give us a new frontier of medicine, and help us to provide new formulations that are protected and out of the risk of medical lawsuits from other companies. This gives the company and investors the strength that we know what we are doing.
“I can say that we will continue to develop more patents and expand the patents into territories, such as North America, and other territories according to the development in our research.”
Zomer says the company hopes CimetrA will be sold later this year, and that CannEpil will enter Phase 2 studies with the hope of also being introduced to patients this year under the early access to medicines scheme (EAMS).
“We are already providing this to patients in Australia and the UK, but I would say that we will see patients benefitting from this drug platform later in 2021 and more in 2022.
“Over the past two years we have registered two new genetics that are protected until 2045 – so we are patenting our genetics, patenting our drug carriers and patenting our formulation. The next level will be to create new tablets and capsules that also incorporate new drug carriers to benefit different treatments.
“We have a lot of developments in all the sectors and we are hoping to bring more surprises to the market in the next few years.”
Growing pains: fresh challenges for the UK’s CBD industry
The regulatory hurdles are many, but the potential UK market – thought to be the largest untapped market in Europe – is significant.
David Hardstaff and John Binns of BCL Solicitors LLP discuss the regulatory landscape in the UK following the EFSA’s decision to pause all novel foods evaluations for CBD products.
The European Food Safety Authority (EFSA) has dealt a blow to the European and UK CBD industries, identifying several hazards related to CBD intake and pointing out deficiencies in both the experimental animal and human research data.
However, its findings primarily highlight a lack of sufficient evidence needed to fully assess the safety of CBD as a food. Whilst the findings are not binding on UK regulators, the beleaguered UK CBD industry must now brace itself for its inevitable fallout.
An industry under fire
Although no longer a member of the EU, the UK continues to align with its Novel Food Regulation; and so, whilst not determinative, the findings of the EFSA are likely to concern UK regulators grappling with the CBD issue.
UK-based CBD companies had already been feeling bruised prior to the release of the EFSA’s statement. From operating within a light-touch regulatory regime, founded on the belief that CBD products were no different to any other readily available food supplement, the closing drawbridge that was the Food Standards Agency’s (FSA) novel food application process has been a shock to the industry’s system.
The process, which required non-medicinal CBD products to be the subject of an application for authorisation, has caused a stir within UK CBD businesses and exposed brands’ reliance on white label goods. This has left many querying the real value behind some of the celebrity-endorsed brands vying for a piece of the UK’s CBD landscape.
The longer-term consequences are unclear.
When announcing the publication of its list of products which have submitted a valid novel food application, the FSA confirmed the role of enforcement authorities and that it had recommended to local authorities that any products not on the list should be withdrawn from the market. Such products would be deemed ‘unsuitable for progressing to authorisation’, or in other words, unsellable.
This was prior to the EFSA’s statement, which will clearly not aid the industry’s plight. The FSA will publish its full list of pending novel food applications this month.
The position of the EFSA
Although the EFSA has not commissioned its own research, its statement points to existing animal and human studies which have been conducted to identify safety concerns linked to CBD. In considering the safety of food products, the same cost-benefit analysis used when assessing the safety versus efficacy of medicines doesn’t apply. Put simply, adverse effects from food consumption are not tolerated, regardless of other perceived benefits. The bar to find grounds for caution in the regulation of CBD as a foodstuff is therefore a low one.
The EFSA statement refers to its finding ‘clear evidence’ for liver toxicity of CBD, demonstrated by liver hypertrophy in laboratory animals and increases in liver enzymes in experimental animal and human studies. Data gaps are identified in relation to other areas of concern, including on gastrointestinal tract, endocrine system, nervous system and on psychological function.
The statement recognises that most of the existing human data emanates from studies into the efficacy of the CBD-based medicine Epidyolex at therapeutic doses. The limitations of such studies in the context of assessing CBD as a food are clear.
As one door closes, another opens?
Although bad news for CBD products marketed as foodstuffs, the EFSA’s statement and novel food considerations shouldn’t impact on the availability of CBD products as medicines, which are separately regulated.
Outside of pharmaceuticals, one of the largest and arguably sustainable CBD customer bases have been consumers with some sort of health or therapeutic need, for which they are unable to access medicinal cannabis.
One potential consequence of the drive to rein in the UK’s CBD industry is reduced access to the previously available wide range of products. In recent times, it has been difficult to find a high street or retail centre between John o’ Groats and Land’s End without CBD products for sale. That position could dramatically change, shifting some products into, and prompting changes to, the medicinal CBD space.
Cannabis-based products for medicinal use, or CBPMs, have been available for prescription in the UK since 2018; however, access is strictly limited through existing and bespoke regulatory controls. In addition to the regulatory barriers to access, funding has long been cited as a problem, with limited patient access through the UK’s National Health Service (NHS). On drilling down into the issue, a lack of UK-based research as to the efficacy of CBPMs is the starting point.
Several laudable initiatives have sought to plug the research gap, including Project Twenty21, the UK’s largest observational medicinal cannabis study. However, observational studies have their limitations, which is why most have recently welcomed with open arms the UK Health Research Authority-approved trial, Canpain.
Canpain is planned to run for three years and aims to conduct clinical trials involving up to 5,000 patients suffering from chronic pain. The trial will be the first of its kind in the UK and could be significant in opening access to CBPMs for the UK’s estimated 1.4 million patients currently accessing cannabis through the illicit market.
As highlighted by the EFSA statement, reliable data on the number of CBD consumers with some sort of therapeutic need is patchy, but as access to CBD products becomes more limited through enforcement of the novel food regime, access to CBD-based medicines could provide an important lifeline.
This could also present opportunities for the CBD industry, which until now has seen a benefit in its separation from the medicinal market. The industry must ask itself whether it is now time to explore the jump from consumer products to medicines.
Can a more agile CBD industry flourish and better serve patients?
No one would suggest that the development and marketing of a new medicinal product is a straightforward task. Although CBD is not a controlled drug in the UK, the position of the UK Home Office remains that it is difficult to produce CBD without any trace element of THC, which is controlled.
Consequently, it is usually necessary to begin the process of developing a CBD-based medicine with an application to the Home Office for a Schedule 1 controlled drug licence for research purposes. Further licences are likely to be necessary throughout the development process, including a Schedule 2 controlled drug licence for operating with CBPMs, as well as Manufacturers (Specials) and Distributors licences from the Medicines and Healthcare products Regulatory Agency (MHRA).
The regulatory hurdles are many, but the potential UK market – thought to be the largest untapped market in Europe – is significant.
Turning to the development of CBD-based medicines could represent a lucrative opportunity for some of the brands which have until now limited their reach to what might be described as the lifestyle market. That may not explain or justify the EFSA and FSA’s stance, and nor does it remove the urgent need to liberalise access to CBPMs in the UK.
But for consumers with a therapeutic need, a more agile CBD industry, equipped to cross the barrier between the medicinal and non-medicinal worlds, would unquestionably be a good thing.
How two former heads at Johnson & Johnson are bringing a science-based approach to CBD
Two former Johnson & Johnson executives teamed up in 2020 to bring their experience in consumer medical products to the CBD industry and create products that are more efficient and effective. The company’s water-soluble technology claims to be 400 per cent more bioavailable than standard oils.
Dr Gerry McNally, former head of consumer healthcare at Johnson & Johnson and John McDonagh, former head of worldwide marketing, joined forces in 2020 to show the CBD industry that there is one thing it is not paying enough attention to – bioavailability.
McDonagh kicked off his career at Johnson & Johnson straight out of university, initially working in the finance department before turning his attention to the marketing of medications like Tylenol, ammonium, Motrin and Pepcid AC. There was a common thread between these medicines. Consumers wanted to be assured of the evidence and data behind the medicine they were taking so they could be taken with full confidence. This is the missing link that McDonagh and McNally saw in the burgeoning CBD supplement industry. Too many products on the market lacked the evidence backing the formulations and too few companies were prioritising bioavailability.
“It’s not just about the ingredient, It’s really [about] how the formulation makes the ingredient accessible to the body,” McDonagh told Cannabis Wealth. “We really want to take that research, the science behind it and the technical parts of formulating quality products, and that’s what we’re really trying to do at NextEvo. There’s a lot of commonality there between my background at Johnson & Johnson and [our] work at NextEvo.”
After leaving Johnson & Johnson in 2018, McDonagh worked with a fund that looked at both cannabis and hemp investments in the wellness and lifestyle space. When he delved deeper into the industry, he found that most products on the market were likely not delivering the therapeutic benefits they were claiming to.
“We really couldn’t find anyone who was addressing some of the key issues with CBD which is the bioavailability issue,” he said. “The management teams of these companies just didn’t have the experience in consumer products like I did at Johnson & Johnson and Gerry did with his research and development background.”
Identifying a gap in the market, the pair joined forces to launch NextEvo and its trademarked technology SmartSorb, a water-soluble 5 per cent CBD concentration liquid that claims to improve bioavailability by 400 percent compared to standard oil-soluble products.
CBD is a highly lipophilic substance, meaning it dissolves particularly well in oil. This is why the majority of CBD products on the market use oil-based formulations. It’s cheaper and generally requires less time, money and expertise to produce. The issue with a lipophilic molecule like CBD, however, is that it does not absorb well in the digestive tract resulting in only a small proportion of the molecule reaching the bloodstream. CBD is also highly metabolised. According to McDonagh, most oils will get “chewed up” by the liver resulting in a bioavailability level of just 5 to 10 percent in most products.
A water-soluble emulsifier like SmartSorb differs in that it can mostly bypass the digestive system and is believed to instead be taken up by the lymphatic system, a network of vessels, organs and tissues that process an average of 20 litres of blood every day. The result is an absorption rate four times greater than that seen in standard oil-based formulations, NexEvo claims.
Preliminary studies from the company also show that water-soluble CBD products are absorbed much quicker than oils and tinctures. In one pharmacokinetic study carried out by NextEvo, SmartSorb reached its maximum concentration within one hour while in oil-based products the research team only recorded signs of uptake between 90 minutes and two hours. So, if water-soluble products appear to be more effective than oil-based, why are they not the norm?
“Most of the products we see in the market are oil-based products, in large part because they’re relatively inexpensive and easily accessible to the market,” Mcdonagh said.
“Maybe the balance of products will shift from oil base to water-soluble at some point in the future. But I think right now, you have a lot of companies that are really just looking at the margins that they can get from some of these poorly formulated products and I think, unfortunately, that’s driving a lot of current trends.”
Due to the complexity of the technology, not all water-soluble products are going to offer the enhanced bioavailability they claim to. For example, McDonagh is sceptical of companies claiming to use nano-technology to break down the particle size of CBD so it can be more easily formulated into a water-soluble emulsifier.
“Nano is kind of a false term in the category. Many people use the term nano when it really just means that they shrunk the size of the molecule,” McDonagh explained. “We don’t know if that’s really the magic key with CBD. We have seen instances where the molecule can actually be too small and so you might get a quick uptake of the product into your bloodstream, but you won’t get a sustained and overall [greater] absorption level.”
The technology behind SmartSorb was developed by one of NextEvo’s technology partners based in Colorado. With 30 years of experience in R&D at Johnson & Johnson and 32 patents under his belt, Gerry McNally took the technology and adapted it into a number of formulations including capsules and gummies.
Although water-soluble technology is still relatively rare in the world of CBD, it is a well-established formulation in the pharmaceutical industry. “It’s not so much a mystery how to make a water-soluble ingredient,” McDonagh said. The challenge lies in making the product consistent and specific.
“The difference here ensuring a couple of things,” he explained. “One is [ensuring] the particle size is the right size to maximise absorption. It’s also about selecting the emulsifiers. We’ve tested different emulsifiers to achieve the results that we have. And then there’s another element which is what we call the fingerprint of the emulsion which makes sure that each particle is emulsified correctly.”
“What Gerry and I really stand for is making sure that we’re making products that are science-based and high quality,” McDonagh added. “The reason we’re doing that is because we have the consumer in mind first; that’s who we’re formulating for. Our approach is to bring quality products and it’s more expensive and it’s more timely and it takes more investment to do that, [but] we want to do things the right way.”
The Happy Hemper: bringing CBD to your front door
Discover one couple’s mission to bring CBD to the masses through its subscription hampers.
Husband and wife duo, Scott and Cally Macdonald, set up Happy Hemper in the belief that people can benefit from CBD.
The Happy Hemper CBD subscription box company was born out of the pair’s own beneficial experience with CBD. Living with anxiety, Scott and Cally began using CBD after looking for help from doctors and not finding results. The pair say that CBD seemed to provide a solution to their daily stress, and when their baby arrived, they utilised the compound to stay on top of their day-to-day lives.
Scott says they wanted to tap into the CBD market – and realised that with 50 per cent of Brits saying they use or have used subscription box services – this could be the perfect way to help bring CBD to UK front doors.
The boxes have been carefully curated by the couple, who include a wide range of CBD products including body scrubs, hair masks, lotions, bath bombs, capsules, drinks and more – varying from month to month.
“We first started taking CBD around about four years ago, and found it to be really beneficial. We both suffer from anxiety and depression. So, it was finding an alternative because we went through the leaps and bounds of doctors which was just a nightmare roller coaster. So, we were trying to find something that works,” said Scott.
“CBD seems to help you manage your day a lot easier and its all-natural.”
Cally said: “We started taking it more of when our now four-year-old was born. It started us off on an even keel and we get along better. It has been a really interesting journey, and learning more about CBD and its capabilities brought us on to figuring out what we could do – that’s how Happy Hemper came about. We were surprised nobody else was doing anything like this.”
“Around 52 per cent of the population say they use a subscription box or are using one,” added Scott. “With Covid-19 we had the opportunity to really make a push for it. The response from the public and industry has been quite overwhelming.
“It is so exciting. There are a lot of big fish in the pond who want to know how they can get involved and tell us it is a really good idea. It is really important to us – we want to build that connection with the suppliers and our customers and get the message out there that CBD can help.”
Happy Hempers’s hampers come in different size options at different prices – all offering customers the chance to save from £60 to £70 per box. The pair do everything themselves, and Cally says with the usual price of CBD products, the subscription hampers allow customers to use up all of their product without worrying about making it last.
For the hampers, Happy Hemper works with a number of different brands, picking products that will be recognised by its customers as well as smaller CBD brands, and now brands are beginning to approach the company. All of the products that Happy Hemper uses are lab tested
“We’ve learned that you build really good connections because brands have already established on their own lane. It’s not really “pick and choose” – we’re trying the product and seeing what works best,” said Cally.
“We always want to make sure that we take less profit and have more savings for our customers and that they are getting good products because it’s about building connections rather than taking money. We want to be in this for the long term because we believe in it.
“We want it to be as afford affordable for everybody. We don’t want it to be a luxury – we’re trying to get out to the masses.”
Customers can use Klarna to spread the cost. The pair point out that their progress has not been without hitches. As many CBD companies discover on their journey, finding payment providers can be one of the problems they have to contend with due to the risk surrounding the product.
Scott commented: “It was a really easy process to get Klarna and we spoke to them prior to make sure it would work. We’ve been through the process before with payment providers – we were building our own website and the payment provider that was incorporated within that website didn’t accept CBD companies. It was a learning curve for us – it was good to be knocked down to then build ourselves back up again.
“Payment providers are the issue and I think that’s where most issues are when it comes to what CBD companies are faced with, because cannabis companies are deemed to be high risk. A lot of payment providers don’t want to touch cannabis. The payment gateway was the most difficult obstacle to get over so we’re talking to more and more companies to try and get more advice.”
Marketing the company has been another huge obstacle say the pair. Contending with the likes of Meta and Google can make marketing CBD companies extremely difficult, because although CBD is legal here in the UK – social platforms tend to take a global approach to risky markets.
Scott said: “It’s hard to get paid ads to Facebook and Instagram and the main platforms So, there’s a lot of other sorts of twists and turns you need to try and go around to get people looking at your website, because that’s what it’s all about.
“We’re just going to keep pushing on what we’re doing try and get our brand out there. We want to be able to build our website and the subscription box. Until then, markets are a good way to get our brand awareness out there.”
Happy Hemper has won the ‘Commended award’ in the Beauty Shortlist at the Wellbeing Awards, and was a runner-up in ‘The Heat’ – Scotland’s equivalent to Dragons den where Scott delivered a three-minute pitch in front of five judges.