Chemical engineer Neil Foster and entrepreneur Paul Long discuss medicinal cannabis uptake in Australia and what it means for patients.
In 2016, the Australian Government joined a global movement by approving the use of medicinal cannabis. Now in 2020, cannabis prescriptions are rising, but many patients are still turning to the unregulated and therefore unreliable black market.
In this episode, David speaks with chemical engineer and Curtin University academic, Professor Neil Foster, and Little Green Pharma Chief Operating Officer Paul Long, who have been working together on research into cannabis to help make the regulated products safer, more accessible, and more affordable.
Professor Foster from the WA School of Mines: Minerals, Energy and Chemical Engineering and his team developed a new drug delivery system called ARISE (Atomised Rapid Injection for Solvent Extraction) and under a new partnership, Curtin has provided an exclusive worldwide licence to Little Green Pharma for the system.
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You can read the full transcript for the episode here
Jess (intro) (00:00): This is The Future Of, where experts share their vision of the future and how their work is helping shape it for the better.
David (00:10): I'm David Blayney. Four years ago, Australia legalised medicinal cannabis and since then prescriptions have snowballed, with 25,000 applications approved in 2019 alone, which is a 10 fold increase from the previous year. Clinical research is relatively scant thanks to a century of prohibition. Today I'm joined by two people who are trying to push things forward. Professor Neil Foster is an academic at Curtin University and a chemical engineer. He's developed a drug delivery system which re-engineers drugs so they can be more readily absorbed into the body, and Paul Long is the Chief Operating Officer of Little Green Pharma, which was very recently listed on the ASX. Thank you very much for joining me.
Professor Neil Foster (00:56): Pleasure.
Paul Long (00:56): Thank you.
David (00:57): Neil, you're working on a project with Curtin and Little Green Pharma. Could you tell us a bit more about it?
Professor Neil Foster (01:04): Yes, what we've done is license off a technology that I invented, it's called ARISE technology. And that is a technology platform which enables us to produce small particles of a drug delivery formulation. So what we plan on doing is taking the resin that comes from an extraction of the cannabis and we will combine that in the ARISE technology to produce drug delivery systems. Whether it be for sublingual, whether it be a fast acting stomach release delivery system or the third one we're looking at is a delivery targeted to the colon.
David (01:42): And could you tell us a little bit more about ARISE? How does it, how does it work and what does it do?
Professor Neil Foster (01:49): Okay. Well, in the pharmaceutical industry, one of the most common processes is crystallisation. That's how you get your drugs, you crystallise out of an organic solvent. And the amount of solvent that's used is just mind blowing. In fact, the pharmaceutical industry is one of the biggest producers of waste product producing sometimes up to 200 kilograms of material of waste for every kilogram of product. So what we have tried to do with our technology is to reduce the amount of solvent that's required. And we do that by using carbon dioxide as an anti solvent. So we will actually take a solution of the drug, in this particular case, the medicinal cannabis, we will then inject carbon dioxide into that solution. The solution expands and once it expands to a certain point it can no longer hold the material in solution, the drug or the cannabis will precipitate out as particles, small particles around about one micron in size. And the other advantage is that the particles not only are not only small, but the distribution and the particle size distribution is very narrow. And that means that we get a very controlled onset of pharmaceutical activity.
David (03:08): And this means that you can get a much more controlled dose?
Professor Neil Foster (03:10): Absolutely a much more controlled dose and also a lower required dose. So that minimises the cost to the patient, but it also minimises any side effects.
David (03:21): There's prohibition has made it rather than difficult to research cannabis. There's quite a lot of research to be done, isn't there?
Paul Long (03:32): Yeah, absolutely. Yeah. Obviously there's a number of countries that have been legalised for a number number of years now, so Israel for over 30 years. So there's lots of really good research now out of countries like Israel. Australia now since 2016. Canada for a few years prior to that. So we're starting to now see more of a pharmaceutical view, David, on research on cannabinoid therapy. But absolutely there's a long way to go. You know, we still feel very much embryonic as an industry. But that's the exciting part and that's the exciting part about our, our partnership with, with Curtin and the opportunity.
David (04:08): What are some of the barriers facing more widespread adoption of medicinal cannabis other than of course, the fact that it was only recently legalised, of course.
Paul Long (04:19): Yeah. Look in Australia, there's been a number of challenges. So the Australian government has taken, and rightly so we believe, quite a conservative view on access. When you transition a product that has historically been a banned substance into a legal substance, the government want to take, wanted to take a different view to say the Canadian view. And so to access medical cannabis this time last year or in early 2017 it was difficult for a patient. So, going through a special access pathway to get a prescription and through a specialist. So a patient had to walk into not just their GP, but a specialist GP and a physician. Yeah, absolutely. Very costly, very slow special access scheme process took a number of months on some occasions. Then it had to go through a state health in each state in Australia. So by the time the patient accessed the product, it could be three to six months later and we're talking hundreds if not thousands of dollars for the product. Now, luckily what we've seen in Australia is a real support from Minister Greg Hunt and the entire you know, cross party support politically and we've seen barriers really dropped to entry now. So the state health approval has dropped off. The special access pathway has now gone electronic. So in a lot of cases our, one of our prescribing doctors told me just yesterday that he had a patient that he submitted for a product at 8:00 PM one evening by 8:00 AM the following morning, the prescription was signed off and ready to go. So that patient technically that day could pick up a bottle. And we've seen a huge increase in volume and there's now over 130 different products, mostly, in fact, all imported products other than Little Green Pharma's. But what that's done is it's brought the price down to an affordable level for Australian patients as well.
David (06:10): Could you explain for us THC and CBD? Well, actually more to the point. Can you get high from medicinal cannabis?
Professor Neil Foster (06:19): That is a really good question. And it's one that I asked when I was first approached by Little Green Pharma. I said, why don't you smoke the stuff?
David (06:28): Bit difficult to smoke a pill, I guess.
Professor Neil Foster (06:30): No, but it's the leaf. Why don't you just smoke the marijuana, the cannabis? And that's the reason, because the THC is what gives you the psychotic effect. The CBD of the cannabinoids are what's giving you the therapeutic effect. And so the different forms of cannabis have grown to reduce the amount of THC for medical reasons. So all of the previous plants, I think the plants that grow in the wild, they will be high in THC.
Paul Long (07:02): Yeah, that's right. The recreational market has evolved to maximise THC for that particular effect in most cases. But the thing that is really unknown is that THC and CBDare two of only 140 plus cannabinoids inside a plant. So we're dealing with a pretty complex range of cannabinoids. So what we hear in the market is THC and CBD, but ultimately there's a whole other range of cannabinoids that we believe in the future will be studied and researched and may have other therapeutic benefits. But.
Professor Neil Foster (07:35): There are about 170 at the moment.
Paul Long (07:38): Every day there seems to be some more discovered. So it's exciting, but it's also it's quite daunting as an industry and I think education's important for patients to know that, and not to be afraid of the, you know, because THC when it's decarboxylated can produce a you know, that feeling of high, like a psychedelic effect. When it's balanced with CBD, and for the right chronic conditions like chronic cancer pain, anxiety and sleep, there's certain conditions where the combination of THC working with CBD and the therapeutic effect of other cannabinoids, it's called the entourage effect, we get a really positive response from our patients.
Professor Neil Foster (08:15): And that's common with a lot of natural products where you get this entourage effect. It's the whole matrix that gives you the effect, not just a particular compound within that matrix.
David (08:26): So it seems that the, the way that we think about cannabis has been quite sort of limited over the years in terms of the, the impact that the approach that we've had with respect to the drug has been wait, let me rephrase it. It seems that our, what we can imagine cannabis is used for, has been quite limited over the years.
Professor Neil Foster (08:50): And that's true. And that's partly just a lack of education and lack knowledge in the marketplace. And that's one of the things that Little Green Pharma have been fantastic at. I mean, they have a particular person who's dedicated to education.
Paul Long (09:03): Yep.
Professor Neil Foster (09:04): So that the market can be properly informed of the difference between the THC and CBD and how the different compounds work and just have a better knowledge so that, you know, whenever you say you're working with Little Green Pharma and say, "Oh, you're working with a marijuana company". And that's not an uncommon response for people to have. So educating the marketplace, educating just the general community is a very important part. And Little Green Pharma's doing that for good reasons, but it's also good for the company.
Paul Long (09:35): Mmm. And I think that it is, there's a lot of misconception about, particularly in sort of a baby boomer generation, so you know, those that have really lived through prohibition.There's a, even today in, you know, we've been legalised here in this country for a long time, it's not uncommon that I'd sort of talk to someone on the street and they had no idea that it was now legalised and that you could access it for medical reasons. The exciting part about this industry is that there is a huge amount of evolution to come. So at the moment we produce a oil-based product, like I was saying before, in a range of cannabinoid profiles, mainly THC and CBD focus. But the future is exciting. The future is more around unique drug delivery systems, unique ratios of cannabinoid therapy, unique genetics that are working for certain chronic illnesses. So there is a lot of work to be done. And, but yeah, absolutely, like Neil said, education is the key for everyone. It's for patients. It's for doctors. It's for a broad range of healthcare professionals. It's for politicians. It's for and we're beginning to see a lot of movement in that space now and more broader acceptance from patients and people who previously would have you know, almost laughed at the idea of using medical cannabis for chronic illness.
Professor Neil Foster (10:51): And part of that education too is to inform people about the difference between legitimate medicinal cannabis such as Little Green Pharma's producing and the black market cannabis, which has no quality control.
Paul Long (11:04): Yep.
Professor Neil Foster (11:05): Um and that's why with that particular sort of material, you don't know whether you're overdosing yourself or underdosing yourself.
David (11:12): And of course, it's much more cost effective to have very potent cannabis in terms of THC levels on the black market than it is for a more sort of balanced mix.
Paul Long (11:24): Yeah. I think what we find is that what we, our view on the market from a pricing perspective is that the medical market will eventually sort of land at the value of the illicit market of cannabis. And we know at the moment in Australia, anecdotally that roughly 10% of Australians are consuming black market cannabis. And a big percentage of that 10% is for medical reasons. So it is, you know, it's someone's mother who has got stage four cancer and is wanting to get, you know some sleep and support with the, you know, chronic cancer pain. And so they're accessing illicit cannabis because it's previously been too hard and too expensive. But what we're finding now and where we think it will land is that the cost of producing a high grade, high quality medicine out of a GMP manufacturing facility will land at roughly the same price. So there'll be this transition of those, call it 5% of Australians that are accessing it for medical reasons in the black market shift across now to the proper market whereby we can guarantee that we've got, you know, a consistent product in the hands of the patients that that is grown in a way that is, can be replicated and can guarantee quality. It's really important.
David (12:39): Can you tell me more about the therapeutic benefits of the, who's using it and what illnesses is it used for treating?
Paul Long (12:49): Yeah, so I think you said in your introduction there, there's been more than 25,000 special access scheme applications. So we have seen a rapid rise. There is now over, I think the last report I saw, that there was well over 50 different chronic conditions that have been prescribed, which is a very, very broad range. But if you break that down and actually have a look at the numbers, the majority of the applications approved has been for chronic pain cancer-induced nausea and vomiting, and then we have a whole raft of sort of smaller PTSD anxiety sleep conditions. So, and then the sort of list goes on, but the vast majority has been connected to chronic pain. So chronic pain is defined as pain that someone is feeling on a day to day basis that lasts for more than three months. And in the case of accessing a special access product, a non-registered drug like medical cannabis, they, the patient must have they must have tried other medications that are registered on the market. So they've had no effect or they have side effects to those registered medications, and at that point they can be prescribed a non-registered drug. But certainly chronic pain is the number one by a long way.
David (14:04): And is it a safer option than using, for example, opioid sort of OxyContin, that sort of thing? Or is that, is that a bit sort of, is it a bit of a difficult question?
Paul Long (14:16): Oh, look, it probably is and there's lots more, there's lots of work to do in this space. I think the thing that we do know about cannabis more broadly and medical cannabis is that, you know, to date there's been no overdose of medical cannabis because we have an endocannabinoid system in our body. What we do know about opioid epidemic is that, you know, last year in the US there was more people that died of opioid overdose than they did car accidents in the United States. So it is a massive problem. Does medical cannabis, is it this amazing drug that will decrease the opioid deaths around the world? You know, there's lots of work to be done in that space, but there seems to be the early stages are talking about some complimentary capabilities. We're conducting with a number of clinics across Australia, we're looking at some investigator-led trials to actually see if there is an opioid drop off. And even a slight drop off in patient opioid use with an increased use of medical-based cannabis we think is a really positive thing. But as we said here today, there's lots more work to be done and research to be done to really prove up that theory.
David (15:27): Do you see listing on the Pharmaceutical Benefits Scheme as being at the end of a long pipeline?
Paul Long (15:33): Yeah. Look, again, affordability is a real challenge. We're talking about, if you think about a patient, a typical patient with chronic pain these people are suffering and, often, they may or may not be working, likely they're not working full time, and even a few hundred dollars a month is a lot of money for people in this scenario. So, as a non-registered product, our products are not registered on the PBS. To go through that pathway, we need to invest as an industry and as a company in a range of studies, including placebo-controlled phase three clinical trials, and then at that point, we need to provide an economic study to the government and apply to be submitted to the Pharmaceutical Benefits Scheme. So that is absolutely the end game for our company and for all medical cannabis companies, but we're not we need to be pretty clear for the listeners that it's a, this is a number of years away, but we're proactively as a company investing in that and pushing towards that to make it more and more affordable for patient use.
David (16:35): Where do you think, [tuts] "where do you think?"... Where do you see things going in the future, Neil?
Professor Neil Foster (16:40): I think the future's very exciting. This technology that I've developed, we've been trying to commercialise for a number of years now and it was just a fantastic opportunity when Little Green Pharma approached us approached me, in fact. I was at the Curtin Innovations Awards ceremony and after the awards were given, I was lucky enough to be a semifinalist, and at the end of that, this big burly chap came racing towards me. I didn't know if he was going to give me a rugby tackle or not and this happened to be Paul Long, who's sitting beside me...
Paul Long (17:14): It was a hug, wasn't it? [laughs] "Please, Will you work with us, Neil?" [laughs]
Professor Neil Foster (17:17): Yeah, and so, he said, let's have a meeting and chat about this. A week after, he, we sat down over coffee and he told me his vision for the company and for medical cannabis, and I told him about my technology and it was just, it seemed like a perfect match.
Paul Long (17:32): Mmm.
Professor Neil Foster (17:33): So what that does, and it sounds cliche, but in my line of work in drug delivery, people don't join academia to become wealthy and rich we do it because we want to make a difference, and this is something that I've been searching for, where we have a real opportunity to commercialise a technology to make a difference in a space for, as I said, mainly for chronic pain, particularly elderly people. We have got an opportunity to now to look at drug delivery systems for other disease states and other illnesses such as epilepsy, autism multiple sclerosis. And these are all a part of the Little Green Pharma agenda for future development work. And that's, I just think that's just a wonderful future to look forward to.
David (18:20): Where do you see things going in terms of policy? In terms of public policy, I mean.
Professor Neil Foster (18:25): That's probably something that Paul could answer better than me.
Paul Long (18:28): Yeah, look, if you look at the political the cross party political support for medical cannabis, this industry is driven by people. It's driven by people thatare suffering, thatare talking to politicians, that are, they're choosing to source products in the black market and are saying "well this is crazy". We need to, you know, talking to politicians, say we must change. And you know, we sit here today, as a countrywe've evolved so much and you know, there's a lot more work to be done. We absolutely believe that. But right now you can walk into a GP and if you fit inside the special access process, then within 24 hours just going into your GP, you can access medical cannabis. Now, where do we see this heading? We see the, we see that access will become easier. We think price will stabilise. And we think thatthere'll be companies, real serious companies in our industry, that say this is not just about producing a 10:10 oil which has got THC and CBD. Let's actually think about the disease profiles and let's think about drug delivery technologies, think about unique cannabinoids. Let's try to almost think more like a pharmaceutical company and develop a product that is, that we run into, you know, phase clinical trials and we go through that process and we actually prove an outcome that we know if a patient comes in with this chronic disease, here is a product that we know through evidence-based research will provide an outcome. At the moment where the market is driven, primarily, the primary dosage form is oil across the, across all the sort of 25,000 prescriptions. But we are seeing there's some flour and there's other delivery technologies at the moment, but ultimately we see it becoming more of a pharmaceutical-based delivery and very, very focused on the actual chronic illness itself.
Professor Neil Foster (20:25): And part of that will be more clinical trials for different disease states.
Paul Long (20:28): Yep.
Professor Neil Foster (20:28): 'Cause at the moment the disease states for which it's being used is largely based on anecdotal evidence that companies like, the ethical companies, like Little Green Pharma will be engaging in clinical trials to prove one way or another if this works and, if it does work, what dose works? And it makes it much more scientific thing that at the moment...
David (20:51): And the dodgy companies?
Professor Neil Foster (20:52): Well, black market is a, it's an interesting thing that they, they're not subject to any regulations, there's no quality control. So you don't know what the profile of cannabinoids is, if there's any in there at all, in fact. And that's a real problem at the moment. I was amazed over the Christmas period with a family gathering, relatives of my age have been using the black market-
Paul Long (21:15): Mmm.
Professor Neil Foster (21:15): -For Their chronic pain. And these are normal people. These are not people that, you know, junkies or anything like that. So the market is out there. But to have black market is just not a good thing because, as I said, you can overdose, you can underdose. It's not controlled.
Paul Long (21:31): Yeah.
Professor Neil Foster (21:32): So this is a much cleaner, more ethical way of going about things. It's slower. Clinical trials are not cheap. I think the number that was given to me yesterday for phase three clinical trials are $50,000 per patient.
Paul Long (21:44): Yeah, that'd be about right. Yeah. Certainly in the millions. So And I think the other thing, David, we find is that the Canadian model has been an interesting model whereby their evolution into an adult-use market so a, you know, recreational market has been quite rapid. We don't believe that the Australian pathway will follow the Canadian pathway. But there are, what's happened after the Canadian model is there are companies here in Australia that have a view that, you know, adult-use recreational models will evolve to Australia pretty quickly. There's a referendum in New Zealand late this year on recreational use. So if that's approved by the, you know, the New Zealand population, then it, you know, it may evolve. But there are companies that are just almost, you know, they've got licenses and they're waiting for that to evolve, rather than thinking about this like a, thinking about the patient, thinking about the chronic illness and thinking about proven outcomes and investing in research. So you know... And the market is evolving in that way. No one's got a crystal ball. No one knows exactly where it's going to land, but Little Green Pharma is very, very much focused on the clinical outcomes.
David (22:57): How much does it cost to get a cannabinoid-based medicine or oil or...
Paul Long (23:03): Yeah, we're unable to sort of talk about our costs as a company, but like I said before, we think there has been a lack of supply in the market historically, in the last two years. So we know that prices have been unaffordable and really high for patients. But we are now seeing through, Freedom of Information, and we're seeing that the price is rapidly coming down. We've now got over 130 different products on the market, so there's more supply, which means that there's more competition for pricing. And we think that it'll pretty rapidly get to the point where it's almost benchmarked with that sort of black market price.
Professor Neil Foster (23:39): Just to give you an example, there was an article on one of the current affairs programs very recently with a young man who suffered from Crohn's disease and he was saying it was costing him $600 a month for the oil and he just couldn't afford it. So that's what the marketplace is charging, in that particular case. I think that's pretty expensive, $600 a month.
Paul Long (24:03): Yeah, it certainly is. Look as a we're a manufacturer, so we then, we have other processes through before, you know, it becomes a retail price, into a pharmacy. But we as a company have been very focused on making product affordable because it has been an issue in our heavily regulated environment. So we've made decisions as a company to really focus on, think about the patient and try to make affordability key. Soand we think that, we're seeing that evolve really quickly now and I think we will continue to see that throughout 2020 and beyond, which is ultimately where it needs to be. This needs to be something that is in the hands of patients that are desperate for this medication at an affordable price.
David (24:47): And Neil, what's next in the pipeline in terms of the research that you're working on in this area?
Professor Neil Foster (24:52): Well, we have recently signed a research services agreement with Little Green Pharma. It's in three stages, three six months stages. The first will be to look at three forms of drug delivery. As I mentioned, a sublingual, a fast actingoral dosage and the targeted release colon delivery system. That will be after six months, we'll make a decision as to which one or more of those we will pursue. The second six months of the research will be to optimise the conditions, the operating conditions, to produce the best cannabinoid profile. And if we get through that second six months, the section successfully, we move into the third phase, which is scale up and doing what we call GMP validation, Good Manufacturing Practice validation, and then commercialisation.
David (25:45): And do you have anything else to add, either of you?
Professor Neil Foster (25:48): Not from my point of view, we've covered most things.
Paul Long (25:51): It's good to, it's certainly good to be here today withon the podcast and to have Neil here and to be, you know, we've got a really close working relationship with Curtin and we have now for a number of years, so we're super excited to be working with Curtin University. And you know, a big part of our research and development budget and focus and our team will be here and really proactively working with Curtin, so....
Professor Neil Foster (26:14): Yeah, that's a good point. The Curtin Research Office team here at Curtin have been fantastic in this whole process. They've been very supportive, proactive...
Paul Long (26:24): Yep. Yep.
Professor Neil Foster (26:27): And Curtin just loves being involved with industry. That's their reputation. It's an international reputation they have. And this is just another demonstration of that whole process.
David (26:37): Well, I think we'll leave it there. Thank you very much Neil and Paul for coming in and for sharing your knowledge on this topic.
Professor Neil Foster (26:44): My pleasure.
Paul Long (26:44): Thanks.
David (26:46): You've been listening to The Future Of, a podcast powered by Curtin University. If you have any questions about the topic that we've discussed today, please feel free to get in touch by following the links in the show notes. Bye for now.