FLETA Solomon, managing director of Western Australian-based cannabis company Little Green Pharma, talks to Jane Hall about the company’s plans to move into Europe whilst staying true to its Antipodean roots.
FIVE years ago Fleta Solomon would have considered herself a cannabis novice.
A serial entrepreneur with experience in the corporate and consumer health markets – including a start-up business that rendered contaminated water drinkable – cannabis had never been on her radar.
But in early 2016 Australia gave the green light to the growing of cannabis for medicinal and research purposes. Then in November of that year the use of medicinal cannabis was legalised at federal level.
Solomon was finishing her MBA at the University of Western Australia when all this was going on and thought it would be a good time to get involved in what was a new and exciting industry for Australia.
But having delved deeper she didn’t think she had the expertise to join the nation’s fledgling cannabis sector.
70 Seizures A Day
Then fate intervened. “Maybe it was serendipity,” Solomon says, “but I was introduced to a young girl who was suffering 70 seizures a day. All traditional medicines had been exhausted and this child was susceptible to brain damage with every seizure.
“I realised that the only thing that was helping manage her seizures was when she was accessing medicinal cannabis. It was at that point that I thought there was an opportunity to provide people around the world with Australian grown cannabis medicines that could solve real patient problems.”
In 2016 she founded Perth-based Little Green Pharma (LGP) where, as managing director, she has rapidly grown the enterprise from a medicinal cannabis start-up into an Australian Stock Exchange-listed company and one of her home nation’s sector leaders spanning cultivation, manufacturing, extraction, and distribution.
More than that, LGP is becoming an increasingly important player on the global medicinal cannabis stage, not least in Europe where the operation is a supplier of high-THC cannabis flower medicine to German pharmaceutical cultivator, importer and wholesaler, Demecan.
And having earlier this year won a government tender, LGP is also now the primary supplier of medicinal cannabis oils for a two-year trial in France testing the efficacy, safety and quality of the plant’s therapeutic benefits in up to 3,000 patients.
LGP beat off competition from potentially better known rivals to win its place on the programme which, if successful, could lead to the legalisation of medicinal cannabis in France – opening up a new lucrative European market.
Casting her mind back five years, Solomon admits. “It’s been a steep learning curve. Before 2016 cannabis was a prohibited substance in Australia, and it was only then that it was legalised for medicinal purposes.
“It was a whole new industry to navigate. The rules were muddled. There wasn’t a pathway that had already been trodden. We could only go on existing pharmaceutical industry rules, and cannabis is a plant that is very different to most pharmaceutical drugs.
“As one of the first companies to be granted a licence in Australia to cultivate and produce cannabis medicines, we had to work really closely with our regulators to almost, not define the industry, but to help each other out to understand the process, because it was brand new.”
Medical Cannabis Success
Australia has been something of a success story when it comes to medicinal cannabis legalisation. Unlike the UK where patients are still finding it challenging to access medicinal cannabis two-and-a-half-years on from the law changing, Australia has around 116,000 Special Access Scheme (SAS) category B approvals, with up to 9,000 more coming on stream each month.
But whereas in the UK only specialists can prescribe medicinal cannabis, in Australia GPs are free to do so, making access quicker and easier.
Ms Solomon confesses the thinking Down Under was that the UK medicinal cannabis market would unfold in the same way as it has in Australia. “Because we have very similar pharmaceutical models, we always thought it wouldn’t be long before GPs were allowed to prescribe and that patient access would be made easier, but it has been slower on the uptake and sadly there just aren’t the patient numbers at the moment.
“Personally, as a business, we think it’s a very important market and it’s one we want to be in, but at the moment there are other countries that require our energy first because they are either more lucrative or easier to deal with.”
Europe is a key target, and to help facilitate this LGP recently completed a A$27m capital raise plan to help speed-up sales and marketing efforts in both Australia and overseas. This has seen the firm take on staff in Germany, and last year Solomon herself spent time living and working in Switzerland as LGP gears up for its assault on the European front.
Australia’s Minister for Health, Greg Hunt, has described the European market as a necessity for the country’s cannabis producers, given it’s almost impossible for companies to make any return on investment based purely on the domestic market.
European Market In Sights
“He’s absolutely right,” Solomon says. “Australia has a population of 25m, and when you look at what that may look like in terms of what the market could be worth at maturity, you might be looking at A$1bn.
“It makes sense that the international market has to be key for us when you start looking at European countries like Germany, France and the UK, where each has upwards of 60m people. It is where, in the future, the profits will come and investors will get a return.”
Solomon proudly states that all LGP’s medicines are EU-GMP (Good Manufacturing Practice) compliant. “We are selling our medicines into countries like France and Germany, where the regulatory and testing requirements are very rigorous, so we are very pleased we are getting our medicines imported into those countries.”
The firm has an agreement with Astral Health in the UK – part of LYPHE group – and has sent over 1,000 bottles of its medicinal cannabis oils on consignment, but Solomon says LGP is exploring further opportunities to make inroads into the British market.
Europe is an exciting and dynamic place for LGP to be moving into, Solomon says. “I just feel that every six months or so there is another country where medicinal cannabis is becoming legal. Some countries might be smaller than others, but when you look at the total addressable market in Europe there is upwards of 700m people, and maybe not every country will legalise cannabis, but it is certainly looking like many will.
“It is safe to say that there are already key countries in Europe, the UK being one of them. Sure, it is a bit slow to begin with, but it will get there, it will ramp up, and we absolutely want to be there for when it does.”
It was recently announced that Demecan had ordered an additional 21,300 units of LGP’s high THC cannabis flower medicine worth A$2.5m, for delivery in the quarter ending December 31 this year. This followed consistent growth in the size of Demecan’s quarterly purchase orders with more than 47,000 units destined for the company in 2021.
Solomon says: “It shows a lot of confidence in LGP’s supply and the quality of our medicine, but also I think the demand coming out of Germany, which gives us evidence that our strategy and our growth into international markets is paying off.
“Australia is the heart of our business, but Europe is the future.”
This is despite a global cannabis supply glut. But Solomon says: “Whatever we can grow in our facility we can sell into Germany and Australia. The demand is there for high quality GMP medicines. What we are finding is that the over supply of biomass is not from companies that have EU-GMP compliance.
“There are a lot of countries that require EU-GMP approved and at the moment it is almost in short supply. There are only a handful of companies across the globe that actually have EU-GMP certification. The GMP in Canada is not the same as EU-GMP, so there is only a handful of companies there that have actually got the authorities from Europe to go to their facility to audit and approve.
A Handful EU-GMP Compliant Companies
“Europe is looking to other markets, such as Australia, perhaps even Colombia, so at the moment I don’t see that there is an oversupply, I see a shortage of supply in the high quality EU-GMP approved. That is the space that LGP is in.”
Solomon is a supporter of Australia’s strict regulatory standards. “I see it as an advantage as it means with all the hoops we have to go through to get to an end product, we know it is of very high quality. We are probably one of only a few countries that can get into certain jurisdictions, such as France and Germany.
“When you are competing with other jurisdictions that don’t necessarily have that same level of oversight and you are up against other products that might potentially be sub-par and haven’t undergone the same scrutiny and testing that we do here in Australia, is that a disadvantage?
“It makes us one of the few companies and countries that can import into places like Germany and France which I think, in terms of Europe, has a huge future in terms of the medicinal cannabis space.”
LGP On A QUEST
Another inroad for LGP into the European market may be QUEST (the Quality of Life Evaluation Study) being facilitated Australia-wide by Sydney University. Running over two years, it hopes to recruit a minimum of 2,100 patients with the aim of providing reliable, objective and clinically-relevant data globally for those accessing medicinal cannabis treatments for a broad range of conditions.
Sponsored by LGP – which is exclusively supplying the medicinal cannabis products – over 800 patients are currently enrolled.
Solomon says: “The beauty of QUEST is that we can engage not just with Australian patients, but with international markets. What is wonderful about QUEST is that it is ethics approved, which makes it quite different from a lot of other studies. It also has an independent panel, which includes doctors who are anti-cannabis as a medicine.
“The goal is that soon we will start to collate data across different conditions and individuals that can be used to explain to doctors the benefits and role that cannabis has to play as a medicine.”
Because it has already been ethics approved, Solomon explains it makes it easier to potentially move QUEST into the European sphere.
“Even in Germany it is a great opportunity to be able to recruit doctors to the QUEST initiative and join the dots between patients and medics.
“It has to be the right time for the UK, though” she adds. “I would love to be able to say it will be this year, but there is so much happening and so many competing priorities in this industry that you have to focus on the top few things. We want to get some invaluable feedback from the Australian study first so we can make it a very seamless experience when we do roll it out.”
Solomon says being involved with QUEST gives LGP the confidence that it’s in the industry for the right reasons. “Our focus is pharmaceutical grade medicines only. We don’t dabble in adult use or recreational areas. Our motivation is, and always will be, patients.”