Michael Sassano has been involved in everything from real estate to banking and cutting-edge tech investment.
But he is perhaps best known as one of the cannabis industry’s original influencers.
An international authority on large-scale cannabis cultivation and medical product development, he is also a respected industry ‘futurist’ with a proven track record of successfully predicting long-term market trends.
A founder and former CEO of US-based cannabis cultivation company, Solaris Farms, which he led to a merger in July 2020 and where he remains on the advisory board, Sassano has since shifted his focus to Dublin-headquartered SOMAÍ Pharmaceuticals.
An international concern focused on extraction of the cannabis plant and the manufacturing of pharmaceutical formulations for the rapidly developing EU market, Sassano is both SOMAÍ’s CEO and chairman.
SOMAÍ is currently developing a state-of-the-art, scalable, high out-put extraction hub in Portugal as the company looks to position itself as one of the top global pharmaceutical distributors of medical-grade EU-GMP certified cannabis formulations.
The Portuguese facility will begin its extraction operations across 3,700sq m in Q2 of 2022, with the ability to expand to up to 12,000sq m, making it one of the largest manufacturing facilities of its kind in Europe.
SOMAÍ is investing more than €20m – which includes an innovative products grant of €2.7m awarded recently by the Portugal 2020 Committee.
SOMAÍ is currently working with Lisbon’s Lusófona University on its dossier prep as it develops multiple branded cannabinoid formulations with various delivery methods – gel caps, oral sprays, drops, sublingual strips and transdermal patches – for launch into the EU market next year.
SOMAÍ has also signed numerous biomass and distribution deals with future partners as it looks to set up additional extraction hubs in other European locations and dominate the market in terms of manufacturing and product formulation.
Here Sassano explains to Cannabis Europa what makes SOMAÍ Pharmaceuticals special, and what the future holds for the company he set up in 2019.
CE: Thank you for agreeing to be interviewed Michael. You’ve described SOMAÍ as being special and very different to its competitors. Can you elaborate?
MS: In Europe there aren’t many companies that are focused on extraction and, more importantly, formulation of products with multiple delivery devices for the medical community.
Just to give you a little background on that, currently under the herbal medicine rules, which cannabis falls under, it’s a shorter path to registering medicine as an API (active pharmaceutical ingredient) into the European market. Instead of five to 10 years of clinical trials to get your product out on the market, it takes about 18 months.
Why is that important? Because as a company we can get to the point of driving revenues earlier than the traditional clinical path of a biotech.
On the other side, we are a manufacturer, so we can make these products. But unlike other companies out there in the biotech world, and this is very important, we are really a biotech company creating IP (Intellectual Property), APIs and cannabinoids that weren’t really accessible to Europe until recently.
In the biotech world you are either a manufacturer or you are a think tank doing biotech. We have the ability to create a medicine that can go to trials. We can also create different cannabinoids for research and development (R&D) or, on top of that, go for registering them under the monographs.
Take the cannabinoid CBN. It currently doesn’t exist under the EU monograph. Ultimately, we can create that API, we can research it, and we can try to show its uses and its safety for human consumption. We can go down that path to register something that although it exists in the US market doesn’t in the EU.
So, we can go the herbal medicine route, we can go the clinical route, but we can also produce specialised cannabinoids for development. These are all very positive things.
Another major differentiator is that we can actually produce a highly purified cannabinoid. Herbal cannabinoids and THC and CBD distillates and combinations thereof, are currently the only accepted herbal medicines. But they can only be about 80% purified, and most companies are happy at that level.
Because of our equipment we can make more API’s by purifying those cannabinoids up to 99%.
You can derive purified THC or CBD, which is not in the herbal medicines but is in the AIM (Acute Internal Medicines). Then we can separate minor cannabinoids for further research and development or for future formulations with exact precision.
To take that a step further, we have a synthesis and isolation room, which means we can ultimately use semi-synthesis in order to produce cannabinoids that you can’t normally get in bulk, like CBN and CBG, and then use those for research, development and formulations.
To push it one last step as to what makes SOMAÍ so special, unlike most of the companies out there which are just producing bottles and droppers, we will be manufacturing multiple delivery devices.
We have designed our facility in Portugal to be able to produce the bottles, like everybody else, an oral spray, and soft gel caps, but we will also be able to make soluble tabs and possibly transdermal patches or vaporiser oils, depending on how far the market develops.
But at least in the beginning we know we will have drops, sprays and soft gel caps and we have enough room to expand with more equipment to produce others as we see demand increase for more products.
The final thing is that our facility can expand roughly four times larger than our current phase one. Most companies make their facility and they can’t expand. If they want to grow they have to build and certify a new facility. All we have to do is keep building rooms on.
It is quite a lot that differentiates us and makes us special.
CE: How does being involved in the US market help with your expansion into Europe?
MS: It has given us the ability to deal directly with patients and customers, to find out what people like, why they are using it, and what they want.
In Europe you give your product to a distributor, the distributor sells it to the pharmacy, the doctor gives the prescription to the patient, the patient fulfils it at the pharmacy, and no-one knows what happens after that. There’s no feedback.
Through our experience from the US, we interact directly with customers. We can say ‘look, how did this go?’ On top of that, it’s not just our products. We know everyone’s because a dispensary can’t just sell one thing, people want variety.
We have been able through loyalty programmes and questionnaires to find out what people like about the other brands, what sells well, what helps them better, and which products worked for them. This helps us determine why a product worked for the majority of people.
We are taking our expertise of being able to talk to patients in the US, of creating hundreds of products in the States, of being able to sample commodities from thousands of brands, and we’re bringing that know-how to the European market and then formulating that under the strict pharmaceutical EU-GMP rules.
Also, when it comes to operations, SOMAÍ already has an expert knowledge base that knows how to optimise extraction operations, how to realise their peak efficiency and, more importantly, there peak profitability.
This is rare in the European market, where many start-ups are still learning. This is something else that makes SOMAÍ stand out from the crowd.
CE: You have a partnership with Lusófona University. Can you explain more about that?
MS: Lusófona has an amazing department focused on plant based medicines. It means we are able to work with talented and knowledgeable scientists and start our dossier prep at lab scale size to more efficiently build our API’s.
You start with extraction, then distillation and then you are able to put those products, the THC and the CBD distillates, into stability studies.
We have well over 18 different growers that we are working with around the EU, and we are sampling their products and finding the best supplier for us, and creating our dossiers at the same time. No one genetic is the same, it’s important to study the results of as many cultivars as you can.
Once we have found the best suppliers, we will move those genetics to industrial production sometime around the end of Q2 in 2022. And we continue innovating and developing more and more API’s as new genetics come online.
These kinds of partnerships propel R&D and also give us access to the academic community which is researching plants, both narcotic and normal. There aren’t many cannabis companies that have partnerships with universities in order to do that.
CE: How many products are you hoping to produce?
MS: The initial roll out will be three products moving to five in our current facility without adding on more rooms and capabilities. Within those, you will have varying degrees of potency because it is not a one size fits all.
Additionally, by varying the CBD and THC contents, we are addressing the needs of various patients. Research tells us that people trying to solve pain, anxiety, stress, aggression, sleep, nausea etc, need different formulations. Even differences exist by age and sex.
We need to provide the doctors with variety and research to support fixing the ailments they are experiencing.
CE: Given the success you’ve had in the US market, why move into Europe?
MS: Europe is going to be one of the largest markets in the world, and being European I want to bring what I have learned to help people gain access to something they should have. We know that if we open a store or grow in the US, we make money tomorrow. In the EU the time to make money and to wait for the market to grow is much longer, and we have the uncertainty of the governments. So, this is more to me than just Euros, it’s a higher level of medicine and biotech.
But if you look at any of the markets that provide access on a medical basis, whether it be the US or Canada, the demand is huge and people are solving issues safely by using cannabis. Providing that access across Europe is an inevitability. We are already seeing expanding access to the medical market, as well as the adult use sector, in Luxembourg, Malta, Switzerland and soon Germany and Portugal.
As one of the largest population masses, of course people need cannabis access in Europe, or are the authorities just going to keep saying no, go to the black market?
Governments are going to wake up and see that people need access medically, that adult use is going to happen. It’s better to provide safe and quality products that are regulated and taxed.
Being one of the first, and also bringing the highest quality of products that are effective for consumers and providing relief for their indications, isn’t that the greatest movement to get into?
CE: Do you have any plans to list on the London Stock Exchange (LSE)?
MS: It’s a logical step. We are not your typical cannabis company. We are not your typical manufacturer. We are also a biotech. Although we can pay our bills by manufacturing and distributing herbal medicines today, the future is biotech for a company like ours where we can produce unique cannabinoids for R&D and unique formulations for clinical trials.
As such, we appeal to a much broader swathe of investors because biotech has been around for ever. There are no barriers as to how far science can push. Because we can create revenue line now, that makes us more special than a company that just spends money and eventually 10 years out has an approved drug.
We will have approved drugs next year and revenue lines that can propel us in R&D and more, so we have a greater flexibility to appeal to the biotech community. We can be revenue producing well before we have a clinical trial approved drug.
CE: What are your plans for IP going forward?
MS: It is to continually create API’s, generate registered medicines and build that IP vault. If we make a distillate from one grower that becomes an API; if we make one from another grower, that also becomes an API. If we mix them, that’s an API.
Different grower API’s are not the same because they are two different products. It doesn’t mean that one is worse or better, it just means that these are registered medicines, registered API’s, and then the mixture thereof becomes an API, and the delivery device it is used for becomes an API, and the creation of different cannabinoids becomes an API. You can start to extrapolate that this becomes an infinite equation of creating API’s.
It becomes a matter of focus and energy because no one has the money, especially in the early stages, to create hundreds of API’s, but over time you will just keep accumulating more registrations, more medicinal API’s, different API’s of cannabinoids, different formulations of cannabinoids, and different delivery devices of cannabinoids and mixtures thereof, different excipients mixed with the API’s, different flavourings, different terpene profiles.
Over time you will create hundreds of different products and you are always improving to the next generation. But luckily, because of our experience in the US, we are able to start with the next gen already as we know what products people are looking for and what helps them the most, so it becomes a matter of getting those registered on a European level under the pharmaceutical world EU-GMP title.
