European medicinal cannabis manufacturing powerhouse SOMAÍ Pharmaceuticals is set to shake up the Australian market with a range of products designed to create new standards in the quality and variety of cannabinoid medicine.
The Portugal-based company, which operates a 3,800 square metre, state-of-the-art manufacturing facility and 2,500sqm indoor cultivation facility boasting Cookies genetics and non-irradiated material, has identified the Australian market entry as the key pillar of its international expansion strategy.
The multi-country expansion, which also includes Germany, Poland and the UK, is the first significant international move for SOMAí and comes six months after it received EU-GMP certification from the Portuguese Health Authority, INFARMED, for its hi-tech Lisbon manufacturing facility.
Australian entrance prioritises access and innovation
SOMAÍ will invest A$1.6 million in the market, with chairman and CEO Michael Sassano explaining the company is setting itself up in Australia with a long-term vision to hold patient interest by introducing a consistent supply while showcasing innovative cannabis formats. SOMAÍ has a wide variety of single-strain extracts and proudly displays its minor cannabinoid profiles and proprietary terpene blends. The company wants patients to taste the difference.
“I want Australia to know that SOMAÍ is here to stay and will supply product lines that prescribers and patients currently do not have, while eliminating worries that inventories will run out,” Sassano said.
“As direct manufacturers, we can assuage those concerns as we control our production and have direct-from-the-manufacturer pricing power. We want people to try as many of our 80-plus growing portfolio until they find the right one, and be sure they will receive the same effect and single strain continuously.”
Already, a four-strong medical science liaison (MSL) team is engaging with medical practitioners on the ground, with a non-exclusive, neutral distribution plan to enable the widest reach. In addition, commercial deals are being finalised with clinics and large doctor groups to try the products and plan for continual releases throughout the year.
Examining SOMAÍ’s product lines in the new market
Sassano forecasts that SOMAÍ’s manufacturing capabilities will set the company apart, with the facility producing a current IP vault of more than 80 stabilised products, a number that continues to grow.
While once describing how SOMAÍ makes products for “today, tomorrow and beyond”, Sassano now suggests “the future is now”, with the company previewing its advanced products for the Australian market in April.
Product lines to be released throughout 2024 feature SOMAÍ-branded oral drops, sprays, vaporisers and gel caps. And before the end of the year, it will preview new live resin and live rosin vaporisers and concentrates, a unique hash line and edible lines.
The company’s initial extracts are made from single-strain cannabis flower, and will be available in a range of formulations and sizes to suit all patient and practitioner preferences.
“It’s unique to have all single-strain extracts and equally singular that all the extract is derived from full flower rather than trim,” Sassano said. “Single-strain genetics will ensure the product you receive today is the product you receive tomorrow and the product you receive forever.”
Down the road, SOMAÍ’s focus on terpene and cannabinoid blending will also set them apart in global markets, Sassano said. In addition to notable CBD and THC content, subsequent extracts to be rolled out in Australia are “packed” with minor cannabinoids and terpenes.
“SOMAÍ is coming to Australia with a full range of products and different formulations that people haven’t seen before,” he said. “We want people to have ‘me too’ alternative product lines from SOMAÍ, and we made those for sampling, but we also believe that early-extract products will eventually disappear as our more advanced products take their place.”
Among those set to be rolled out in Australia are a range of vapes and oils manufactured and distributed in collaboration with US-based Airo Brands.
Under the terms of a recent agreement, SOMAÍ will exclusively make Airo’s vaporiser battery technologies and its AiroPod oil formulations with the first products expected to be available under the Special Access Scheme in the second quarter of the year.
Presenting quality cannabis products to patients and practitioners
Critically, SOMAÍ’s state-of-the-art manufacturing processes will remove all poor-tasting and non-essential materials to create products that enhance the patient experience.
“There is no illusion to what I call the golden triangle of extraction,” Sassano said. “You want products to be economically priced, have a great effect and a good taste. If you can’t achieve those three components, you’re doing something wrong.”
Sassano noted that good or bad taste makes or breaks a cannabis product, pointing out the unpopularity of Sativex due to its taste and many early-form oral drops.
“As an example, we have made a better-tasting, faster-absorbing Sativex-like spray to provide people with a far better consumer experience,” he added.
Varied products mean access to the most Australian patients possible
While Australia has moved from an oil-dominant market to flower over the past two years, Sassano believes it will continue to evolve.
“Over time, we believe people change their tastes or want different things, and although SOMAÍ provides all formats and options, as markets mature people want different formats, and the market balances out,” he said. “In the US, the market is about 40% flower and 60% extract-based products.”
Speaking about varied product formatting, Sassano said: “It’s kind of like the Field of Dreams. If you make it, they will come. Extract adoption happens as better performing products are made – some may want increased absorption and faster onset, others great terpenes and cannabinoid profiles. In a nutshell – excellent performance.”
However, he emphasised that SOMAÍ is not coming Down Under to tell people what and how they should consume their cannabis medication.
“We’re not here to tell anyone they’re right or wrong,” Sassano said. “We’re here to say ‘we’ve made a broad range of products to address people’s preferences and deliver a large selection of inventories to ensure patients prefer to stay within the SOMAÍ product ranges’.”
SOMAÍ ensures medical cannabis affordability via direct manufacturing
Sassano said part of SOMAÍ’s unique proposition as the direct manufacturer is its ability to control pricing and inventory and ensure quality is maintained throughout the production stages. If you like a product, it will remain consistent and affordable.
All production lines are automated – including for its 24 vape offerings – and techniques like extracting terpenes before major cannabinoid extraction are the most advanced in global medical markets to date. The facility also includes its own on-site microbiology lab to facilitate the rapid dispatch of microbe-free products.
“We control the entire output with precision and manufacture to the highest EU pharmaceutical standards,” Sassano said. “SOMAÍ has invested heavily in making these products – all with a minimum of one-year stability attached to them – and we’ll find out what Australia likes best.”
“But we already know that people want an economical price and stable supply,” he continued. “They don’t want to hear that their extract manufacturer has changed because suppliers are bidding for the next cheapest extract rather than stable, quality products that fulfill the extract golden triangle equation of excellent effect, good pricing and taste.”
Practitioner education is a core component in SOMAÍ’s success
Key to SOMAÍ’s success in Australia will be its educational outreach as new products are launched and its MSL team educates doctors to help patients choose the right products and try others.
Sassano said he wants to continue to expand the team with top extract sales people in the region and that they will conduct doctor education in a way that makes sense with a staged rollout of products.
Newly acquired indoor cultivation and brands
Recently, through the acquisition of RPK Biopharma, Somai added a 2,500sqm indoor grow facility near its manufacturing HQ, just outside Lisbon with Cookies strains being harvested in a month.
The acquisition will significantly accelerate the firm’s global leadership and improve its ability to deliver a ground-breaking, differentiated, cannabinoid-containing product portfolio to meet patients’ needs worldwide, Sassano said.
Additionally, it will expand SOMAÍ’s capacity with cultivation, manufacturing and distribution assets, making it one of the few verticals in the EU able to cater to the diverse needs of fast-growing European cannabis markets.
Furthermore, the deal will give it immediate dried flower market leadership, an expanded product portfolio and a partnership with the well-known Cookies brand that has met the highest German standards not requiring the flower to be irradiated.
Somai also boasts the global contract with the largest vaporiser brand in the US, AiroPro, and will be bringing the most innovative vapes to the Australian market.
Sassano said SOMAÍ’s facility and know-how – after years of making vaporisers – “shines out among the crowd and knows patient preference”.
To illustrate its expanding international footprint, the firm struck a number of deals late last year to build its presence in the lucrative German market.
In December, SOMAÍ announced a landmark two-year, €10m agreement with medicinal cannabis wholesaler Canymed that will see it leverage Canymed’s extensive distribution network to ship products to Germany.
At the same time, a deal was signed with cannabis healthcare brand Grünhorn to create an exclusive co-branded product line to include various ratios of CBD and THC.
Sassano said the collaborations with Canymed and Grünhorn underscored SOMAÍ’s dedication to meeting Germany’s evolving healthcare needs.
The firm also signed a three-year marketing and distribution agreement with Canify. The partnership will encompass a joint brand-building approach where products will be manufactured and formulated using SOMAÍ’s technology. The product portfolio will feature multiple product lines new to the German market, and specifically adapted for German patients.
Sassano said the partnership is forecast to generate €5m over the duration of the agreement and capture 10% of the German market.
Global medical cannabis explosion
Germany has removed the narcotics classification of cannabis, and the US has the potential to reclassify cannabis from a Schedule I to a Schedule III drug.
However, Sassano said the most important medical cannabis documents to ever be released are the US Health and Human Services letter and corresponding 252-page Food and Drug Administration report, which definitively say that cannabis is not only safe – safer than pharma alternatives – but that the medicine is effective in treating “at least” 15 indications, including neuropathic pain.
He added: “Just about every regulator around the globe is weighing this report based on six million cannabis patients and 30,000 prescribing doctors and thinking to themselves that they have a chance to transition people to safer alternatives with proper policies.”
SOMAÍ has a global reach of products, with EU-GMP the gold standard for any country. When any new medical cannabis markets open, the company said it will be there with early-stage products and more advanced ones like those Australia will covet.
Sassano said the company has research and development (R&D) budgets to produce and pay for stability studies on more than 100 products by the end of Q1 2024 which will keep it innovating and addressing the needs spectrum for any market, young or mature, for decades to come.
