European medicinal cannabis manufacturer SOMAÍ Pharmaceuticals is preparing to enter the Australian market with a product range intended to raise the bar on quality and variety in cannabinoid medicine.
The Portugal-based company operates a 3,800 square metre manufacturing facility and a 2,500sqm indoor cultivation facility featuring Cookies genetics and non-irradiated material. It has identified Australia as a central pillar of its international expansion strategy.
The multi-country push — which also covers Germany, Poland, and the UK — is SOMAÍ's first major international move, arriving six months after the company secured EU-GMP certification from Portuguese health authority INFARMED for its Lisbon manufacturing site.
Australian entry prioritises access and innovation
SOMAÍ will commit A$1.6 million to the Australian market. Chairman and CEO Michael Sassano said the company is positioning itself for the long term, aiming to hold patient interest through consistent supply and novel cannabis formats. SOMAÍ offers a wide selection of single-strain extracts and prominently discloses its minor cannabinoid profiles and proprietary terpene blends, with the goal of giving patients a noticeably different experience.
"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."
A four-person medical science liaison (MSL) team is already meeting with medical practitioners across the country. The company plans a non-exclusive, neutral distribution arrangement to maximise its reach, and is in the final stages of commercial agreements with clinics and large doctor groups, with product releases planned throughout the year.
A closer look at SOMAÍ's product lines for the new market
Sassano expects SOMAÍ's manufacturing capabilities to distinguish the company from competitors. Its facility currently holds an IP vault of more than 80 stabilised products, a figure that continues to climb.
Having previously described SOMAÍ as making products for "today, tomorrow and beyond," Sassano now says "the future is now," with the company previewing its most advanced offerings for the Australian market in April.
Product lines scheduled for release throughout 2024 include SOMAÍ-branded oral drops, sprays, vaporisers, and gel caps. Before year's end, the company also plans to preview live resin and live rosin vaporisers, concentrates, a unique hash line, and edible products.
The company's initial extracts are drawn from single-strain cannabis flower and will be offered in a variety of formulations and sizes to suit different patient and prescriber needs.
"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."
Going forward, SOMAÍ's work in terpene and cannabinoid blending will further differentiate it in global markets, Sassano said. Beyond significant CBD and THC content, subsequent extracts to be introduced 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 the products headed to Australia is a range of vapes and oils manufactured and distributed in collaboration with US-based Airo Brands.
Under a recent agreement, SOMAÍ will exclusively produce Airo's vaporiser battery technologies and AiroPod oil formulations, with the first products expected to be available through the Special Access Scheme in the second quarter of the year.
Delivering quality cannabis products to patients and practitioners
SOMAÍ's advanced manufacturing processes are designed to strip out off-tasting and non-essential compounds, improving the overall 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 pointed to taste as a decisive factor in whether a cannabis product succeeds or fails, citing the limited uptake of Sativex as a product undermined by its flavour, alongside many early 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.
Broad product range aims to reach as many Australian patients as possible
Although Australia has shifted from an oil-dominated market toward flower over the past two years, Sassano expects the market to keep evolving.
"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."
On the subject of product format diversity, 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."
He was clear, however, that SOMAÍ is not arriving in Australia to dictate how patients should use 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'."
Direct manufacturing gives SOMAÍ control over pricing and quality
As the direct manufacturer, SOMAÍ's ability to control both pricing and inventory — while maintaining quality at every stage of production — is central to its pitch to patients, Sassano said. Products that work will remain consistent and affordable.
All production lines are automated, including for its 24 vape offerings, and the facility uses techniques such as extracting terpenes prior to major cannabinoid extraction — among the most advanced approaches in global medical markets. An on-site microbiology lab allows 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 central to Australian strategy
A significant part of SOMAÍ's Australian plan rests on educational outreach. As new products are introduced, its MSL team will work with doctors to help patients identify the right products and explore alternatives.
Sassano said he aims to grow the team by bringing in experienced extract sales professionals across the region, who will conduct doctor education in a structured manner aligned with the staged product rollout.
Newly acquired cultivation facility and brand partnerships
Through the recent acquisition of RPK Biopharma, SOMAÍ gained a 2,500sqm indoor growing facility located near its manufacturing headquarters just outside Lisbon, with Cookies strains due for harvest within a month.
The acquisition will considerably accelerate the company's global position and sharpen its capacity to deliver a differentiated, cannabinoid-containing product portfolio to patients worldwide, Sassano said.
It also expands SOMAÍ's capabilities across cultivation, manufacturing, and distribution, making it one of the few vertically integrated operations in the EU capable of meeting the varied demands of rapidly growing European cannabis markets.
The deal also gives SOMAÍ immediate leadership in the dried flower segment, a broader product portfolio, and a partnership with the well-known Cookies brand — products that have met the highest German standards without requiring irradiation.
SOMAÍ also holds a global contract with the largest vaporiser brand in the US, AiroPro, and will be bringing its most advanced vape products to the Australian market.
Sassano said SOMAÍ's facility and expertise — built over years of vaporiser production — "shines out among the crowd and knows patient preference."
Reflecting its growing international footprint, the company concluded several deals late last year to build its presence in the German market.
In December, SOMAÍ announced a landmark two-year, €10m agreement with medicinal cannabis wholesaler Canymed, through which it will use Canymed's distribution network to ship products into Germany.
Simultaneously, a deal was signed with cannabis healthcare brand Grünhorn to develop an exclusive co-branded product line featuring various CBD and THC ratios.
Sassano said the agreements with Canymed and Grünhorn reflected SOMAÍ's commitment to addressing Germany's changing healthcare requirements.
The company also signed a three-year marketing and distribution agreement with Canify. The partnership involves a joint brand-building approach in which products will be manufactured and formulated using SOMAÍ's technology. The portfolio will introduce multiple product lines to the German market, tailored specifically for German patients.
Sassano said the partnership is projected to generate €5m over the life of the agreement and capture 10% of the German market.
Global medical cannabis growth
Germany has removed cannabis from its narcotics classification, while the US is considering reclassifying cannabis from a Schedule I to a Schedule III drug.
Sassano described the US Health and Human Services letter and the accompanying 252-page Food and Drug Administration report as the most consequential medical cannabis documents ever published — definitively stating that cannabis is not only safe, safer than pharmaceutical alternatives, but also 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."
With EU-GMP certification as the global gold standard, SOMAÍ said it will be positioned in any new medical cannabis markets that open, ready with both entry-level and advanced products of the kind Australia is expected to embrace.
Sassano said the company has research and development (R&D) budgets in place to produce and fund stability studies on more than 100 products by the end of Q1 2024, keeping SOMAÍ at the forefront of innovation and capable of meeting the needs of any market — new or mature — for decades ahead.
