Oz Medicann Group (OMG) is moving out of "stealth mode" as it readies the launch of its pharmaceutical division, bringing a topical pain-relief salve and CBD products — including a flower range — to market for patients managing a range of medical conditions.
OMG is also collaborating with NICM Health Research Institute on what it describes as a "ground-breaking, research-backed clinical trial" of a sublingual insomnia tablet, with the goal of registering it as a Schedule 3 (over-the-counter) medicine.
The pain-relief salve — OMG's first product to combine full-spectrum CBD with Kunzea oil — will be accessible through Australia's special access scheme and sold as a non-prescription product in international markets. Development of the flower range has been driven by a recent uptick in patient demand.
Founder John Leith said the pharmaceutical division's launch stems from the company's personalised medicine strategy, which centres on patient outcomes rather than revenue targets. He added that the success of sister company Hemp Oz has given OMG both the breathing room and the funds to grow on its own terms.
"It's management consultancy 101," he said. "Who's your customer? It's no use thinking 'if you build it, they will come'. The approach we've taken is to ask patients what they want to address — sleep for example — and then we've looked to solve that problem.
"We have researched the common conditions suffered by patients in Australia and globally, and these are predominantly insomnia, chronic pain, anxiety and depression.
"And we have worked closely with our research partners at NICM Health Research Institute as well as the Medical Research Institute of New Zealand and our broad-based medical advisory team to come up with the best solutions.
"Personalised medicine is the biggest opportunity in the world today, a new era, not just for cannabis. As the legal and regulatory framework matures, OMG is well positioned to address the medical needs of patients and make them feel at ease. That's what we do."
Leith's path into the industry, like that of many others, has personal roots. His interest in medicinal cannabis was sparked when his brother, a solicitor, was diagnosed with cancer and found relief through CBD oil.
At the time, however, the medicine remained illegal, meaning his brother was putting his career on the line by obtaining it through illicit channels.
Leith said: "The only reason OMG exists is because of my belligerence. When my brother — whose quality of life was dependent on this stuff — told me it was illegal and he would be disbarred if he was caught taking it, I was raging."
With legalisation still a distant prospect at that point, Leith channelled the bulk of his energy into Hemp Oz, a move that allowed OMG to remain self-funded and grow without outside pressure.
“Personalised medicine is the biggest opportunity in the world today, a new era, not just for cannabis.”
john leith
That pace is now set to accelerate — though for Leith, the priority remains quality over scale, with patients and patient access at the centre of everything the company does.
"We're coming out of stealth mode, and while we would welcome it, we don't want to be necessarily the biggest in this space, we want to be recognised as the best," he said. "We are building a brand that's trusted to deliver what patients need."
Central to that ambition is OMG's CBD sleep trial, which will put its sublingual cannabis tablet through a rigorous process in pursuit of over-the-counter registration for insomnia treatment.
After disappointing phase III clinical trial results for Ecofibre and Cann Group — both of whose drug candidates failed to demonstrate a sufficient difference from a placebo — Leith could be excused for harbouring some doubt.
But he said he remains confident the trial will succeed, pointing to the tablet's distinctive characteristics, including improved bioavailability, and the calibre of the team behind it. Emeritus Professor Alan Bensoussan, former director of NICM Health Research Institute, is overseeing the project for OMG.
"We've worked on this formulation for two years, we're quietly confident," he said.
Having substantial financial backing has also helped — something the performance of Hemp Oz has made possible.

"I've spent more money (on OMG) than on my retirement, I've practically sold the family silver," Leith said with a wry chuckle.
"But we knew we needed a revenue stream [via Hemp Oz], you need some money coming in, right? That was always part of the business model. Unlike some others in the industry, OMG enjoys a healthy level of financial security."
That financial position has allowed OMG to put the final element of its patient-centred approach in place: a compassionate access scheme that Leith considers one of the company's key points of difference in the market.
"Patients above profits is the mantra we work with at all times," he said. "It's not just rich people who need this medicine. We will be providing access to those that can't afford it with a compassionate access module that goes above and beyond."
"It's a specific program that we've written, in conjunction with medical professionals. It's one of the biggest reasons we are providing flower products, because we can see the numbers and we can see the cost of sourcing them.
"We know that's a massive barrier to people and we want to offer them medicine they can actually afford. If it needs to be free for some patients, because they're end of life for example, that's what we'll do.
"We put patients above profits. That's our entire DNA and we'll make good on that by providing quality products at a breakthrough price."