German pharmaceutical company Vertanical believes it is on course to deliver the first ‘whole-plant’, cannabis medicine with international approval.
After seven years of endeavour, and an investment of over $250m, its VER-01 chronic pain-relief drug has passed a Phase 3 trial in its home market.
As the first multi-compound cannabis medicine to have successfully passed through the Randomised Control Trial (RCT) procedure, VER-01’s development is a significant milestone.
Vertanical says VER-01 has the potential to become the planet’s leading, non-opiate, chronic-pain treatment.
With approval as an ‘authorised medicinal product’ in Germany, the ‘mutual recognition procedure’ will allow it access to the rest of the European Union market.
And, it believes it will help overcome the caution exercised by many clinicians – steeped in a pharmaceutical mindset – when it comes to prescribing medical cannabis.
UK And The US
As well as Europe, it is looking at the UK and US markets with trials underway in both countries as it seeks to gain access to markets totalling over one billion people.
In the UK, the results of its Phase 2 trial at St Pancras Hospital in London, which was completed in July this year, are currently being assessed, and it is set to launch a Phase 3 study in the US.
The company told us: “Being in communication with the FDA (Food and Drug Administration) we believe we can overcome the hurdles by providing significant data.”
Ver-01’s emergence as a potential alternative to opioid-based pain-relief treatments has been welcomed.
Dr Callie Seaman, Executive Director and Scientific Lead at the UK’s medical cannabis support group the Medcan Family Foundation, said: “This is a fantastic step in the right direction and of particular significance is the multi-compound nature of the drug.
“Flower has its place, but some doctors are reluctant to prescribe it because of its delivery method and variability.
“I like the focus on one disease, and hope it will pave the way for other multi-compound, cannabis medicines to be developed to treat other diseases and conditions.
“For many generations, clinicians have been taught that cannabis is the devil’s lettuce, but this approach should secure the support of these specialists and remove the stigma.
“This will definitely push things forward; this is a very exciting and the right route to follow. Many people using opioids do not recognise how dependent they can become. So I like the company’s focus on the potential of cannabis to solve these problems with no risk of overdose.”
In e-mail dialogues with Business of Cannabis Vertanical’s Dr Merit Renner, Senior Manager Business Development, and colleague Katharina Castlunger, outlined the company’s ambitions.
“VER-01 is expected to be available in Germany in 2026. Through the mutual recognition procedure, we plan on expanding to other countries, including the UK.
“We are confident that VER-01 will receive market authorisation and be prescribed by doctors.”
Vertanical was established by 50-year-old Clemens Fischer, a medical doctor and founder of the Munich-based Futrue Group, which has a portfolio of around two dozen companies in the over-the-counter and supplement space.
Its medical cannabis cultivation site and pharmaceutical manufacturing plant are in Denmark, and after passing the Phase 3 German trial, featuring 800 patients, it anticipates securing market approval next year.
Its trials have so far shown significant improvements in patients suffering from chronic back pain. Vertanical told Business of Cannabis that patients experienced ‘mild to moderate side-effects such as dizziness or dry mouth in the initial phase’ before these ‘tapered off’, with no evidence of addiction.
In an interview with Forbes, Mr Fischer said: “We believe that we will be the first non-opiate, chronic-pain treatment worldwide.
“If you have a drug which shows it is more efficacious and has fewer side effects, you can get a significant share of this market. I don’t want to do any projections, but the market is huge, and there is not a single replacement for opioids in the world.”
Ver-01 contains more than 100 compounds featuring a number of cannabinoids, including low levels of THC, CBD and CGN.
Multi-Compound Complexities
Securing regulatory approval for multi-compound, botanical medicines has so far proven to be quite a task in the US and elsewhere.
Jazz Pharmaceuticals, formerly GW Pharmaceuticals, has tried and failed to clear this bar in the US with its multiple sclerosis-spasticity treatment Sativex, containing both THC and CBD.
The RCT procedures tend to favour single-compound medicines such as Jazz’s Epidyolex, which contains CBD, and Nabilone containing THC.
The pharmaceutical pathway for medicine favours single-compound treatments, whilst botanical drugs struggle to clear this bar due to the elevated number of active compounds in plants.
Currently, there are only four US Federal Drug Agency-approved botanical drugs, including Filsuvez, which is made from birch bark extracts, for treating wounds in some patients.
The UK’s Medicines and Healthcare products Regulatory Agency confirmed that, following Brexit, the EU Mutual Recognition Procedure is defunct.
To secure a Marketing Authorisation Application, the available submission routes for Ver-01 include the ‘national assessment route or, if a licence has already been obtained in another eligible territory, via the International Recognition Procedure.’
It added: “A Marketing Authorisation will only be granted in the UK after the MHRA have assessed the supporting data that demonstrate the quality, safety and efficacy of the medicine for the conditions it is intended to treat and to confirm that it has an acceptable balance of risk and benefit.”
This article was originally published by Business of Cannabis and is reprinted here with permission.
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Author: Business of Cannabis
