Användningen av medicinsk cannabis har stark medvind i stora delar av världen, inte bara när det gäller medicinsk acceptans, men också för att den bygger på modern forskning och blomstrande affärer. I Danmark är en av de mest profilerade aktörerna inom området bioteknikbolaget DanCann Pharma; som trots att det bara har varit ett börsnoterat bolag i några månader redan har etablerat flera samarbeten. De senaste veckorna har varit särskilt intensiva för DanCann Pharma och BioStock vände sig till vd och grundare Jeppe Krog Rasmussen för att få veta mer om det senaste nyhetsflödet.

Målsättningen för det danska bioteknikbolaget DanCann Pharma är att upptäcka, utveckla, tillverka och kommersialisera nya terapeutiskacannabinoider för ett antal sjukdomsindikationer, där dagens läkemedel inte ger tillräcklig effekt eller för vilka det inte finns någrabehandlingsalternativ.

I april driftsattes bolagets första högteknologiska odlingsanläggning, BIOTECH PHARM1, för odling av medicinsk cannabis.

Nytt avtal med kanadensiskt läkemedelsbolag

Den 25 februari undertecknade DanCann Pharma en avsiktsförklaring (LOI) med kanadensiska Tetra Bio-Pharma Inc gällande exklusivdistribution av de cannabinoidbaserade läkemedlen Reduvo Adversa och Qixleef i Danmark, Norge, Sverige, Finland och Tyskland. Avtalet omfattaräven Tetras over-the-counter-produkt Enjouca. Den 5 maj tecknades ett slutgiltigt distributionsavtal med Tetra Bio.

Qixleef är ett botaniskt läkemedel som härrör från cannabinoiderna THC och CBD. Planen är att positionera läkemedlet mot genombrottssmärta, för inhalering med en medicinsk enhet av klass 2 som har godkänts av Health Canada.

Den 23 april meddelades det att Tetra Bio-Pharma hade skickat Qixleef till USA för att inleda REBORN1-studien, en 10-veckors öppen randomiserad fas II proof-of-concept-studie. Fem dagar senare meddelade Tetra-Bio att man har lämnat in en begäran till Malta Medicines Authority om ett vetenskapligt yttrande rörande Qixleef, inklusive vägledning om REBORN2-studien som ska genomföras i Europa.

Cannabis för behandling av genombrottssmärta

Genombrottssmärta är en typ av svår smärta som uppstår plötsligt, särskilt vid kroniska sjukdomar och svår cancer, trots regelbunden användningav smärtstillande opioider och snabbverkande morfintabletter.

Under de senaste åren har den medicinska användningen av opioider ökat avsevärt, delvis på grund av att de är mycket effektiva somsmärtstillande medel vid behandling av svår akut eller kronisk smärta. Problemet är att de är mycket beroendeframkallande och risken för missbrukär därför mycket hög. Inom läkemedelsforskningen pågår ett ihärdigt arbete med att utveckla nya substanser som kan ge lika god smärtlindring,men med färre biverkningar och en mindre risk för att utveckla beroende än opioider.

BioStock kontaktade DanCanns vd Jeppe Krog Rasmussen för en kommentar kring de senaste veckornas intensiva nyhetsflöde.

Jeppe, let´s start out with the collaboration with Tetra Bio-Pharma, with whom you now have a definitive distribution agreement. What do the hopes look like for being able to use cannabis as a treatment for breakthrough pain in cancer, and is there any scientific evidence that THC and CBD have pain-relieving properties?

– Early-stage research has so far concluded that there is substantial evidence that cannabis (among THC and CBD) is an effective treatment for pain treatments. We just need to fully understand them now (the pain-relieving properties) between formulations and how to administer in the best way, so to speak.

– The area has been “darkened” for many, many years, thus making it difficult to work in the field with cannabis and cannabinoids for research purposes. Fortunately, this has changed radically in recent years, and most recently by The United Nations (UN), which removed cannabis from the list of most dangerous drugs following a recommendation from the World Health Organization (WHO), a decision that is expected to have future far-reaching impact on cannabis and cannabinoid research and for medical use and purposes worldwide.

The opioid crisis in the United States in particular has claimed many victims in recent years. How is the need for new viable side-effect-free alternatives reflected in the market value of a viable and market-approved alternative?

– The call for an alternative has probably never been bigger, I think. The national opioid crisis in the United States, which in fact was a recognized “epidemic crisis” before we became acquainted with the terms of epidemics and pandemics, cf. our encounter with COVID19. The US opioid epidemic kills 130 people every day in the United States – equal to one person every 11 minutes. There is, in other words, a huge demand for new alternatives (with fewer side effects). The medication itself (opioids) is a bigger problem than the disease (2017: 70,000 deaths due to opioids).

– Preparations for pain relief purchased as prescription medicines (Rx) are likewise the largest group of preparations in Danish pharmacies and represents a market value of approx. 2 billion DKK, based on Rx-pharmaceuticals delivered in Denmark (2018).

– And if we are looking into Germany, we see a market, which today is worth over 1.25 billion DKK solely based on medical cannabis and cannabinoid-based pharmaceuticals (and not pain treatment in general), where approx. 80 per cent of these are prescribed to the area for pain treatment and pain patients.

– Just to put things in perspective: the global opioids market size was valued at 25.4 billion USD in 2018. In other words, once we have succeeded in our efforts, the potential is enormous.

You recently published adjusted forecasts for when sales can take off in the Danish market. Can you tell us a little about the background to this and when you expect the sales start to happen?

– We stick to our expectations about getting the actual approval for the handling and import during the end of Q2 or at least beginning of Q3. As you probably know, we applied for this approval all the way back in December 2020. From the achievement of these, the individual product applications await, and where the time aspect here was 30 days for processing an product application from DMA until late Q1 2021, the timetable for these can now be a bit unpredictable; it can, so to speak, take anywhere from 30 days to 100 days depending on several factors, and especially in these times of pandemic and COVID19.

You plan to start subsidiaries in Germany and Sweden at the same time as your pipeline will be expanded from medical cannabis only to approved medicines. Tell us more!

– The industry – and hereby also the patients – have had some challenges and restrictions regarding the Danish Pilot Program with medical cannabis (non-registered / non-approved medicals). With this step we are now entering into a completely new path around approved pharmaceuticals with cannabinoid-derived medicines, where these restrictions are assumed to be minimal. This provides us with a portfolio of products, where the risk is widely spread and a much more transparent business plan and future. In continuation of the above, we have, as another initiative, chosen to accelerate our market penetration, and are currently in the process of establishing ourselves in the German and Swedish markets, with a small dream of becoming a first mover in our field around exclusive distribution of approved cannabinoid-based medicines – for us to see a huge potential. In other words: a goal of building and achieving the position as market leader in the distribution of IP-based cannabinoid pharmaceuticals. Doesn’t sound bad, right?

Last week DanCann Pharma also issued warrants to the Board of Directors. Would you argue this is an effective way of keeping key competencies in the organisation?

– For sure, making a “small” amount of DKK 45 – 65,000 a year being a board member in a rapid growing “start-up” like DanCann Pharma is not a golden business compared to the many hours spent in the company. It is only in our interest that our board of directors share the same interest as our shareholders and thereby gives them the right incentive for the development of the company.

Also last week, Christian Carlsen joined DanCann as a member of the board, a recruitment that you called a huge gain for the company. In what way was this a big step forward for DanCann?

– Christian Carlsen is for me one of the strongest cards in relation to all our operations – the fact that he actually makes things happen, including the whole sparring part around it, not just for me, but for the whole executive management team and especially for those around our facility operations. He has been part of the industry since its inception here in Europe, and in addition participated in many of the major projects.

– Not only is he well-liked, he is obviously also a brilliant professional.

Finally, by the autumn at the latest, you expect your import handling licence to have been approved. Whatdoors will this open for DanCann Pharma?

– The fact that we will hopefully soon be able to help the many Danish patients who need a company like DanCann Pharma by improve health and life quality for patients with challenges.

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