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Expert Interview: Marianne Hundtofte Nielsen, VP Business Development & Medical Affairs, Aurora Europe

Expert Interview: Marianne Hundtofte Nielsen, VP Business Development & Medical Affairs, Aurora Europe
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Extracts of cannabis are on the rise in Europe and North America. In the case of Europe why do you think this trend is occurring?

In contrast to North American markets, manufacturing and formulation activities have grown significantly in Europe due to demand for dosable, pharmaceutical-style products. Adherence to the relevant regulations and,
in particular the GMP criteria during manufacture, are an indispensable prerequisite for guaranteeing patient safety and must not be circumvented by open interpretations. Aurora plans to launch in the course of the year more extracts (high-THC and balanced) from our facility in Denmark, in numerous markets in Europe.

Where do you see the balance of cannabis flower vs. extracts and isolates going in Europe in the coming years?

Developments in manufacturing techniques further enable targeting of specific conditions, in line with growing research for conditions medical cannabis can be prescribed for. This will influence the market preference for formulation types. There is a growing preference for oils and extracts in Europe, due to the need for precise dosing and targeted formulations. However, despite an increasing demand for liquid cannabinoid formulations, we believe that flowers will always have a place in the portfolio of cannabis medicines. The absorption mechanism and pharmacokinetics of cannabinoids from flowers and liquid formulations are different and each have their specific field of application based on a patient’s indication.

Overall, the entire medical cannabis market will grow substantially, due to the huge gap between patient needs and current prescription possibilities. More importantly, we hope that European countries not allowing medical prescription of pharmaceutical quality / GMP cannabis for patients, fill this treatment gap and give physicians the tools on hand to improve patients’ lives. France is a good ex- ample, where a two-year pilot programme will commence at the end of March 2021. Aurora, together with its local partner Ethypharm, will be the sole supplier of dried flowers (high- THC, THC:CBD-balanced and high-CBD) in the programme. Other countries are investigating an access programme, which starts hopefully very soon.

Projected medical cannabis sales europe

What role do you see magistral preparations playing in the future, will they be replaced by finished products?

Several key European markets allow pharmacists to prepare patient-specific magistral preparations in accordance with national monographs, offering doctors and patients a greater choice of formats and strengths. Ma- gistral preparations are prepared using active pharmaceutical ingredients (e.g. isolated THC and CBD) rather than the alternative method of performing in-house extraction using plant material. Pharmacists play an important role in preparing formulations. This allows for the provision of personalised medicines to patients. The focus is therefore less on off-the-shelf cannabis products, and more on targeting a patient’s specific need.

In Germany for example, medical cannabis supplied to pharmacies must be a ‘bulk intermediate product’ rather than a finished product, and compounding is a compulsory step. The DAC/NRF (New German Formulary) states the types of cannabis medicines pharmacists can formulate, including oils and capsules, by using dried flower or dronabinol. For dried flower, weighing and re-packaging are the required processing step by pharmacists.

Understanding country specific regulations and healthcare practitioner perceptions is vital to success in bringing new products to market in Europe. Developments in manufacturing techniques will enable this further, in line with growing research for conditions medical cannabis can be prescribed for. This will influence the market preference for formulation types.

What is Aurora focused on currently in the European context, are there any developments that you find particularly important?

It is very important for the individual and patient-specific therapy that the required supply of medical cannabis products is guaranteed (in accordance to EU-GMP standards) and available in the various presentations. We address the growing demand and need to reduce time to market with Aurora’s first greenhouse facility on European soil – Aurora Nordic. In less than two years, we outfitted and licensed this high-tech cultivation and production facility in Odense, Denmark. With more than 9,200 m2 production space and an output of approximately 10,000 kilograms of high-quality medical cannabis per year, we are positioned to service European and international markets in accordance with local medical cannabis regulations.

Aurora also supports medical education in opening and growing markets. We are one of the lead sponsors of the Clinical, Scientific & Regulatory Cannabinoid Conference by the Centre for Medicinal Cannabis UK in April. The event focuses on key aspects relating to research and clinical evidence. Leading figures across the UK regulatory and clinical sectors will be speaking at the event. The attendance of such senior policy makers and researchers promises to make this a land- mark event and highlights the importance

of research and evidence in the UK medical cannabis policy debate. www.thecmcuk.org/events/scientific-conf

Germany medical cannabis import

What would Aurora like to see in the European cannabis space in the near future in terms of regulations or policies?

It is very important to us that we always focus on the well-being of the patient. To this end, existing barriers to access must be further dismantled, more education and research must be available to doctors and patients about the effects of medicinal cannabis, and prejudices must be fought further. However, this must not happen by generous interpretations of regulations. So regulators should continue – for the safety of patients – to very carefully watch for compliance with EU-GMP regulations.

Additionally, there are numerous patients left out by the existing guidelines and regulations for cannabis medicine. Emerging data indicates that there are various areas where medical cannabis shows a positive effect, in addition to those for which it is prescribed for today.

My hope is that the countries where medicinal cannabis is not yet legalised will look at the success of the programmes in countries with legalisation and legalise them as well, so that gaps in supply are closed and patients have access to a better quality of life.

The European Cannabis Report: 6th Edition takes a deep dive on the current social, economic, regulatory and health trends. The report also includes sales forecasts of medical and adult-use cannabis in the US and Canada.

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