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French Biotech Start-up Secures Country’s First Medical Cannabis Research Licence

Biotech start-up Overseed has been awarded the first licence for agronomic and genetic research on cannabis in France by the National Agency for the Safety of Medicines and Health Products (ANSM). Newsweed interviews Hugues Peribere, its founder.

Hello Hugues. You are the President of Overseed, a biotech start-up which was awarded the first licence for agronomic and genetic research on cannabis in France. How did you get here?

It has been a long journey! It all started more than two years ago from a question I was asked, relating to my professional past in horticultural production and the food industry in highly-certified environments: ‘There are many questions in this regard. moment around medical cannabis . Do you know this subject’?

From there, I started to focus on the subject, which took hold of me and never let go. It took me because it is extremely complex. Everything is happening abroad so far. It took me a long time to understand the subject and see it clearly. Understand market segmentation, understand risks, opportunities and obstacles.

After having accumulated a lot of information, I developed a very strong interest in finding a positioning that could respond to the French issues which are a few years behind compared to North America, the goal being to transform this delay into an opportunity. 

With the professional experience I had, it seemed interesting to me to go upstream in the value chain to develop an ambitious project in the field. To be able to carry it out, it was necessary to position a project that brings together the best French expertise whether in the world of genetics, on production, extraction, and downstream through the pharmaceutical industry and the medical world. 

It was important to build a structured project with a long-term vision and focused on the needs of the patients.

The subject, which extends from genetics to the production of pharmaceutical grade raw materials, was strategic but was only interesting if it was based on research and development on cannabinoids, their modes of action and on the applications that could be made in the pharmaceutical world.

The whole process vis-à-vis the ANSM was to position the project as an experimental project. A very structured scientific approach and a very clear vision justify the importance of setting up two years of R&D in this field. The project will be articulated with French partnerships positioned on the expertise of the proposed actors.

Could the ANSM legally oppose your project?

The ANSM evaluates the files, processes them on the aspects of the experimental protocols presented and on the safety aspects, then renders a decision. 

From there, I started a complicated work of exchanges, with a strong need to know the keys of evaluation. Little by little, I saw that the file went through the various stages until reception of the approval.

What does this allow you to do today?

The accreditation allows us to set up an R&D program for two years, which allows us to advance in parallel with the experimentation on 3,000 patients.

This obviously gives us the possibility of being ready while waiting for the generalization of drugs and sending to the market drugs that meet the current specifications of the ANSM and which are French to position ourselves against international competition.

At the same time, the objective will be to seek a characterization of cannabinoids and their modes of action, certification of all processes and production which will be GMP on the agricultural part and GMP on the laboratory part. in order to ultimately be able to  offer the flower and GMP certified extracts for patients, with a French origin.

The project thus goes further than a simple production of medical cannabis by bringing together the best French expertise to take advantage of the know-how and expertise to develop innovative products tomorrow.

After this licence, what are the next steps? Do you already have a grow site, a research site, a mining site?

Yes, we have a very high quality hybrid greenhouse, which is somewhere between the indoor and a traditional greenhouse. It must now be upgraded with very sophisticated equipment.

The objective will then be to put all the environmental conditions in place to be able to stabilize genetics which are not as well as possible. We will have to control this production, stabilize the plants, set up the multiplication, the genetic conservation of the batches that are launched.

Finally, we will conduct the first pharmaceutical runs to lead behind all the work that will be the fine characterization of products, work with our partner on extractions and their setting in pharmaceutical standard and in parallel work on approaches such as molecular screening, extraction of purified active ingredients to be able to find modes of action.

Overseed is a biotech start-up, which raises funds for this first step. There will be a second stage in 2 years to pass the next stage.

Where will the cannabis produced in R&D go?

All cannabis produced will go to research.

Are the cultivation methods already defined? Are you going to grow it in the ground?

We will be completely in hydroponics, in a neutral and inert substrate.

Again, the goal is to turn our delay into an opportunity. We rely on external expertise and do not want to reproduce the mistakes that may have been made by those who cleared the land, particularly in Canada or North America.

The idea is to rely on what is being done in research today, on the mastery of this plant, vis-à-vis the different cultivation methods, so as to be able to produce plants without any chemical treatment and which are really in line with what pharmaceutical quality can expect.

How will genetic selection be done? Where do you go to look for the varieties?

We carried out a very complete varietal screening of what could be on the market with breeders licensed in their country, who are recognized, who have already done important work in genetic selection and stabilization. 

It doesn’t mean that these varieties are stable and homogeneous, but we have worked on this approach. Genetics are essential in a project like this.

From there, we made a varietal selection that comes from different places and sourced through clearly identified international companies on which we provide the ANSM with all the guarantee of traceability.

Do you think you will be able to supply the French patients at the end of the experiment?

The ambition of the project is to be ready as quickly as possible to meet the expectations of the launch of the French market and the supply of drugs that will initially respond to what has been selected by the ANSM. Now no one knows if this will be the case. It is necessary at minimum 2 years to be able to set all the parameters and be able to position themselves.

We obviously want to include our tempo in the schedule of the experimentation, which would lead us to the opening of the market on time so as not to leave it completely dependent on foreign players.

For that, we will have a lot of steps to go through but the project is set up to unfold as quickly as possible.

What will your production capacities be?

The objective of R&D is to qualify all the equipment put in place and to validate all the technical parameters, performance compared to the quality obtained.

Our R&D part only uses part of the greenhouse for the first two phases of the project. If necessary, if the generalization of medical cannabis is done or if we have the expected results and the possibility of exporting our products, we already have the possibility of developing production capacity extremely quickly.

We have of course a fairly precise idea of what should be able to be obtained in terms of production capacities, but this is not the issue, which is rather how the market will be set up, what the conditions will be. that will allow it to develop properly or not, the regulatory criteria, the membership and training of doctors, what will be the scope that will allow it to be done … We do not have all the keys.

But that’s also why we created the Santé France Cannabis union to be able to build a dialogue with the authorities and try to ensure that in France all the players who may be concerned by this sector can also benefit from this interface. .

Are you going to hire French staff? Who can apply?

Of course, we will do it gradually. Today, the team is small. A solid base will be able to carry out R&D. In addition, on the parts that revolve around regulatory, pharmaceutical, medical, which supports industrial production, certifications and their implementation, the idea is to create an ecosystem around Overseed that is dynamic.

As and when everything is written, the team will expand with skills identified in the areas that we will need.

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