[INTERVIEW] ANSM awards France's first medical cannabis production license

The start-up biotech Overseed has been awarded one of the first agronomic and genetic cannabis research licenses in France. Interview with founder Hugues Peribere.

Hello Hugues. You're Chairman of Overseed, a biotech start-up that has been awarded one of the first agronomic and genetic cannabis research licenses in France. How did you go about obtaining this license?

It's been a long road! It all started over 2 years ago with a question I was asked about my professional background in horticultural production and agri-food in highly certified environments: «There are a lot of questions at the moment about the medical marijuana. Do you know anything about this subject?.

From that point on, I started looking into the subject, which took hold of me and hasn't let go since. It grabbed me because it's extremely complex. It's all happening abroad so far. It took me a long time to understand the subject and see it clearly. To understand the market segmentation, to understand the risks, opportunities and obstacles.

After accumulating a great deal of information, I developed a strong interest in finding a positioning that could respond to French issues, which lag a few years behind North America, with the aim of turning this lag into an opportunity.

With the professional experience I had gained, I thought it would be interesting to enter the upstream part of the value chain to develop an ambitious project in this field. To do this, we needed to position a project that would bring together the best French expertise in genetics, production and extraction, as well as downstream expertise from the pharmaceutical industry and the medical world.

It was important to build a structured project with a long-term vision and a focus on patient needs.

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

The whole process vis-à-vis the ANSM was to position the project as an experimental one. A highly structured scientific approach and a very clear vision justify the importance of setting up 2 years of R&D in this field. The project will be structured around French partnerships based on the expertise of the proposed players.

Could the ANSM legally oppose your project?

The ANSM evaluates the dossiers, examines them in terms of the experimental protocols presented and the safety aspects, and then makes a decision. From there, I began a complicated process of exchanges, with a strong need to know the evaluation keys. Little by little, I saw that the file went through the various stages until approval was received.

In concrete terms, what does this enable you to do today?

The approval authorizes us to set up an R&D program for 2 years, enabling us to move forward in parallel with the experimentation on 3,000 patients.

This obviously gives us the opportunity to be ready in anticipation of the generalization of medicines, and to address the market with medicines that meet the ANSM's current specifications and that are French in order to position ourselves in the face of international competition.

At the same time, the aim will be to characterize cannabinoids and their modes of action, and to obtain certification for all processes and production, which will be GAP for the agricultural part and GMP for the laboratory part, so as to be able to in fine offer GMP-certified flower and extracts for patients, with French origin.

The project goes beyond the simple production of medical cannabis, bringing together the best French expertise to take advantage of know-how and expertise to develop tomorrow's innovative products.

After this license, what are your next steps? Do you already have a cultivation site, a research site, an extraction site?

Yes, we have a very high-quality hybrid greenhouse, somewhere between an indoor and a traditional greenhouse. It now needs to be upgraded with very sophisticated equipment.

The aim will then be to put all the environmental conditions in place to stabilize the genetics that are not yet stabilized. We need to control this production, stabilize the plants, set up multiplication and genetic conservation of the batches that are launched.

Lastly, we'll be conducting the first pharmaceutical runs, so as to be able to carry out the detailed characterization of the products, work with our partner on extractions and their pharmaceutical standardization, and at the same time work on approaches such as molecular screening and the extraction of purified active ingredients in order to identify modes of action.

Overseed is a biotech start-up, raising funds for this first stage. There will be a second stage in 2 years' time to take it to the next level.

Where will the cannabis produced in R&D go?

All the cannabis produced will be used for research.

Are the growing methods already defined? Will you be growing in the ground?

We'll be completely hydroponic, with a neutral, inert substrate.

Once again, our aim is to turn our backwardness into an opportunity. We're relying on external expertise, and we don't want to repeat the mistakes made by those who pioneered the field, particularly in Canada and North America.

The idea is to build on what's being done in research today, on the mastery of this plant, with regard to the various cultivation methods, so as to be able to produce plants without any chemical treatment and which are truly in line with what pharmaceutical quality can expect.

How will genetic selection be carried out? Where do you source your varieties?

We carried out a very thorough varietal screening of what was available on the market from breeders who are licensed in their country, who are recognized, and who have already done a great deal of work in genetic selection and stabilization. This does not mean that these varieties are stable and homogeneous, but we have worked on this approach. Genetics is essential in a project like this.

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

Do you think you'll be able to supply French patients at the end of the trial?

The aim of the project is to be ready as quickly as possible to meet the expectations of the French market launch, and to supply drugs that will initially meet the requirements selected by the ANSM. Now, nobody knows whether this will be the case. We need to at a minimum 2 years to set all the parameters and position ourselves.

Of course, we want to keep our tempo in line with the experimentation timetable, which would lead us to open up the market on schedule, so as not to leave it completely dependent on foreign players.

To achieve this, we'll have to go through a lot of stages, but the project has been set up to be completed as quickly as possible.

What will your production capacity be?

The aim of R&D is to qualify all the equipment installed and to validate all the technical and yield parameters in relation to the quality obtained.

Our R&D department is only using part of the greenhouse for the first two phases of the project. If need be, if medical cannabis becomes widespread, or if we have the expected results and the possibility of exporting our products, we already have the possibility of expanding production capacity extremely rapidly.

Of course, we have a fairly precise idea of what should be achievable in terms of production capacity, but that's not the issue, which is rather to know how the market is going to be set up, what conditions will enable it to develop properly or not, the regulatory criteria, the buy-in and training of doctors, what the scope will be that will enable it to do so... We don't have all the keys.

But that's also why we created the Santé France Cannabis syndicate, to build a dialogue with the authorities and try to ensure that in France all the players who may be involved in this sector can also benefit from this interface.

Will you be hiring French staff? Who can apply?

Of course, we'll do it gradually. Today, the team is small. A solid base will be able to lead R&D. In addition, the idea is to create a dynamic ecosystem around Overseed, covering the regulatory, pharmaceutical and medical aspects of industrial production, as well as certifications and their implementation.

As we continue to write, we'll be adding to the team with skills in the areas we need.