Many forms of technology are being supplemented into Canada’s upcoming ediblecannabis market. Now, an oral film is being brought onto the stage. Montreal, QC-based pharmaceutical company IntelGenx (TSX.V: IGX.)(OTCQX:IGXT) is planning to integrate its own Intellectual Property into the realm of cannabis consumption through a partnership with Tilray.
To learn more about the oral film, we spoke with the Founder and CEO Dr. Horst Zerbe
Dr. Zerbe is an industrial pharmacist with a Ph.D. in medicinal chemistry. He has worked in drug-delivery virtually since he started working in the pharmaceutical industry some 35 years ago. He started IntelGenx in 2003 as a drug delivery company.
Cannabis Life Network: What is IntelGenx’s model of business?
Dr. Horst Zerbe: “For seven to eight years, our focus has been on oral films. While we initially focused on just development, we have now expanded our portfolio. Our full-service portfolio ranges from R&D to clinical and regulatory services, and commercial manufacturing. The only thing we don’t do is commercialize our products.
Our business model is to move forward with pre-commercialization. We receive payments and development fees from our licensing partners. Those go towards the commercialization phase. Our revenue stream holds two components. One would be manufacturing revenues. The other component is the royalty on sales of our partners, or in many cases, we also agree on monetary profit sharing.”
How has IntelGenx staged themselves in the cannabis market?
“We actually had a THC effort going for 7 to 8 eight years, but that was synthetic. End of last year we entered a co-operation with Tilray, so naturally-derived THC is quite new for us…
That co-operation incorporates the development and manufacturing of oral films for adult use and medicinal applications, but it is a worldwide agreement. So initially we are intending to supply the Canadian market, but down the line, we will also supply product for markets outside of Canada as well.”
There will certainly be focus on the US and Europe according to Tilray’s commercialization and expansion plans.
What are IntelGenx’s own licensed permissions in regards to cannabis processing?
“We are fully licensed by Health Canada to handle and manufacture controlled substances including THC. We have an R&D license to use cannabis and cannabis derivatives for the purpose of developing edible products.
What we need and are in the process of applying for and currently reviewing is a micro-processing license. This will allow us to manufacture commercial supplies of cannabis containing products.
Typically, what happens between Tilray and ourselves is we receive raw materials. The raw material would either be pure THC or CBD, or solutions of some sort of extract we would use to process.”
“We administer those molecules via a film and achieve oral absorption through the oral mucosa. In that case, the molecule goes directly into the bloodstream and bypasses this first liver pass.
Both THC and CBD, the main actives in cannabis, are pretty heavily metabolized when they are administered orally. What happens is, the active gets absorbed through the gastric wall before it enters the systemic circulation. It first passes through the liver where it gets fairly significantly metabolized.
In the case of THC, we were able to demonstrate in clinical studies where we increase the concentration by a factor of five compared to conventional oral administration. That is the most important advantage of films.
Secondly, with the film, the user would get exactly the same dose by a fraction of a milligram from film to film. That accuracy is particularly important for medical applications.”
Would you describe the oral film more as a sublingual (ie. taken under the tongue)?
“It doesn’t have to be sublingual; it could be anywhere on the oral mucosa – on the cheek for example.”
Profit or patients
Where do you predict oral film’s strongest avenue to be: medicinal, adult-use, or both?
Initially, it will be adult-use but down the line, we think the greatest potential is with medicinal applications. That is where, as a matter of fact, the film application would fully unfold its potential in terms of those accuracies and maximization of absorption.”
We recently conducted a market research study that shows, only in Canada, there is a potential $4 Billion market opportunity for medicinal cannabis film.
Are you planning on pushing your oral film through clinical trials for the medicinal side?
“At this point, we don’t have plans, but we are involved. As a matter of fact, there is research available suggesting that CBD might be helpful for the treatment of degenerative diseases of the brain. Through our contact in Salzberg, Austria, we are conducting some animal experiments looking more closely into this.”
Your previous intellectual property explored methods to slow degradation of medication not only in packaging but during delivery as well. Will your cannabis films explore retarding nucleation or metabolism of cannabinoids?
“Intuitively, the film is intended for rapid release and optimization of drug absorption. However, we have in fact worked on films that provide extended release of THC. We know how to provide a controlled release, for example, of THC over 46 hours. We have that experiment experience.”
As a pharmaceutical company can you detail your niches within the non-medical cannabissector?
“We are a sophisticated drug delivery company. What we look at are essentially two areas. The first is to deliver the precise amount of drug as labeled and not allow any variability there. The second and even more important aspect is to optimize the absorption of the drug as to ensure as little active ingredients like CBD and THC, gets lost through a digestive process as possible.”
Oral film versus encapsulation
You incorporate nanoemulsions in other technology. Do you see any benefit in using these techniques for cannabis products?
“We do work with nano encapsulations. Both actives and flavors, for example, are in our film development programs. We have to see if that brings any tangible benefits to the markets because I am not a fan of doing things just for the sake of doing things. When you do that, it should provide users with a tangible benefit and as soon as we see that we will look more closely into that.
At this point, I don’t see any benefit.”
What is Intellgenx’ view on surfactants (glycols, ethoxylates, or polysorbates or succinates) used in orally delivered cannabis? Also, if you can elaborate on the use of these things in nano-emulsions as well as smoked/vaped cannabis products? Even tocopherol derivitives considering concerns over other products?
Let us begin by mentioning that our confidentiality obligations prevent us from actually disclosing what our formulation contains.
However, we can say that we are aware of the issue with vaping products and are quite concerned by the health risks presented by those same vaping products.
We are confident that the oral film will provide an alternative way for cannabis users to safely consume cannabis products without the danger of current vaping products.
That said, our understanding of the current vaping crisis differs somewhat from what is implied in your question. The underlying problem with potentially hazardous vaping products lies from the combustion of the surfactants, not from the ingestion of those same surfactants. The surfactants mentioned in your question have been approved as surfactant by FDA and are already ingested in large quantities by everyday people, surfactant are present in several commercially available non-cannabis containing products. The unknown at the moment related to the surfactant is really their impact on health when the combusted surfactant are inhaled.
Regardless, we are monitoring the situation very closely and are committed to manufacture products that are free from any potentially hazardous component.
A new industry
How does IntelGenx view the impact brought on by the legalization of edible cannabis?
I think the impact is huge if I look at this from an IntelGenx perspective – for two reasons. One reason is that we are opening new therapeutic opportunities. The medicinal value of THC, CBD, and the many other alkaloids that are present in the cannabis plant are still largely untapped.
But, there is research available indicating essential benefits for the treatment of degenerative diseases… Alzheimer’s and dementia. CBD is already being used for the treatment of Schizophrenia.
So, there is in my view, huge potential and films will play a very significant role… They address many of the issues associated with the conventional delivery of cannabis derivatives.
If you put the medicinal potential and commercial potential together, I see a very significant impact and that is why we made our cannabis program, and our cannabis co-operation with Tilray, a high priority program in our company.
If you take conventional delivery systems, it’s quite complicated to provide an elegant and working child proof feature.
We package each film individually in a heat-sealed pouch that is childproof. You must apply a certain technique to open that pouch.
Do you see any concerns for the
environment with that strategy?
That is a bit of a trade-off. By pouching each film individually in a heat-sealed pouch, you create a little more packaging waste than you do, let’s say, with one these dispensers for mouth freshening film. We have to trade childproof features against having to produce a little more waste and I think that is justified.
You have applied for a patent document regarding a lipophilic oral strip, does this mean the technology for Cannabis-Infused oral strips may soon have a patent associated with it?
There are several still unpublished applications pending in review. We will have a pretty impressive IP fence surrounding and protecting our technology and our cannabis films, in particular.
Thank for your time, Dr. Horst Zerbe.
End of interview
It is a mystery that will actually take off with so many strange and obscure options coming onto Canada’s edible cannabis field next year. Cannabis sales depend on many highly personable factors. Do Tilray and IntelGenx meet those qualifications, or will they end up like so many other cannabis stocks?