The capital market has been swooning recently over listed cannabis companies, especially over the as yet unfulfilled promise of marketing the product overseas. Meanwhile, while approval for exporting cannabis is being delayed, quite a few less prominent private companies are starting to fulfill their promises in the Israeli market.
For example, Syqe Medical made headlines a few years ago when it signed a marketing agreement with Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) and also afterwards when it began marketing its products in hospitals. Two weeks ago, the company obtained confirmation from the minister of health of Good Manufacturing process (GMP) approval for its plant to market cannabis in Israel. This is the first approval in Israel that includes both the device through which the cannabis is administered and the plant compound itself. The company hopes to also begin marketing its product soon through pharmacies. Like other companies, Syqe Medical also regards the Israeli market as a steppingstone to more profitable places. For now, the company is conducting feasibility studies and banking revenue to fund its activity, but the profits will come from abroad.
Syqe Medical was founded by CEO Perry Davidson, who entered the medical cannabis field as early as 2005 as part of Tikun Olam, the first cannabis growing company in Israel. Davidson, who came from the high-tech sector, made the switch long before the medical cannabis boom in the wake of the failure of Pharmos, which developed cannabinoid derivatives, but whose trial of the product failed in 2004. He says that he left the cannabis growing sector in 2006 in order to found a company that would bring order to the market.
"The field is very colorful, a green-gray field, in which activity is not always responsible or organized. The potential is undoubtedly enormous, but scaling up has to take place. There are currently 36,000 patients just in Israel and at least 100,000 in need of treatment."
"Doctors don't prescribe plants"
Syqe Medical was founded in 2011 in order to develop a measurable and repeatable method of administering medical cannabis. The company is trying to solve the main problem in the sector - on the one hand, a large proportion of the researchers and doctors believe that all of the cannabis elements work better together than a single element from the plant that can be isolated and produced synthetically. On the other hand, when a whole plant is involved, it is very difficult to repeatedly administer the same precise dosage of the compound.
According to Davidson, Syqe Medical has several basic principles. "We don't manipulate the raw plant; we administer the extract through inhalation because this is the right way in which the product has been consumed for years by 90% of users. The dosage has to be measurable because when you don't know the dosage of the active ingredients being given to the patient, no medical discourse about the product can take place and doctors are unwilling to deal with this."
"A doctor wants to be a scientist," adds Syqe Medical executive medical chairperson and former Minister of Health director general Dr. Eytan Hyam. "He wants to know how the drug works, its side effects, the effect of a change in the dosage, and the product's long-term effect. When you can't describe these things, doctors steer clear of the product."
Davidson: "In general, in conventional Western medicine, doctors don't prescribe plants. Medicinal plants are a much-abused category that medicine regards with suspicion. Our inhaler therefore has to look like inhalers in the pharma market, such as an asthma inhaler. The correlation between the inhaled dosage and the quantity of active ingredients in the bloodstream has be at least as predictable as in conventional medicine. We have to hide the plant a little in order to smooth its path into the medical system. The inhalers have therefore been designed in a slightly 'boring and medically clean' way."
In contrast, Syqe Medical's offices radiate unadorned innovation, and that is also the atmosphere in the company - half cooking laboratory, half high-tech company. Davidson says that the company's employees built the second floor with their own hands on a company team spirit building day. The company offices have newfangled 3D printers, which Davidson persuaded the world's leading companies in that field to donate in order to try them out.
A solution for the inhalers problem
"When we founded the company, we discovered at the beginning that we were aiming too high. We didn't realize the scope of the challenge posed by achieving a measurable dosage," Davidson says. "We have a vaporization pill in which the whole plant is within a polymer - a plastic envelope that holds the plant in place. Every clip holds 75 vaporization chips. As soon as the clip enters into the inhaler (when you want to use the product), it retrieves one chip, and an electrical circuit is closed on the envelope, which becomes a heating element operating uniformly over time. There's nothing like this in any vaporization technology." Every breath activates a mechanism that closes the electrical circuit and maintains a constant temperature through heat sensors operating in real time.
The plant itself is produced under as controlled conditions as possible in a laboratory in the Netherlands, not in an open field. "It's still a challenge to produce a plant that will be exactly the same in every dose," Davidson says. "The unique problem with cannabis, in contrast to other medicinal plants, is that the active ingredient is not spread around the plant uniformly; it is in pockets called trichomas. If you grind them up into powder, you burst the trichoma and oxidation of the plant begins. We have developed a method of grinding the plant that leaves the trichomas whole."
Another concern was that the different force of breathing in each patient would affect the quantity of breathed ingredient. "We developed a mouthpiece that moves according to the force of breathing and compensates for the differences in breaths between a small child with lung disease and a PTSD patient who breathes very heavily, for example," Davidson explains. "We conducted a clinical trial to make sure that the same dosage is always obtained.
"In addition, the product has to be simple to use because some of the patients are already past their cognitive peaks. What restarts the mechanism is the breathing itself, and after exactly two seconds, access to the ingredient is blocked and a route for breathing air is opened. When the patient feels the air, he immediately realizes that the dose is used up. It's very instinctive. This pulse also pushes the vapor inside and does not allow it to remain in the throat."
According to Davidson, they discovered in the course of their work that the conventional inhalers currently used in medicine "have a serious problem of incorrect use and a long training process. It is possible that the company may have a future in the inhalers business, rather than in cannabis. It can't be ruled out that this explains some of Teva's interest in the company."
Quantifying the psychoactive effect
In a clinical trial by the company that ended in 2014, it showed that the main active ingredients in cannabis reaching the patients' bloodstream are indeed measurable. The product is currently being sold in the pharmacy of Rambam Health Care Campus. "It's logical to begin in hospitals, because smoking is forbidden there and patients there can't consumer the medical cannabis that helped them at home. The product is now being prescribed at Rambam just like any other medical product. The doctor sets the dosage by computer and the nurse administers it," Davidson says.
The trial also showed that the patients who smoked medical cannabis before they began using Syqe Medical's product succeeded in reducing the consumed dosage of cannabis by using the company's inhaler, in comparison with ordinary smoking.
"Globes": The name "Syqe hints at something slightly crazy and non-medical.
Davidson: "We like the fact that in some of its strains, the product has a psychoactive effect. Among other things, that's important for treating pain. We want to be capable of quantifying this psychoactive effect, control it, and not eliminate it. It is definitely part of the benefit from cannabis. All the research now conducted into these effects vanishes into thin air because nothing is measurable."
Davidson hopes that other psychoactive plants, such as mushrooms, will be scientifically evaluated after the problems of dosage and repeatability are solved, among other things through Syqe Medical's device.
How did you manage to be pioneers in an area of interest to so many people?
"At conferences about inhalers, they told us that there had never been a company that simultaneously developed both the device and the drug - the device always looked for the drug, or vice versa. We're a hardware company, a medical devices company, and also a company dealing in pharma and plants."
Syqe Medical is currently in negotiations with the regulators for entry into Canada and Germany. In the US, the company believes that entering through the federal track is preferable and is therefore waiting for this track to be approved.
Davidson: "In the future, I want to challenge every drug in the world with a plant administered as a drug. Cannabis is showing the way."
Published by Globes [online], Israel business news - www.globes-online.com - on June 6, 2018
© Copyright of Globes Publisher Itonut (1983) Ltd. 2018