R&D services and CBD and THC products
"MedPharm is a research-focused company for cannabis," says Towle. The mission is to conduct studies on the plant's cannabinoids and terpenes, he notes, with the goal of eventually obtaining FDA approval for products it develops.
In order to further research involving cannabis, the company has applied to the Drug Enforcement Administration (DEA) for a federal license to grow cannabis, which would then be distributed to medical researchers who've been vetted to conduct cannabis studies. Only a few applicants will ultimately make the cut to cultivate cannabis with the approval of the federal government. Towle says about the lengthy application process, "It is moving very slowly, but we are still in the running."
However, if things go according to schedule, MedPharm will begin a study early next year related to Alzheimer's disease and dementia, since Towle says his company is "the first, and only [one], so far" to be granted a license from the State of Colorado and the City and County of Denver to conduct research involving cannabis.
The designation makes it easier for MedPharm to distribute cannabis directly to patients for research purposes. Previously, Towle says "you would have to go through a dispensary" to distribute cannabis-containing compounds -- a step which could be especially burdensome for patients participating in an Alzheimer's-related study. Furthermore, since cannabis dispensaries in Colorado are required to only carry items which contain at least some amount of THC, placebos could not be distributed through that channel.
As Cannabis Business Times describes the upcoming research, "MedPharm will administer gel capsules that contain both cannabinoids and other natural, non-cannabis-derived compounds that have been shown to have a positive effect on brain health. The company will also distribute a cannabinoid-only formulation, as well as a placebo, to compare how each formulation performs."
Why study cannabis in relation to Alzheimer's?
Towle says, "There's definitely anecdotal evidence out there that people with Alzheimer's disease and dementia have improved symptoms by taking cannabinoids." He also notes how "most antioxidants are water soluble -- and your brain really won't let them cross the blood-brain barrier. What's exciting about cannabinoids is that they are antioxidants that can cross the blood brain barrier -- and so they seem very likely to reduce inflammation and oxidation in the brain versus other compounds."
In order to fund its research, MedPharm manufactures products for sale within Colorado's legal cannabis markets. In terms of sales metrics, Towle says, "We've grown massively. We've experienced incredible year over year growth." The company's products can be presently found in "over 400 dispensaries in the state."
The company has three brands. Aliviar includes a high-CBD tincture, which Towle says is the company's best-selling product; there's a topical cream formulated with niosomes in order to "enhance penetration into the skin without achieving blood levels" of THC within people; and, soon to come, there's its reformulated line of pressed tablets. There are also two brands of vape products: Batch, which caters to customers looking for high-THC products; and Become, which mixes THC with CBD. The company has also formulated water-soluble products in powder and liquid form.
At its 13,000-square-foot facility in Denver, Towle -- who has a PhD in medicinal and natural products chemistry -- utilizes a high pressure liquid chromatography machine to "test our own potency throughout the process," he says. "We'll test the potency of the air-dried plant material, the material that comes out of our oven as it's dried and decarboxylated. We'll even test the [remaining plant] material that's been extracted to make sure we're getting everything out [in terms of cannabinoids] that we can possibly get out of the material. And we also test the winterized oil, and the final distillate. And that's the minimum amount of testing that we do in any production batch."
Towle adds, "We also have an in-house gas chromatograph-mass spectrometer that allows us to look at our terpene profile." The company employs a supercritical CO2 extraction machine to produce cannabis oil, and it uses a wiped film distillation machine to produce its distillate from the extracted oil.
MedPharm also cultivates more than 1,000 plants at its headquarters, and has successfully completed Good Agricultural Practice (GAP) and Good Manufacturing Practice (GMP) audits.
In terms of allowing a company like MedPharm to conduct research, Towle observes, "Colorado has really positioned itself to be the research hub of the United States -- and really the world -- as it continues down this path."
Challenges: Towle says, "The continuing headwinds from federal and state regulations that don't make sense, that make it very difficult to perform research on cannabis and cannabinoids -- that is the biggest challenge and remains the biggest challenge, to this day. The state research license [we've been granted] certainly helps a lot; but, even still, there are things that are difficult for us to do that we should be able to do as scientists." He cites how state universities won't allow their employees to collaborate with MedPharm on the company's state-sanctioned research for fear of the schools' federal funding being denied, since cannabis remains illegal federally.
He says of his own work, which is taking place within a tough regulatory environment, "I'm always up for a challenge -- and this is probably the biggest research challenge I can imagine taking on."
Opportunities: "Once we're able to launch some of these studies, and see success, some of these medications we are developing should continue down the path to FDA approval," says Towle. "And, in that case, that would be a huge accomplishment. And I think that's where our biggest opportunity lies."
Needs: Towle says that "there needs to be more state and federal funding that looks at the actual benefits of cannabis and cannabinoids, instead of always looking at harms."