1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Global Hemp Acreage Comparison
EU Canada US
Source: US state agencies for cultivated acres, nova-Institute and EIHA for EU cultivation. Health Canada for Canadian licensed acreage (acres). 2017 unconfirmed estimates for EU and Canada
Hemp as an Ag Commodity
CBD as an “Ingredient”
Seed Fiber Cannabidiol
Primary Secondary Lignin
Things to Watch – 2018 & early 2019
1. Introduction of Senate Bill: Leadership Support
2. Epidiolex® Go to Market: FDA/GW actions
3. HIA (Hoban Law) vs. DEA: Response By the Court
4. Farm Bill 2018: Sec. 7606 Update/Amendment?
5. Clarification on Statement of Principles: TBD
The New Drug
Application (NDA) submitted
End of December, 2017:
The FDA accepts the
The Prescription Drug User Action
(PDUFA) outlines the timeline and
protocol by which drug companies
submit fees and the FDA approves
drug applications. PDUFA is typically a
one year timeline unless the drug is
“fast tracked,” and then it’s 6 months.
Epidiolex was fast tracked.
June 27, 2018 PDUFA Date.
Upon the FDA’s approval
under PDUFA, the DEA has
up to 90 days to reschedule
a drug. HBJ anticipates
Epidiolex will be re-
scheduled on the CSA as a
Schedule IV drug in
September or October 2018.
team will take
Epidiolex to market.
HBJ estimates an
initial wave of pent
up demand at the
end of 2018.
End of 2018 or beginning
of 2019. The hemp
industry should watch for
increased FDA action or
regulation to enforce CBD
as a drug given Epidiolex
Epidiolex sales ramp-up.
Continued regulatory clashes
between FDA, DEA and
cannabis companies (hemp and
marijuana) concerning labeling,
marketing and scheduling.
Note: If the DEA reschedules (to Schedule
II) or de-schedules marijuana from the
Controlled Substances Act, it will have an
impact on this timeline. HBJ estimates no
such scheduling action will occur – until at
the earliest - Epidiolex becomes a
scheduled drug and pharmaceutical
financial interests are ‘in play’ across
regulatory agencies and financial markets.
and Accepted for
Review by the
approval decision in the
first quarter of 2019
• “Current information does not justify scheduling CBD”
• “CBD could have therapeutic value for seizures due to
epilepsy and related conditions”
• Postponed full review of CBD until May 2018
• Oversees World Anti-Doping Code: Used by 600+
sports organizations including International Olympic
Committee and the U.S. Anti-Doping Agency.
• “Cannabidiol is no longer prohibited”
• THC remains banned
Researchers bought 84 CBD products
online and had them tested in Colorado labs.
• 43% contained more CBD than the label claimed.
• 26% contained less CBD than promised.
• 31% were within 10 percentage points of the promise.
Some sort of audience pump up
Poll the Audience, (owners, entrepreneurs, work for an NPI company?, practioneer? Attorney? Regulator? Pharmacuetical Company? FDA or DEA?
Story time - begin with a short story that brought us to where we are today…
How many people remember this advertisement?
My story begins about this time….
Compound fracture foot, never felt better.
Take a moment and think about what brought you into this industry. Mine is just a boring story about a sick kid, but there are some amazing stories—some miraculous stories.
How many people know what DSHEA is?
DSHEA defines the term "dietary supplement" to mean a product (other than tobacco) intended to supplement the diet that bears or contains one or more dietary ingredients, including a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients. Furthermore, a dietary supplement must be labeled as a dietary supplement and be intended for ingestion and must not be represented for use as conventional food or as a sole item of a meal or of the diet. In addition, a dietary supplement cannot be approved or authorized for investigation as a new drug, antibiotic, or biologic, unless it was marketed as a food or a dietary supplement before such approval or authorization. Under DSHEA, dietary supplements are deemed to be food, except for purposes of the drug definition
To Protect Investors
About HBJ, Pedigree
Overused term, I know.
I’m going to use it a bunch of times today, and then never use it again.
But there’s also another good word to describe the CBD market….
Canada grew about 120,000 acres of hemp this year, 10 times the acreage of hemp in the United States.
“We can be in an excellent position to get a whole lot more CBD out of this product,” said Jordan Sinclair of Canopy Growth.
Canadian hemp farmers will be able to sell flower and leaves for CBD extraction – but only to the few dozen entities licensed to process and sell CBD.
That’s because U.S. hemp guidelines are expected to get an update in the 2018 Farm Bill. In addition, Canada’s hemp changes could spark more interest in a languishing proposal to remove hemp from the list of controlled substances in the United States.
Canopy Growth is moving farther into the Canadian hemp market with the acquisition of hemp land in Saskatchewan that could scale to over 2,000 acres.
The medical marijuana producer, which trades on the Toronto Stock Exchange as WEED, on Monday announced the acquisition of Green Hemp Industries.
As of January 25, 2018, Green Hemp Industries Ltd., Certain Assets And Intellectual Property was acquired by Canopy Growth Corporation. Green Hemp Industries Ltd., Certain Assets And Intellectual Property comprises hemp farming operations and associated assets, equipment, and genetic stock. The operations are located in Canada.
Canada’s global cannabis-buying spree is moving to Uruguay.
Vancouver, British Columbia-based Cannabis Wheaton announced Tuesday that it plans to spend up to $15 million to acquire 80% of Inverell shares.
Based in Uruguaya’s capital, Montevideo, Inverell produces high-CBD hemp and low-THC marijuana.
While Canadian marijuana companies have expanded their international reach by purchasing businesses in countries such as the United States, Australia and Germany, the Inverell deal is the first venture into Latin America for Cannabis Wheaton, which plans to produce CBD products for export.
The transaction includes $2 million in cash, plus an additional $3.5 million worth of shares in Cannabis Wheaton, according to a news release.
Cannabis Wheaton will give Inverell an additional $9.5 million worth of stock once the Uruguayan company registers its cannabis genetics and successfully exports CBD. Inverell holds a license in Uruguay – the first nation to legalize recreational marijuana – to grow three strains of hemp, plus a marijuana strain that contains about 0.5% THC.
The company is currently growing the strains on about 40 acres (16 hectares) and has an additional 1,420 acres (574 hectares) available for additional production. Raul Urbina will stay on as CEO of Inverell. Wheaton CEO Chuck Rifici said in the release that the Inverell acquisition gives his company “a diversified source of low-cost CBD production for our international distribution channels.”
The BIG… Tobacco, Alcohol, Outside of NPI,
Scopia 3,455,054 of GW
Capital Group 3,375,000 of GW
John Kapoor 42,430,310 of Insys
OrbiMed 5,406,844 of Insys
Lucky’s 17 Stores, product classes, like a diversified portfolio, mention Kroger “significant stake”
Who will be next?
At the end of December, GW achieved the important milestone of FDA acceptance of its Epidiolex NDA submission. Also at the end of December, we submitted a regulatory application to the European Medicines Authority and I'm pleased to announce today that this application has been accepted for review by the EMA. These achievements position us for a midyear NDA approval and an anticipated U.S. launch in the second half of the year. This timeline reflects an expedited review by the FDA. In Europe, we anticipate an approval decision in the first quarter of 2019.
WHO: “Recent evidence from animal and human studies shows that its use could have some therapeutic value for seizures due to epilepsy and related conditions. Current evidence also shows that cannabidiol is not likely to be abused or create dependence as for other cannabinoids (such as Tetra Hydro Cannabinol (THC), for instance). The ECDD therefore concluded that current information does not justify scheduling of cannabidiol and postponed a fuller review of cannabidiol preparations to May 2018, when the committee will undertake a comprehensive review of cannabis and cannabis related substances.
which is used by more than 600 sports organizations, including the International Olympic Committee and the U.S. Anti-Doping Agency (USADA).
They may take our “CBD on the Label” but they will take take our “Hemp”!