Weed Week: France temporarily overturns CBD ban and Canada gets a classy culinary cannabis facility
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In December France banned the sale of hemp flower and leaf loaded with CBD, but the Conseil d’Etat provisionally overruled the decision on Wednesday – pending further examination of the order.
Basically, the French court said that flowers and leaves of certain varieties of cannabis were devoid of narcotic properties and could therefore be marketed in France.
But rules for cultivation, sale and consumption are unchanged, with only registered hemp growers allowed to grow the varieties listed in the official French catalogue.
It seems like quite a classy establishment, which hosts a state-of-the-art test kitchen that will serve as a hub to create and develop cutting-edge infused products such as THC/CBD olive oil and coconut oil.
No winners in weed this fortnight, with six companies flatlining and 31 in the losers column.
Here are the ones with notable news:
The company signed a retail distribution deal to enter the US market with its hemp consumer brand 13 Seeds across chains operating nationwide like Wal-Mart, Albertson’s, Safeway, CVS, Walgreen’s, Costco, Target, Kroger, BJ’s, Kmart, Sam’s Club, and Rite-Aid.
The deal with TruLife Distribution involves online and brick-n-mortar retailers,
Covering over 50,000 regional nutrition food and drug retailers, and over 25,000 speciality health and nutrition stores.
LV1 said its unable to accurately assess the revenue impact of this distribution agreement at this stage but considers the agreement “to be material for its strategic importance as a beachhead agreement for distributing the 13 Seeds product in the US market.”
Cann reached a pretty big milestone with the granting of a GMP licence to manufacture therapeutic goods for its Southern facility by the Therapeutic Goods Administration (TGA).
The dried cannabis flower products produced under the Southern GMP Licence are expected to be available for supply to patients under the TGA’s Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme within the next few weeks.
“Over the last 12 months, we have seen increasing demand for cGMP products from both domestic and international customers and have had pre-orders in place since late last year pending the granting of this licence,” CEO Peter Crock said.
“We are now able to service the needs of those customers. The granting of this licence is also another important achievement for Cann as we develop our integrated supply chain.”
The company recently secured clinical trial authorisation to commence a trial into medicinal cannabis efficacy on long-COVID by the UK’s Medicines & Healthcare Products Regulatory Agency.
The six-month clinical trial to be undertaken in collaboration with the UK’s leading independent scientific body on drugs, Drug Science UK, with 30 trial participants suffering from long-COVID to be recruited and administered daily doses of Bod’s medicinal cannabis product, MediCabilis® 5%.
BOD says the trial allows it to pursue a large market opportunity – with an estimated 1.3m people in the UK suffering long-COVID – with one in 40 COVID-19 infections having symptoms lasting upwards of three months.
Plus, the company also recently secured ethics approval for phase IIB clinical trials for a new Schedule 3 CBD product for the Australian market – with the formulation to be tested on 200 participants over eight weeks who have symptoms associated with insomnia.
It’s another big market opportunity, with a demonstrated a 4.2% CAGR since 2017, plus it’s expected to reach $5.48 billion by 2023.
LGP’s strategy of acquiring a production facility in Denmark is paying off, with the company securing distribution agreements in Germany and Greece in recent weeks.
It’s nabbed a three-year distribution agreement with AMP – a leading pharmaceutical supplier of medical cannabis products – for the distribution of LGP-branded cannabis oil medicines in Germany.
Under the agreement, AMP must purchase Minimum Annual Quantities (MAQ) of at least 2,000 x 50ml units in the first year, 5,000 units in the second year and 10,000 units in the third year, provided that if LGP distributes LGP branded oils on its own account the quantities in the second and third years are reduced by 50%.
And AMP must ensure that at least 10% of the MAQ purchased are non-exclusive oil products.
Expanding into Greece too
In Greece, the company signed a four-year agreement with PharmaServe for the distribution of LGP-branded oil medicines and cannabis flower, with a two-year exclusivity period.
With a population of ~11 million, there are no registered medicinal cannabis products in the market, and LGP anticipates PharmaServe will be one of the first distributors to apply for a medicinal cannabis marketing authorisation in Greece, giving LGP a significant foothold in a new, currently under-served market in the EU.
EMD is gearing up to commence the Phase 1 human clinical trials to assess the safety and bioavailability of its first ultra-pure CBD formulation as compared to Epidyolex – the only TGA- and FDA-registered CBD medicine.
The company says its formulation, EMD-RX5, is expected to support multiple Real-World Evidence (RWE) guided registration programs for Emyria including:
The Phase 1 trial protocol has been submitted to ethics with recruitment expected to start in Q1, 2022.
EMD has also started GMP-grade production of EMD-RX5 to support the pivotal randomised clinical trials required for the TGA submission of the formulaton as a Schedule 3, over-the-counter medicine for psychological distress (EMD-003).