Tag Archives: Euro

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Where Is The German Cultivation Bid?

By Marguerite Arnold
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For those following the German cultivation bid drama, there appears to be a real light at the end of a now two year tunnel– driven by a domestic demand that essentially requires that there be no more delays.

Then again, given developments so far, who knows really what will happen in April. It could be a whole new “fresh start” for a much-beleaguered process or it could just go down as yet another “train” on the basis of a “technical fault.”

One thing is for sure: BfArM again appears to be cautiously optimistic. Yet they have been there before, too. Yes, there is a rising patient count. But there are also now many other import options and cheaper prices coming into the EU. As a result, there is still the likelihood, however implausible, that the German government will want to kick this can a bit further down the road.

German Parliament Building

What is the newest development? In late January, BfArM, the German equivalent to the FDA and the agency in charge of oversight and regulation of all medicines and medical devices, issued a press release about the status of the cannabis cultivation bid they are tasked with overseeing.

If things are not taken off track by the next still pending lawsuit (due to be heard by the high court in Dusseldorf on 10 April of this year), the agency will award the bid. Not before, as the press release also states categorically.

The Highlights

There is no award date yet of course. However, if the court case is decided in favour of BfArM this time (namely defending their exclusion of a bidder even though the deadline was delayed again for seven weeks last fall), there is reason to believe the public airing of that final list of license holders will be released soon after. That means the bid decision could come as soon as the next day and certainly by the end of April.

There were over 200 questions asked of the agency this time by around 79 bidders who submitted a total of 817 bids for a total of 13 cultivation lots. No more than five lots can go to any one bidder or consortium.

The amount to be cultivated under this first bid is 10,400 kg over four years (up from the first amount). Even this is expected to be too low to meet a clear and increasing domestic demand. That said, there is clear expectation that the remainder between what is cultivated domestically and consumed will be taken up by imports (although from where was not explicitly discussed).

The agency also stressed that they are responsible only for the administration of the tender itself. They will not receive, store or redistribute the cannabis or cannabis products. Further, BfArM also stressed that they are not responsible for the regulation of the final retail price at pharmacies.

Finally, the target date for the delivery of the first crops is a conservative estimate which says two things. One, BfArM are not tipping their hand in favour of Wayland (who at present has the largest licensed GMP facility in the country), and second, they are leaving themselves and bid respondents a little more wiggle room. Just in case. For whatever reason.

As the bid states, successful respondents do not need to have suitable real estate under contract until the finalists are announced, but if they are awarded the bid, they will have to not only move fast to secure a facility, but also set up a grow facility that can be certified in the next interim period.

By way of contrast, Wayland announced its purchase of the Ebersbach facility in the summer of 2017. They have just received, 18 months later, their GMP certification. Anyone starting from scratch, in other words, would have to move at least as fast as Wayland has. If not a bit faster, considering that Wayland is already up and running, and at this point certified.

Between The Lines

The entire cannabis legalization discussion has been caught up in the cultivation bid since the beginning. Patients in fact, lost their temporary right to grow if they could not afford the expensive cannabis being sold in pharmacies before 2017. After the law changed, only licensed and regulated operators were allowed to distribute the imported variety and then only from Holland and Canada.

Since then, the first cultivation bid went down in a legal challenge, the price of cannabis at the retail end has effectively increased at least 1,000 euros a month and there are as many as 80,000 German patients taking some kind of cannabinoid, mostly for chronic pain.

It is insurers, in other words, at least as much and now more than patients who are now on the sharp and expensive end of the stick.

Then again, until the actual announcement from the Dusseldorf high court if not BfArM itself, expect late breaking developments and drama until the very end.However, the interim frustrating period auf Deutschland plus the continuing needle of political reform just about everywhere (certainly in Europe) has changed the scenery dramatically in just two years. There are cultivation operations in Spain and Portugal with crops ready to be exported to the German consumer. Eastern Europe and Italy are also cultivating. Greece is preparing to. And Israel finally allowed its producers to jump into the medical game globally.

Prices will inevitably come down. The German government and insurance industry beyond that are two powerful drivers to insure the same. And a big part in bringing that price down is setting a bid reference price to begin with.

The situation, in other words, is being staged to move into the next “four-year plan” where Germany begins to understand how widely effective cannabinoids can be, for what conditions and what kind of delivery mechanisms work best for different patients.

It also aligns the country’s medical program perfectly with Luxembourg’s own four-year medical trial and now stated timeline of ensuring there is recreational reform by 2022.

All of which, in other words, also spells victory and potentially the end game to the first part of the German medical cannabis cultivation question and a larger first step for the EU beyond that to finally end medical cannabis prohibition.

Then again, until the actual announcement from the Dusseldorf high court if not BfArM itself, expect late breaking developments and drama until the very end.

Stay tuned.

Epidiolex-GW

GW Pharma’s Enormous Price for Epidiolex

By Marguerite Arnold
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Epidiolex-GW

In a fascinating early August conference call with Seeking Alpha, British-based GW Pharmaceuticals finally revealed their retail price point for CBD-based drug, Epidiolex, as it goes into distribution in the U.S.

The drug is designed for the treatment of certain kinds of childhood epilepsy – although not all kinds. Also notable of course, is that GW Pharma’s “other” drug for treatment of resistant epilepsy failed in late stage trials in Eastern Europe earlier this year. It also knocked off 5% of the price of the company’s stock.The company is estimating it has a potential patient pool of between 25,000- 30,000 patients in the U.S.

British Advocacy Over Access And Pricing

The ineffectiveness of GW Pharma’s drugs for many patients (along with the cost charged for them) was responsible for pre-empting the entire access discussion in the UK this year. The mother of an epileptic British child tried to import a personal store of cannabis oil (produced by Canadian LP Tilray) only to have it confiscated at the airport this summer. Her son ended up in the hospital shortly thereafter.

The national uproar this caused pushed forward the country’s new medical cannabis policy– indeed drug rescheduling is due to go into effect in October. Conveniently, right as Epidiolex goes on sale in the U.S. (where cannabis remains a Schedule I drug).

The company is estimating it has a potential patient pool of between 25,000- 30,000 patients in the U.S.

Price Tags and Politics

What is the price of Epidiolex? $32,500 per patient, per year. If that sounds high, the company insists it is pricing the drug to be “in line” with other drugs for this segment of the market.

The majority of this cost will not be picked up by private health insurers but rather the federal governmentActually, according to industry analysis, this is about 70% more than the price of one comparable drug (Onfi), and slightly more expensive than Banzel, the two competing (non-cannabinoid based) medications now available in the U.S. for this market.

Here is the other (widely unreported) kicker. The majority of this cost will not be picked up by private health insurers but rather the federal government, which is also not negotiating with GW Pharma about that high price  (unlike for example what is going on in Europe and the German bid).

Why the difference?

Two reasons. The first is that Epidiolex has obtained “orphan drug” status (a medication for a disease that affects fewer than 200,000 patients in the U.S.) The second is that the majority of the insurance that will be picking up this tab is Medicaid. The patient pool will be unable to afford this. As a result, the bulk of the money will remit not from private insurance companies but rather federal taxpayers. And, unlike in say, Germany, none of this is pre-negotiated in bulk.

Epidiolex-GW
What is the price of Epidiolex? $32,500 per patient, per year.

Co-payments are expected to range from $5 to $200 per month per patient after insurance (read: the government) picks up the tab. This essentially means that the company plans to base participation at first at least on a sliding scale, highly subsidized by a government that has yet to reschedule cannabis from a Schedule I in the U.S.

Creating, in other words, a new monopoly position for GW Pharmaceuticals in North America.

A Hypocrisy Both Patients And The Industry Should Fight

The sordid, underhanded politicking that has created this canna monster is hardly surprising given the current political environment in both the U.S. and the U.K. right now. The people who benefit the most from this development are not patients, or even everyday shareholders, not to mention the burgeoning legitimate North American cannabis industry, but in fact highly placed politicians (like British Prime Minister Theresa May). Philip May, the PM’s husband’s firm is the majority shareholder in GW Pharma. Her former drugs minister (with a strong stand against medical cannabis) is married to the managing director of British Sugar, the company that grows GW Pharma’s cannabis stock domestically.

So far, despite a domestic outcry over this in the UK (including rescheduling), there has been no political backlash in the United States over this announcement. Why not?

Look To Europe For A More Competitive Medical Market

This kind of pricing strategy is also a complete no go in just about every other market – including medical-only markets where GW Pharma already has a footprint.

For example, German health insurers are already complaining about this kind of pricing strategy for cannabis (see the Cannabis Report from one of the country’s largest insurers TK – out earlier this year). And this in an environment where the government, in fact, does negotiate a bulk rate for most of the drugs in the market. Currently most German cannabis patients are being given dronabinol, a synthetic form of THC which costs far less.

GW logo-2On top of this, there are also moves afoot by the German government to begin to bring the costs of medical cannabis and medicines down, dramatically. And this too will impact the market – not only in Europe, but hopefully spark a debate in every country where prices are also too high.

The currently pending German cultivation bid for medical cannabis has already set an informal “reference” price of at most 7 euros a gram (and probably will see bid competitors come in at under half that). In other words, the government wholesale price of raw, unprocessed cannabis flower if not lightly processed cannabis oil is expected to be somewhere in the neighbourhood of 3-4 euros per gram come early next year. If not, as some expect, potentially even lower than that.

Processed Cannabis Medicine vs. Whole Plant Treatment

The debate that is really raging, beyond pricing, is whether unprocessed cannabis and cannabis oil is actually “medicine.” At the moment, the status quo in the U.S. is that it is not.

GW Pharmaceuticals, in other words, a British company importing a CBD-based derivative, is the only real “medical cannabis” company in the country, per the FDA. Everyone else, at least according to this logic, is placed in the “recreational camp.” And further, hampered still, with a lack of rescheduling, that affects everyone.

If that is not an organizing issue for the American cannabis industry, still struggling with the many issues inherent in the status quo (from insurance coverage and banking to national distribution across state lines) leading up to the midterms, nothing will be.

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Green Relief Enters European Market Via Switzerland

By Marguerite Arnold
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It is old news that Canadian companies are entering the European market. And it is also no stop-the-presses flash that Germany is a big prize in all of this. But there are other Euro markets to watch right now. Switzerland is one of them.

Look for the Canadian influx here too.

One of the more interesting entrants this month? Green Relief – a Canadian LP with a really unique twist. They are the only company in the world to produce cannabis oil from flower grown with aquaponics. This unique method creates unbelievably “clean” cannabis with no pesticides – and no residue of them.

It also sets the company up for a really unique market opportunity on the ground outside Canada. Especially as they have now just announced a partnership with two Swiss companies– Ai Fame GmbH and Ai Lab Swiss AG. Both companies have been leading European pharmaceutical companies since the turn of the century. The idea is to leverage all three company’s intellectual capital with Green Relief’s additional and first international investment with an eye to the entire European cannabis market. Ai Fame specializes in cultivation, manufacturing, sales and distribution to both the food and medical sectors. Ai Lab Swiss AG operates as a laboratory and testing facility.Less than three weeks before Green Relief publicized their European announcement, there were also strategic developments afoot at home.

From this unique perch in the Swiss canton of St Gallen, the three companies are setting up to conquer Europe.

Why Is Switzerland So Strategic?

Switzerland has been on the legalization track since 2011. As of this date, the Swiss government began allowing adults to buy and use CBD-only cannabis. Shops were allowed to obtain licenses. A trickle of sales began. However, rather suddenly, as reform hit Europe, the craze took off. Last year, for the first time, the industry generated a significant amount of revenue (close to $100 million). That is $25 million for the government via taxes- just on CBD sales. Even more intriguing for those looking for market opportunity across borders? Less than a week ago, the German-based budget discount store Lidl just announced they were carrying smokeable CBD  – in Swiss grocery stores. The leap across the border is imminent.

That has opened up other conversations, including the “legalize everything” push that makes an awful lot of sense to the ever tax-aware Swiss. This is a push afoot just about everywhere across the continent, including, of course, just across the border in Germany.

GreenRelief LogoThe cities of Zurich and the cantons of both Winterthur and St Gallen (home of the Swiss companies behind the new venture with Green Relief) have already indicated that they will not pursue possession fines for those busted with 10 grams or less– no matter what kind and even of the THC variety.

Read between the lines, and it is clear that the cannabinoid conversation locally has begun to attract the Canadians. And not just because of the many opportunities of the Swiss CBD market – but the huge medical and THC German and European opportunities now opening beyond that.

No matter which way Green Relief and their new partners slice it, they are now in the game – and across Europe – with a unique new play and product, and further one set to enter both the medical THC and “consumer,” albeit still CBD, market now burgeoning.

A Cross Market Play

Here is the truly interesting part about this new announcement. Less than three weeks before Green Relief publicized their European announcement, there were also strategic developments afoot at home. Cannabis Growth Opportunity Corporation also just announced an investment in Green Relief. The share purchase agreement netted Green Relief $750,000 in both cash and common shares.

With this, Green Relief seems to have set sail on its European expansion. Look for more interesting turns to this developing saga soon!