Tag Archives: opioid

Alcaliber Spinoff Linneo Health Gets Greenhouse GMP Certification In Spain

By Marguerite Arnold
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As the industry faces what is undoubtedly a watershed moment for the international cannabis vertical, a new Spanish firm steps into the market with its own EU GMP certification license. Linneo Health is also helmed by the ever eloquent and highly experienced Jose Antonio de la Puente – a tall drink of water with a conscience, a brain and an admirable mission statement.

As Cannabis Industry Journal broke in our last story, a lack of international standards in Europe have been on trial of late. The same day that the CannTrust scandal began to blow in Canada and as Danish authorities rang global alerts, the only qualified packager in Holland was issued a new EU GMP cert. That is a government decision, not a commercial one.

This also implies, at minimum, government lack of coordination and agreement on EU GMP cert even between European nations, for a nascent industry while also trying to avoid the thorny issue of patient home grow. See also the trials and travails of the erstwhile German cultivation bid and its reconstituted Frankenstein-esque bigger if younger sister. In fact, this contretemps is almost certainly involved if not indirectly to blame.

Not All Is Entirely Rosy On Cannabis Europe’s Eastern Front

Almost simultaneously to Linneo Health’s announcement, however, the news came that in Poland, authorities had suspended the pending product registration process. Will this be on hold until after the October election?

In this environment it is almost impossible to know.

Here is one thing to consider. These almost simultaneous developments in Spain and Poland and the newest announcement about further certification of the Dutch recreational system under a new pending “recreational trial” are almost directly related.

That said, even such political maneuverings are not new – and far from limited to any single company. Both Germany and Poland have been wracked by reform stuttered by short term gain and market entry strategies executed by most of the biggest players in the room. Aurora, for example, announced their first import into Poland the same day the Polish government changed the law last fall. Aurora uses Germany as its breakpoint distribution center for Europe.

A Stamp of Authenticity That Is Sorely Needed

Beyond the pharma and market entry politics, however, this Alcaliber-helmed project creates a ring of authority to the same that creates at least one cannabis brand the European medical community can see the certification for.

For now at least, certainly among the ranks of the upper echelons of the international cannabis industry, there must surely be a sigh of relief.

EU GMP certifications (in other words, the authorization to produce product bound for a medical, pharma market) do not happen overnight. On the European front, this is surely at least a step in the right direction for an industry embattled by scandals, particularly of the securities, production, certification and accounting kind right now.

In this case, however, it is also clear that no matter the egregious oversteps and potentially illegal and certainly dubious behaviour of some members of the industry, there are also clearly those within it, and at high levels, who have tried to do the right thing. And further, from the beginning of the nascent industry here as of 2015.

Who Is Alcaliber?

Alcaliber is one of the world’s largest opioid manufacturers. Unlike American counterparts, the company decided several years ago to invest in and back ideas of the opioid-to-cannabinoid therapy model. Linneo Health is a 60% subsidiary of Alcaliber and 40% owned by a Spanish family office called Torreal, S.A.

This is, as a result, one of the most important GMP licenses in Europe at the moment if not the world. It means that within a pharmaceutical environment, the first widespread research and production of plants and therapies for those suffering from both chronic pain, plus neurological and oncological conditions that cause or are related to the same, will be put on a fast track long in the offing. Certainly in Europe.

And that for one, is a positive development that will have widespread implications elsewhere. Particularly given the news that the opioid epidemic in the United States finally has a name, and culpable parties.

What Else Is Unusual About This Project?

GMP certification is a vastly misunderstood concept at the moment. It is also a highly thorny one because of a still standardizing set of agreements. The regulatory environment is in place, in other words, but there are many, many gaps, as well as shifting rules and underlying treaties.

GMPHowever, on top of this, there is also an amazing lack of innovation in interpretation, in part because of many misadvised consultants who are actually seeking to “save” production costs for their clients, or because they do not know any better. Or because producers are scared of doing the wrong thing.

The new project in Spain is unusual because it is a greenhouse grow that got EU GMP cert – although look for more of this in the future. It means that with careful, standardized, pharma production, not all regulated cannabis grows, even for the medical market, have to use huge amounts of energy in repurposed post-industrial developments. It is also certainly cleaner than growing outside. And, when done right, saves huge amounts of water.

Cleantech, in other words, has finally hit the cannabis industry in Europe. As well as a pharmaceutical company invested in the cannabinoid treatment of (at least) chronic pain.

That is an overdue and hugely positive development. No matter what else can be said for shenanigans engulfing the rest of the industry at the moment.

First Cannabis Clinical Trials All Set In UK

By Marguerite Arnold
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Beckley Canopy Therapeutics, based in Oxford, England has raised ₤7.4 million for the purposes of cannabinoid research and drug development. The new company is a unique partnership established between Canopy Growth Corporation and the Beckley Foundation, a research institute which examines the utilization of psychotropic drugs for the treatment of physical and mental conditions.

Studies focusing on the use of cannabinoids for the treatment of opioid addiction and cancer pain will be conducted in Europe, the UK and the US.

Why Is This Significant?

Here is the first reason: the woman behind it all. Her name is Lady Amanda Feilding, Countess of Wemyss and March. Born into a landed gentry family at Beckley Park (a Tudor hunting lodge with three towers and three moats) she also has a long history of engaging and supporting scientific endeavours that use stigmatized drugs in the treatment of both intractable disease and mental illness via the use of scientific research.

In 1998, Amanda Feilding set up the Beckley Foundation, a charitable trust which initiates, directs and supports neuroscientific and clinical research into the effects of psychoactive substances. She has also co-authored over 50 scientific papers in peer-reviewed journals.

The so-called “hidden hand” behind the rebirth of psychedelic science, Fielding’s contribution to global drug policy reform has been widely acknowledged in international drug policy circles. She was named as one of the bravest men and women in the history of science in 2010 by the British Guardian.

And here is the second reason: The foundation is now partnered with Canopy Cannabis, one of the leading cannabis firms in the world, which is also working closely with Spanish opioid manufacturer Alcaliber.

In other words, this coalition is almost the mirror opposite of the approach taken by the American Sackler family, makers of Oxycontin, who have fought cannabinoids as an alternative or even transition drug in multiple state legalization campaigns. Meanwhile the death rates from overdoses have quadrupled since 1999. In 2016, opioid-related drug overdoses killed about 116 people a day (or about 42,249 for the year). It is estimated that about 11 million people in the U.S. are currently misusing or dependent on opioids.

Amanda Fielding
Image credit: Robert Funke

Beyond The Politics of The Opioid-Cannabinoid War

While opioids clearly have a role particularly in chronic pain treatment, the question now at the global scientific table is this: Are cannabinoids a substitute for longer term chronic pain management? It is a fiercely battled scientific debate that has frequently, particularly in the U.S., crossed over into political drug reform questions.

The unique partnership of Beckley and Canopy is well placed both scientifically and culturally to take on a discussion which has languished for too long in the grass of political debate and reform.

Even better, it is taking place in a country where English is the first language, but outside the U.S. and further, in a country where cannabis has now been legally reclassified as a Schedule II drug.

Do not expect, in other words, the same trials and tribulations that faced noted U.S.-based researcher Sue Sisley, to slow down research, trials or findings.

Why Is A Cultural and Scientific Reset Required?

For the past forty years, since the end of the 1970s, cannabis in particular, has been pushed into a strange scientific territory in part, because of the culture surrounding the drug. This in turn, along with the schedule I classification of cannabis, has led to not only a dearth of research, but a reluctance on the part of prescribing doctors to examine its efficacy.

In the present, this means that doctors are still (beyond insurers who demand medical evidence before approving payment) the biggest hurdles in every medical system where cannabis is becoming legal. See the debate in Canada, the UK and of course, Germany, where patients frequently report asking for a drug their doctors refuse to prescribe.

This is exactly the kind of high-placed, societally influential effort in other words, that might finally break the medical taboo at the most important remaining logjam– at the point of prescription and approval for patients.

PA flag

Pennsylvania Adjusts Medical Cannabis Program

By Aaron G. Biros
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PA flag

On Monday, Pennsylvania Health Secretary Dr. Rachel Levine announced plans to allow patients access to whole plant, dried flower, as well as more qualifying conditions. The move reverses the previous rule permitting dispensaries to sell only processed forms of cannabis, which some say limited access and kept costs high for patients.

According to the Marijuana Policy Project (MPP), the Department of Health approved changes to the program at a hearing on Monday, which were recommended by the Advisory Board last week. While smoking remains theoretically prohibited, patients can now access the flower for vaporization.

The medical cannabis program in Pennsylvania has only been functional for a few months now; patients began getting access to the drug back in February of 2018. In a press release, MPP says only a small number of cultivators and dispensaries are currently operating. This fact, coupled with the need to purchase processed forms of cannabis, has created product shortages and costly medicine for patients.

It is expected that this move could help alleviate some of those problems in the state’s new program. “Allowing cannabis in its natural, flower form and expanding the list of qualifying conditions will have a huge positive impact on seriously ill Pennsylvanians,” says Becky Dansky, legislative counsel for the Marijuana Policy Project, who helped lead the legalization effort in Pennsylvania’s legislature. “By being able to provide medical marijuana in plant form, producers will be able to get medicine into the hands of patients much more quickly and for much lower cost to patients,” says Dansky. “This is vitally important for patient access right now while the program is still getting off the ground and production is not yet at full capacity. We hope these rules are promulgated as quickly as possible so even more patients will be able to find relief.”

The qualifying conditions added to the list for patients seeking medical cannabis is set to include cancer remission therapy as well as opioid-addiction therapy, which are two very notable additions. With more qualifying conditions and a potentially cheaper form of medicine, these changes could improve the program’s efficacy in treating patients.

Steep Hill Expands To Oregon

By Aaron G. Biros
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Last week, Steep Hill announced they are expanding into Oregon with a laboratory in Portland. According to the press release, the company has licensed its testing technology to Dr. Carl Balog, a renowned pain and addiction physician.

Steep Hill has expanded significantly over the past year, including new laboratories in Pennsylvania, Maryland, Washington D.C. and Hawaii, among other states. The Berkeley-based company works in lab testing, research and development, licensing, genetics and remote testing. In 2008, Steep Hill opened the first-ever commercial cannabis-testing laboratory in the country.

Jmîchaeĺe Keller, president and chief executive officer of Steep Hill, says this is a development that will help them better understand cannabis chemistry and its medical applications. “We are pleased to announce our expansion into Oregon and especially pleased to partner with Dr. Balog, a physician who brings years of pain and addiction experience to the Steep Hill body of expertise,” says Keller. “In addition, Dr. Balog plans to use his specialized knowledge to aid Steep Hill’s research and development efforts to broaden our understanding of cannabis chemistry and to explore its wider medical applications. In partnering with Dr. Balog, we hope that Steep Hill will be able to help physicians around the United States to curb the opioid epidemic by offering Steep Hill Verified™ medicinal cannabis as an alternative to a crisis that plagues this country.”

Examination of cannabis prior to testing- credit Steep Hill Labs, Inc.

Dr. Balog, now owner and medical director of Steep Hill Oregon, says medical cannabis could be an excellent harm reduction tool, and hints at it being a possible tool in the opioid crisis. “I deal with the consequences of the opioid epidemic on a daily basis as a pain and addiction specialist,” says Dr. Balog. “The growing trend of using cannabis products as an alternative to opioids highlights the need for regulated testing. Because of the variability of marijuana preparations, testing ensures that scientific rigor is applied in a standardized way. I am dedicated to ensuring that patients have access to safe, tested cannabis, free from contaminants and to verified labels that can be trusted for their content.”

They expect Steep Hill Oregon to be open for business in the second quarter of 2018.