Thanks to legal recreational use of marijuana about to launch in California and nationwide up in Canada, sometimes it’s easy to forget where we got started here.
Legal marijuana first came to my attention because of the “War on Pain.”
Let me explain…
In a study a year or so ago, the National Institutes of Health (NIH) found that about 11% of Americans suffered from debilitating pain. Other sources say the number of this country’s pain sufferers may run as high as 50 million.
But I don’t need statistics to know that millions of Americans suffer from serious pain problems.
I do so myself – and so do many of my friends and family members.
And that has turned the market for pain medication into a huge business. According to market researcher VisionGain, the worldwide business for pain drugs is worth about $68 billion right now.
Other studies say it’s even bigger.
Equally huge is the nation’s opioid crisis.
President Donald Trump has declared the opioid crisis a “public health emergency,” and a White House commission has released its final report on the epidemic, calling for more drug courts, greater training for doctors, and penalties for insurers who do not cover addiction treatment.
The number of opioid-related deaths rose 75%, from roughly 20,000 in 2010 to 35,000 in 2015. In other words, opioid-based drugs kill more than 100 Americans every day.
This surge in the number of pain sufferers – coupled with the snapback against the prescription of opioid drugs – has opened the door to a wholly new approach to pain treatment.
I’m talking about medical marijuana and all its derivatives.
And there’s one company, in particular, that you should be watching…
Why We Believe in Medical Marijuana
In fact, marijuana’s medicinal potential could be worth billions more than the recreational market.
Study after study has shown that up to two dozen medical conditions could be treated with marijuana.
Two of its more intriguing components, non-psychoactive cannabidiol (CBD) and psychoactive tetrahydrocannabinol (THC), have a clear impact on brain function and pain management.
Glaucoma sufferers, for example, have long known that pot can reduce ocular swelling. Many people swear by pot’s ability to improve lung function, counterintuitive as that may seem. And people suffering from conditions such as multiple sclerosis will tell you that this drug can greatly ease the daily pain they must live with.
In fact, some of my friends can tell you that.
Results like those are part of the reason medical marijuana has been approved in 29 states (and Washington, D.C.) and in many countries around the world. And it’s the reason why the global medical marijuana market topped $11 billion in 2016 – and could reach $55.8 billion by 2025.
And it’s what brought medical marijuana – and all the biotechnology behind it – to my attention.
Just one company – a biotech that first hit my radar in 2014 and has delivered peak gains of more than 65% to folks who got in early with my Roadmap to Marijuana Millions – is favorably positioned to make a classic “corner-the-market” move on this incredibly lucrative segment.
I’m recommending it once more today, because I think there’s every reason for it to keep on delivering…
This Company Will Dominate
All this got the scientists at the Cambridge, U.K.-based GW Pharmaceuticals Plc (Nasdaq ADR: GWPH) thinking: If marijuana has such a broad range of potentially healing properties, and is finally receiving more respect among doctors, why not build a business around CBD and THC?
GW has an unbeatable head start in the race to build drug franchises around the healing powers of cannabis.
You see, all the way back in 1998 – the Dark Ages, in terms of legal cannabis – this company successfully lobbied the U.K. government for the country’s first-ever “cultivation license” to grow cannabis for commercial, scientific research.
For the past five years, GW has been cultivating strains of the plant with an eye to increasing concentrations of these two key ingredients. This effort has made it possible for GW to provide its engineers with a robust supply of the raw material they need as they ramp up research into a broad range of new drug candidates.
GW’s scientists are looking to capitalize on a series of medical breakthroughs made in the 1990s, when researchers first realized that the body actually has three systems that regulate disease and pain. Two of these, the central nervous system and the immune system, were already well understood. But what researchers discovered was that our body is also regulated by proteins called endocannabinoid receptors.
THC and CBD go right to these receptors and can have a profound impact on the body’s various mental and physical responses. GW Pharma has focused on the impact of CBD, which targets the brain’s receptors that control mood and brain seizures.
Its research has been fruitful, showing incredible promise.
A “Miraculous” Treatment
For the 3 million epilepsy sufferers in the United States (and the 62 million sufferers worldwide), relief from debilitating seizures would be nothing short of a miracle.
That’s why so many of them are focused on GW’s Epidiolex, which has been quickly moving through clinical trials.
A turning point came in 2012, when an 11-year-old boy named Sam was given high doses of CBD for the first time.
You see, despite having taken a dozen anti-seizure medications, Sam still suffered from more than 100 seizures every day.
Thanks to GW Pharma’s CBD formulation, Sam now experiences only three to five seizures each day. Some days, he doesn’t have a single one.
As you’d imagine, many families are clamoring to get their children enrolled in Epidiolex clinical trials. They soon got their wish.
By 2015, 20 separate studies were underway involving 750 children. On average, patients have experienced a greater than 50% reduction in seizures.
Fully 95% of all patients enrolled in clinical trials for this drug have stayed in the program.
That’s very significant, because, typically, a combination of toxic side effects and lack of effectiveness leads 20% or more of patients to drop out of trials like this.
But Epidiolex has shown only fatigue (in 17% of patients), diarrhea (17%), and sleepiness (21%) as side effects.
Based on these results, GW Pharmaceuticals has a head start on all of its competitors. In fact, Epidolex’s U.S. trials are already wrapped up, and GW plans to file for U.S. Food and Drug Administration approval soon.
And that means Epidiolex could launch early next year.
Following approval, GW Pharma will have exclusive sales rights to the drug for seven years in the United States and 10 years in Europe.
Those will be very profitable years.
Right now, GW Pharma is looking to make its treatments available to 466,000 children in the United States who suffer from epilepsy and another 208,000 in key European markets.
These patients currently consume tens of thousands of dollars in epilepsy medicine each year, drugs that barely make a dent in the number of daily seizures they must endure.
GW is also testing Epidiolex in Phase II trials with adult epilepsy patients. That’s a far larger market, as there are around 65-million adults with epilepsy worldwide.
Simply put, sales for juveniles alone could be a blockbuster drug launch. Solely based on approval for children with epilepsy, annual sales for Epidiolex may exceed $1 billion five years from now – “official” blockbuster status.
Don’t expect the pot pioneers at GW to stop at Epidiolex, either.
On the Fast Track
Even as GW prepares to tackle the epilepsy market, its scientists have been testing high concentrations of CBD on patients with:
- type 2 diabetes;
- perinatal asphyxia;
- and other types of seizure.
Another non-psychoactive compound, a homolog of CBD known as cannabidivarin (CBDV), is also showing a lot of promise in other areas, including treating certain social and repetition behaviors associated with autism.
In April 2014, the company received the coveted FDA “Fast Track” designation for Sativex for “the treatment of pain in patients with advanced cancer.” The drug has already been launched in 30 other countries for the treatment of spasticity caused by multiple sclerosis.
The FDA’s Fast Track program grants a drug maker favorable treatment for the purpose of accelerating the development of a drug that both treats a deadly condition and also addresses an unmet medical need.
Ahead of its first drug hitting the U.S. market, GW Pharma is already building the foundation to become a top-tier drug maker.
For instance, Julian Gangolli is president of its North America division. Gangolli earlier ran the North American sales operations for Allergan PLC (NYSE: AGN), a $97 billion drug and medical supplier.
Plus, GW has already identified the 4,000 to 5,000 U.S. physicians that specialize in epilepsy – and has sales reps lined up ready to hit them.
This firm is well armed to pursue an active slate of drug trials and the buildout of a sales force. It has around $372.1 million in cash in the bank, as of the end of the second quarter of 2017.
The success in treating epilepsy will change how the marijuana-based drugs are perceived.
We’re incredibly close now, and once the medical community sees how compounds such as CBD, CBDV, and THC deliver much better results than existing treatments, GW Pharma and other cannabis-focused stocks will be no longer be seen as outliers; they’ll be must-own stocks, and essential earners in savvy investors’ portfolios.
Now, I’ve just released my updated Roadmap to Marijuana Millions: Phase II. That’s an incredibly diversified list of more than 30 of the best legal marijuana stocks on the market. This market could be worth $20 billion or more by 2020, and my “weed investors’ bible” can show you how to potentially get your share. It’s free with a subscription to my Nova-X Report investing research service.
Have a great weekend.
I’ll see you back here next week.