UPDATE 3-14-2016: For much of 2016 our pick of GWPH was looking iffy at best. We help our readers help strong and picked up some shares earlier this month at the $30 dip as today was a record day for GWPH with a positive phase 3 trial announcement that led to a 120% increase in the stock price.
For my money, I think GWPH is the best long term play in the medical marijuana industry. The other strong play that I have invested in is MJNA.
GW Pharmaceuticals leads the research, development and commercialisation of cannabinoid prescription medicines to meet patient needs in a wide range of medical conditions. GWPH has outperformed the S&P 500 year to date by 151% and the Drug Manufacturers sector by over 148%. The company’s market cap sits at 1.33 billion.
GW Pharmaceuticals has a price to book ratio of 8.5 versus the industry average of 3.9 and the S&P 500 average of 18.8. The price to cash ratio however is -60.6 which is well below the industry average of -7.8 and the S&P’s 11.2.
GW Pharmacuticals, was founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas.
GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex(R), which is approved for the treatment of spasticity due to multiple sclerosis in 25 countries outside the United States. Sativex is also in Phase 3 clinical development as a potential treatment of pain in people with advanced cancer. This Phase 3 program is intended to support the submission of a New Drug Application for Sativex in cancer pain with the U.S. Food and Drug Administration and in other markets around the world.
GW has a deep pipeline of additional cannabinoid product candidates, including Epidiolex which has received from the FDA Fast Track Designation for the treatment of Dravet syndrome and Orphan Drug Designation from the FDA for the treatment of Dravet and Lennox-Gastaut syndromes, severe, drug-resistant epilepsy syndromes.
GW’s product pipeline also includes compounds in Phase 1 and 2 clinical development for glioma, ulcerative colitis, type-2 diabetes, and schizophrenia. For further information, please visit www.gwpharm.com.
GW Pharmacuticals Products
Sativex is the first natural cannabis plant derivative to gain full market approval in any country. It is derived from 2 unknown strains of cannabis that is extracted with carbon dioxide and ethanol to produce a constant amount of active ingredients. Sativex is a patented cannabinoid oromucosal mouth spray developed for multiple sclerosis (MS) patients, who can use it to alleviate neuropathic pain, spasticity, overactive bladder, and other symptoms.
The spray is peppermint-flavoured and it’s patented pump delivery system delivers a precise amount of medicine every time you spray it.
Sativex is made under strictly controlled laboratory conditions and contains a balance of these active ingredients that have been shown to help improve the symptoms of MS spasticity. Treatment with Sativex must be initiated and supervised by a physician with specialist expertise in treating MS.
It is always being studied to help relieve pain in cancer patients and the potential in this area is very promising.
If you know anyone that has been through chemotherapy, you understand how much pain cancer patients go through in order to fight the disease.
This is what originally got me interested in GW Pharmacuticals, as a friend of mine was undergoing chemotherapy and had an aversion for the typical pain medications available here in the US. His doctor was surprising upfront about medical marijuana (although not legal in our state) and encouraged him to visit Colorado if/when he felt like traveling.
Beyond Sativex, GW Pharmaceuticals is developing Epidiolex, another marijuana-derived chemical called, cannabidiol, or CBD, for two types of childhood epilepsy: Dravet and Lennox-Gastaut. Epidiolex, is being developed as an experimental treatment of epilepsy. It is will undergoing stage-two trials in the US this year and has shown great promise thus far. Independent investigators who have been testing Epidiolex on their own, have had very promising results.
Epidiolex also comes in liquid form to be dispensed from syringes. It comes in two strengths, either 25 milligram per meter or 100 milligram per meter for the FDA trials. The goal is to provide an effective treatment for childhood epileptic
There are around 5,440 patients in the US with Dravet’s Syndrome and 6,710 in Europe and approximately 1,500 in the UK, but it is believed that these figures are an underestimation as the disease often goes undiagnosed.
Dravet’s Syndrome is a rare and severe form of infantile-onset, genetic, drug-resistant epilepsy syndrome. Symptoms include clonic and clonic-tonic seizures and Grand Mal seizures that start early in the child’s life and are likely to continue multiple times daily (sometimes up to 300) for the rest of their lives.
Trauma is caused to the brain from not just the violent seizures themselves, but from accidents that happen when the seizures strike – such as striking their head on the ground or an object. Speech and learning abilities are hindered.
If the early feedback on Epidiolex continues through the phase 2 trials, this will be a revolutionary treatment for kids and their families suffering from Dravet’s Syndrome. Research has shown that Epidiolex not only exerts significant anticonvulsant effects in a wide range of preclinical models of seizure and epilepsy but is also better tolerated compared to existing anti-epileptic drugs.
Epidolex has been designated as an orphan drug. This means that it has been designed specifically for this purpose and is able to be granted this status because Dravets and similar pediatric seizure disorders are orphan diseases meaning there is nothing currently available under a doctor’s prescription that works to suppress it. In both the US and the Europe it is easier to gain marketing approval for orphan drugs and quite often they come with periods of exclusivity, which is something GW Pharmaceuticals are familiar with.
The Future For GWPH
With four other marijuana-derived drugs in its pipeline, taking aim at diseases like diabetes, schizophrenia, and lucerative colitis, investors should start looking at GW Pharmaceuticals like any other drug company and not just a medical marijuana stock. They company has tons of upside with one clear hurdle on the horizon: if Sativex can produce sales of $500 million, it’s not hard to see GW Pharmaceuticals being valued at $2.5 billion.
Beyond that, if one of their other products get fast tracked by the FDA, the long term potential for this stock is very promising and should be looked at as long term play.
GWPH US Patent Allowance for Use of Cannabidivarin (CBDV) in Treating Epilepsy
We hope you got on board with GWPH back in the fall of 2014 when we first featured it as our #1 Medical Marijuana stock pick. At that point, it was in the low to mid $60 range. This morning in pre-market trading it is double that at over $124.
Offical Press Release:
GW Pharmaceuticals plc (AIM:GWP) (Nasdaq:GWPH) (“GW”) announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Application Serial Number 13/075,873, a patent application which covers the use of cannabidivarin (CBDV) for treating epilepsy.
The subject patent claims cover CBDV, a non-psychoactive cannabinoid extracted from the cannabis plant, for use in the treatment of patients with epilepsy and specifically for the control of generalised or temporal lobe seizures. This patent covers CBDV alone or in combination with standard anti-epileptic drugs. The issued patent from this application will provide an exclusivity period until 30 March 2031.
“This patent is important as we believe that CBDV has the potential to become an important new treatment option in the field of epilepsy,” stated Justin Gover, GW’s Chief Executive Officer. “Whilst the primary focus of GW’s epilepsy research program remains on Epidiolex in pediatric epilepsy, we believe that CBDV may offer an additional treatment advance in this therapeutic area in the medium and longer term.”
In 2014, GW completed a Phase 1 clinical trial of its CBDV product candidate, known as GWP42006, and expects to commence a Phase 2 study in adult patients with epilepsy in the second quarter of 2015.