Robert Celt
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Children afflicted with Dravet Syndrome, a rare form of epilepsy, have been effectively treated with a cannabis-based drug, Epidiolex, containing cannabinoids, the GW Pharmaceuticals announced Monday. Investors snapped up shares of the little-known firm, effectively doubling the company's market value overnight.
Analysts expect GW Pharmaceuticals Epidiolex to cost $2,500 to $5,000 a month, which would be more expensive than some of the medical marijuana products, which cost from about $100 to more than $1,000 per month. However, Epidiolex might be covered by insurance, unlike the other products.
GW Pharmaceuticals may be a new play for investors, but the Salisbury, England-based company is widely known in the cannabis world, where it enjoys the respect if not the love of many in the legalization movement.
GW Pharmaceuticals , which has been around since 1998 and public since 2001, has carved out a niche in cannabis-based pharmaceuticals by focusing on CBD, cannabidiol, the part of the plant thought to be most tonic to health. Sativex, a drug that treats multiple sclerosis spasticity, has been a major driver to the companies success, and with the rise of Epidiolex and a number of other drugs planned to treat ulcerative colitis, Type 2 diabetes and schizophrenia, GWPH has huge growth potential. This has inspired confidence across the industry.
"GW Pharmaceuticals has been an industry bellwether for the better part of the last three years as it relates to the burgeoning cannabis space," said Matthew Mills, COO of Med-X, Inc. "What GW and Epidilex have demonstrated is that there is viability for companies to both flourish and help the general public with drug treatments that can be life saving. There is also an intrinsic value as it relates to the continued study of the cannabis plant in search of meaningful remedies."
GW is planning to have a meeting with the U.S. Food and Drug Administration (FDA) in order to get Epidiolex out on the market.
"The results of this Epidiolex pivotal trial are important and exciting as they represent the first placebo-controlled evidence to support the safety and efficacy of pharmaceutical cannabidiol in children with Dravet syndrome, one of the most severe and difficult-to-treat types of epilepsy," said Orrin Devinsk from the New York University Langone Medical Center's Comprehensive Epilepsy Center. "These data demonstrate that Epidiolex delivers clinically important reductions in seizure frequency together with an acceptable safety and tolerability profile, providing the epilepsy community with the prospect of an appropriately standardized and tested pharmaceutical formulation of cannabidiol being made available by prescription in the future."
In other words: Epidiolex, the company's epilepsy drug now moving through the FDA approval process, is only the beginning.
On its web page, GW Pharma lists a number of other pharmaceuticals in the development pipeline. Those drugs treat everything from glioma (a form of brain cancer) to diabetes and schizophrenia.
But the company is also, unbeknownst to many, applying for and receiving patents that cover substances and techniques already widely used in the cannabis world.
The company's latest patent (No. 9,205,063), granted last December, covers the prevention and treatment of neural degeneration with a pharmaceutical formulation of cannabis obtained by running the plant through a common carbon dioxide (CO2) extraction method. The patent lists all the usual active components of cannabis: THC, CBD, terpenes, sterols, triglycerides, alkanes, flavonoids, etc.
The potential value of patent No. 9,205,063 is clear. GW Pharma is trying to claim ownership of cannabis as a drug in the prevention and treatment of Alzheimer's disease, Parkinson's disease, and multiple sclerosis.
No. 9,168,278, issued last October, is for the use of the cannabinoid THCV as an appetite suppressant in a weight loss medication. No. 9,017,737, issued last April, is for the use of CBD and other cannabinoids to prevent or treat psychotic disorders. No. 8,771,760 deals with the use of cannabinoids for constipation.
No. 8,790,719 is a big one. It makes an intellectual property claim for the use of plant-derived cannabinoids in the treatment of prostate cancer, breast cancer, and colon cancer.
Some of these patents are pending. Others have already been issued.
The relationship between GW Pharmaceuticals and American cannabis culture goes back to the 1990s
When the U.S. and British governments both commissioned studies into the effectiveness of cannabis as medicine. The U.K. study was spurred by multiple sclerosis patients using cannabis to calm their spasticity. The U.S. study came in response to California's passage of the first statewide medical marijuana law in 1996. Both studies reached a similar conclusion: Cannabis actually seemed to have a medical effect. Research by the Institute of Medicine, an arm of the U.S. government, showed that the plant held therapeutic potential for specific conditions, including epilepsy, chronic pain, and glaucoma.
The British responded by issuing a license to GW Pharma, a startup lab in Salisbury. GW was allowed to grow its own strains of cannabis and develop cannabinoid drugs. The license allowed the company to custom-breed its own strains, with higher or lower levels of various cannabinoids like THC and CBD. The result: a $1.9 billion company with drugs in the FDA pipeline and patents certified by the U.S. Patent and Trademark Office.
GW Pharmaceuticals PLC's Epidiolex would be the first drug approved in the U.S. that contains the marijuana derivative cannabidiol, but two earlier drugs were approved that contain tetrahydrocannabinol, or THC, another marijuana derivative. An earlier version of this article incorrectly said Epidiolex would be the first marijuana-based drug approved in the U.S
News Moderator: Robert Celt 420 MAGAZINE ®
Full Article: GW Pharmaceuticals Seeks FDA Approval For Cannabis Based Epidiolex
Author: Staff
Photo Credit: Douglas Levere
Website: Daily Star Albany
Analysts expect GW Pharmaceuticals Epidiolex to cost $2,500 to $5,000 a month, which would be more expensive than some of the medical marijuana products, which cost from about $100 to more than $1,000 per month. However, Epidiolex might be covered by insurance, unlike the other products.
GW Pharmaceuticals may be a new play for investors, but the Salisbury, England-based company is widely known in the cannabis world, where it enjoys the respect if not the love of many in the legalization movement.
GW Pharmaceuticals , which has been around since 1998 and public since 2001, has carved out a niche in cannabis-based pharmaceuticals by focusing on CBD, cannabidiol, the part of the plant thought to be most tonic to health. Sativex, a drug that treats multiple sclerosis spasticity, has been a major driver to the companies success, and with the rise of Epidiolex and a number of other drugs planned to treat ulcerative colitis, Type 2 diabetes and schizophrenia, GWPH has huge growth potential. This has inspired confidence across the industry.
"GW Pharmaceuticals has been an industry bellwether for the better part of the last three years as it relates to the burgeoning cannabis space," said Matthew Mills, COO of Med-X, Inc. "What GW and Epidilex have demonstrated is that there is viability for companies to both flourish and help the general public with drug treatments that can be life saving. There is also an intrinsic value as it relates to the continued study of the cannabis plant in search of meaningful remedies."
GW is planning to have a meeting with the U.S. Food and Drug Administration (FDA) in order to get Epidiolex out on the market.
"The results of this Epidiolex pivotal trial are important and exciting as they represent the first placebo-controlled evidence to support the safety and efficacy of pharmaceutical cannabidiol in children with Dravet syndrome, one of the most severe and difficult-to-treat types of epilepsy," said Orrin Devinsk from the New York University Langone Medical Center's Comprehensive Epilepsy Center. "These data demonstrate that Epidiolex delivers clinically important reductions in seizure frequency together with an acceptable safety and tolerability profile, providing the epilepsy community with the prospect of an appropriately standardized and tested pharmaceutical formulation of cannabidiol being made available by prescription in the future."
In other words: Epidiolex, the company's epilepsy drug now moving through the FDA approval process, is only the beginning.
On its web page, GW Pharma lists a number of other pharmaceuticals in the development pipeline. Those drugs treat everything from glioma (a form of brain cancer) to diabetes and schizophrenia.
But the company is also, unbeknownst to many, applying for and receiving patents that cover substances and techniques already widely used in the cannabis world.
The company's latest patent (No. 9,205,063), granted last December, covers the prevention and treatment of neural degeneration with a pharmaceutical formulation of cannabis obtained by running the plant through a common carbon dioxide (CO2) extraction method. The patent lists all the usual active components of cannabis: THC, CBD, terpenes, sterols, triglycerides, alkanes, flavonoids, etc.
The potential value of patent No. 9,205,063 is clear. GW Pharma is trying to claim ownership of cannabis as a drug in the prevention and treatment of Alzheimer's disease, Parkinson's disease, and multiple sclerosis.
No. 9,168,278, issued last October, is for the use of the cannabinoid THCV as an appetite suppressant in a weight loss medication. No. 9,017,737, issued last April, is for the use of CBD and other cannabinoids to prevent or treat psychotic disorders. No. 8,771,760 deals with the use of cannabinoids for constipation.
No. 8,790,719 is a big one. It makes an intellectual property claim for the use of plant-derived cannabinoids in the treatment of prostate cancer, breast cancer, and colon cancer.
Some of these patents are pending. Others have already been issued.
The relationship between GW Pharmaceuticals and American cannabis culture goes back to the 1990s
When the U.S. and British governments both commissioned studies into the effectiveness of cannabis as medicine. The U.K. study was spurred by multiple sclerosis patients using cannabis to calm their spasticity. The U.S. study came in response to California's passage of the first statewide medical marijuana law in 1996. Both studies reached a similar conclusion: Cannabis actually seemed to have a medical effect. Research by the Institute of Medicine, an arm of the U.S. government, showed that the plant held therapeutic potential for specific conditions, including epilepsy, chronic pain, and glaucoma.
The British responded by issuing a license to GW Pharma, a startup lab in Salisbury. GW was allowed to grow its own strains of cannabis and develop cannabinoid drugs. The license allowed the company to custom-breed its own strains, with higher or lower levels of various cannabinoids like THC and CBD. The result: a $1.9 billion company with drugs in the FDA pipeline and patents certified by the U.S. Patent and Trademark Office.
GW Pharmaceuticals PLC's Epidiolex would be the first drug approved in the U.S. that contains the marijuana derivative cannabidiol, but two earlier drugs were approved that contain tetrahydrocannabinol, or THC, another marijuana derivative. An earlier version of this article incorrectly said Epidiolex would be the first marijuana-based drug approved in the U.S
News Moderator: Robert Celt 420 MAGAZINE ®
Full Article: GW Pharmaceuticals Seeks FDA Approval For Cannabis Based Epidiolex
Author: Staff
Photo Credit: Douglas Levere
Website: Daily Star Albany
