United Kingdom

GW Pharmaceuticals

gwpharm.com
United Kingdom
SEARCH FILTERS
Time filter
Source Type

News Article | May 25, 2017
Site: www.chromatographytechniques.com

Although cannabis had been used for many centuries for treatment of seizure disorders, medical use became prohibited in the 20th century. However, with the loosening of laws regarding medical marijuana, research and clinical use of marijuana-derived substances are increasing. This has prompted the editors of Epilepsy & Behavior to produce a special issue that presents an in-depth assessment of the potential of cannabinoids for the effective treatment of epilepsy. Cannabinoids are components of the cannabis plant. "There is an enormous dissociation between the widespread use of cannabis-based therapies to treat diverse epilepsies and our understanding about the efficacy and safety of different cannabinoids in treating different epilepsy syndromes," said guest editors Jerzy Szaflarski, Director of the Epilepsy Center, University of Alabama at Birmingham, and Orrin Devinsky, Director, Epilepsy Center, New York University Langone Medical Center, New York. Because much of the political pressure to allow for medical marijuana use came from patients and lay groups, the goal of this special issue is "to evaluate the concerns and gaps in cannabinoid knowledge and medical education, and to create a curriculum as a first step in building a broader Education Roadmap." This special issue provides an overview for general neurologists and epileptologists, including historical aspects of cannabis use for epilepsy, overview of cannabis botany, general aspects of the endocannabinoid system as it pertains to epilepsy, pharmacology of cannabinoids, available anecdotal and clinical trial data of cannabinoid use for the treatment of epilepsy, safety data, discussion of possible effects of cannabinoids on the brain including neuroimaging data, and the legal aspects of cannabis production, distribution, and use for the treatment of epilepsy. Raphael Mechoulam, Head of the School of Pharmacy and Director of the Institute for Drug Research at Hebrew University, provides an insightful historical perspective. He notes that non-psychoactive cannabidiol (CBD) is officially approved for the treatment of intractable pediatric epilepsy in Israel, but it took more than 35 years to conduct the studies and obtain the results. "I expect that over the next decade we shall see major advances both in the medical-scientific and the treatment aspects of epilepsy with the help of CBD and related cannabinoids," explained Mechoulam. To move a plant-based drug from research studies to clinical use is a particular challenge for pharmaceutical companies. Suman Chandra, Senior Research Scientist at the University of Mississippi, and co-authors review how the United States and United Kingdom have addressed the problem of securing uniform supplies of medically pure and potent cannabinoids. They review cultivation and processing of marijuana at two institutions with extensive experience, GW Pharmaceuticals in the U.K. and the University of Mississippi in the U.S. Because both media coverage of cannabis use in epilepsy and inconsistent classification of medical marijuana usage in different U.S. states have short-circuited the rigorous scientific protocols of the U.S. Food and Drug Administration (FDA), quality validation may be lacking. Dustin Sulak, DO, Integr8 Health (Falmouth, ME) and co-investigators review how "artisanal" cannabis preparations, not subject to state regulatory controls, are being used in Washington and California. They also relate four case studies of pediatric epilepsy patients that illustrate the complexities of treatment due to variability of these preparations. As an example of how interest in medical use of cannabis can be driven by social media and word-of-mouth, Anastasia S. Suraev, the Lambert Initiative for Cannabinoid Therapeutics, the University of Sydney, and co-authors surveyed the Australian epilepsy community. This online survey was promoted by Epilepsy Action Australia, a national non-profit organization that provides education and services to people with epilepsy and their families. There were 976 responses, about 60 percent from adults with epilepsy and the remainder from children with epilepsy. Overall, 14 percent reported currently using or having previously used cannabis products to treat epilepsy. Of the 389 children with epilepsy included in the survey, 13 percent had a reported history of cannabis product use for epilepsy. Of these, 71 percent of parents/guardians rated cannabis products as successful in helping them manage their child's seizures. Furthermore, 51 percent of parents/guardians reported reduced use of anti-epileptic drugs by their child after commencing use of cannabis products. Although cannabis is currently legal for medical purposes in half of the states and another seventeen states allow products that are high in cannabidiol (CBD) and low in THC (tetrahydrocannabinol) for medical use, none of these products has been approved by the FDA. Alice Mead, JD, LLM, GW Pharmaceuticals, Inc. (Carlsbad, CA) provides an overview of the legal aspects of cannabis and cannabidiol, including cultivation, manufacture, distribution, and use for medical purposes. "We hope these articles help stimulate greater understanding and more importantly, stimulate more studies to scientifically define the potential benefits and harms of cannabis-based therapies for epilepsy," said Szaflarski and Devinsky. "We need to develop a curriculum to address the rapidly changing scientific and regulatory landscape surrounding the medical use of cannabis and cannabinoids."


News Article | May 25, 2017
Site: www.biosciencetechnology.com

Although cannabis had been used for many centuries for treatment of seizure disorders, medical use became prohibited in the 20th century. However, with the loosening of laws regarding medical marijuana, research and clinical use of marijuana-derived substances are increasing. This has prompted the editors of Epilepsy & Behavior to produce a special issue that presents an in-depth assessment of the potential of cannabinoids for the effective treatment of epilepsy. Cannabinoids are components of the cannabis plant. Guest Editors Jerzy Szaflarski, M.D., Ph.D., Director of the Epilepsy Center, University of Alabama at Birmingham, and Orrin Devinsky, M.D., Director, Epilepsy Center, New York University Langone Medical Center, New York, comment that, "There is an enormous dissociation between the widespread use of cannabis-based therapies to treat diverse epilepsies and our understanding about the efficacy and safety of different cannabinoids in treating different epilepsy syndromes." Because much of the political pressure to allow for medical marijuana use came from patients and lay groups, the goal of this special issue is "to evaluate the concerns and gaps in cannabinoid knowledge and medical education, and to create a curriculum as a first step in building a broader Education Roadmap." This special issue provides an overview for general neurologists and epileptologists, including historical aspects of cannabis use for epilepsy, overview of cannabis botany, general aspects of the endocannabinoid system as it pertains to epilepsy, pharmacology of cannabinoids, available anecdotal and clinical trial data of cannabinoid use for the treatment of epilepsy, safety data, discussion of possible effects of cannabinoids on the brain including neuroimaging data, and the legal aspects of cannabis production, distribution, and use for the treatment of epilepsy. Raphael Mechoulam, PhD, Head of the School of Pharmacy and Director of the Institute for Drug Research at Hebrew University, provides an insightful historical perspective. He notes that non-psychoactive cannabidiol (CBD) is officially approved for the treatment of intractable pediatric epilepsy in Israel, but it took over 35 years to conduct the studies and obtain the results. "I expect that over the next decade we shall see major advances both in the medical-scientific and the treatment aspects of epilepsy with the help of CBD and related cannabinoids," explains Dr. Mechoulam. To move a plant-based drug from research studies to clinical use is a particular challenge for pharmaceutical companies. Suman Chandra, PhD, Senior Research Scientist at the University of Mississippi, and co-authors review how the United States and United Kingdom have addressed the problem of securing uniform supplies of medically pure and potent cannabinoids. They review cultivation and processing of marijuana at two institutions with extensive experience, GW Pharmaceuticals in the U.K. and the University of Mississippi in the U.S. Because both media coverage of cannabis use in epilepsy and inconsistent classification of medical marijuana usage in different U.S. states have short-circuited the rigorous scientific protocols of the U.S. Food and Drug Administration (FDA), quality validation may be lacking. Dustin Sulak, DO, Integr8 Health (Falmouth, ME) and co-investigators review how "artisanal" cannabis preparations, not subject to state regulatory controls, are being used in Washington and California. They also relate four case studies of pediatric epilepsy patients that illustrate the complexities of treatment due to variability of these preparations. As an example of how interest in medical use of cannabis can be driven by social media and word-of-mouth, Anastasia S. Suraev, The Lambert Initiative for Cannabinoid Therapeutics, The University of Sydney, and co-authors surveyed the Australian epilepsy community. This online survey was promoted by Epilepsy Action Australia, a national non-profit organization that provides education and services to people with epilepsy and their families. There were 976 responses, about 60 percent from adults with epilepsy and the remainder from children with epilepsy. Overall, 14 percent reported currently using or having previously used cannabis products to treat epilepsy. Of the 389 children with epilepsy included in the survey, 13 percent had a reported history of cannabis product use for epilepsy. Of these, 71 percent of parents/guardians rated cannabis products as successful in helping them manage their child's seizures. Furthermore, 51 percent of parents/guardians reported reduced use of anti-epileptic drugs by their child after commencing use of cannabis products. Although cannabis is currently legal for medical purposes in half of the states and another seventeen states allow products that are high in cannabidiol (CBD) and low in THC (tetrahydrocannabinol) for medical use, none of these products has been approved by the FDA. Alice Mead, JD, LLM, GW Pharmaceuticals, Inc. (Carlsbad, CA) provides an overview of the legal aspects of cannabis and cannabidiol, including cultivation, manufacture, distribution, and use for medical purposes. "We hope these articles help stimulate greater understanding and more importantly, stimulate more studies to scientifically define the potential benefits and harms of cannabis-based therapies for epilepsy," note Dr. Szaflarski and Dr. Devinsky. "We need to develop a curriculum to address the rapidly changing scientific and regulatory landscape surrounding the medical use of cannabis and cannabinoids."


– Pharmaceutical formulation of cannabidiol significantly reduced convulsive seizure frequency in children on multiple anti-epileptic drugs with poor seizure control – – First well-controlled clinical study of cannabidiol in Dravet syndrome, a rare, severe type of epilepsy with no FDA-approved treatments – LONDON, May 24, 2017 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq:GWPH) (“GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, along with its U.S. subsidiary Greenwich Biosciences, announced today that The New England Journal of Medicine has published results from a Phase 3 study of Epidiolex® (cannabidiol) in children with Dravet syndrome.1 Epidiolex, GW’s lead product candidate and the potential first in a new category of anti-epileptic drugs, is a liquid formulation of purified, plant-derived cannabidiol (CBD), a non-psychoactive cannabinoid, which is being studied for the treatment of a number of rare, severe pediatric-onset epilepsy disorders. In the study, Epidiolex significantly reduced monthly convulsive seizure frequency compared to placebo in highly treatment-resistant children when added to existing treatment. Treatment with Epidiolex was generally well tolerated, with a safety profile consistent with prior open label experience. There are currently no treatments approved by the U.S. Food and Drug Administration (FDA) for Dravet syndrome, a rare form of epilepsy associated with a high mortality rate and significant developmental delays. Results from this study represent the only well-controlled clinical evaluation of a cannabinoid medication for this devastating and drug-resistant condition. The New Drug Application for Epidiolex remains on track for submission to the FDA in the middle of 2017. "Dravet syndrome is one of the most difficult types of epilepsy to treat and many of the children in this study were experiencing dozens, even hundreds, of seizures per month despite taking multiple concurrent anti-epileptic medications," said Orrin Devinsky, M.D., of NYU Langone Medical Center's Comprehensive Epilepsy Center and lead author of the study. “These results suggest that Epidiolex can provide clinically meaningful benefits and I look forward to the prospect of an appropriately standardized and tested pharmaceutical formulation of cannabidiol available as a treatment option for these patients.” "The publication of these highly-anticipated positive results represents an important milestone for the Dravet syndrome community in that it provides hope that a new treatment option is within sight for this rare and devastating disease," said Nicole Villas, Scientific Director of the Dravet Syndrome Foundation. "As a foundation dedicated to research and patient assistance, we hope the burden of Dravet syndrome on patients and families is recognized and welcome new, well-researched treatments such as this that might help ease the burden." The study randomized 120 children ages two to 18 years (mean age 9.8), with Dravet syndrome whose seizures were not controlled by their current anti-epileptic regimen, to receive either Epidiolex (20mg/kg/day) or placebo in addition to standard treatment. Conducted in 23 study centers in the United States and Europe, patients in the study had tried a median of four prior anti-epileptic drugs (range 0-26) and were taking a median of three (range 1-5) during the study. At baseline, patients had a median frequency of 13 convulsive seizures per month, with a wide range of 3.7 to 1,717 seizures per month. Over the 14-week treatment period, patients taking Epidiolex had a significantly greater median reduction in convulsive seizures (39 percent) compared to placebo (13 percent). The estimated median treatment difference between groups was 23 percent (p=0.01). The proportion of patients who had a 50 percent or better reduction in convulsive seizure frequency was 43 percent with Epidiolex versus 27 percent with placebo (p=0.08). The study also measured improvement on the Caregiver Global Impression of Change (CGIC) scale. Sixty-two percent of patients treated with Epidiolex were rated as improved in overall condition on the CGIC compared to 34 percent of the placebo group (p=0.02). Additionally, more patients became seizure-free on Epidiolex than placebo (5 percent vs 0 percent: p=0.08) and total monthly seizure count was significantly reduced with Epidiolex (p=0.03). Epidiolex was generally well tolerated in the trial. The most common adverse events (AEs) (>10 percent) were somnolence, diarrhea, decreased appetite, fatigue, vomiting, pyrexia, lethargy, convulsion, upper respiratory tract infection. Of the 93 percent of patients on Epidiolex that experienced an AE, 84 percent reported it to be mild or moderate. Ten patients on Epidiolex experienced a serious adverse event compared with three patients on placebo. Eight patients on Epidiolex discontinued treatment due to adverse events compared with one patient on placebo. Elevations in liver enzymes occurred in 12 patients taking Epidiolex and one patient taking placebo, all of whom were on concomitant valproic acid. Four of these patients withdrew from the trial, three on Epidiolex and one on placebo. In the remaining nine patients taking Epidiolex, elevations returned to normal while on treatment. “The publication of results from this landmark study by The New England Journal of Medicine and the accompanying editorial commentary2 highlight the potential of Epidiolex to address the significant unmet need in Dravet syndrome,” said Justin Gover, GW's Chief Executive Officer. “We remain committed to these patients and their families, and are determined to make this important new medicine available to them as quickly as possible.” Dravet syndrome is a severe infantile-onset and highly treatment-resistant epileptic syndrome frequently associated with a genetic mutation in sodium channels. Onset of Dravet syndrome occurs during the first year of life in previously healthy and developmentally normal infants. Initial seizures are often temperature related, severe, and long-lasting. Over time, people with Dravet syndrome can develop multiple types of seizures, including tonic-clonic, myoclonic, and atypical absences and are prone to bouts of prolonged seizures called status epilepticus, which can be life threatening. Risk of premature death including SUDEP (sudden unexpected death in epilepsy) is elevated in people with Dravet syndrome. Additionally, the majority will develop moderate to severe intellectual and development disabilities and require lifelong supervision and care. There are currently no FDA-approved treatments and nearly all patients continue to have uncontrolled seizures and other medical needs throughout their lifetime. Epidiolex, GW's lead cannabinoid product candidate, is a liquid formulation of plant-derived cannabidiol (CBD), which is in development for the treatment of a number of rare childhood-onset epilepsy disorders. GW has conducted extensive pre-clinical research of CBD in epilepsy since 2007. This research has shown that CBD has significant anti-epileptiform and anticonvulsant activity using a variety of in-vitro and in-vivo models and efficacy in reducing seizures in acute animal models of epilepsy. To date, GW has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for Epidiolex for the treatment of Dravet syndrome, Lennox-Gastaut syndrome (LGS), Tuberous Sclerosis Complex (TSC) and Infantile Spasms (IS), each of which are severe infantile-onset, drug-resistant epilepsy syndromes. Additionally, GW has received Fast Track Designation from the FDA for the treatment of Dravet syndrome and Orphan Designation from the European Medicines Agency, or EMA, for Epidiolex for the treatment of Dravet syndrome and LGS. GW is currently evaluating additional clinical development programs in other orphan seizure disorders. 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 is advancing an orphan drug program in the field of childhood-onset epilepsy with a focus on Epidiolex® (cannabidiol), which is in Phase 3 clinical development for the treatment of Dravet syndrome, Lennox-Gastaut syndrome, Tuberous Sclerosis Complex and Infantile Spasms. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex® (nabiximols), which is approved for the treatment of spasticity due to multiple sclerosis in 31 countries outside the United States. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioma, schizophrenia and epilepsy. In the United States, GW operates through its subsidiary Greenwich Biosciences, Inc. For further information, please visit www.gwpharm.com. This news release contains forward-looking statements that reflect GW's current expectations regarding future events, including statements regarding financial performance, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions, the relevance of GW products commercially available and in development, the clinical benefits of Epidiolex® and the safety profile and commercial potential of Epidiolex. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Epidiolex and other products by consumer and medical professionals. A further list and description of risks and uncertainties associated with an investment in GW can be found in GW’s filings with the U.S. Securities and Exchange Commission, including the most recent Form 20-F filed on 5 December 2016. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. PDFs accompanying this announcement are available at http://www.globenewswire.com/NewsRoom/AttachmentNg/0e56d80b-2ae0-4b73-aae4-02645d14c8a0 http://www.globenewswire.com/NewsRoom/AttachmentNg/71639bb9-ccd0-468d-920e-7aae9bafcc70 http://www.globenewswire.com/NewsRoom/AttachmentNg/a573f62d-8bc6-488e-8a68-9f22e69034c5 A video accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/3159234c-082c-4923-bb4a-7e9dd0e05f63 These photos are also available via AP PhotoExpress. 1 Devinsky O, Cross JH, Laux L, et al. Trial of cannabidiol for drug-resistant seizures in the Dravet syndrome. N Engl J Med 2017; 376;2011-20. 2 Berkovic, SF. Editorial: Cannabinoids for epilepsy – real data, at last. N Engl J Med 2017; 376;2075-76.


News Article | May 26, 2017
Site: news.yahoo.com

A highly anticipated clinical trial has shown that treating patients with epilepsy with a compound derived from marijuana can significantly reduce and, in some cases, eliminate seizures in children and young adults. In the study, children and young adults with a rare and debilitating form of epilepsy called Dravet syndrome who took doses of marijuana extract experienced half as many seizures per month as those who received a placebo. And 5 percent of those treated with the marijuana extract, called cannabidiol, became seizure-free during the study period. [25 Odd Facts About Marijuana] Currently, there aren't any medications that can completely control seizures in children with Dravet syndrome, according to the Epilepsy Foundation. The study, published today (May 24) in the New England Journal of Medicine, is among the first to provide solid, clinical evidence to support a form of treatment that is becoming fairly widespread with the advent of medical marijuana, but which remains largely unregulated. "I can't say enough about the importance of these kinds of medical trials. People have a sense that if 10 people say it works and it's a bad disease like cancer or epilepsy, then it's safe to use. That's just false," said Dr. Orrin Devinsky, the director of NYU Langone's Comprehensive Epilepsy Center and a co-lead author of the study. "Just because it's natural and just because there may be anecdotal support from people, doesn't mean it's effective and safe." Cannabidiol, also known as CBD, is one of dozens of compounds in marijuana called cannabinoids. But unlike tetrahydrocannabinol (THC), which is the main psychoactive chemical in marijuana, CBD does not get users "high." The compound is typically administered in an oil form and is thought to work by interacting with receptors on nerve cells. Interest in using the drug to treat epilepsy grew significantly in 2013 when an 8-year-old girl from Colorado with Dravet syndrome entered the public spotlight. The girl showed remarkable improvement after taking CBD administered by a Denver medical marijuana dispensary. Since then, other anecdotal cases have shown promise and a December 2015 study (also led by Devinsky) suggested positive outcomes from the drug. The 2015 study, however, did not use a placebo. Results, therefore, were vulnerable to a bias since patients and doctors could associate any progress to the drug. The new study was a randomized, double-blind, placebo-controlled trial — a study design that's considered the gold standard for clinical research. That means that neither the researchers nor the participants know if they have been given the drug being studied or a placebo. The study included 120 children and young adults, ages 2 to 18, with Dravet syndrome. Half of the patients received a placebo, while the other half received 20 milligrams per kilogram of body weight per day of the CBD drug, Epidiolex. Epidiolex is a 99 percent cannabidiol preparation made by the U.K.-based company, GW Pharmaceuticals, which funded the study. [Healing Herb? Marijuana Could Treat These 5 Conditions] At the end of the three-month trial, the researchers compared the frequency of patients' seizures to their seizure frequencies from a four-week period before the trial began. Those who received the drug had, on average, 12 seizures per month before the study began. After the study period, the frequency dropped to six seizures per month, on average. Those patients who took CBD showed some side effects, including diarrhea, vomiting, fatigue and abnormal results on liver-function tests. But Devinsky said most of these reactions were mild and could be reduced with an adjustment in dose. Dr. Helen Cross, also a co-lead author of the study, told Live Science that it was critical to measure the effects of a drug with carefully prepared levels of CBD. "We know exactly what’s in every single batch," said Cross, a clinical neuroscientist at University College London's Institute of Child Health. "It's not like the hemp oils that you can buy from the internet, which are so variable in their content." Indeed, in the U.S., CBD oil is legal (with varying limitations) in 44 states, but the substance is not regulated, and many patients and parents of children with elpilepsy are not waiting for clinical data and instead are trying these unregulated versions of the cannabis-derived drug. [3 More States Legalize Recreational Marijuana Use: How the Map Looks Now] “We desperately need other studies like this in other forms of epilepsy and using other cannabis preparations. That should be a priority,” Devinsky told Live Science. While Dravet syndrome is rare, affecting 1 in 40,000 children, epilepsy is the fourth most common neurological condition and affects more than 65 million people worldwide, according to the Epilepsy Foundation. Research from April 2017 showed CBD to be effective in treating another, relatively rare, but severe form of epilepsy, Lennox-Gastaut syndrome. "The big question now is whether this drug is also effective for a larger group of people with epilepsy who don't have these rare syndromes," Devinsky said. In an editorial published in the same journal as the study, Dr. Sam Berkovic, a neurologist and the director of the Epilepsy Research Centre at the University of Melbourne, in Australia,emphasized the importance of the clinical trial ― and the need for more like it. Berkovic was not involved with the new research. "Medical practice cannot be decided by anecdotes," Berkovic told Live Science in an email. "They are subject to many forms of bias." 9 Weird Ways You Can Test Positive for Drugs


LONDON, ENGLAND / ACCESSWIRE / May 8, 2017 / GW Pharmaceuticals plc (NASDAQ: GWPH) will host a conference call and live webcast to discuss the results of the second quarter 2017, to be held Tuesday, May 9, 2017 at 4:30 PM Eastern Time. To participate, connect approximately 5 to 10 minutes before the beginning of the event. If you are unable to participate during the live webcast, the event archive will be available at www.investorcalendar.com or www.gwpharm.com. 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 is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex® (cannabidiol), which is in Phase 3 clinical development for the treatment of Dravet syndrome, Lennox-Gastaut syndrome, Tuberous Sclerosis Complex and Infantile Spasms. GW commercialized the world's first plant-derived cannabinoid prescription drug, Sativex® (nabiximols), which is approved for the treatment of spasticity due to multiple sclerosis in 31 countries outside the United States. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioma, schizophrenia and epilepsy. For further information, please visit www.gwpharm.com.


- Epidiolex® NDA submission expected mid-year - - New data in Lennox-Gastaut syndrome presented at the American Academy of Neurology - - Conference call today at 4:30 p.m. EDT- LONDON, May 09, 2017 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH) (GW, the Company or the Group), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced financial results for the second quarter ended 31 March 2017.                                        “Our primary focus is on the submission of the Epidiolex NDA, which is expected in the middle of this year. Based on the efficacy and safety profile, we are confident in the prospects for an Epidiolex approval and continue to expand the commercial organization in preparation for a highly successful launch,” stated Justin Gover, GW’s Chief Executive Officer. “Beyond Epidiolex, we continue to advance a number of additional exciting clinical programs.” • Epidiolex (CBD) orphan epilepsy program in Dravet syndrome, Lennox-Gastaut Syndrome (LGS), Tuberous Sclerosis Complex (TSC) and infantile spasms (IS) Solely for the convenience of the reader, the above balances have been translated into U.S. dollars at the rate on 31 March 2017 of $1.25331 to £1. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at that or any other exchange rate as at that or any other date. Conference Call and Webcast Information GW Pharmaceuticals will host a conference call and webcast to discuss the second quarter 2017 financial results today at 4:30 pm EDT. To participate in the conference call, please dial 800-860-2442 (toll free from the U.S. and Canada) or 412-858-4600 (international). Investors may also access a live audio webcast of the call via the investor relations section of the Company’s website at http://www.gwpharm.com. A replay of the call will also be available through the GW website shortly after the call and will remain available for 90 days. Replay Numbers: (toll free):1-877-481-4010, (international):1-919-882-2331. For both dial-in numbers please use conference ID # 13661781. 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 is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex (cannabidiol), which is in Phase 3 clinical development for the treatment of Dravet syndrome, Lennox-Gastaut syndrome, Tuberous Sclerosis Complex and Infantile Spasms. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 31 countries outside the United States. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioma, schizophrenia and epilepsy. For further information, please visit www.gwpharm.com. This news release contains forward-looking statements that reflect GW's current expectations regarding future events, including statements regarding financial performance, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions, the relevance of GW products commercially available and in development, the clinical benefits of Sativex and Epidiolex and the safety profile and commercial potential of Sativex and Epidiolex. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex, Epidiolex and other products by consumer and medical professionals. A further list and description of risks and uncertainties associated with an investment in GW can be found in GW’s filings with the U.S. Securities and Exchange Commission including the most recent Form 20-F filed on 5 December 2016. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Condensed consolidated statement of comprehensive loss For the three months ended 31 March 2017 Condensed consolidated statement of comprehensive loss For the six months ended 31 March 2017 GW Pharmaceuticals plc Condensed consolidated statement of changes in equity Six months ended 31 March 2017


Brodie J.S.,GW Pharmaceuticals | Di Marzo V.,National Research Council Italy | Guy G.W.,GW Pharmaceuticals
Trends in Pharmacological Sciences | Year: 2015

Chronic diseases are due to deviations of fundamental physiological systems, with different pathologies being characterised by similar malfunctioning biological networks. The ensuing compensatory mechanisms may weaken the body's dynamic ability to respond to further insults and reduce the efficacy of conventional single target treatments. The multitarget, systemic, and prohomeostatic actions emerging for plant cannabinoids exemplify what might be needed for future medicines. Indeed, two combined cannabis extracts were approved as a single medicine (Sativex®), while pure cannabidiol, a multitarget cannabinoid, is emerging as a treatment for paediatric drug-resistant epilepsy. Using emerging cannabinoid medicines as an example, we revisit the concept of polypharmacology and describe a new empirical model, the 'therapeutic handshake', to predict efficacy/safety of compound combinations of either natural or synthetic origin. © 2015 Elsevier Ltd. All rights reserved.


Russo E.B.,GW Pharmaceuticals
British Journal of Pharmacology | Year: 2011

Tetrahydrocannabinol (THC) has been the primary focus of cannabis research since 1964, when Raphael Mechoulam isolated and synthesized it. More recently, the synergistic contributions of cannabidiol to cannabis pharmacology and analgesia have been scientifically demonstrated. Other phytocannabinoids, including tetrahydrocannabivarin, cannabigerol and cannabichromene, exert additional effects of therapeutic interest. Innovative conventional plant breeding has yielded cannabis chemotypes expressing high titres of each component for future study. This review will explore another echelon of phytotherapeutic agents, the cannabis terpenoids: limonene, myrcene, α-pinene, linalool, β-caryophyllene, caryophyllene oxide, nerolidol and phytol. Terpenoids share a precursor with phytocannabinoids, and are all flavour and fragrance components common to human diets that have been designated Generally Recognized as Safe by the US Food and Drug Administration and other regulatory agencies. Terpenoids are quite potent, and affect animal and even human behaviour when inhaled from ambient air at serum levels in the single digits ng·mL -1. They display unique therapeutic effects that may contribute meaningfully to the entourage effects of cannabis-based medicinal extracts. Particular focus will be placed on phytocannabinoid-terpenoid interactions that could produce synergy with respect to treatment of pain, inflammation, depression, anxiety, addiction, epilepsy, cancer, fungal and bacterial infections (including methicillin-resistant Staphylococcus aureus). Scientific evidence is presented for non-cannabinoid plant components as putative antidotes to intoxicating effects of THC that could increase its therapeutic index. Methods for investigating entourage effects in future experiments will be proposed. Phytocannabinoid-terpenoid synergy, if proven, increases the likelihood that an extensive pipeline of new therapeutic products is possible from this venerable plant. © 2011 The British Pharmacological Society.


The present invention relates to cannabinoids for use in the prevention or treatment of neurodegenerative diseases or disorders. Preferably the cannabinoids are cannabichromene (CBC) cannabidivarin (CBDV) and/or cannabidivarin acid (CBDVA). More preferably the neurodegenerative disease or disorder to be prevented or treated is Alzheimers disease.


The present invention relates to the phytocannabinoid tetrahydrocannabivarin (THCV) for use in the protection of pancreatic islet cells. Preferably the pancreatic islet cells to be protected are beta cells. More preferably the protection of the pancreatic islet cells maintains insulin production at levels which are able to substantially control or improve control of blood glucose levels in a patient.

Loading GW Pharmaceuticals collaborators
Loading GW Pharmaceuticals collaborators