GWPH GW Pharmaceuticals Plc

135.73
-2.1  -2%
Previous Close 137.83
Open 137.9
52 Week Low 67.98
52 Week High 143.9999
Market Cap $4,232,295,399
Shares 31,181,724
Float 25,621,332
Enterprise Value $3,778,756,864
Volume 379,940
Av. Daily Volume 420,834
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Upcoming Catalysts

Drug Stage Catalyst Date
Sativex (Nabiximols)
Spasticity due multiple sclerosis
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
GWP42003
Schizophrenia
Phase 2b
Phase 2b
Phase 2b trial enrolling.
Epidiolex
Rett syndrome
Phase 3
Phase 3
Phase 3 trial underway.
GWP42006 (CBDV)
Autism
Phase 2
Phase 2
Phase 2 trial has resumed - noted November 3, 2020.
Nabiximols
Post-Traumatic Stress Disorder (PTSD)
Phase 2/3
Phase 2/3
Phase 2/3 trial to commence 1H 2021
Epidiolex
Tuberous Sclerosis Complex
Approved
Approved
FDA approval announced August 3, 2020.
GWP42006 (CBDV)
Rett syndrome
Phase 2
Phase 2
Phase 2 open-label trial underway - noted February 25, 2020.
Epidiolex
Dravet Syndrome and Lennox-Gastaut syndrome
Approved
Approved
Approval announced June 25, 2018.
GWP42006 (CBDV)
Epilepsy
Phase 2
Phase 2
Phase 2 data released February 21, 2018 - primary endpoint not met.
GWP42004
Type 2 diabetes
Phase 2
Phase 2
Phase 2 trial did not meet endpoint

Latest News

  1. - Total preliminary net product sales of approximately $148 million for the fourth quarter and approximately $526 million for the full year -
    - Total Epidiolex® preliminary net product sales of approximately $144 million for the fourth quarter and approximately $510 million for the full year –
    - Pivotal US clinical program for nabiximols in MS spasticity underway. Initial data expected in 2021 -

    LONDON and CARLSBAD, Calif., Jan. 11, 2021 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, today reported preliminary, unaudited net product sales for the fourth quarter and full year 2020 and key priorities for 2021. Justin Gover, GW's…

    - Total preliminary net product sales of approximately $148 million for the fourth quarter and approximately $526 million for the full year -

    - Total Epidiolex® preliminary net product sales of approximately $144 million for the fourth quarter and approximately $510 million for the full year –

    - Pivotal US clinical program for nabiximols in MS spasticity underway. Initial data expected in 2021 -

    LONDON and CARLSBAD, Calif., Jan. 11, 2021 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, today reported preliminary, unaudited net product sales for the fourth quarter and full year 2020 and key priorities for 2021. Justin Gover, GW's Chief Executive Officer, expects to discuss these updates as part of a webcast presentation at the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 12th at 10:00 a.m. ET.

    "Epidiolex sales increased by over 70% in 2020 despite the challenges of COVID-19, reflecting the positive impact this medicine has on patients as well as the performance of our commercial team. We remain encouraged by our patients' experience on this product, as demonstrated by high persistence and refill rates. This, combined with our expansion of payer coverage and the recently approved Tuberous Sclerosis Complex indication, leads us to expect continued strong growth in 2021 in both the US and Europe," said Justin Gover, GW's Chief Executive Officer. "Our goals in 2021 include driving further Epidiolex growth and advancing multiple US pivotal trials for nabiximols in the treatment of MS spasticity, with the first data readout expected this year. In addition to our previously announced pipeline activities, we are leveraging our world leadership in cannabinoid science to design and synthesize novel cannabinoid molecules and expect our first novel product candidate to enter the clinic in 2021."

    Preliminary Unaudited Fourth Quarter and Full-Year 2020 Net Product Sales

    Based on preliminary unaudited financial information, the Company expects total net product sales to be approximately $148 million for the fourth quarter and approximately $526 million for the year ended December 31, 2020. Total net product sales of Epidiolex are expected to be approximately $144 million for the fourth quarter, comprising $129 million in the US and $15 million ex-US. Total net product sales of Epidiolex for the year ended December 31, 2020 are expected to be approximately $510 million compared to $296 million in 2019. Cash and cash equivalents at December 31, 2020 were approximately $486 million.

    Key Priorities for 2021

    EPIDIOLEX commercialization:

    • Continue to drive revenue growth in US and Europe:

      • Execute on TSC label expansion and continued penetration in Dravet and LGS

      • Build further on expanded payer coverage achievements

      • Accelerate adoption across a broader prescriber base

      • Increase penetration in long-term care segment

      • Continue launches in Germany and UK and achieve successful pricing and reimbursement, and launch execution in France, Spain and Italy, as well as other European countries

      • Obtain approval of the Tuberous Sclerosis Complex indication in Europe
    • Supplement existing 14 Orange Book listed patents (expiry 2035) with additional use patents, and obtain grant of the Epidiolex "composition" patent
    • Commence pivotal trial in fourth target orphan epilepsy indication

    Nabiximols in the US:

    • Continue recruitment of two ongoing pivotal MS spasticity trials and commence three additional pivotal trials in MS spasticity
    • Achieve data from at least one pivotal MS spasticity trial in 2021
    • NDA submission expected following first positive pivotal MS spasticity trial
    • Commence clinical program to expand future label to include spasticity associated with Spinal Cord Injury

    Additional pipeline:

    • Continue recruitment of ongoing Phase 2b study of a cannabidiol formulation for the treatment of schizophrenia
    • Conduct placebo-controlled trials with both CBDV and CBD in autism
    • Advance NHIE clinical program utilizing an intravenous formulation of cannabidiol
    • Complete Phase 1 trial for novel botanical drug candidate GW541
    • Advance first novel NCE cannabinoid candidate into Phase 1

    About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.

    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. The Company's lead product, EPIDIOLEX® (cannabidiol) oral solution, is commercialized in the U.S. by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients one year of age and older. This product has received approval in the European Union under the tradename EPIDYOLEX® for the adjunctive treatment of seizures associated with LGS or Dravet syndrome in conjunction with clobazam in patients two years and older and is under EMA review for the treatment of TSC. The Company has a deep pipeline of additional cannabinoid product candidates, in particular nabiximols, for which the Company is advancing multiple late-stage clinical programs in order to seek FDA approval in the treatment of spasticity associated with multiple sclerosis and spinal cord injury. The Company has additional cannabinoid product candidates in clinical trials for autism and schizophrenia. For further information, please visit www.gwpharm.com.

    Forward-looking statements

    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®/EPIDYOLEX® (cannabidiol) oral solution and Sativex® (nabiximols), and the safety profile and commercial potential of both medicines, and those associated with the COVID-19 pandemic. 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 and uncertainties related to the regulatory process, and the acceptance of EPIDIOLEX®/EPIDYOLEX®, Sativex® 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. 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.

    Enquiries:

    GW Pharmaceuticals plc 
    Scott Giacobello, Chief Financial Officer



    760 795 2200
    U.S. Media

    Christy Curran

    Sam Brown Inc. Healthcare Communications





    615 414 8668

    Ex-U.S. Media Enquiries

    Ben Atwell, FTI Consulting
    +44 (0)203 727 1000


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  2. LONDON and CARLSBAD, Calif., Jan. 05, 2021 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH, GW, the Company or the Group))), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announced that Justin Gover, GW's Chief Executive Officer, will present a business update and 2021 outlook at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 10:00 am PT (1:00 pm ET). In addition, a Q&A breakout session will immediately follow the presentation at 10:20 am PT (1:20 pm ET).

    A live audio webcast of the presentation will be available through GW's corporate website at www.gwpharm.com in the Investors section under Events & Presentations. A replay will…

    LONDON and CARLSBAD, Calif., Jan. 05, 2021 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH, GW, the Company or the Group))), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announced that Justin Gover, GW's Chief Executive Officer, will present a business update and 2021 outlook at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 10:00 am PT (1:00 pm ET). In addition, a Q&A breakout session will immediately follow the presentation at 10:20 am PT (1:20 pm ET).

    A live audio webcast of the presentation will be available through GW's corporate website at www.gwpharm.com in the Investors section under Events & Presentations. A replay will be available soon after the live presentation.

    About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.

    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. The Company's lead product, EPIDIOLEX® (cannabidiol) oral solution, is commercialized in the U.S. by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients one year of age and older. This product has received approval in the European Union under the tradename EPIDYOLEX® for the adjunctive treatment of seizures associated with LGS or Dravet syndrome in conjunction with clobazam in patients two years and older and is under EMA review for the treatment of TSC. The Company has a deep pipeline of additional cannabinoid product candidates, in particular nabiximols, for which the Company is advancing multiple late-stage clinical programs in order to seek FDA approval in the treatment of spasticity associated with multiple sclerosis and spinal cord injury. The Company has additional cannabinoid product candidates in clinical trials for autism and schizophrenia. For further information, please visit www.gwpharm.com.

    Enquiries:

    GW Pharmaceuticals plc 
    Scott Giacobello, Chief Financial Officer

    760 795 2200

      
    U.S. Media 
    Christy Curran

     615 414 8668
    Sam Brown Inc. Healthcare Communications 


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  3. CARLSBAD, Calif., Dec. 21, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH, GW, the Company or the Group))), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, along with U.S. subsidiary Greenwich Biosciences, announced today that JAMA Neurology has published results of the company's positive Phase 3 clinical trial of EPIDIOLEX® (cannabidiol) oral solution in seizures associated with tuberous sclerosis complex (TSC). EPIDIOLEX, a pharmaceutical formulation of cannabidiol (CBD), is the first prescription, plant-derived cannabis-based medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS…

    CARLSBAD, Calif., Dec. 21, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH, GW, the Company or the Group))), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, along with U.S. subsidiary Greenwich Biosciences, announced today that JAMA Neurology has published results of the company's positive Phase 3 clinical trial of EPIDIOLEX® (cannabidiol) oral solution in seizures associated with tuberous sclerosis complex (TSC). EPIDIOLEX, a pharmaceutical formulation of cannabidiol (CBD), is the first prescription, plant-derived cannabis-based medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or TSC in patients one year of age and older.

    The study found that individuals treated with EPIDIOLEX 25 mg/kg/day or 50 mg/kg/day experienced a significantly greater reduction in TSC-associated seizures (48.6% for 25 mg/kg/day and 47.5% for 50 mg/kg/day) compared to placebo (26.5%; p<0.001 and p=0.002, respectively). This trial provided the basis for the July 2020 FDA approval of EPIDIOLEX for seizures associated with TSC.

    "People living with TSC may experience focal seizures and spasms as infants and continue to suffer from seizures throughout their lifetime," said Elizabeth Thiele, M.D., Ph.D., director of pediatric epilepsy and director of The Carol and James Herscot Center for Tuberous Sclerosis Complex at Massachusetts General Hospital, professor of neurology at Harvard Medical School, Boston and lead investigator of the trial. "This study demonstrated that for patients with TSC and a high baseline burden of treatment-resistant, primarily focal, seizures, EPIDIOLEX significantly reduced the frequency of seizures compared with placebo."

    The safety profile observed in the study was generally consistent with findings from previous studies of EPIDIOLEX. Both doses had an acceptable safety profile, with fewer adverse events (AEs) reported with 25 mg/kg/day than 50 mg/kg/day. The most common AEs were diarrhea, decreased appetite, and somnolence. AEs occurred in 93% of the 25 mg/kg/day group, 100% of the 50 mg/kg/day group, and 95% of the placebo group. Eight patients on EPIDIOLEX 25 mg/kg/day, 10 on 50 mg/kg/day, and two on placebo discontinued treatment due to an AE. Additionally, 12% of 25 mg/kg/day patients and 26% of 50 mg/kg/day patients experienced elevated liver enzymes; 79% of these patients were also taking the antiepileptic drug (AED) valproate. Elevations in ALT/AST resolved in all patients. There were no cases meeting Hy's law criteria observed and there were no deaths in the trial.

    Secondary endpoint data showed more patients on EPIDIOLEX experienced a 50% or greater reduction in seizures (36% for 25 mg/kg/day and 40% for 50 mg/kg/day) compared to placebo (22%; p=0.07 and p=0.02, respectively). Additionally, patients taking either dose of EPIDIOLEX in the study experienced a greater reduction in total seizure frequency (48%) compared to placebo (27%; p<0.001 and p=0.002, respectively). Caregivers and patients also reported overall improvement on the subject/caregiver global impression of change (S/CGIC) more frequently with EPIDIOLEX: 69% of patients on 25 mg/kg/day and 62% of patients on 50 mg/kg/day compared to 39% on placebo (p=0.007 and p=0.06, respectively).

    "The publication of these results in JAMA Neurology reinforces the importance of EPIDIOLEX as a new treatment option for people experiencing treatment-resistant seizures associated with TSC," said Justin Gover, Chief Executive Officer, GW Pharmaceuticals. "We hope that the data will help clinicians to better understand the potential of EPIDIOLEX to reduce focal and generalized seizure frequency in their patients with this condition."

    The results of this study were previously presented at the 2019 American Epilepsy Society (AES) Annual Meeting.

    Study Design

    The randomized, double-blind, placebo-controlled trial was conducted at 46 sites in six countries. A total of 224 people (aged 1 to 65) with a confirmed diagnosis of treatment-resistant TSC were randomized to receive either EPIDIOLEX 25 mg/kg/day (n=75), EPIDIOLEX 50 mg/kg/day (n=73), or placebo (n=76) for 16 weeks (4-week titration and 12-week maintenance phase), added to current AED treatment. The primary endpoint was percent change from baseline in TSC-associated focal and generalized seizure frequency for EPIDIOLEX vs placebo over the treatment period. Key secondary endpoints were ≥50% responder rate, percent reduction in total seizure frequency (including focal sensory and epileptic spasms), and S/CGIC in overall condition. On average, patients were taking three AEDs, having previously tried and discontinued four other AEDs. The most common concomitant AEDs in this trial were valproate (45%), vigabatrin (33%), levetiracetam (29%), and clobazam (27%).

    About Tuberous Sclerosis Complex (TSC)

    Tuberous sclerosis complex (TSC) is a rare genetic condition that affects approximately 50,000 individuals in the U.S. and nearly one million people worldwide.1 At least two children born each day will develop TSC, with an estimated prevalence of one in 6,000 newborns.1 The condition causes mostly benign tumors to grow in vital organs of the body including the brain, skin, heart, eyes, kidneys and lungs2 and is a leading cause of genetic epilepsy.3 People with TSC may experience a variety of seizure types. One of the most common is infantile spasms that typically present in the first year of life; focal (or partial) seizures are also very common.4 TSC is associated with an increased risk of autism and intellectual disability5 and the severity of the condition can vary widely. In some children the disease is very mild, while others may experience life-threatening complications.2 Epilepsy is present in about 85 percent of patients with TSC and may progress to become intractable to medication.4,6,7 More than 60 percent of individuals with TSC do not achieve seizure control8 with standard treatments such as antiepileptic drugs, epilepsy surgery, ketogenic diet, or vagus nerve stimulation6 compared to 30-40 percent of individuals with epilepsy who do not have TSC who are drug resistant.9,10

    About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.

    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. The Company's lead product, EPIDIOLEX® (cannabidiol) oral solution, is commercialized in the U.S. by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients one year of age and older. This product has received approval in the European Union under the tradename EPIDYOLEX® for the adjunctive treatment of seizures associated with LGS or Dravet syndrome in conjunction with clobazam in patients two years and older and is under EMA review for the treatment of TSC. The Company has a deep pipeline of additional cannabinoid product candidates, in particular nabiximols, for which the Company is advancing multiple late-stage clinical programs in order to seek FDA approval in the treatment of spasticity associated with multiple sclerosis and spinal cord injury. The Company has additional cannabinoid product candidates in clinical trials for autism and schizophrenia. For further information, please visit www.gwpharm.com.

    Important Safety Information

    Important safety information for EPIDIOLEX is available at EPIDIOLEX.com.

    Forward-looking statements

    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®/EPIDYOLEX® (cannabidiol) oral solution and Sativex® (nabiximols), and the safety profile and commercial potential of both medicines. 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 and uncertainties related to the regulatory process, and the acceptance of EPIDIOLEX®/EPIDYOLEX®, Sativex® 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. 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.

    U.S. Media Enquiries:

    Sam Brown Inc. Healthcare Communications
    Christy Curran

    Mike Beyer
    615 414 8668

    312 961 2502

    _____________________

    1 TS Alliance, What is TSC? https://www.tsalliance.org/about-tsc/what-is-tsc/. Accessed April 15, 2019.

    2 NIH Tuberous Sclerosis Fact Sheet. Accessed November 19, 2019.

    3 TS Alliance Website. https://www.tsalliance.org/. Accessed November 19, 2019.

    4 Kingswood JC, d'Augeres GB, Belousova E, et al. TuberOus SClerosis registry to increase disease Awareness (TOSCA) - baseline data on 2093 patients. Orphanet J Rare Dis. 2017;12(1):2.

    5 de Vries PJ, Belousova E, Benedik MP, et al. TSC-associated neuropsychiatric disorders (TAND): findings from the TOSCA natural history study. Orphanet J Rare Dis. 2018;13(1):157.

    6 Tuberous Sclerosis Alliance. Diagnosis, Surveillance, and Management for Healthcare Professionals https://www.tsalliance.org/healthcareprofessionals/diagnosis/. Accessed February 19, 2019.

    7 Jeong A, Wong M. Systemic disease manifestations associated with epilepsy in tuberous sclerosis complex. Epilepsia. 2016;57(9):1443-1449.

    8 Chu-Shore CJ, Major P, Camposano S, Muzykewicz D, Thiele EA. The natural history of epilepsy in tuberous sclerosis complex. Epilepsia. 2010;51(7):1236-1241.

    9 Kwan P., Brodie M.J. Early identification of refractory epilepsy. N. Engl. J. Med. 2000;342(5):314–319.

    10 French JA. Refractory epilepsy: clinical overview. Epilepsia. 2007;48 Suppl 1:3-7.



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  4. LONDON and CARLSBAD, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH, GW, the Company or the Group))), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announced that the Company will present at the Needham Virtual Epilepsy & Pain – Specialty CNS Therapeutics Conference on Thursday, December 10, 2020 at 11:00am EST.

    A live audio webcast of the presentation will be available through GW's corporate website at www.gwpharm.com in the Investors section under Events & Presentations. A replay will be available soon after the live presentation.

    About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.
    Founded in 1998, GW is a biopharmaceutical company focused…

    LONDON and CARLSBAD, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH, GW, the Company or the Group))), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announced that the Company will present at the Needham Virtual Epilepsy & Pain – Specialty CNS Therapeutics Conference on Thursday, December 10, 2020 at 11:00am EST.

    A live audio webcast of the presentation will be available through GW's corporate website at www.gwpharm.com in the Investors section under Events & Presentations. A replay will be available soon after the live presentation.

    About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.

    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. The Company's lead product, EPIDIOLEX® (cannabidiol) oral solution, is commercialized in the U.S. by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients one year of age and older. This product has received approval in the European Union under the tradename EPIDYOLEX® for the adjunctive treatment of seizures associated with LGS or Dravet syndrome in conjunction with clobazam in patients two years and older and is under EMA review for the treatment of TSC. The Company has a deep pipeline of additional cannabinoid product candidates, in particular nabiximols, for which the Company is advancing multiple late-stage clinical programs in order to seek FDA approval in the treatment of spasticity associated with multiple sclerosis and spinal cord injury. The Company has additional cannabinoid product candidates in clinical trials for autism and schizophrenia. For further information, please visit www.gwpharm.com.

    Enquiries:

    GW Pharmaceuticals plc 
    Scott Giacobello, Chief Financial Officer760 795 2200



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  5. - Meeting Highlights Include New Long-Term Data in Tuberous Sclerosis Complex -

    CARLSBAD, Calif., Dec. 01, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, along with U.S. subsidiary Greenwich Biosciences, announced today that a variety of data, including long-term data in the treatment of tuberous sclerosis complex (TSC) and in multiple seizure subtypes for EPIDIOLEX® (cannabidiol) oral solution, will be presented at the virtual American Epilepsy Society (AES) Annual Meeting, taking place December 4-8, 2020. EPIDIOLEX, a pharmaceutical formulation of cannabidiol (CBD), is the first prescription, plant-derived, cannabis-based…

    - Meeting Highlights Include New Long-Term Data in Tuberous Sclerosis Complex -

    CARLSBAD, Calif., Dec. 01, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, along with U.S. subsidiary Greenwich Biosciences, announced today that a variety of data, including long-term data in the treatment of tuberous sclerosis complex (TSC) and in multiple seizure subtypes for EPIDIOLEX® (cannabidiol) oral solution, will be presented at the virtual American Epilepsy Society (AES) Annual Meeting, taking place December 4-8, 2020. EPIDIOLEX, a pharmaceutical formulation of cannabidiol (CBD), is the first prescription, plant-derived, cannabis-based medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients one year of age and older.

    New long-term data for people with TSC who enrolled from the EPIDIOLEX expanded access program will be presented for the first time at the meeting, along with other data evaluating the efficacy and safety of EPIDIOLEX for TSC and treatment-resistant epilepsies.

    "Following FDA approval of EPIDIOLEX in TSC earlier this year, AES is an important opportunity to review additional positive, long-term data," said Justin Gover, Chief Executive Officer, GW Pharmaceuticals. "Given that the majority of individuals living with TSC experience treatment-resistant epilepsy, we believe there is a need for promising new treatment options and are pleased to present more than three years of TSC patient data in both convulsive and nonconvulsive seizure subtypes."

    Meeting activities include:

    Data Presentations

    All posters will be available in the ePoster Hall for the duration of AES2020.

    Long-Term Safety & Efficacy of EPIDIOLEX

    • Long-Term Safety and Efficacy of Add-on Cannabidiol (CBD) for Treatment of Seizures Associated with Tuberous Sclerosis Complex (TSC) in an Open-Label Extension (OLE) Trial (GWPCARE6)
    • Efficacy and Safety of Cannabidiol (CBD) in Patients with Treatment-Resistant Epilepsies in the Expanded Access Program (EAP): Additional Efficacy Data for Convulsive and Nonconvulsive Seizure Subtypes
    • Long-Term Efficacy and Safety of Cannabidiol (CBD) in Patients with Tuberous Sclerosis Complex (TSC): 4-year Results from the Expanded Access Program (EAP)

    Post Hoc Analysis of Phase 3 EPIDIOLEX data

    • Efficacy of Add-On Cannabidiol (CBD) Treatment in Patients with Tuberous Sclerosis Complex (TSC) and a History of Infantile Spasms (IS): Post Hoc Analysis of Phase 3 Trial GWPCARE6

    EPIDIOLEX Virtual Booth (accessible in the AES Leadership Exhibitor Hall)

    December 5-8, 2020

    About Tuberous Sclerosis Complex (TSC)

    Tuberous sclerosis complex (TSC) is a rare genetic condition that affects approximately 50,000 individuals in the U.S. and nearly one million people worldwide.1 At least two children born each day will develop TSC, with an estimated prevalence of one in 6,000 newborns.1 The condition causes mostly benign tumors to grow in vital organs of the body including the brain, skin, heart, eyes, kidneys and lungs2 and is a leading cause of genetic epilepsy.3 People with TSC may experience a variety of seizure types. One of the most common is infantile spasms that typically present in the first year of life; focal (or partial) seizures are also very common.4 TSC is associated with an increased risk of autism and intellectual disability5 and the severity of the condition can vary widely. In some children the disease is very mild, while others may experience life-threatening complications.2 Epilepsy is present in about 85 percent of patients with TSC and may progress to become intractable to medication.4,6,7 More than 60 percent of individuals with TSC do not achieve seizure control8 with standard treatments such as antiepileptic drugs, epilepsy surgery, ketogenic diet, or vagus nerve stimulation6 compared to 30-40 percent of individuals with epilepsy who do not have TSC who are drug resistant.9,10

    About EPIDIOLEX® (cannabidiol) oral solution

    EPIDIOLEX® (cannabidiol) oral solution, a pharmaceutical formulation of highly purified cannabidiol (CBD), is the first in a new class of anti-epileptic medications with a novel mechanism of action, and the first prescription, plant-derived cannabis-based medicine approved by the U.S. Food and Drug Administration (FDA). In the U.S., EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome or tuberous sclerosis complex (TSC) in patients one year of age and older. Epidiolex has received approval in the European Union under the tradename EPIDYOLEX® for adjunctive use in conjunction with clobazam to treat seizures associated with LGS and Dravet syndrome in patients two years and older. EPIDIOLEX/EPIDYOLEX has received Orphan Drug Designation from the FDA and the EMA for the treatment of seizures associated with Dravet syndrome, LGS and TSC, each of which are severe childhood-onset, drug-resistant syndromes and is under EMA review for the treatment of TSC. Important safety and prescribing information for EPIDIOLEX is available at Epidiolex.com.

    About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.

    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. The Company's lead product, EPIDIOLEX® (cannabidiol) oral solution, is commercialized in the U.S. by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients one year of age and older. This product has received approval in the European Union under the tradename EPIDYOLEX® for the adjunctive treatment of seizures associated with LGS or Dravet syndrome in conjunction with clobazam in patients two years and older and is under EMA review for the treatment of TSC. The Company has a deep pipeline of additional cannabinoid product candidates, in particular nabiximols, for which the Company is advancing multiple late-stage clinical programs in order to seek FDA approval in the treatment of spasticity associated with multiple sclerosis and spinal cord injury. The Company has additional cannabinoid product candidates in clinical trials for autism and schizophrenia. For further information, please visit www.gwpharm.com.

    Important Safety Information

    Important safety information for Epidiolex is available at Epidiolex.com.

    Enquiries:

    U.S. Media Enquiries:

    Sam Brown Inc. Healthcare Communications
     
    Christy Curran

    Mike Beyer
    615 414 8668

    312 961 2502



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