Greenwich Biosciences to Present Data on EPIDIOLEX® (cannabidiol) Oral Solution at the American Epilepsy Society Annual Meeting

Rhea-AI Summary

GW Pharmaceuticals plc announced the presentation of long-term data on EPIDIOLEX (cannabidiol) at the upcoming American Epilepsy Society (AES) Annual Meeting from December 4-8, 2020. This data will focus on the treatment of tuberous sclerosis complex (TSC) and various seizure subtypes. The newly available data highlights more than three years of patient outcomes, emphasizing the drug's efficacy and safety in treating treatment-resistant epilepsy in TSC patients. The presentation aims to address the high demand for effective treatment options in this population.

- 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

^{________________________
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. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/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.

FAQ

What long-term data will GW Pharmaceuticals present at AES 2020 for GWPH?

GW Pharmaceuticals will present long-term data on EPIDIOLEX, particularly its efficacy in treating tuberous sclerosis complex (TSC) and treatment-resistant seizures.

When is the American Epilepsy Society Annual Meeting in 2020?

The AES Annual Meeting will take place from December 4-8, 2020.

What is EPIDIOLEX and its significance for GWPH?

EPIDIOLEX is the first FDA-approved cannabidiol oral solution for treating seizures associated with TSC, highlighting GW Pharmaceuticals' leadership in cannabinoid-based treatments.

Why is the long-term data for TSC important for GW Pharmaceuticals?

The long-term data is crucial as it addresses the needs of the majority of TSC patients who experience treatment-resistant epilepsy, providing insights into the safety and efficacy of EPIDIOLEX.

What are the common seizure types associated with tuberous sclerosis complex (TSC)?

Common seizure types in TSC include infantile spasms and focal seizures.