GWPH GW Pharmaceuticals PLC

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 the company will present results from completed trials of EPIDIOLEX® (cannabidiol) oral solution and nabiximols, known as Sativex® outside of the U.S., at the virtual American Academy of Neurology (AAN) Annual Meeting taking place April 17-22. The company will also present findings of a survey in partnership with the North American Research Committee on Multiple Sclerosis (NARCOMS) – the world’s largest voluntary, patient-driven multiple sclerosis (MS) registry – highlighting the prevalence of cannabis use among people with MS. Additionally, the company will share an update on cannabis-based products, including the evidence-based pathway to FDA approval and related regulatory challenges.

“AAN provides us with an opportunity to continue sharing the safety and efficacy data of EPIDIOLEX in the treatment of tuberous sclerosis complex and other treatment-resistant forms of epilepsy,” said Justin Gover, Chief Executive Officer, GW Pharmaceuticals. “We will also highlight the potential value of nabiximols for people living with spasticity associated with multiple sclerosis as we continue to advance the product in clinical trials with a view to seeking U.S. regulatory approval. We are committed to building the body of evidence which proves cannabinoid medicines can be well characterized and meet the highest standards for FDA approval – rigorously studied and consistently manufactured – so that neurologists can feel confident prescribing them to those in need.”

2021 AAN presentations will include:All posters will be available in the Virtual Poster Hall for the duration of AAN.

EPIDIOLEX Posters:

• P7.016: Efficacy and Safety of Cannabidiol (CBD) in Patients with Treatment-Resistant Epilepsies (TREs) in the Expanded Access Program (EAP): Additional Efficacy Data for Convulsive and Nonconvulsive Seizure Types – Lyons et al.
• P7.025: Long-term Efficacy and Safety of Cannabidiol (CBD) in Patients with Tuberous Sclerosis Complex (TSC): 4-year Results from the Expanded Access Program (EAP) – Weinstock et al.
• P7.004: 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 – Sparagana et al.
• P7.002: 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) – Wheless et al.

Nabiximols Posters:

• P15.115: Prevalence of Cannabis Use and Associated Factors Among People with Multiple Sclerosis (PwMS): A 2020 NARCOMS Survey – Salter et al.
• P15.181: Study of nabiximols in persons with multiple sclerosis (PwMS) with inadequately managed spasticity: post hoc analyses of a controlled enrichment design study – Ben-Zacharia et al.
• P15.185: Effect of nabiximols cannabinoid oral-mucosal spray on depressive symptoms, suicidality, and cognition in persons with multiple sclerosis (PwMS) – DeLuca et al.

Additional company activities (accessible in the AAN Virtual Exhibit Hall):

• EPIDIOLEX Virtual Booth
• Cannabinoid Clinical Virtual Booth
• Industry Therapeutic Update, a discussion exploring the evidence-based pathway to FDA approval and the regulatory challenges facing cannabis-based products (April 19, 2021 at 7 p.m. ET)

About EPIDIOLEX® (cannabidiol) oral solutionEPIDIOLEX® (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.

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

About NabiximolsNabiximols is in pivotal Phase 3 development in the United States for the treatment of MS spasticity. The U.S. commercial rights are owned by GW. In addition to MS spasticity, GW expects to develop nabiximols in Spinal Cord Injury spasticity.

Nabiximols is a complex botanical medicine formulated from extracts of the cannabis plant that contains the cannabinoids THC and CBD and also contains other constituents, including non-cannabinoid plant components, such as terpenes, sterols, and triglycerides. The product is administered as an oral spray.

Nabiximols is known as Sativex® outside of the U.S. and is indicated in 29 countries as a treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy. These approvals were based on multiple pivotal trials conducted in Europe. Nabiximols is currently not approved for any indication in the U.S.

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.

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