GW Pharmaceuticals plc (GWPH) Announce FDA Acceptance of sNDA Filing with Priority Review for EPIDIOLEX®

“We are pleased with the FDA’s acceptance of our EPIDIOLEX sNDA filing with Priority Review, an action that underscores the unmet need for new treatment options for patients with TSC, a rare and severe childhood-onset disease,” said Justin Gover, GW’s Chief Executive Officer. “More than 60% of individuals with TSC do not achieve seizure control with standard anti-epileptic drug treatments. Today’s news is therefore important for TSC patients and their clinicians, and we look forward to working with the FDA during the review process to expand the EPIDIOLEX product label for use in TSC.”

Priority Review status is designated for drugs that may offer major advances in treatment or provide a treatment where no adequate therapies exist.  The granting of Priority Review for the EPIDIOLEX sNDA accelerates the timing of the FDA review of the application to a six month period compared to a standard review of ten months.

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.⁵ The condition causes mostly benign tumors to grow in vital organs of the body including the brain, skin, heart, eyes, kidneys and lungs ² and is a leading cause of genetic epilepsy.³ TSC often occurs in the first year of life as either focal seizures or infantile spasms¹ and is associated with an increased risk of autism and intellectual disability.⁴ The severity of the condition can vary widely. In some children the disease is very mild, while others may experience life-threatening complications.⁶ Epilepsy is present in about 85% of patients with TSC and may progress to become intractable to medication.^1,2,3 More than 60% of individuals with TSC do not achieve seizure control⁴ with standard treatments such as antiepileptic drugs, epilepsy surgery, ketogenic diet, or vagus nerve stimulation² compared to 30-40 percent of individuals with epilepsy who do not have TSC who are drug resistant.^5,6

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, CV, is commercialized in the U.S. by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. This product has received approval in the European Union under the tradename EPIDYOLEX^®. The Company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the indication for Epidiolex to include seizures associated with Tuberous Sclerosis Complex (TSC), for which it has reported positive Phase 3 data, and is carrying out a Phase 3 trial in Rett syndrome. 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, as well as for the treatment of PTSD. The Company has additional cannabinoid product candidates in Phase 2 trials for autism and schizophrenia. For further information, please visit www.gwpharm.com.