- New Phase 3 Data in Lennox-Gastaut Syndrome Selected for Inclusion in the Emerging Science Program -
London, UK, 13 April 2017: 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, today announced that the Company will present results from three completed Phase 3 studies of Epidiolex® (cannabidiol or CBD) as adjunctive therapy – two in Lennox-Gastaut syndrome (LGS) and one in Dravet syndrome (DS) – at the American Academy of Neurology (AAN) Annual Meeting, April 22-28, 2017, in Boston. Company-sponsored activities at AAN will be conducted under Greenwich Biosciences, Inc., GW's operating unit in the United States.
"We are very excited to share data from our Phase 3 epilepsy programs with the broader neurology community, particularly new results from the second of our two placebo-controlled studies in Lennox-Gastaut syndrome, which will be featured in the Emerging Science Program during the meeting,” said Justin Gover, GW's Chief Executive Officer. “We are looking ahead to finalizing and submitting the NDA to FDA for Epidiolex in the coming months, which will bring us one step closer towards our goal of making this much-needed treatment available to patients."
Tuesday, April 25, 2017
Clinical Trials Plenary Session
9:15 - 11:30 a.m. (GW Presentation 10:45 - 11:00 a.m.)
Cannabidiol (CBD) reduces convulsive seizure frequency in Dravet syndrome: Results of a multi-center, randomized, controlled trial (GWPCARE1)
Epilepsy/Clinical Neurophysiology (EEG) I
1:00 – 3:00 p.m. (GW Presentation 1:00 - 1:12 p.m.)
Presentation 001: Cannabidiol (CBD) significantly reduces drop seizure frequency in Lennox-Gastaut syndrome (LGS): Results of a multi-center, randomized, double-blind, placebo controlled trial (GWPCARE4)
Emerging Science Session
5:45 - 7:15 p.m. (GW Presentation 6:06 - 6:09 p.m.)
Poster 008: Cannabidiol (CBD) significantly reduces drop seizure frequency in Lennox-Gastaut syndrome (LGS): results of a dose-ranging, multi-center, randomized, double blind, placebo controlled trial (GWPCARE3)
Wednesday, April 26, 2017
Poster Session 4: Epilepsy/Clinical Neurophysiology (EEG)
11:45 a.m. to 12:35 p.m. (GW Presentation 12:20 - 12:25 p.m.)
Poster 108: A dose ranging safety and pharmacokinetic study of cannabidiol (CBD) in children with Dravet syndrome (GWPCARE1)
Sunday, April 23, 2017
Poster Session 1: Epilepsy and Clinical Neurophysiology: Basic Science
8:30 a.m. to 5:30 p.m. (GW Presentations between 4:00 - 5:30 p.m.)
Poster 224: Cannabidiol does not convert to Δ9- tetrahydrocannabinol (THC) in an in vivo animal model
Poster 228: The effect of cannabidiol on human CNS-expressed voltage-gated sodium channels
About GW Pharmaceuticals plc
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. In the United States, GW operates as 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.
GW Pharmaceuticals plc
Stephen Schultz, VP Investor Relations
401 500 6570
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