GW Pharmaceuticals and its U.S. Subsidiary Greenwich Biosciences to Present Data on Epidiolex® (cannabidiol) at the 2017 Ame...
April 13 2017 - 7:00AM
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 the 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, 2017Clinical
Trials Plenary Session9:15 - 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) 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, 2017Poster
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 Science8:30
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 modelPoster 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.
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® 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.
Enquiries:
GW Pharmaceuticals plc |
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Stephen Schultz, VP Investor Relations |
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U.S. Media Enquiries:Sam Brown Inc.
Healthcare Communications |
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Christy CurranMike Beyer |
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