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RNS Number : 7013Q
GW Pharmaceuticals PLC
01 December 2016
GW Pharmaceuticals plc Announces Epidiolex(R) (cannabidiol) Data
Presentations and Educational Programs at the American Society of
Epilepsy Annual Meeting
- Presentations include clinical results from Phase 3 programs
in Lennox-Gastaut Syndrome and Dravet Syndrome, as well as
additional independent reports from Epidiolex Expanded Access
Program sites -
- GW will also unveil its new U.S. operating name, Greenwich
Biosciences, Inc. -
LONDON, December 1, 2016 - GW Pharmaceuticals plc (NASDAQ: GWPH,
AIM: GWP) ("GW," "the Company" or "the Group"), a biopharmaceutical
company focused on discovering, developing and commercializing
novel therapeutics from its proprietary cannabinoid product
platform, announces results from two completed Epidiolex(R)
(cannabidiol or CBD) Phase 3 trials, one in Lennox-Gastaut syndrome
(LGS) and one in Dravet syndrome (DS), will be presented at the
American Epilepsy Society (AES) Annual Meeting, December 2-6, 2016,
in Houston, Texas.
More than a dozen independent reports from the State-sponsored
Epidiolex Expanded Access Program, as well as additional laboratory
studies of CBD, scientific updates, and an overview of the legal
and regulatory climate for cannabinoids will also be presented
during the meeting. For the first time, company-sponsored
activities will be conducted under Greenwich Biosciences, Inc.,
GW's new name for its operating unit in the United States.
"We are very excited to share these data from our Phase 3
programs with the epilepsy community. These presentations are the
culmination of intensive effort by the GW in-house team and more
than 50 participating sites over the past two years, and reflect
the courage and commitment of patients and their families. We can
now focus on the ultimate goal, which is to gain approval for
Epidiolex and make this much-needed treatment available," said
Justin Gover, GW's Chief Executive Officer. "We have also reached
an ideal moment to introduce our new U.S. identity, Greenwich
Biosciences, which will be the face of our company to patients and
their families, clinicians, and the general public in the United
States."
Greenwich Biosciences (pronounced "gren-ich"), headquartered in
Carlsbad, California, is incorporated in the United States and 100%
owned by UK-based GW Pharmaceuticals plc. As the corporate parent,
GW will remain the publicly-traded entity, be responsible for
regulatory filings in the United States, and control the ongoing
development and intellectual property associated with Epidiolex and
the rest of the company's cannabinoid pipeline.
Results of Phase 3 Studies
Saturday, December 3; 12:00 - 6:00 PM CST/Poster Session
Cannabidiol (CBD) significantly reduces drop seizure frequency
in Lennox-Gastaut syndrome: results of a multi-center, randomized,
double-blind, placebo-controlled trial (GWPCARE4)
Sunday, December 4; 10:00 AM - 4:00 PM CST/Poster Session
A dose ranging safety and pharmacokinetic study of cannabidiol
(CBD) in children with Dravet syndrome (GWPCARE1)
Cannabidiol (CBD) reduces convulsive seizure frequency in Dravet
syndrome: results of a multi-center, randomized, controlled trial
(GWPCARE1)
Additional Laboratory Results
Saturday, December 3; 12:00 - 6:00 PM CST/Poster Session
The effect of a pharmaceutical formulation of pure cannabidiol
on human CNS-expressed voltage-gated sodium channels
Expanded Access Program Presentations
Thirteen independent reports from the State-sponsored Expanded
Access Program, including 11 posters from Alabama (two of which
will also be given as oral presentations) and one each from Georgia
and Idaho, covering varying aspects of the use of Epidiolex in
children and adults, will be presented during sessions on Saturday,
Sunday and Monday.
Scientific Exhibit Presentations
Monday, December 5
8:00 AM - 11:00 CST AM, Room 330A, Convention Center Level 3
The company will host a satellite exhibit providing meeting
attendees with a comprehensive overview of the Epidiolex
development program, including the data presented in the AES poster
sessions and the
following additional topics (authors will be on hand):
-- Cannabidiol does not convert to <DELTA>(9)
-tetrahydrocannabinol (THC) in an in vivo animal model
-- Epidiolex (cannabidiol) phase III data in treatment resistant
epilepsy (encore to poster presentations)
-- Assessment of the anticonvulsant effects and tolerability
profile of cannabidiol in GW pharmaceuticals' preclinical and
anticonvulsant screening programs
-- Pipeline update
-- Ongoing Epidiolex trials
-- History of cannabidiol (CBD)
GW Pharmaceuticals Innovation Pavilion
Alice Mead, JD, Vice President, U.S. Professional Relations,
will present information on the evolving legal and regulatory
climate for cannabinoids:
Monday, December 5
Demystifying the Legality of Cannabinoids
11:00 AM - 11:20 AM CST/Q&A: 11:20 AM CST
12:00 PM - 12:20 PM CST/Q&A: 12:20 PM CST
1:00 PM - 1:20 PM CST/ Q&A 1:20 PM CST
George R. Brown Convention Center, Pavilion C
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(R) (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(R), which is
approved for the treatment of spasticity due to multiple sclerosis
in 30 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.
Enquiries:
GW Pharmaceuticals plc
Stephen Schultz, VP Investor Relations
(U.S.) 917 280 2424 / 401 500 6570
Sam Brown, Inc.
Christy Curran 615-414-8668
FTI Consulting
Ben Atwell / Simon Conway
Peel Hunt LLP (UK NOMAD) +44 20 3727 1000
James Steel +44 20 7418 8900
This information is provided by RNS
The company news service from the London Stock Exchange
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