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, along with its US
subsidiary Greenwich Biosciences, announced today that new results
from completed Phase 3 trials of Epidiolex® (cannabidiol or CBD) in
Lennox-Gastaut syndrome (LGS) and Dravet syndrome, along with other
supportive data, will be presented at the American Epilepsy Society
(AES) Annual Meeting, December 1-5, 2017, in Washington D.C.
Abstracts released today include the following
highlights:
- Responder analyses from pooled Phase 3 data of LGS patients
on/off clobazam
- Data from two expanded access sites in patients on/off
clobazam
- Long-term maintenance treatment effect and safety in the open
label extension study and the expanded access program
- Exposure-response analysis of CBD in Phase 3 LGS studies
“We continue to see a robust flow of data from
the Epidiolex clinical program and look forward to sharing these
new data with the epilepsy community at AES. Importantly, data in
the abstracts show long-term maintenance of safety and efficacy, as
well as that patients on Epidiolex who achieved clinically
meaningful responses did so regardless of concomitant clobazam
therapy,” said Justin Gover, GW’s Chief Executive Officer. “Having
recently completed our New Drug Application submission to the FDA,
we are now focused on the goal of gaining approval for Epidiolex in
mid-2018 and making this much-needed, first-in-class medicine
available to the patients who need it.”
The Epidiolex-related presentations at AES will
include more than 20 posters from the Phase 3 pivotal trials,
reports from the Expanded Access Program, as well as additional
Phase I and pre-clinical studies of CBD. GW/Greenwich will also
host a scientific pavilion where additional scientific updates,
legal and regulatory perspectives, and other related data will be
presented. Company-sponsored activities will be conducted under the
Greenwich Biosciences, Inc. name.
Highlights:
Drug-drug interaction data:
Cannabidiol (CBD) Treatment Responders Analysis
in Patients with Lennox-Gastaut Syndrome (LGS) On and Off Clobazam
(CLB) – Thiele et al (Poster #1.436, Poster Session 1, Saturday,
December 2, 2017)
Efficacy of Cannabidiol in Patients with
Refractory Epilepsy Relative to Concomitant Use of Clobazam – Bruno
et al (Poster #3.181, Poster Session 3, Monday, December 4,
2017)
Presence of Clobazam does not affect Seizure
Frequency and Severity in Patients Taking a Pharmaceutical
Formulation of Cannabidiol (CBD) – Gaston et al (Poster #2.319,
Poster Session 2, Sunday, December 3, 2017)
Bidirectional Drug-drug Interaction with
coadministration of Cannabidiol and Clobazam in a Phase 1 Healthy
Volunteer Trial – Sommerville et al (Poster #1.433, Poster Session
1, Saturday, December 2, 2017)
CBD Exposure-response
Exposure-Response Analysis of CBD Oral Solution
for the Treatment of LGS – Morrison et al (Poster #2.281,
Poster Session 2, Sunday, December 3, 2017)
Long-term Epidiolex data:
Maintenance of Long-Term Safety and Efficacy of Cannabidiol
(CBD) Treatment in Dravet Syndrome (DS): Results of the Open-Label
Extension (OLE) Trial (GWPCARE 5) – Devinsky et al (Poster
#: 1.289, Poster Session 1, Saturday, December 2, 2017)
Maintained Safety and Efficacy of CBD in a
Long-Term Open-Label Trial in Patients with LGS (GWPCARE 5) – Marsh
et al (Poster #2.271. Poster Session 2, Sunday, December 3,
2017)
Long-Term Effectiveness and Safety of
Cannabidiol in Children and Adults with Treatment-resistant
Lennox-Gastaut Syndrome or Dravet Syndrome - Laux et al (Poster
#1.434 Poster Session 1, Saturday, December 2, 2017)
Long-term Efficacy and Safety of Cannabidiol
(CBD) in Children and Adults with Treatment‑Resistant Epilepsies
(TRE) - Bebin et al (Poster #2.427; Poster Session 2, Sunday,
December 3, 2017)
Pooled Phase 3 LGS Data:
CBD Significantly Reduces Drop Seizure Frequency
in LGS: Pooled Efficacy and Safety Results from 2 Randomized,
Controlled Trials - Patel et al (Poster #1.291, Poster Session 1,
Saturday, December 2, 2017)
CBD Treatment Effect and Adverse Events by Time
in Patients with LGS: Pooled Results from 2 Trials - Privitera et
al (Poster #2.279; Poster Session 2, Sunday, December 3, 2017)
Burden of Illness Data:
Poster Session 1, Saturday, December 2, 2017
- The Direct Cost Burden of Illness of Dravet Syndrome in the US
– Chez et al (Poster #1.314)
- The Direct Cost Burden of Illness of LGS in the US – Montouris
et al (Poster #1.315)
Pre-Clinical and Phase I
Results:
Poster Session 1, Saturday, December 2, 2017
- The human metabolite of cannabidiol, 7-hydroxy cannabidiol, but
not 7-carboxy cannabidiol, is anticonvulsant in the maximal
electroshock seizure threshold test (MEST) in mouse – Whalley et al
(Poster #1.435)
- Antiseizure properties of CBD are attenuated in the absence of
TRPV1 receptors – Jones et al (Poster #1.022)
- A role of GPR55 in the anti-epileptic properties of CBD –
Bazelot et al (Poster #1.029)
Poster Session 2, Sunday, December 3, 2017
- CBD improves the welfare and survival of Dravet syndrome mice –
Petra et al (Poster #2.263)
- Single Therapeutic and Supratherapeutic Doses of CBD Do Not
Significantly Impact Heart Rate (HR) Corrected QT Interval (QTc) –
VanLandingham et al (Poster #2.280)
Expanded Access Program:
More than a dozen posters from the Expanded
Access Program covering varying aspects of the use of Epidiolex in
children and adults will be presented during sessions on Saturday,
Sunday and Monday.
Scientific Exhibit:
Advancing Cannabidiol: GWPCARE Phase III Trials
and Long-term ResultsMonday, December 48:00 – 11:00 AM EST Salon B,
Street Level
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):
- GW Pipeline
- History of Cannabidiol (CBD) and GW Clinical Trial Program
- Ongoing GWPCARE Phase III Trials
- Assessment of the Abuse Potential of Cannabidiol (CBD) in
Recreational Polydrug Users: A Randomized, Double-blind, Controlled
Trial
- Pharmacokinetics and Safety Evaluation of Cannabidiol (CBD) in
Subjects With Hepatic or Renal Impairment: Results of Two Phase I
Trials
- Cannabidiol improves seizures and epilepsy associated
co-morbidities in rats
GW Pharmaceuticals Innovation Pavilion:
Presentations on Continuum of Care and Cannabinoid
ScienceSaturday, December 212:00pm – 6:00pm ESTPavilion
D
12:00pm-1:00pm |
Nurses Hour w/light lunch Demystifying the legal landscape of
cannabinoids Cannabinoid Experiences and learnings |
Alice Mead, JD Patricia Bruno, RN, BSN, MGH |
2:30pm – 3:30pm |
Syndrome Identification and Continuum of Care |
Elizabeth Thiele, MD, PhDIan Miller, MD |
1:15pm-1:45pmand4:00pm –4:30pm |
Demystifying the legal landscape of cannabinoids |
Alice Mead, JD |
1:45pm-2:15pmand 4:30pm-5:00pm |
Cannabinoid Preclinical Science |
Ben Whalley, PhD |
About
Epidiolex®
(cannabidiol)
Epidiolex, GW's lead cannabinoid product
candidate is a pharmaceutical formulation of purified cannabidiol
(CBD), which is in development for the treatment of several rare
childhood-onset epilepsy disorders. GW has submitted a New Drug
Application with the FDA for Epidiolex as adjunctive treatment for
seizures associated with LGS and Dravet syndrome with an expected
approval and launch in 2018. To date, GW has received Orphan Drug
Designation from the FDA for Epidiolex for the treatment of Dravet
syndrome, LGS, TSC and IS. Additionally, GW has received Fast Track
Designation from the FDA for the treatment of Dravet syndrome and
conditional grant of rare pediatric disease designation by FDA. The
Company has also received Orphan Designation from the European
Medicines Agency, or EMA, for Epidiolex for the treatment of LGS
and Dravet syndrome. GW is currently evaluating additional clinical
development programs in other orphan seizure disorders including
Phase 3 trials in Tuberous Sclerosis Complex and Infantile
Spasms.
About GW Pharmaceuticals plc and
Greenwich Biosciences
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, along with its U.S.
subsidiary Greenwich Biosciences, is advancing an orphan drug
program in the field of childhood epilepsy with a focus on
Epidiolex (cannabidiol), for which GW has submitted an NDA to the
FDA for the adjunctive treatment of LGS and Dravet syndrome. The
Company continues to evaluate Epidiolex in additional epilepsy
conditions and currently has ongoing clinical trials in 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 numerous 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 glioblastoma, schizophrenia and epilepsy. 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® (cannabidiol) 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 and uncertainties related to the regulatory
process, and the acceptance of Sativex, 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 (U.S.) |
917
280 2424 / 401 500 6570 |
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U.S. Media Enquiries:Sam Brown Inc.
Healthcare Communications |
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Christy CurranMike Beyer |
615
414 8668312 961 2502 |
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