GW Pharmaceuticals and U.S. Subsidiary Greenwich Biosciences to Present Data on Epidiolex® (cannabidiol oral solution) at th...
April 12 2018 - 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, along with its U.S.
subsidiary Greenwich Biosciences, today announced that the Company
will present data from the pivotal Phase 3 trials of Epidiolex®
(cannabidiol oral solution) in Lennox-Gastaut syndrome (LGS) and
Dravet syndrome, along with other supportive data, at the American
Academy of Neurology (AAN) Annual Meeting, April 21-27, 2018, in
Los Angeles, California.
Highlights of the data to be presented
include:
- Long-term safety and efficacy data in patients with LGS and
Dravet syndrome
- Safety and efficacy outcomes by time in Phase 3 LGS
studies
- Exposure-response analysis in Phase 3 LGS studies
- Results from a study evaluating the abuse potential of purified
cannabidiol oral solution
- Analyses of the direct cost burden associated with LGS and
Dravet syndrome in the U.S.
“We look forward to sharing additional findings from our
Epidiolex clinical program with the broader neurology community at
AAN and expect that the significant continued flow of data should
be supportive for neurologists as they grow their understanding of
our medicine,” said Justin Gover, GW’s Chief Executive Officer.
“With regulatory applications for Epidiolex accepted for review in
both the U.S. and Europe, and an expected U.S. launch in the second
half of this year, this is a very exciting time for our Company and
those awaiting this new potential treatment option.”
Sunday, April 22, 2018Poster
Session P111:30 a.m. - 5:30 p.m. PT
- Poster 264: Long-term Safety and Efficacy of Cannabidiol Oral
Solution in Patients with Lennox-Gastaut Syndrome (LGS): Results
from Open-label Extension Trial (GWPCARE5)
- Poster 271: Exposure-Response Analysis of Cannabidiol Oral
Solution for the Treatment of Lennox–Gastaut Syndrome
- Poster 266: A Randomized, Double-Blind, Placebo-Controlled,
Crossover Study to Evaluate the Abuse Potential of Purified
Cannabidiol Oral Solution in Subjects with a History of
Recreational Polydrug Use
Monday, April 23Session S19:
Epilepsy/Clinical Neurophysiology (EEG) II3:30 p.m. - 5:30 p.m.
PT
- Presentation 003 (3:54 p.m. - 4:06 p.m. PT): Maintenance of
Long-Term Safety and Efficacy of Cannabidiol Oral Solution
Treatment in Dravet Syndrome (DS): Results of the Open-Label
Extension (OLE) Trial (GWPCARE 5)
- Presentation 006 (4:30 p.m. - 4:42 p.m. PT): Cannabidiol Oral
Solution Treatment Effect and Adverse Events (AEs) by Time in
Patients (Pts) with Lennox-Gastaut Syndrome (LGS): Pooled Results
from 2 Trials
Monday, April 23Poster Session
P211:30 a.m. - 7:00 p.m. PT
- Poster 277: A Role of GPR55 in the Anti-Epileptic Properties of
Cannabidiol
Friday, April 27Poster Session
P611:30 a.m. - 5:00 p.m. PT
- Poster 272: The Direct Cost Burden of Illness of Lennox-Gastaut
Syndrome in the US
- Poster 290: The Direct Cost Burden of Illness of Dravet
Syndrome in the US
Friday, April 27Session S53:
Epilepsy/Clinical Neurophysiology (EEG) III3:30 p.m. - 5:30 p.m.
PT
- Presentation 004 (4:06 p.m. - 4:18 p.m. PT): Antiseizure
Properties of Cannabidiol Oral Solution are Attenuated in the
Absence of TRPV1 Receptors
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, which has been assigned a goal date of 27 June 2018 and,
if approved, the medicine is expected to be available by
prescription in the second half of 2018. GW has also submitted
a Marketing Authorization Application (MAA) to the European
Medicines Agency (EMA) with an expected decision date in early
2019. 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, Dravet
syndrome, West syndrome and TSC. 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 BiosciencesFounded 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-onset epilepsy with a focus
on Epidiolex (cannabidiol), for which GW has submitted regulatory
applications in the U.S. and Europe for the adjunctive treatment of
Lennox-Gastaut syndrome and Dravet syndrome. The Company continues
to evaluate Epidiolex in additional rare 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 and for which the company is now planning a US
Phase 3 trial. The Company has a deep pipeline of additional
cannabinoid product candidates which includes compounds in Phase 1
and 2 trials for epilepsy, glioblastoma, and schizophrenia. For
further information, please visit www.gwpharm.com.
Forward-looking statementsThis
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 4 December 2017.
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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6570 / 917 280 2424 |
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U.S. Media Enquiries:Sam Brown Inc.
Healthcare Communications |
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