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, announced today that the U.S.
Food and Drug Administration (FDA) has approved EPIDIOLEX®
(cannabidiol) oral solution for the treatment of seizures
associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in
patients two years of age or older. EPIDIOLEX is the first
prescription pharmaceutical formulation of highly-purified,
plant-derived cannabidiol (CBD), a cannabinoid lacking the high
associated with marijuana, and the first in a new category of
anti-epileptic drugs (AEDs). Product availability is pending
rescheduling which is expected to occur within 90 days.
“Today’s approval of EPIDIOLEX is a historic
milestone, offering patients and their families the first and only
FDA-approved CBD medicine to treat two severe, childhood-onset
epilepsies,” said Justin Gover, GW’s Chief Executive Officer. “This
approval is the culmination of GW’s many years of partnership with
patients, their families, and physicians in the epilepsy community
to develop a much needed, novel medicine. These patients deserve
and will soon have access to a cannabinoid medicine that has been
thoroughly studied in clinical trials, manufactured to assure
quality and consistency, and available by prescription under a
physician’s care.”
LGS and Dravet syndrome, which develop in
childhood, are rare, severe forms of epilepsy that are notoriously
treatment-resistant.1,2 Most patients with LGS and Dravet
syndrome require multiple seizure medications and the majority are
resistant to currently approved AEDs.2,3,4 The day-to-day
impact of these conditions is significant with high rates of early
mortality.5,6
“In my practice, I often see patients with these
highly treatment-resistant epilepsies who have tried and failed
existing therapies and are asking about CBD,” said Orrin Devinsky,
M.D., of NYU Langone Health’s Comprehensive Epilepsy Center and a
lead investigator in the EPIDIOLEX clinical program. “I am
delighted that my physician colleagues and I will now have the
option of a prescription cannabidiol that has undergone the rigor
of controlled trials and been approved by the FDA to treat both
children and adults.”
“LGS and Dravet syndrome are two of the most
severe and difficult-to-treat forms of childhood-onset epilepsy.
These children and their families face a long and challenging road
and very few achieve adequate seizure control,” said Elizabeth
Thiele, M.D., director of the pediatric epilepsy program at
Massachusetts General Hospital, professor of neurology at Harvard
Medical School and a lead investigator in the EPIDIOLEX clinical
program. “Based on numerous clinical trials, this medication may
help meet the need for this specific pediatric patient population
and is now the first to be approved by the FDA in Dravet
syndrome.”
The EPIDIOLEX clinical development program
included three randomized, controlled Phase 3 clinical trials and
an open-label extension study. In the Phase 3 studies, published in
The New England Journal of Medicine7,8 and Lancet9, EPIDIOLEX
added to other antiepileptic therapies significantly reduced the
frequency of seizures in patients with LGS and Dravet syndrome. The
most common adverse reactions that occurred in EPIDIOLEX-treated
patients were somnolence; decreased appetite; diarrhea;
transaminase elevations; fatigue, malaise, and asthenia; rash;
insomnia, sleep disorder and poor quality sleep; and
infections. The company’s development program represents the
only well-controlled clinical evaluation of a cannabinoid
medication for patients with LGS and Dravet syndrome.
“For those living with intractable seizures
caused by LGS and Dravet syndrome, EPIDIOLEX represents a true
medical advancement,” said Philip Gattone, president and CEO of the
Epilepsy Foundation. “Clinical development for these rare and
severe conditions is essential, and today’s news brings hope for
these patients and their families that a new treatment option may
have the potential to help better control their seizures.”
EPIDIOLEX will be marketed in the U.S. by
Greenwich Biosciences, the U.S. subsidiary of GW Pharmaceuticals
plc. As part of the approval process, EPIDIOLEX must be rescheduled
from its current Schedule I before it can be made available to
patients. Rescheduling is expected to occur within 90 days. Access
is expected to be similar to other branded AEDs and EPIDIOLEX is
expected to be available to appropriate patients by Fall 2018. More
information can be found at Epidiolex.com.
Outside the U.S., this medicine is currently
under review by the European Medicines Agency (EMA) for the
treatment of seizures associated with LGS and Dravet Syndrome. An
EMA decision on whether to recommend approval is expected in the
first quarter of 2019.
For more information on Dravet syndrome and
Lennox-Gastaut syndrome, including community support, please visit
the Dravet Syndrome Foundation at www.dravetfoundation.org and the
Lennox-Gastaut Syndrome Foundation at www.lgsfoundation.org.
About EPIDIOLEX® (cannabidiol) oral
solutionEPIDIOLEX, the first prescription, plant-derived
cannabinoid medicine in the United States and the first in a new
class of anti-epileptic medications, is a pharmaceutical
formulation of pure cannabidiol (CBD) now FDA-approved for the
treatment of seizures associated with Lennox-Gastaut syndrome (LGS)
or Dravet syndrome in patients two years of age or older, pending
DEA rescheduling. GW has submitted a Marketing Authorization
Application (MAA) to the European Medicines Agency (EMA) for
EPIDIOLEX with an expected decision date in the first quarter of
2019. GW has received Orphan Drug Designation from the FDA for
EPIDIOLEX for the treatment of tuberous sclerosis complex (TSC) and
infantile spasms (IS). 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 a Phase 3
trial in TSC.
About GW Pharmaceuticals plc and
Greenwich Biosciences, Inc.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, has received U.S. FDA
approval for EPIDIOLEX (cannabidiol) oral solution for the
treatment of seizures associated with Lennox-Gastaut syndrome (LGS)
or Dravet syndrome in patients two years of age or older, pending
DEA rescheduling. The Company has submitted a regulatory
application in Europe for the adjunctive treatment of LGS and
Dravet syndrome. The company continues to evaluate EPIDIOLEX in
additional rare epilepsy conditions and currently has ongoing
clinical trials in tuberous sclerosis complex (TSC) and infantile
spasms (IS). 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 U.S. 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)
oral solution 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 |
|
Stephen Schultz, VP Investor Relations (U.S.) |
917 280 2424 / 401 500 6570 |
|
|
U.S. Media Enquiries:Sam Brown Inc.
Healthcare Communications |
|
Christy CurranMike Beyer |
615 414 8668312 961 2502 |
EU Media
Enquiries:FTI Consulting |
|
Ben
AtwellAndrew WardCon Franklin |
+44
(0) 203 727 1715GWPAPRLondon@fticonsulting.com |
|
________________________________1 LGS Foundation. About
Lennox-Gastaut Syndrome. Available at
http://www.lgsfoundation.org/aboutlgs. Accessed May 7, 2018.2
Dravet C. The core Dravet syndrome phenotype. Epilepsia.
2011;52(Suppl. 2):3–9.3 Epilepsy Foundation. Lennox-Gastaut
Syndrome. Available at
http://www.epilepsy.com/learn/types-epilepsy-syndromes/lennox-gastaut-syndrome-lgs.
Accessed May 7, 2018.4 Epilepsy Foundation. Dravet syndrome.
Available at
https://www.epilepsy.com/learn/types-epilepsy-syndromes/dravet-syndrome.
Accessed May 7, 2018.5 Cooper MS, Mcintosh A, Crompton DE, et al.
Mortality in Dravet syndrome. Epilepsy Res. 2016;128:43-47.6
Trevathan, E. Infantile Spasms and Lennox-Gastaut Syndrome. Journal
of child neurology 17, 2S9-2S22 (2002).7 Devinsky O, Cross JH, Laux
L, et al. Trial of cannabidiol for drug-resistant seizures in the
Dravet syndrome. N Engl J Med 2017;376;2011-20.8 Devinsky O, Patel
AD, Cross JH, et al. Effect of Cannabidiol on Drop Seizures in the
Lennox–Gastaut Syndrome. N Engl J Med 2018;378;20:1888-97.9 Thiele
EA, Marsh ED, French JA, et al. Cannabidiol in patients with
seizures associated with Lennox-Gastaut syndrome (GWPCARE4): a
randomized, double-blind placebo-controlled phase 3 trial.
Published online January 24, 2018
http://dx.doi.org/10.1016/S0140-6736(18)30136-3.
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