LONDON, December 29, 2017 /PRNewswire/ --
GW Pharmaceuticals plc (Nasdaq: GWPH, "GW" or "the Company"), a
biopharmaceutical company focused on discovering, developing and
commercializing novel therapeutics from its proprietary cannabinoid
product platform, today announced it has submitted its Marketing
Authorisation Application (MAA) to the European Medicines Agency
(EMA) for Epidiolex® (cannabidiol or CBD) as adjunctive
treatment for seizures associated with Lennox-Gastaut syndrome
(LGS) and Dravet syndrome, two highly treatment-resistant forms of
childhood-onset epilepsy. GW has received Orphan Designations from
the EMA for Epidiolex for the treatment of LGS, Dravet syndrome,
and recently, West syndrome and Tuberous Sclerosis Complex. In
October 2017, GW completed the
submission of its rolling Epidiolex New Drug Application (NDA) to
the United States Food and Drug Administration (FDA), also for
seizures associated with LGS and Dravet syndrome. This NDA has been
accepted by FDA for Priority Review.
"This MAA submission marks another major milestone for the
Epidiolex program and is an important next step toward providing
this potential new treatment option globally," stated Justin Gover, CEO of GW Pharmaceuticals. "GW is
committed to making Epidiolex available to patients in Europe that struggle with the burden of living
with LGS and Dravet syndrome, both very difficult to treat and
devastating conditions. We continue to build a commercial
infrastructure in Europe in
anticipation of future approval and launch."
The MAA for Epidiolex is supported by data from three Phase 3
safety and efficacy studies, each of which met their primary
endpoint. Epidiolex was generally well tolerated in these trials.
The MAA includes safety data on approximately 1,500 patients, with
approximately 400 patients on continuous therapy for more than one
year. Approximately 26% of the Epidiolex patients from the Phase 3
pivotal program came from European sites. Beyond pivotal safety and
efficacy data, the MAA includes a comprehensive clinical
pharmacology, pre-clinical and toxicology package.
About Lennox-Gastaut Syndrome
The onset of LGS typically occurs between ages of 3 to 5 years
and can be caused by a number of conditions, including brain
malformations, severe head injuries, central nervous system
infections, and genetic neuro-degenerative or metabolic conditions.
In up to 30 percent of patients, no cause can be found. Patients
with LGS commonly have multiple seizure types including drop and
convulsive seizures, which frequently lead to falls and injuries,
and non-convulsive seizures. Resistance to anti-epileptic drugs
(AEDs) is common in patients with LGS. Most children with LGS
experience some degree of intellectual impairment, as well as
developmental delays and aberrant behaviors.
About Dravet Syndrome
Dravet syndrome is a severe infantile-onset and highly
treatment-resistant epileptic encephalopathy frequently associated
with genetic mutations in the SCN1A sodium channels. Onset of
Dravet syndrome occurs typically during the first year of life in
previously healthy and developmentally normal infants. Initial
seizures are often body temperature related, severe, and
long-lasting. Over time, patients with Dravet syndrome often
develop multiple types of seizures, including tonic-clonic,
myoclonic, and atypical absences and are prone to bouts of
prolonged seizures including status epilepticus, which can be life
threatening. Risk of premature death including SUDEP (sudden
unexpected death in epilepsy) is elevated in patients with Dravet
syndrome. Additionally, the majority will develop moderate to
severe intellectual and development disabilities and require
lifelong supervision and care. There are currently
no FDA-approved treatments and nearly all patients continue to
experience seizures and other medical needs throughout their
lifetime.
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,
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
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 gliobastoma,
schizophrenia and epilepsy. For further information, please visit
http://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 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
EU Media Enquiries:
FTI
Michael Trace
+44(0)20-3319-5674
U.S. Media Enquiries:
Sam Brown Inc. Healthcare Communications
Christy Curran
615-414-8668
Mike Beyer
312-961-2502