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
Peripheral and Central Nervous System Drugs Advisory Committee of
the U.S. Food and Drug Administration (FDA) unanimously recommended
supporting the approval of the New Drug Application (NDA) for the
investigational cannabidiol oral solution (CBD), also known as
Epidiolex®, for the adjunctive treatment of seizures associated
with Lennox-Gastaut syndrome (LGS) and Dravet syndrome in patients
two years of age and older. If approved, Epidiolex would be the
first pharmaceutical formulation of purified, plant-based CBD, a
cannabinoid lacking the high associated with marijuana, and the
first in a new category of anti-epileptic drugs (AEDs). This public
meeting was presented live through FDA’s website.
LGS and Dravet syndrome, which develop in
childhood, are devastating forms of epilepsy with high morbidity
and mortality rates and a significant burden on families and
caregivers. More than 90% of patients with LGS or Dravet syndrome
have multiple seizures per day, which puts them at constant risk
for falls and injury. Physicians who treat LGS and Dravet syndrome
patients struggle to reduce the sheer volume of dangerous seizures
with currently available therapies. If approved, Epidiolex would be
the first-ever FDA-approved medicine for Dravet syndrome
patients.
“We are pleased by the Advisory Committee’s
unanimous recommendation to approve Epidiolex, which would provide
an important treatment option for patients with LGS and Dravet
syndrome, two of the most severe and treatment-resistant forms of
epilepsy,” said Justin Gover, GW’s Chief Executive Officer. “This
favorable outcome marks an important milestone in our company’s
unwavering commitment to address the significant unmet need for
patients with LGS and Dravet syndrome and our resolve to study
Epidiolex under the highest research and manufacturing standards.
We look forward to our ongoing discussions with the FDA as it
continues to review the Epidiolex NDA."
During the meeting, the company presented the
results of a robust clinical development program that included
three randomized, controlled Phase 3 clinical trials and an open
label extension study. In the Phase 3 studies, Epidiolex added to
other antiepileptic therapies significantly reduced the frequency
of seizures in patients with LGS and Dravet syndrome. The company’s
development program represents the only well-controlled clinical
evaluation of a cannabinoid medication for patients with LGS and
Dravet syndrome. Epidiolex was generally well tolerated with most
adverse events reported as mild or moderate.
“As a physician who treats LGS and Dravet
syndrome, I know that patients and their families usually face
significant difficulties getting seizures under control using
existing therapies,” said Elizabeth Thiele, MD, PhD, director of
pediatric epilepsy at Massachusetts General Hospital, professor of
Neurology at Harvard Medical School and a primary investigator for
one of GW’s and Greenwich’s studies in LGS patients. “The results
from these studies suggest that this pharmaceutical formulation of
cannabidiol may provide hope for a new treatment option that may be
effective for some patients.”
FDA Advisory Committees are independent expert
panels. Their votes are not binding but are considered by the FDA
when deciding whether to approve a new medicine. The PDUFA
(Prescription Drug User Fee Act) goal date for completion of the
NDA review of the cannabidiol oral solution is June 27, 2018.
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, 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, Tuberous Sclerosis Complex (TSC)
and infantile spasms (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-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 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, outcomes and protection 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 (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 |
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