GW Pharmaceuticals and its U.S. Subsidiary Greenwich Biosciences Completes Rolling New Drug Application Submission to U.S. Fo...
October 30 2017 - 7:00AM
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, along with its U.S. subsidiary Greenwich
Biosciences, today announced it has completed the rolling
submission of a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) for Epidiolex® (cannabidiol) as
adjunctive treatment of seizures associated with Lennox-Gastaut
syndrome (LGS) and Dravet syndrome, two highly treatment-resistant
forms of childhood-onset epilepsy.
GW has received Rare Pediatric Disease and
Orphan Drug Designations from the FDA for Epidiolex in
the treatment of both LGS and Dravet syndrome. Additionally, GW has
received Fast Track Designation from the FDA for
Epidiolex for the treatment of Dravet syndrome.
"The submission of the Epidiolex NDA is an
important milestone for patients with LGS and Dravet syndrome in
that a potential new treatment option is within sight for these
very difficult to treat and devastating conditions," stated Justin
Gover, CEO of GW Pharmaceuticals. “On behalf of all those patients,
clinicians and GW employees who have supported the Epidiolex
program, we are pleased to submit this promising therapy for FDA
review and we look forward to working with the FDA throughout the
review process. This regulatory submission is a demonstration of
GW’s commitment to developing innovative cannabinoid-based
treatments that have the potential to address significant unmet
medical needs.”
The NDA 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 NDA includes safety data on approximately 1,500
patients, with approximately 400 patients on continuous therapy for
more than one year. Beyond pivotal safety and efficacy data, the
NDA includes a comprehensive clinical pharmacology, pre-clinical
and toxicology package. The CMC section of the NDA incorporates the
Company’s recently expanded UK manufacturing facilities.
The Company plans to file a Marketing
Authorization Application (MAA) in Europe for Epidiolex in the near
future.
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, 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 and Dravet
syndrome. GW is currently evaluating additional clinical
development programs in other orphan seizure disorders including
Phase 3 trials in TSC and IS.
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 30 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 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 |
|
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 |
|
Christy Curran |
615
414 8668 |
Mike
Beyer |
312
961 2502 |
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