GW Pharmaceuticals Announces the European Medicines Agency (EMA) Accepts Epidiolex® (cannabidiol) Marketing Authorization Ap...
February 05 2018 - 4:00PM
GW Pharmaceuticals plc (Nasdaq:GWPH) (“GW,” “the Company” or “the
Group”), a biopharmaceutical company focused on discovering,
developing and commercialising novel therapeutics from its
proprietary cannabinoid product platform, announced today that the
European Medicines Agency (EMA) has accepted for review the
Marketing Authorization Application (MAA) for Epidiolex®
(cannabidiol) for adjunctive treatment of seizures associated with
Lennox-Gastaut syndrome (LGS) and Dravet syndrome. This acceptance
follows submission of the MAA in December 2017.
“The successful filing of the MAA for Epidiolex
with the EMA builds on the momentum of acceptance by the U.S. Food
and Drug Administration of the Epidiolex New Drug Application in
December and recent publication of Phase 3 LGS results in The
Lancet,” said Justin Gover, GW's Chief Executive Officer. “We
continue to build European commercial infrastructure in
anticipation of future approval and launch with the goal of making
this important new medicine available to appropriate patients and
their caregivers, addressing the significant unmet need in LGS and
Dravet syndrome, two rare and debilitating conditions of
childhood-onset epilepsy.”
The outcome of the MAA review by the EMA is
expected in Q1 2019. In preparation for the commercialization of
Epidiolex in Europe, GW continues to hire staff in the areas of
medical affairs, market access and marketing, all with strong
epilepsy or specialist disease experience. Significant progress has
been made in hiring country leadership and local medical staff in
the five major European markets. This European commercial effort is
being led by Chief Operating Officer Chris Tovey, who has
significant experience commercializing and launching pharmaceutical
products, including within the field of epilepsy.
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, 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 and an MAA with the EMA 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
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 Consulting |
|
Michael Trace |
+44 (0) 20 3727 1000 |
|
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|
|
U.S. Media
Enquiries:Sam Brown Inc. Healthcare
Communications |
|
Christy Curran Mike
Beyer |
|
615 414 8668 312 961 2502 |
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