GW Pharmaceuticals plc (Nasdaq: GWPH) (“GW”, “the Company” or “the
Group”), the world leader in discovering, developing and
commercialising cannabinoid prescription medicines, today announced
that the European Medicines Agency’s (EMA) Committee for Medicinal
Products for Human Use (CHMP) has adopted a positive opinion
recommending marketing authorisation of EPIDYOLEX™ (cannabidiol
oral solution) for use as adjunctive therapy of seizures associated
with Lennox‑Gastaut syndrome (LGS) or Dravet syndrome, in
conjunction with clobazam, for patients 2 years of age and older.
The European Commission (EC) is expected to make a final decision
on the marketing authorisation application (MAA) in approximately
two months.
“Today’s positive CHMP opinion for EPIDYOLEX™
marks a major milestone for patients, and their families, battling
to control two of the most severe and life-threatening forms of
childhood onset epilepsy. Cannabidiol oral solution is the first in
a new class of epilepsy medicines and the first plant-derived
cannabis-based medicine to be submitted for European regulatory
review, representing a historic breakthrough,” said Justin Gover,
GW’s Chief Executive Officer. “We are excited by the potential to
bring patients and physicians a rigorously tested and evaluated
cannabis-based medicine with a documented safety and efficacy
profile, manufactured to the highest standards and approved by a
medicines regulator.”
“This is a significant milestone for patients
with LGS and Dravet syndrome as there remains a severe unmet
medical need for these rare, lifelong forms of epilepsy,” said
Professor Martin Brodie, President, International Bureau for
Epilepsy. “Today’s positive opinion brings hope to both patients
and their families of a treatment option which has the potential to
better control seizures and notably improve quality of life.”
“In my clinic, I often see patients with these
highly treatment-resistant epilepsies who have tried and failed
existing therapies. These patients and their families face a long
and challenging road and very few achieve adequate seizure
control,” said Dr Antonio Gil-Nagel Rein, Director of the Epilepsy
Programme, Ruber International Hospital, Madrid. “Based on numerous
clinical trials and the scrutiny of the European medicines
regulator, this medicine has the potential to make a real
difference to the lives of many patients.”
The CHMP’s positive opinion is based on results
from four randomised, controlled Phase 3 trials. These studies
incorporate data from more than 714 patients with either LGS or
Dravet syndrome, two forms of epilepsy with high morbidity and
mortality rates, which place a significant burden on families and
caregivers. Many patients with LGS or Dravet syndrome have multiple
seizures per day, which puts them at ongoing risk of falls and
injury. Despite current anti-epileptic drug treatment, both of
these severe forms of epilepsy remain highly
treatment-resistant.1,2,3
GW’s cannabidiol oral solution was approved by
the U.S. Food and Drug Administration (FDA) in June 2018 under the
trade name EPIDIOLEX® for the treatment of seizures associated with
LGS or Dravet syndrome in patients two years of age or older.
The EC has the authority to approve medicines
for use in the 28 countries of the European Union, alongside
Norway, Iceland and Liechtenstein.
1: Bourgeois, B. F., Douglass, L. M. and Sankar,
R. (2014), Lennox‐Gastaut syndrome: A consensus approach to
differential diagnosis. Epilepsia, 55: 4-9.
Doi:10.1111/epi.12567.
2. Arzimanoglou A, French J, Blume WT, et al.
Lennox-Gastaut syndrome: a consensus approach on diagnosis,
assessment, management, and trial methodology. Lancet Neurol.
2009;8(1):82-93.
3. Dravet C. The core Dravet syndrome phenotype.
Epilepsia. 2011;52 Suppl 2:3-9.
ADDITIONAL INFORMATION
About GW Pharmaceuticals plc and
Greenwich Biosciences, Inc.
Founded in 1998, GW is a UK-based global
biopharmaceutical company focused on discovering, developing and
commercialising novel therapeutics from its proprietary cannabinoid
product platform in a broad range of disease areas. In June 2018
GW, along with its U.S. subsidiary Greenwich Biosciences, 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. GW
developed the world’s first plant-derived cannabinoid prescription
medicine, Sativex® (nabiximols), which is approved for the
treatment of spasticity due to multiple sclerosis in more than 25
countries around the world. The Company has a deep pipeline of
additional cannabinoid product candidates, which includes compounds
in Phase 1, 2 and 3 trials for epilepsy, autism, glioblastoma, and
schizophrenia.
About
EPIDIOLEX®/EPIDYOLEX™
(cannabidiol oral solution)
EPIDIOLEX®/EPIDYOLEX™ (cannabidiol oral
solution), the first prescription, plant-derived cannabis-based
medicine approved by the FDA for use in the U.S., is an oral
solution which contains highly purified cannabidiol (CBD). The
medicine is for the treatment of seizures associated with
Lennox-Gastaut syndrome (LGS) and Dravet syndrome in patients two
years of age or older and is the first in a new class of
anti-epileptic medications with a novel mechanism of action. GW
submitted a Marketing Authorisation Application (MAA) to the
European Medicines Agency (EMA) for EPIDYOLEX™ in December 2017,
which was accepted for review in February 2018. GW received Orphan
Drug Designation from the EMA for the treatment of seizures
associated with LGS, Dravet syndrome, and Tuberous Sclerosis
Complex (TSC).
About Dravet syndrome
Dravet syndrome is a severe infantile-onset and
highly treatment-resistant epileptic encephalopathy frequently
associated with genetic mutations in the sodium channel gene SCN1A.
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 of patients will develop
moderate to severe intellectual and development disabilities and
require lifelong supervision and care.
About Lennox-Gastaut syndrome
(LGS)
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
patients with LGS experience some degree of intellectual
impairment, as well as developmental delays and aberrant
behaviours.
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®/EPIDYOLEX™ (cannabidiol oral solution) and Sativex®
(nabiximols), and the safety profile and commercial potential of
both medicines. 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 EPIDIOLEX®/EPIDYOLEX™, Sativex® 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
10-K filed on 29 November 2018. 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 |
|
|
|
All investor and media enquiries |
publicrelations@gwpharm.com |
|
|
Investor Relations |
|
Stephen Schultz, VP Investor Relations, GW |
+1 917 280 2424 / +1 401 500 6570 |
|
|
UK, EU and ex-U.S. media enquiries |
|
Andrew Ward/Mike Trace, FTI Consulting |
+44 (0)203 727 1000 |
|
|
U.S. media enquiries |
|
Sam Brown Inc Healthcare Communications |
|
Christy Curran |
+1 615 414 8668 |
Mike Beyer |
+1 312 961 2502 |
GW Pharmaceuticals (NASDAQ:GWPH)
Historical Stock Chart
From Aug 2024 to Sep 2024
GW Pharmaceuticals (NASDAQ:GWPH)
Historical Stock Chart
From Sep 2023 to Sep 2024