GW Pharmaceuticals plc (Nasdaq: GWPH) (“GW”, “the Company” or “the
Group”), world leader in discovering, developing and
commercialising cannabinoid prescription medicines, today announces
that two of its medicines, EPIDYOLEX (cannabidiol) oral solution
and Sativex (nabiximols), have been recommended by the UK’s
National Institute for Health and Care Excellence (NICE) to receive
routine reimbursement from NHS England.
This represents the first-time any plant-derived
cannabis-based medicine has been recommended by NICE for use on the
NHS. Cannabidiol oral solution is recommended as an adjunctive
therapy for seizures associated with Lennox Gastaut syndrome (LGS)
or Dravet syndrome, in conjunction with clobazam, for patients two
years of age and older. Nabiximols, reviewed as part of NICE’s
evaluation of cannabis-based medicinal products (CBMPs), has been
considered cost effective for the treatment of spasticity due to
multiple sclerosis.
“This is a momentous occasion for UK patients
and families who have waited for so many years for rigorously
tested, evidenced and regulatory approved cannabis-based medicines
to be reimbursed by the NHS,” said Chris Tovey, GW’s Chief
Operating Officer. “This is proof that cannabis-based medicines can
successfully go through extensive randomised placebo-controlled
trials and a rigorous NICE evaluation process to reach patients. I
am hugely proud of the entire GW team for achieving this milestone
in the country where the company was founded and where both of
these medicines were developed and are manufactured.”
Commenting on the NICE recommendation for
cannabidiol oral solution, Dr Rhys Thomas, Consultant Neurologist
at the Royal Victoria Hospital in Newcastle, said: “This is a
significant moment for adults and children with the most difficult
to treat epilepsies. NICE’s recommendation of cannabidiol oral
solution follows a period of great anticipation and enthusiasm for
patients and their clinicians. The European Medicines Agency (EMA)
licence and availability through the NHS is welcome as we badly
need additional effective treatments for Dravet and Lennox Gastaut
syndromes.”
“We welcome the addition of cannabidiol oral
solution as a new medicine to add to the Dravet syndrome treatment
armamentarium. Dravet syndrome is a devastating condition and
having a new treatment option offers potential new hope to patients
and their families searching for better seizure control,” said
Galia Wilson, Chair, Dravet Syndrome UK. “Many families come to us
asking about the potential of cannabis-based medicines,
particularly cannabidiol (CBD), and we are thrilled that one is now
available on the NHS.”
When added to other anti-epileptic therapies,
GW’s cannabidiol oral solution significantly reduced the frequency
of seizures in patients with LGS and Dravet syndrome. The most
common adverse reactions that occurred in patients treated with the
medicine were somnolence, decreased appetite, diarrhoea, pyrexia,
fatigue and vomiting. GW’s development programme represents
the only well-controlled clinical evaluation of a cannabinoid
medication for patients with refractory epilepsy.
GW’s cannabidiol oral solution was approved by
the EMA and received marketing authorisation in September 2019
under the trade name EPIDYOLEX as an adjunctive therapy for
seizures associated with LGS or Dravet syndrome, in conjunction
with clobazam, for patients two years of age and older. Following
this approval, GW has been working with the relevant bodies in the
UK, Germany, Spain, France and Italy to secure reimbursement ahead
of the anticipated launch of the medicine in these countries.
The inclusion of nabiximols in NICE guidelines
comes as part of the comprehensive evaluation of the clinical and
cost-effectiveness of CBMPs. Nabiximols has been approved by
medicines regulators in more than 25 countries around the world.
Nabiximols was approved in the UK by the Medicines and Healthcare
products Regulatory Agency (MHRA) in 2010 and is marketed in the UK
by GW’s commercial partner, Bayer.
About GW Pharmaceuticals plc and
Greenwich Biosciences, Inc.Founded in 1998, GW is a
biopharmaceutical company focused on discovering, developing and
commercialising novel therapeutics from its proprietary cannabinoid
product platform in a broad range of disease areas. GW’s lead
product, EPIDIOLEX (cannabidiol oral solution) is commercialised in
the US by its U.S. subsidiary Greenwich Biosciences for the
treatment of seizures associated with Lennox-Gastaut syndrome (LGS)
or Dravet syndrome in patients two years of age or older. This
product has received approval in Europe under the tradename
EPIDYOLEX. The Company continues to evaluate EPIDIOLEX in
additional rare conditions including Tuberous Sclerosis Complex
(TSC) and Rett syndrome. GW commercialised the world’s first
plant-derived cannabinoid prescription medicine, 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 advancing a late stage
programme in order to seek FDA approval. The Company has a deep
pipeline of additional cannabinoid product candidates which
includes compounds in Phase 1 and 2 trials for epilepsy, autism,
glioblastoma, and schizophrenia. For further information, please
visit www.gwpharm.com.
About
EPIDIOLEX®/EPIDYOLEX® (cannabidiol) oral
solutionEPIDIOLEX®/EPIDYOLEX® (cannabidiol), 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) or 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. EPIDYOLEX received a positive opinion from the European
Medicines Agency’s (EMA) Committee for Medicinal Products for Human
Use (CHMP) in July 2019 and the European Commission (EC) granted
the marketing authorisation on 23 September 2019 for adjunctive use
in conjunction with clobazam. The medicine was granted an Orphan
Drug Designation from the EMA for the treatment of seizures
associated with LGS, Dravet syndrome, and Tuberous Sclerosis
Complex (TSC).
About Sativex®
(nabiximols)Sativex® (nabiximols), the first cannabinoid
medicine derived from the cannabis plant, is an oromucosal spray
which contains a complex mixture of cannabinoids, including
delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and
specific minor cannabinoids and other non-cannabinoid components.
Nabiximols is approved in over 25 countries around the world for
the treatment of spasticity due to multiple sclerosis (MS) in
people who have not responded adequately to other anti-spasticity
medication and who demonstrate clinically significant improvement
in spasticity related symptoms during an initial trial of therapy.
Nabiximols is currently licensed to Almirall in Europe (excluding
the UK), to Bayer in the UK and Canada, Neopharm in Israel, IDS
Medical in UAE, Al-Mojil in Kuwait, Ipsen in Latin America
(excluding Mexico and Islands of Caribbean), and Emerge Healthcare
in New Zealand and Australia.
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 typically occurs 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 the 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.
About Multiple Sclerosis
(MS)Multiple sclerosis (MS) is a chronic neurological
condition characterized by progressive and disabling loss of motor
and sensory nervous system functions. In Europe, the prevalence
rate of MS is estimated to be 83 per 100,000 and is most commonly
diagnosed between the ages of 20 and 40, although it can affect
younger and older people too. In the UK, it affects around 100,000
people. Spasticity related to MS is an involuntary increase in
muscle tone affecting more than 80% of MS patients across their
disease evolution, and being moderate or severe in one third of
them despite physiotherapy and first line drug treatments. The
burden of spasticity grows as the MS evolves. When the muscle is
moved externally, there is more resistance to this movement than
there normally would be and the muscle feels stiff or rigid.
Increased muscle tone also means that muscles are slow to relax,
and this causes stiffness. Spasticity, beyond the continuous
stiffness, may also cause muscles to jerk suddenly in an
uncontrolled way.
Forward-looking statementsThis
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.
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.
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