GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the
Group), the world leader in the science, development, and
commercialization of cannabinoid prescription medicines, along with
its U.S. subsidiary Greenwich Biosciences, Inc., announced today
that it has submitted a supplemental New Drug Application (sNDA) to
the U.S. Food and Drug Administration (FDA) for
Epidiolex® (cannabidiol) oral solution, CV. The sNDA seeks to
expand the Epidiolex label to include the treatment of seizures
associated with Tuberous Sclerosis Complex (TSC), a rare genetic
condition. Epidiolex is currently approved in the U.S. to treat
seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet
syndrome and has been granted Orphan Drug Designation from
the FDA for the treatment of TSC.
"The submission of this sNDA for Epidiolex is an
important step towards the prospect of offering a new treatment
option for those patients with TSC who battle difficult-to-treat
seizures," said CEO, Justin Gover. "Having already obtained
approval for Epdiolex in the treatment of seizures associated with
Lennox-Gastaut Syndrome and Dravet Syndrome, this submission is
based on positive Phase 3 data showing that Epidiolex reduced
TSC-associated seizures, which include both focal and generalized
seizures types. We look forward to working with the FDA toward an
expected approval later this year."
TSC is a condition that causes mostly benign
tumors to grow in vital organs of the body including the brain,
skin, heart, eyes, kidneys and lungs1 and is a leading cause of
genetic epilepsy.2 TSC is typically diagnosed in childhood. More
than 60% of individuals with TSC do not achieve seizure control4
with standard treatments.
The sNDA is supported by data from a Phase 3
safety and efficacy study, results of which were recently presented
at the American Epilepsy Society 2019 annual meeting. The study met
its primary endpoint with patients treated with Epidiolex 25
mg/kg/day experiencing a significantly greater reduction from
baseline in TSC-associated seizures compared to placebo (49% vs
27%; p=0.0009). Results for the 50 mg/kg/day dose group were
similar, with seizure reductions of 48% from baseline vs 26.5% for
placebo (p=0.0018). All key secondary endpoints were supportive of
the effects on the primary endpoint. The safety profile observed
was consistent with findings from previous studies, with no new
safety risks identified.
About Tuberous Sclerosis Complex
(TSC)Tuberous sclerosis complex (TSC) is a rare genetic
condition that affects approximately 40-80 thousand individuals in
the U.S. and nearly one million people worldwide.3 At least two
children born each day will develop TSC, with an estimated
prevalence of one in 6,000 newborns.5 The condition causes mostly
benign tumors to grow in vital organs of the body including the
brain, skin, heart, eyes, kidneys and lungs4 and is a leading
cause of genetic epilepsy.5 TSC often occurs in the first year of
life with patients suffering from either focal seizures or
infantile spasms1 and is associated with an increased risk of
autism and intellectual disability.6 The severity of the condition
can vary widely. In some children the disease is very mild, while
others may experience life-threatening complications.6
Seizures are present in about 85% of patients
with TSC.1,2,3 More than 60% of individuals with TSC do not achieve
seizure control4 with standard treatments such as antiepileptic
drugs, epilepsy surgery, ketogenic diet, or vagus nerve
stimulation2 compared to 30-40% of individuals with epilepsy who do
not have TSC who are drug resistant.7,8
About GW Pharmaceuticals plc and Greenwich Biosciences,
Inc.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. The Company’s lead product,
EPIDIOLEX® (cannabidiol) oral solution, CV, is commercialized
in the U.S. 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 the European Union under the
tradename EPIDYOLEX®. The Company has submitted a supplemental New
Drug Application (sNDA) to the U.S. Food and Drug Administration
(FDA) to expand the indication for Epidiolex to include seizures
associated with Tuberous Sclerosis Complex (TSC), for which it has
reported positive Phase 3 data, and is carrying out a Phase 3 trial
in Rett syndrome. The Company has a deep pipeline of additional
cannabinoid product candidates, in particular nabiximols, for which
the Company is advancing multiple late-stage clinical programs in
order to seek FDA approval in the treatment of spasticity
associated with multiple sclerosis and spinal cord injury, as well
as for the treatment of PTSD. The Company has additional
cannabinoid product candidates in Phase 2 trials for autism and
schizophrenia. For further information, please
visit www.gwpharm.com.
About EPIDIOLEX® (cannabidiol) oral solution,
CV
EPIDIOLEX® (cannabidiol) oral solution, CV, a pharmaceutical
formulation of highly purified cannabidiol (CBD), is the first in a
new class of anti-epileptic medications with a novel mechanism of
action, and the first prescription, plant-derived cannabis-based
medicine approved by the U.S. Food and Drug Administration (FDA).
In the U.S., Epidiolex is indicated for the treatment of seizures
associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in
patients two years of age or older. A supplemental New Drug
Application (sNDA) has been submitted to the FDA for the treatment
of seizures associated with tuberous sclerosis complex (TSC).
Epidiolex has received approval in the European Union under the
tradename EPIDYOLEX® for adjunctive use in conjunction with
clobazam to treat seizures associated with LGS and Dravet syndrome.
Epidiolex/Epidyolex has received Orphan Drug Designation from the
FDA and the EMA for the treatment of seizures associated with
Dravet syndrome, LGS and TSC, each of which are severe
childhood-onset, drug-resistant syndromes.
Important Safety InformationImportant safety
information for Epidiolex is available
at Epidiolex.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®/EPIDYOLEX® (cannabidiol) oral
solution CV 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.
Enquiries:
GW Pharmaceuticals plc |
Stephen Schultz, VP Investor Relations (U.S.) |
917 280 2424 / 401 500 6570 |
|
|
U.S. Media Enquiries: |
Sam Brown Inc. Healthcare Communications |
Christy Curran |
615 414 8668 |
Mike Beyer |
312 961 2502 |
1 NIH Tuberous Sclerosis Fact Sheet.
https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Tuberous-Sclerosis-Fact-Sheet.
Accessed November 19, 2019.2 TS Alliance Website.
https://www.tsalliance.org/. Accessed November 19, 2019.3 TS
Alliance, What is TSC?
https://www.tsalliance.org/about-tsc/what-is-tsc/. Accessed April
15, 2019.4 NIH Tuberous Sclerosis Fact Sheet.
https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Tuberous-Sclerosis-Fact-Sheet.
Accessed November 19, 2019.5 TS Alliance Website.
https://www.tsalliance.org/. Accessed November 19, 2019.6 de Vries
PJ, Belousova E, Benedik MP, et al. TSC-associated neuropsychiatric
disorders (TAND): findings from the TOSCA natural history study.
Orphanet J Rare Dis. 2018;13(1):157.7 Kwan P., Brodie M.J. Early
identification of refractory epilepsy. N. Engl. J.
Med. 2000;342(5):314–319.8 French JA. Refractory epilepsy:
clinical overview. Epilepsia. 2007;48 Suppl 1:3-7.
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