GW Pharmaceuticals plc (Nasdaq: GWPH, “GW,” “the Company” or “the
Group”), the world leader in the development and commercialization
of cannabinoid prescription medicines, along with its U.S.
subsidiary Greenwich Biosciences, will present data from the
pivotal Phase 3 trials of Epidiolex® (cannabidiol) oral solution,
CV in Lennox-Gastaut syndrome (LGS) and Dravet syndrome, along with
other supportive data, at the American Academy of Neurology (AAN)
Annual Meeting, May 4-10, 2019, in Philadelphia.
“The launch of Epidiolex, the first prescription
pharmaceutical formulation of highly purified CBD in the U.S. for
seizures associated with LGS or Dravet syndrome, has been very well
received by the community,” said Justin Gover, GW’s Chief Executive
Officer. “We look forward to sharing our latest clinical data for
Epidiolex with a wider neurology audience at AAN, including results
from our second Phase 3 study in Dravet syndrome along with
long-term safety and efficacy data.”
GW/Greenwich will host an Epidiolex exhibit
booth where attendees can participate in a virtual reality
experience of the company’s CBD growing and manufacturing processes
through a tour of its facilities in the United Kingdom. The company
will also provide educational information on the science of
cannabinoids for clinicians with a “Cannabinoid Clinical” booth
hosted by Medical Affairs. The Brain Health Fair, a free event
connecting neurology patients, caregivers and the general public,
will also feature a booth from the company.
Exhibit BoothsSunday, May 5 –
Wednesday, May 8 (hours vary)
- Epidiolex – Booth #2129
- Cannabinoid Clinical – Booth #2011
Brain Health FairThursday, May
9 (10a.m. to 4p.m.)
Data Presentations
Phase 3 and long-term Epidiolex
data
- Emerging Science: Cannabidiol (CBD)
Significantly Reduces Convulsive Seizure Frequency in Children and
Adolescents with Dravet Syndrome: Results of a Dose-ranging,
Multi-center, Randomized, Placebo-controlled Trial – Miller et al.
(Tuesday, May 7: Poster #076, 11:30a.m.-6:30p.m. Data Blitz #006,
12p.m. Authors present posters 12:20-12:45p.m. and
5:30-6:30p.m.)
- Time to Onset of Efficacy of
Cannabidiol (CBD) During Titration in Patients with Lennox–Gastaut
Syndrome and Dravet Syndrome Enrolled in 3 Randomized Controlled
Trials – Mazurkiewicz-Beldzinska et al. (Thursday, May 9: Podium
S48: Epilepsy/Clinical Neurophysiology (EEG) III,
2:28p.m.)
- Long-term Safety and Efficacy of
Add-on Cannabidiol (CBD) Treatment in Patients with Lennox Gastaut
Syndrome in an Open-label Extension Trial – Patel et al. (Thursday,
May 9: Poster Session P5; 5-001, Authors present posters
5:30-6:30p.m.)
- Long-Term Safety and Efficacy of
Add-on Cannabidiol (CBD) Treatment in Patients with Dravet Syndrome
in an Open-Label Extension Trial – Halford et al. (Thursday, May 9:
Poster Session P5; 5-005, Authors present posters
5:30-6:30p.m.)
Drug-drug interactions
- Drug-drug Interaction Studies with
Coadministration of Cannabidiol (CBD) and Clobazam (CLB), Valproate
(VPA), Stiripentol (STP) or Midazolam (MDZ) in Healthy Volunteers
and Adults with Epilepsy – Szaflarski et al. (Sunday, May 5: Podium
S3: Epilepsy/Clinical Neurophysiology (EEG) I, 1:22p.m.)
Mechanism of action
- The Proposed Multimodal Mechanism
of Action of Cannabidiol in Epilepsy: Modulation of Intracellular
Calcium and Adenosine-Mediated Signaling – Nichol et al. (Thursday,
May 9: Poster Session P5; 5-007, Authors present posters
5:30-6:30p.m.)
About EPIDIOLEX® (cannabidiol) oral
solutionEPIDIOLEX, the first prescription, plant-derived
cannabinoid medicine in the United States and the first in a new
class of anti-epileptic medications, is a pharmaceutical
formulation of highly purified cannabidiol (CBD) now FDA approved
for the treatment of seizures associated with Lennox-Gastaut
syndrome (LGS) or Dravet syndrome in patients two years of age or
older. GW has submitted a Marketing Authorization Application (MAA)
to the European Medicines Agency (EMA) for EPIDIOLEX. GW has
received Orphan Drug Designation from the FDA for EPIDIOLEX for the
treatment of seizures associated with tuberous sclerosis complex
(TSC). The Company has also received Orphan Designation from the
EMA for EPIDIOLEX for the treatment of seizures associated with
LGS, Dravet syndrome, and TSC. GW is currently conducting an
additional Phase 3 clinical development program in the treatment of
seizures associated with TSC.
Important Safety Information &
Indications What is the Most Important Information
I Should Know About EPIDIOLEX?Do not take if you are
allergic to cannabidiol or any of the ingredients in
EPIDIOLEX.EPIDIOLEX may cause liver problems. Your doctor may order
blood tests to check your liver before you start taking EPIDIOLEX
and during treatment. In some cases, EPIDIOLEX treatment may need
to be stopped. Call your doctor right away if you start to have any
of these signs and symptoms of liver problems during treatment with
EPIDIOLEX:
- loss of appetite, nausea, vomiting
- fever, feeling unwell, unusual tiredness
- yellowing of the skin or the whites of the eyes (jaundice)
- itching
- unusual darkening of the urine
- right upper stomach area pain or discomfort
EPIDIOLEX may cause you to feel sleepy, which
may get better over time. Other medicines (e.g., clobazam) or
alcohol may increase sleepiness. Do not drive, operate heavy
machinery, or do other dangerous activities until you know how
EPIDIOLEX affects you.
Like other antiepileptic drugs, EPIDIOLEX may
cause suicidal thoughts or actions in a very small number of
people, about 1 in 500. Call a healthcare provider right away if
have any signs of depression or anxiety, thoughts about suicide or
self-harm, feelings of agitation or restlessness, aggression,
irritability, or other unusual changes in behavior or mood,
especially if they are new, worse, or worry you.
Take EPIDIOLEX exactly as your healthcare
provider tells you. Do not stop taking EPIDIOLEX without first
talking to your healthcare provider. Stopping a seizure medicine
suddenly can cause serious problems.
What Else Should I Know When Taking
EPIDIOLEX?The most common side effects of EPIDIOLEX
include sleepiness, decreased appetite, diarrhea, increase in liver
enzymes, feeling very tired and weak, rash, sleep problems, and
infections.EPIDIOLEX may affect the way other medicines work, and
other medicines may affect how EPIDIOLEX works. Do not start or
stop other medicines without talking to your healthcare provider.
Tell healthcare providers about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
herbal supplements, and cannabis-based products.
EPIDIOLEX is a federally controlled substance
(CV) because it has a low potential for abuse. Keep EPIDIOLEX in a
safe place to prevent theft, misuse, or abuse.
What Additional Information Applies to
Women?If you are pregnant or plan to become pregnant,
EPIDIOLEX may harm your unborn baby. You and your healthcare
provider will have to decide if you should take EPIDIOLEX while you
are pregnant.
If you become pregnant while taking EPIDIOLEX,
talk to your healthcare provider about registering with the North
American Antiepileptic Drug Pregnancy Registry (by calling
1-888-233-2334). The purpose of this registry is to collect
information about the safety of antiepileptic medicines during
pregnancy.Because many medicines like EPIDIOLEX are passed into
breast milk, talk to your healthcare provider about the best way to
feed your baby while taking EPIDIOLEX.
What is EPIDIOLEX?EPIDIOLEX is
a prescription medicine that is used to treat seizures associated
with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years
of age and older.
It is not known if EPIDIOLEX is safe and
effective in children under 2 years of age.
Please refer to the EPIDIOLEX Medication Guide
and Instructions for Use for additional important information.
You are encouraged to report side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088. You may also contact Greenwich Biosciences at
1‑833-424-6724 (1-833-GBIOSCI).
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. GW, along with
its U.S. subsidiary Greenwich Biosciences, has 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 and which is now available by prescription in
the U.S. The Company has submitted a regulatory
application in Europe for the adjunctive treatment of
seizures associated with LGS and Dravet syndrome. The company
continues to evaluate EPIDIOLEX in additional rare epilepsy
conditions and currently has an ongoing clinical trial in tuberous
sclerosis complex (TSC). 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 and for which the company is now planning a U.S. Phase
3 trial. The Company has a deep pipeline of additional cannabinoid
product candidates which includes compounds in Phase 1 and 2 trials
for epilepsy, glioblastoma, and schizophrenia. For further
information, please visit www.gwpharm.com.
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 (cannabidiol)
oral solution and Sativex (nabiximols) and the safety profile and
commercial potential of EPIDIOLEX and Sativex. 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 10-KT filed on February 28, 2019.
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 |
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Stephen Schultz, VP Investor Relations |
401 500 6570 / 917 280 2424 |
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U.S. Media Enquiries:Sam Brown Inc.
Healthcare Communications |
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Christy CurranMike Beyer |
615 414
8668312 961 2502 |
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EU Media
Enquiries:FTI Consulting |
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Ben AtwellAndrew Ward |
+44 (0)
3727 1000publicrelations@gwpharm.com |
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