Meeting activities include presentations of Phase 3 data, cannabinoid education for clinicians, and a virtual reality experience
CARLSBAD, Calif., May 02, 2019 (GLOBE NEWSWIRE)
-- GW Pharmaceuticals plc (Nasdaq: GWPH, “GW,†“the Company†or
“the Groupâ€), 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.â€
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 Booths
Sunday, May 5 – Wednesday, May 8 (hours vary)
Brain Health Fair
Thursday, May 9 (10a.m. to 4p.m.)
Data Presentations
Phase 3 and long-term Epidiolex data
Drug-drug interactions
Mechanism of action
About EPIDIOLEX® (cannabidiol)
oral solution
EPIDIOLEX, 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:
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 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) 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 | ||||
| Stephen Schultz, VP Investor Relations | 401 500 6570 / 917 280 2424 | |||
| U.S. Media Enquiries: Sam Brown Inc. Healthcare Communications |
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| Christy Curran Mike Beyer |
615 414 8668 312 961 2502 |
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| EU Media Enquiries: FTI Consulting |
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| Ben Atwell Andrew Ward |
+44 (0) 3727 1000 [email protected] |
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