GW Pharmaceuticals and U.S. Subsidiary Greenwich Biosciences to Present Data on EPIDIOLEX® (cannabidiol) Oral Solution at th...
December 05 2019 - 7:00AM
GW Pharmaceuticals plc (Nasdaq: GWPH), the world leader in the
science, development, and commercialization of cannabinoid
prescription medicines, along with U.S. subsidiary Greenwich
Biosciences announced today that a variety of data, including
results from completed Phase 3 trials of EPIDIOLEX® (cannabidiol)
oral solution CV, will be presented at the American Epilepsy
Society (AES) Annual Meeting, December 6-10, in Baltimore.
EPIDIOLEX is approved in the U.S. for the treatment of seizures
associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome.
It is also approved in Europe, in conjunction with clobazam, for
seizures associated with both conditions under the brand name
EPIDYOLEX. It is available by prescription for patients two years
of age and older.
New data from the Phase 3 study of EPIDIOLEX in
patients with tuberous sclerosis complex (TSC) will be presented
for the first time at the meeting, along with 3-year safety and
efficacy results from an open-label extension study in patients
with LGS and Dravet syndrome. GW/Greenwich will host commercial and
medical booths as well as a scientific exhibit where AES attendees
can learn more about EPIDIOLEX.
The Company will also host an Innovation
Pavilion where attendees can discover the stories of those treated
with EPIDIOLEX; hear about the journey of the only CBD product
approved by the FDA; and attend an interactive expert-panel
discussion on managing patients on EPIDIOLEX. Attendees can also
immerse themselves in the Company’s CBD growing and manufacturing
processes through an award-winning virtual reality experience.
“We are excited to share our latest data for
EPIDIOLEX at AES. This is the first time Phase 3 results in TSC
will be presented to the epilepsy medical community, along with
updated long-term safety and efficacy results in LGS and Dravet
syndrome,” said Justin Gover, GW’s Chief Executive Officer. “This
has been an exciting first year, with over 15,000 patients treated
with EPIDIOLEX, the only FDA-approved cannabidiol (CBD) and the
first in a new class of antiepileptic drugs. Our goal is to expand
the EPIDIOLEX product label in 2020 to include seizures associated
with TSC. Given that the majority of these patients have
treatment-resistant epilepsy, we believe there is a need for
promising new treatment options.”
Meeting activities include:
EPIDIOLEX (Booth #517)Saturday,
December 7 – Monday, December 9
Innovation Pavilion: Growing Together
(Pavilion D)Saturday, December 7 – Monday, December 9
- See how Greenwich Biosciences is Growing Innovation
with an award-winning virtual reality
experience° Saturday
12:00PM-6:00PM° Sunday 10:00AM-4:00PM° Monday
10:00AM-2:00PM
- Hear the EPIDIOLEX journey to FDA approval and learn
about non-FDA-approved CBDAlice Mead, J.D., LLM, &
Jennifer Marlo-Triemstra, M.S., Ph.D.Saturday & Sunday
1:00PM-2:00PM
- Learn about EPIDIOLEX patient managementAn
interactive panel with Ian Miller, M.D.; Barry Gidal, Pharm.D.;
& Robert Wechsler, M.D., Ph.D.Saturday & Sunday
2:00PM-3:00PM
Scientific Exhibition (Convention
Center: Room 324-326, Level 300)Monday, December 9,
8:00AM-11:00AM
Data Presentations
Phase 3 and
Long-term EPIDIOLEX data
- Cannabidiol (CBD) Treatment in
Patients with Seizures Associated with Tuberous Sclerosis Complex:
A Randomized, Double-blind, Placebo-controlled Phase 3 Trial –
Thiele et al. (Saturday, December 7, Poster #1.293)
- Long-Term Safety and Efficacy of
Add-on Cannabidiol (CBD) Treatment in Patients with Lennox-Gastaut
Syndrome (LGS): 3-Year Results of an Open-Label Extension Trial –
Patel et al. (Sunday, December 8, Poster #2.436)
- Long-Term Safety and Efficacy of
Add-on Cannabidiol (CBD) Treatment in Patients with Dravet Syndrome
(DS): 3-Year Results of an Open-Label Extension Trial – Scheffer et
al. (Sunday, December 8, Poster #2.437)
- Time to Onset of Cannabidiol (CBD)
Treatment Effect and Resolution of Adverse Events – Madan Cohen et
al. (Monday, December 9, Poster #3.317)
Drug-drug
interactions
- Cannabidiol Drug-Drug Interaction
with Other Commonly Used Antiepileptic Drugs in an Acute Mouse
Model of Generalized Seizures – Rana et al. (Monday, December 9,
Poster #3.333)
About EPIDIOLEX® (cannabidiol) oral solution
CV
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. EPIDYOLEX® (European brand name) is approved in Europe for
use as an adjunctive therapy for seizures associated with LGS or
Dravet syndrome, in conjunction with clobazam, for patients two
years of age and older. GW has received Orphan Drug Designation
from the FDA, for EPIDIOLEX for the treatment of Dravet syndrome,
LGS and TSC, each of which are severe childhood-onset,
drug-resistant syndromes. GW has also received Orphan Designation
from the European Medicines Agency, or EMA, for Epidyolex for the
treatment of seizures associated with LGS, Dravet syndrome and
TSC.
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’s lead product,
EPIDIOLEX (cannabidiol) oral solution CV, is commercialized 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 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 advancing a late-stage program 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.
Important Safety
InformationImportant safety information for Epidiolex is
available at Epidiolex.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®/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 |
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Stephen Schultz, VP Investor Relations (U.S.) |
917 280 2424 / 401 500 6570 |
|
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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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