GW Pharmaceuticals and the Government of New South Wales Announce a Strategic Agreement to Study Epidiolex(R) and CBDV in a C...
October 27 2015 - 7:05AM
GW Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP) ("GW," "the Company"
or "the Group"), a biopharmaceutical company focused on
discovering, developing and commercializing novel therapeutics from
its proprietary cannabinoid product platform, today announced that
a Memorandum of Understanding (MOU) has been signed with the
Government of New South Wales (NSW) in Australia to progress a
research program for Epidiolex® (cannabidiol or CBD) and
cannabidivarin (CBDV) in children with severe, drug resistant
childhood epilepsy.
"GW is pleased to have been able to respond to the needs of the
New South Wales government and its citizens by establishing this
research program for cannabinoid-based medicines in children with
treatment resistant epilepsy," stated Justin Gover, GW's Chief
Executive Officer. "As part of this research partnership, GW
expects to advance clinical trials in Australia for both Epidiolex
and our earlier stage pipeline product CBDV."
"This confirms NSW's position as a world leader in cannabinoid
research and demonstrates the determination of our Government to
ensure we secure these groundbreaking trials," stated NSW Premier
Mike Baird. "Our research and development is driven by compassion
for those suffering so we hope that these initiatives will bring
relief to many children and their loved ones."
The MOU will facilitate:
- A world first, Phase 2 clinical trial in children for GW's
novel product containing the cannabinoid cannabidivarin (CBDV)
- A compassionate access program for Epidiolex which is currently
in Phase 3 clinical trials with the U.S. Food and Drug
Administration for Dravet syndrome and Lennox-Gastaut syndrome, two
rare, extremely debilitating epilepsy syndromes that begin in
infancy or early childhood
- Provision for NSW to host additional Phase 3 clinical trials of
Epidiolex in children with treatment-resistant epilepsy
- A Phase 4 clinical trial of Epidiolex based on Phase 3
studies
As part of this agreement, the NSW Government is providing $3.5
million to the Sydney Children's Hospitals Network to lead this
world first, Phase 2 clinical trial of CBDV in children, which is
expected to commence in 2016. Like CBD, CBDV does not produce the
psychoactive effects associated with herbal cannabis.
The agreement also delivers a compassionate access program for
Epidiolex for a small number of children who are too sick to
participate in a clinical trial, due to the unrelenting nature of
their epilepsy. To date, Australian children have had great
difficulty accessing this drug. The partnership between the NSW
Government and GW Pharmaceuticals also means NSW could host
additional clinical trials in the future, including an
international Phase 3 trial for children with Tuberous Sclerosis
Complex. The agreement also includes a future Phase 4 clinical
trial of Epidiolex for children with severe, drug resistant
epilepsy which will be led by clinicians at the Sydney Children's
Hospitals Network and which would take place following completion
of the ongoing Phase 3 trials. The goal will be to gather local
medication safety data which will support an application to the
Australian Therapeutic Goods Administration to make the product
more widely available, if proven safe and effective.
The MOU, between the NSW Government and GW Pharmaceuticals,
comes as part of the NSW Government's $21 million commitment to
support medicinal cannabis reforms.
About GW Pharmaceuticals plc
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. In 17 years of operations, GW has established a
world leading position in the development of plant-derived
cannabinoid therapeutics through its proven drug discovery and
development processes, intellectual property portfolio and
regulatory and manufacturing expertise. GW commercialized the
world's first plant-derived cannabinoid prescription drug,
Sativex®, which is approved for the treatment of spasticity due to
multiple sclerosis in 27 countries outside the United States. GW is
advancing an orphan drug program in the field of childhood epilepsy
with a focus on Epidiolex®, which is in Phase 3 clinical
development for the treatment of Dravet syndrome and Lennox-Gastaut
syndrome, two rare and extremely debilitating epilepsy syndromes
that begin in infancy or early childhood. Epidiolex is also
expected to enter Phase 3 clinical trials in the treatment of
Tuberous Sclerosis Complex. GW has a deep pipeline of additional
cannabinoid product candidates which includes compounds in Phase 1
and 2 development for both orphan (Neonatal Hypoxic Ischemic
Encepholapthy and glioma) and non-orphan (type 2 diabetes and
schizophrenia) indications. For further information, please visit
www.gwpharm.com.
Forward-looking statements
This news release may contain forward-looking statements that
reflect GWs current expectations regarding future events, including
statements regarding the therapeutic benefit, safety profile and
commercial value of the company's investigational drug Epidiolex®
and cannabidivarin (CBDV), the development and commercialization of
Epidiolex and CBDV, plans and objectives for product development,
plans and objectives for present and future clinical trials and
results of such trials, plans and objectives for regulatory
approval. 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 the GW's research strategies, the
applicability of the discoveries made therein, the successful and
timely completion of uncertainties related to the regulatory
process, and the acceptance of Sativex®, Epidiolex®, CBDV, and
other products by consumer and medical professionals. A further
list and description of risks, uncertainties and other risks
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.
CONTACT: Enquiries:
GW Pharmaceuticals plc
(Today) + 44 20 3727 1000
Stephen Schultz, VP Investor Relations (U.S.)
917 280 2424 / 401 500 6570
FTI Consulting (Media Enquiries)
Ben Atwell / Simon Conway
+ 44 20 3727 1000
GW Pharmaceuticals (NASDAQ:GWPH)
Historical Stock Chart
From Aug 2024 to Sep 2024
GW Pharmaceuticals (NASDAQ:GWPH)
Historical Stock Chart
From Sep 2023 to Sep 2024