GW Pharmaceuticals PLC Epidiolex Orphan Designation from EMA (9433U)
October 22 2014 - 1:01AM
UK Regulatory
TIDMGWP
RNS Number : 9433U
GW Pharmaceuticals PLC
22 October 2014
GW Pharmaceuticals Announces Epidiolex(R) Receives Orphan
Designation from European Medicines Agency for the Treatment of
Dravet Syndrome
London, UK; 22 October 2014: 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 the European Medicines
Agency (EMA) has granted orphan designation to GW's investigational
product Epidiolex(R) (cannabidiol or CBD) in the treatment of
Dravet syndrome, a rare and catastrophic treatment-resistant form
of childhood epilepsy.
In addition to this orphan designation by the EMA, GW has been
granted Fast Track designation by the U.S. Food and Drug
Administration (FDA) for Epidiolex in the treatment of Dravet
syndrome as well as orphan designations in both Dravet syndrome and
Lennox-Gastaut syndrome (LGS). GW is about to commence a full
clinical development program for Epidiolex in the treatment of both
Dravet syndrome and LGS, working with leading pediatric epilepsy
specialists across the U.S. The first Phase 2/3 clinical trial is
due to commence in the coming weeks.
On October 14(th) , GW announced updated physician reports of
Epidiolex treatment effect in children and young adults with
treatment-resistant epilepsy participating in open-label, "expanded
access" studies. Of the 58 patients in this report, 12 patients had
Dravet syndrome. These Dravet syndrome patients reported a median
overall reduction in convulsive seizure frequency of 51%-72% across
a range of time points and analyses. The most common adverse events
were somnolence and fatigue.
"Dravet syndrome represents a very substantial unmet need in
Europe and a significant therapeutic challenge as many of the
children suffering with this condition are resistant to current
treatments and have exhausted all options," stated Justin Gover,
GW's Chief Executive Officer. "GW is now advancing a full clinical
development program for Epidiolex in Dravet syndrome and looks
forward to commencing this program in the coming weeks. We believe
that the clinical effect and safety data recently released on
Epidiolex support GW's confidence in the prospect of ultimately
enabling children with Dravet syndrome around the world to have
access to an approved prescription CBD medicine."
The EMA orphan designation is a status assigned to a medicine
intended for use against a rare condition (prevalence of the
condition in the European Union must not be more than 5 in 10,000)
and allows a pharmaceutical company to benefit from incentives
offered by the EU to develop a medicine for the treatment,
prevention or diagnosis of a disease that is life-threatening or a
chronically debilitating rare disease. These incentives can include
reduced fees and protection from competition once the medicine is
placed on the market.
About Dravet syndrome
Dravet syndrome, also known as Severe Myoclonic Epilepsy of
Infancy (SMEI), is a rare and catastrophic form of epilepsy for
which there is currently no cure. Seizures begin in the first year
of life in an otherwise typically developing infant. Initial
seizures are most often prolonged events (status epilepticus) and,
in the second year of life, other seizure types emerge. All seizure
types are remarkably resistant to medical therapy and the prognosis
for Dravet syndrome is poor. Individuals with Dravet syndrome face
a higher incidence of SUDEP (sudden unexplained death in epilepsy)
and have associated co-morbid conditions, which also need to be
properly managed. Children with Dravet syndrome do not outgrow this
condition and it affects every aspect of their daily lives.
About GW Pharmaceuticals plc
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 commercialized the world's first plant-derived
cannabinoid prescription drug, Sativex(R), which is approved for
the treatment of spasticity due to multiple sclerosis in 27
countries outside the United States. Sativex is also in Phase 3
clinical development as a potential treatment of pain associated
with advanced cancer. This Phase 3 program has received Fast Track
Designation from the U.S. Food and Drug Administration (FDA) and is
intended to support the submission of a New Drug Application for
Sativex in cancer pain with the FDA and in other markets around the
world. GW has a deep pipeline of additional cannabinoid product
candidates, including Epidiolex(R) in the treatment of childhood
epilepsy, which has received Fast Track Designation from the FDA
for Dravet syndrome as well as Orphan Drug Designations from the
FDA in both the treatment of Dravet syndrome and Lennox-Gastaut
syndrome. GW's product pipeline also includes compounds in Phase 1
and 2 clinical development for glioma, ulcerative colitis, type 2
diabetes, and schizophrenia. For further information, please visit
www.gwpharm.com.
Note Regarding Expanded Access Studies
Expanded access studies are uncontrolled, carried out by
individual investigators, and not typically conducted in strict
compliance with Good Clinical Practices, all of which can lead to a
treatment effect which may differ from that in placebo-controlled
trials. Data from these studies provide only anecdotal evidence of
efficacy for regulatory review, contain no control or comparator
group for reference and are not designed to be aggregated or
reported as study results. Moreover, data from such small numbers
of patients may be highly variable. Such information may not
reliably predict data collected via systematic evaluation of the
efficacy in company-sponsored clinical trials. Reliance on such
information may lead to Phase 2 and 3 clinical trials that are not
adequately designed to demonstrate efficacy and could delay or
prevent GW's ability to seek approval of Epidiolex. Expanded access
programs may provide supportive safety information for regulatory
review. Physicians conducting these studies may use Epidiolex in a
manner inconsistent with the protocol, including in children with
conditions different from those being studied in GW-sponsored
trials. Any adverse events or reactions experienced by subjects in
the expanded access program may be attributed to Epidiolex and may
limit GW's ability to obtain regulatory approval with labeling that
GW considers desirable, or at all.
Forward-looking statements
This news release may contain forward-looking statements that
reflect GWs current expectations regarding future events, including
statements regarding the benefits of the Company's products
including Epidiolex(R), therapeutic and commercial value of
Epidiolex, the development and commercialization of Epidiolex,
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, Epidiolex(R), 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.
Enquiries:
GW Pharmaceuticals plc (Today) + 44 20 3727 1000
Justin Gover, Chief Executive Officer (Thereafter) + 44 1980
557000
Stephen Schultz, VP Investor Relations
(US) 401 500 6570
FTI Consulting (Media Enquiries)
Ben Atwell / Simon Conway / John Dineen
(UK) + 44 20 3727 1000
Robert Stanislaro (US) 212 850 5657
Trout Group, LLC (US investor relations)
Todd James / Chad Rubin 646 378 2900
Peel Hunt LLP (UK NOMAD)
James Steel / Clare Terlouw +44 20 7418 8900
This information is provided by RNS
The company news service from the London Stock Exchange
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