GW Pharmaceuticals Announces New Planned Epidiolex (Cannabidiol or CBD) Development Program in Infantile Spasms (IS)
June 21 2016 - 7:00AM
- Orphan Drug
Designation Granted from FDA for Epidiolex for the Treatment
of IS -
GW Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP) (“GW” or “the
Company”), a biopharmaceutical company focused on discovering,
developing and commercializing novel therapeutics from its
proprietary cannabinoid product platform, today announced that the
Company has selected infantile spasms (IS) as the fourth target
indication for its Epidiolex orphan pediatric epilepsy development
program. In addition, the U.S. Food and Drug Administration (FDA)
has granted Orphan Drug Designation for Epidiolex (cannabidiol or
CBD) for the treatment of IS. GW expects to commence a two-part
pivotal Phase 3 study in the fourth quarter of 2016.
Epidiolex is already being developed in three
other orphan indications within the field of pediatric epilepsy –
Dravet syndrome, Lennox-Gastaut syndrome (LGS) and Tuberous
Sclerosis Complex (TSC). In March 2016, GW announced positive
results from the first Phase 3 trial in Dravet syndrome. Results of
the first Phase 3 trial in LGS are expected in June 2016.
“We are pleased to add infantile spasms as a
fourth target indication for Epidiolex, demonstrating GW’s ongoing
commitment to addressing the significant unmet medical need within
the field of pediatric epilepsy,” stated Justin Gover, CEO of GW
Pharmaceuticals. “Currently, there are limited treatment options
for children suffering from infantile spasms and outcomes for
patients with the disorder include higher mortality, ongoing
development of additional seizure disorders as the patient matures,
and often severe cognitive and developmental delay.”
An infantile spasm is a specific type of seizure
seen in an epilepsy syndrome of infancy and childhood known as West
Syndrome. The onset of infantile spasms usually occur in the first
year of life, typically between 4-8 months of age. The condition
constitutes 2 percent of childhood epilepsies and 25 percent of
epilepsies with onset in the first year of life. There are
approximately 2,000 to 4,000 new cases in the United States each
year. The long-term overall prognosis for patients with infantile
spasms is poor. Cognitive and developmental delay is severe in 70
percent of patients, often with psychiatric problems such as
autistic features or hyperactivity. It has been found that 50-70
percent of patients develop other seizure types and that 18 to 50
percent will develop LGS or some other form of symptomatic
generalized epilepsy.
About Orphan Drug
Designation
Under the Orphan Drug Act, the FDA may grant
orphan drug designation to drugs intended to treat a rare disease
or condition - generally a disease or condition that affects fewer
than 200,000 individuals in the U.S. The first NDA applicant to
receive FDA approval for a particular active moiety to treat a
particular disease with FDA orphan drug designation is typically
entitled to a seven-year exclusive marketing period for that drug
and use except under a few exceptions.
About Infantile Spasms
According to the National Institute of
Neurological Disorders and Stroke, an infantile spasm (IS) is a
specific type of seizure seen in an epilepsy syndrome of infancy
and childhood known as West Syndrome. West Syndrome is
characterized by infantile spasms, developmental regression, and a
specific pattern on electroencephalography (EEG) testing called
hypsarrhythmia (chaotic brain waves). The onset of infantile spasms
is usually in the first year of life, typically between 4-8 months
of age. The seizures primarily consist of a sudden bending forward
of the body with stiffening of the arms and legs; some children
arch their backs as they extend their arms and legs. Spasms tend to
occur upon awakening or after feeding, and often occur in clusters
of up to 100 spasms at a time. Infants may have dozens of clusters
and several hundred spasms per day. Infantile spasms usually stop
by age five, but may be replaced by other seizure types. Many
underlying disorders, such as birth injury, metabolic disorders,
and genetic disorders can give rise to spasms, making it important
to identify the underlying cause. In some children, no cause can be
found.
About Epidiolex
Epidiolex, GW’s lead cannabinoid product
candidate, is an oral solution of pure plant-derived CBD, which is
in development for the treatment of a number of rare pediatric
epilepsy disorders. GW has conducted extensive pre-clinical
research of CBD in epilepsy since 2007. This research has shown
that CBD has significant anti-epileptiform and anticonvulsant
activity using a variety of in vitro and in vivo models and reduced
seizures in acute animal models of epilepsy with significantly
fewer side effects than comparator anti-epileptic drugs. To date,
GW has received Orphan Drug Designation from the U.S. Food and Drug
Administration (FDA) for Epidiolex in the treatment of Dravet
syndrome, Lennox-Gastaut syndrome and Tuberous Sclerosis Complex.
Additionally, GW has received Fast Track Designation from the FDA
and Orphan Designation from the European Medicines Agency for
Epidiolex for the treatment of Dravet syndrome. GW is currently
evaluating additional clinical development programs in other orphan
pediatric seizure disorders.
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 is advancing an
orphan drug program in the field of childhood epilepsy with a focus
on Epidiolex® (cannabidiol), which is in Phase 3 clinical
development for the treatment of Dravet syndrome, Lennox-Gastaut
syndrome and Tuberous Sclerosis Complex. GW previously
commercialized the world’s first plant-derived cannabinoid
prescription drug, Sativex®, which is approved for the treatment of
spasticity due to multiple sclerosis in 28 countries outside the
United States. GW has a deep pipeline of additional cannabinoid
product candidates which includes compounds in Phase 1 and 2 trials
for glioma, type 2 diabetes, schizophrenia and epilepsy. For
further information, please visit
www.gwpharm.com.
To obtain information about this clinical trial or eligibility
criteria, the treating physician should contact:
medicaldirector@gwpharm.com
References:1:
http://www.ninds.nih.gov/disorders/infantilespasms/infantilespasms.htm 2:
http://emedicine.medscape.com/article/1176431-overview 3:
http://infantilespasmsproject.org/ 4:
http://www.epilepsy.com/learn/types-epilepsy-syndromes/infantile-spasms-wests-syndrome 5:
http://misc.medscape.com/pi/iphone/medscapeapp/html/A1176431-business.html
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®, 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, and the acceptance of Epidiolex, 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 |
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