GW Pharmaceuticals Announces Epidiolex® Receives Orphan Drug Designation from the European Medicines Agency for the Treatmen...
March 29 2017 - 07:00AM
GW Pharmaceuticals plc (Nasdaq:GWPH) (“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 Drug Designation
to GW’s investigational product Epidiolex® (cannabidiol or CBD) in
the treatment of Lennox-Gastaut Syndrome (LGS), a
treatment-resistant, debilitating childhood-onset epilepsy.
"Following two positive Phase 3 trials of
Epidiolex in patients with LGS, GW is committed to pursuing
registration of Epidiolex in Europe in order to provide these
patients access to an approved prescription CBD medicine," stated
Justin Gover, GW's Chief Executive Officer. "In addition to
preparing to submit a New Drug Application with the U.S. Food and
Drug Administration in the middle of 2017, we are also planning a
submission to the EMA shortly afterwards.”
In addition to this Orphan Drug Designation by
the EMA in LGS, GW has also previously been granted Orphan Drug
Designation by the EMA for Epidiolex in the treatment of Dravet
syndrome. In the U.S., GW has received Orphan Drug Designation from
the FDA for Epidiolex in the treatment of LGS, Dravet syndrome,
Tuberous Sclerosis Complex, and Infantile Spasms, each of which are
severe infantile-onset, drug-resistant epilepsy syndromes.
Additionally, GW has received Fast Track Designation from the FDA
for Epidiolex in the treatment of Dravet syndrome.
The EMA orphan drug 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.
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, Tuberous Sclerosis Complex and Infantile Spasms. 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 31
countries outside the United States. The Company has a deep
pipeline of additional cannabinoid product candidates which
includes compounds in Phase 1 and 2 trials for glioma,
schizophrenia and epilepsy. 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 the timing of clinical
trials, the timing and outcomes of regulatory or intellectual
property decisions, the relevance of GW products in development,
the clinical benefits of Epidiolex® and the safety profile and
commercial potential of Epidiolex. 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 of 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
20-F filed on 5 December 2016. 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 |
|
|
Sam Brown Inc. Healthcare Communications (U.S. Media
Enquiries) |
|
Mike
Beyer |
312 961 2502 |
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