GW Pharmaceuticals Announces Receipt of Notices of Allowance by the United States Patent and Trademark Office (USPTO) for Fiv...
March 13 2018 - 4:01PM
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, along with its U.S.
subsidiary Greenwich Biosciences, today announced receipt of
Notices of Allowance for five new Epidiolex® patent applications
that will be listed in the Approved Drug Products with Therapeutic
Equivalence Evaluations (commonly known as the Orange Book) if the
NDA for Epidiolex is approved. Once issued, these patents are set
to expire in 2035. One or more patents may be eligible for
additional patent term through patent term adjustment and/or
regulatory exclusivities.
“The allowance of these important patent
applications confirms GW’s innovative science and leadership in
developing cannabinoid-based medicines and provides meaningful
additional exclusivity for Epidiolex,” stated Justin Gover, GW’s
Chief Executive Officer. “We have numerous additional patent
applications under prosecution at the USPTO and will continue to
work to expand our patent portfolio as we innovate and develop new
Epidiolex formulations and additional products.”
Exemplary claims from the allowed patent
applications are as follows:
US
15/449,084
A method of reducing seizure frequency in a
patient suffering from a treatment-resistant childhood-onset
epilepsy selected from Lennox-Gastaut syndrome or Dravet syndrome
and who was previously treated with clobazam, comprising
administering CBD and clobazam to the patient in need thereof,
wherein the dose of clobazam used in combination with the CBD is
reduced relative to the dose of clobazam administered to the
patient prior to treatment with the CBD, wherein the CBD has a
purity of at least 98 percent (w/w) CBD and comprises not more than
0.15 percent (w/w) THC.
US 15/449,124
A method of reducing seizure frequency in a
patient with a treatment-resistant epilepsy, which is
Lennox-Gastaut syndrome, comprising administering to the patient in
need thereof clobazam and CBD, wherein the purity of the CBD is at
least 98 percent (w/w) CBD and comprises not more than 0.15 percent
(w/w) THC, wherein the dose of the CBD is at least 10
mg/kg/day.
US 15/449,185
A method of reducing seizure frequency in a
patient with a treatment-resistant epilepsy, which is Dravet
syndrome, comprising administering to the patient in need thereof
clobazam and CBD, wherein the purity of the CBD is at least 98
percent (w/w) CBD and comprises not more than 0.15 percent (w/w)
THC, wherein the dose of the CBD is at least 10 mg/kg/day.
US 15/449,204
A method of reducing convulsive seizure
frequency in a patient with a treatment-resistant epilepsy, which
is Lennox-Gastaut syndrome, comprising administering to the patient
in need thereof CBD, wherein the CBD has a purity of at least 98
percent (w/w) CBD and comprises not more than 0.15 percent (w/w)
THC, wherein the dose of the CBD is at least 10 mg/kg/day.
US 15/449,177
A method of reducing convulsive seizure
frequency in a patient with a treatment-resistant epilepsy, which
is Dravet syndrome, comprising administering to the patient in need
thereof CBD, wherein the CBD has a purity of at least 98 percent
(w/w) CBD and comprises not more than 0.15 percent (w/w) THC,
wherein the dose of the CBD is at least 10 mg/kg/day.
GW has submitted regulatory applications in both
the U.S. and Europe for Epidiolex in the treatment of seizures
associated with Lennox-Gastaut Syndrome and Dravet syndrome, two
rare, severe infantile-onset, drug-resistant epilepsy syndromes The
Food and Drug Administration (FDA) has set a PDUFA goal date of
June 27, 2018. Epidiolex is expected to receive New Chemical Entity
exclusivity and Orphan Drug exclusivity in the US. The FDA has
granted Orphan Drug Designation for the use of Epidiolex for
seizures associated with the following severe infantile-onset,
drug-resistant epilepsy syndromes: Dravet syndrome, Lennox-Gastaut
syndrome, Tuberous Sclerosis Complex, and Infantile Spasms.
About GW Pharmaceuticals plc and
Greenwich Biosciences
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, along with its U.S.
subsidiary Greenwich Biosciences, is advancing an orphan drug
program in the field of childhood-onset epilepsy with a focus on
Epidiolex (cannabidiol), for which GW has submitted regulatory
applications in the U.S. and Europe for the adjunctive treatment of
Lennox-Gastaut syndrome and Dravet syndrome. The Company continues
to evaluate Epidiolex in additional rare epilepsy conditions and
currently has ongoing clinical trials in 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 numerous countries outside the United States and for
which the company is now planning a US Phase 3 trial. The Company
has a deep pipeline of additional cannabinoid product candidates
which includes compounds in Phase 1 and 2 trials for epilepsy,
gliobastoma, and schizophrenia. 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 financial performance, the
timing of clinical trials, the timing, outcomes and protection of
regulatory or intellectual property decisions, the relevance of GW
products commercially available and in development, the clinical
benefits of Epidiolex (cannabidiol) 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 and 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 4 December 2017. 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
Curran |
615 414 8668 |
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