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RNS Number : 6590O
GW Pharmaceuticals PLC
10 February 2016
GW Pharmaceuticals plc Reports First Quarter 2016 Financial
Results and Operational Progress
-Three Phase 3 Epidiolex clinical trials fully recruited above
target sample size - on track for initial data in March 2016-
-Conference Call Today at 8:00 a.m. EST, 1:00 p.m. GMT-
London, UK, 10 February 2016: 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, announces financial results for the first quarter ended
31 December 2015.
"We are on track to report topline data from four Epidiolex
Phase 3 trials in the months ahead and remain very excited at the
transformational potential of these data for GW. The treatment
effect data from our expanded access program provide a solid basis
for confidence in the outcome of these trials and the potential for
Epidiolex to make a meaningful difference to the lives of patients
with Dravet syndrome and Lennox-Gastaut syndrome," stated Justin
Gover, GW's Chief Executive Officer. "We are looking forward to an
active 2016, that, in addition to the Epidiolex Phase 3 data, is
expected to include our first NDA filing, expansion of our U.S.
commercial organization, and ongoing data read-outs from a number
of clinical pipeline programs."
RECENT OPERATIONAL HIGHLIGHTS
-- Epidiolex(R) (CBD) childhood epilepsy program:
o Company sponsored Phase 3 development programs in Dravet
syndrome and Lennox-Gastaut syndrome (LGS)
-- First Phase 3 Dravet syndrome trial fully enrolled above
original target sample size (120 randomized), data expected March
2016
-- Second Phase 3 Dravet syndrome trial ongoing, data expected
H2 2016
-- Both LGS Phase 3 trials fully enrolled above original target
sample sizes (171 for 2-arm, 225 for 3-arm randomized), data
expected Q2 2016
-- 97% transition rate of eligible patients from Phase 3 trials
to long term open label extension
-- NDA submission with FDA expected Q4 2016
-- Phase 3 Tuberous Sclerosis Complex trial due to commence Q1
2016
-- Additional clinical development for Epidiolex expected to
commence in H2 2016
o Expanded access program
-- Recent data update at the American Epilepsy Society December
2015 Annual Meeting showing promising safety and effectiveness
consistent with prior updates
-- Over 375 children and young adults on treatment at 22 U.S.
clinical sites
-- Over 900 children and young adults authorized for treatment
by FDA under Expanded Access Treatment INDs and 6 U.S. State
programs
-- Advanced clinical programs in multiple cannabinoid pipeline product candidates:
o THCV Phase 2 study in type 2 diabetes data expected Q2
2016
o THC:CBD Phase 1b/2a study for the treatment of Recurrent
Glioblastoma Multiforme (GBM) fully enrolled with data expected in
mid-2016
-- Orphan Drug Designation granted from FDA and EMA
o Sativex(R) Phase 2 study in spasticity due to cerebral palsy
ongoing with data expected H2 2016
o CBDV Phase 2 partial-onset epilepsy study in adults ongoing.
Part A complete and Part B underway with data expected around the
end of 2016
o Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous
CBD Phase 1 clinical program expected to commence in H2 2016
-- Orphan Drug and Fast Track Designations granted from FDA and
EMA
o Clinical trials within the field of autism spectrum disorders
expected to commence in H2 2016
-- Pre-clinical progress addressing a number of areas of unmet
need including autism spectrum disorders, Duchenne muscular
dystrophy, glioma, ovarian and pancreatic cancers
FINANCIAL HIGHLIGHTS
-- Revenue for the three months ended 31 December 2015 of GBP3.7
million ($5.4 million) compared to GBP8.0 million for the three
months ended 31 December 2014
-- Loss for the three months ended 31 December 2015 of GBP17.7
million ($26.2 million) compared to GBP3.4 million for the three
months ended 31 December 2014
-- Cash and cash equivalents at 31 December 2015 of GBP219.3
million ($324.1 million) compared to GBP234.9 million as at 30
September 2015
Conference Call and Webcast Information
GW Pharmaceuticals will host a conference call and webcast to
discuss the first quarter 2016 financial results today at 8:00 a.m.
EST / 1:00 p.m. GMT. To participate in the conference call, please
dial 877-407-8133 (toll free from the U.S. and Canada), or
0800-756-3429 (toll free from the UK) or 201-689-8040
(international). Investors may also access a live audio webcast of
the call via the investor relations section of the Company's
website at http://www.gwpharm.com. A replay of the call will also
be available through the GW website shortly after the call and will
remain available for 90 days. Replay Numbers: (toll
free):1-877-660-6853, (international):1-201-612-7415. For both
dial-in numbers please use conference ID # 13629628.
Enquiries:
GW Pharmaceuticals plc
Stephen Schultz, VP Investor
Relations 401 500 6570
FTI Consulting (Media Enquiries)
Ben Atwell / Simon Conway +44 20 3727 1000
Peel Hunt LLP (UK NOMAD)
James Steel +44 20 7418 8900
GW Pharmaceuticals plc
("GW" or "the Company" or "the Group")
Financial Results for the First Quarter Ended 31 December
2015
GW Overview
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 its nearly 20 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(R) , which is approved for the treatment
of spasticity due to multiple sclerosis in 28 countries outside the
United States. GW is advancing an orphan drug program in the field
of childhood epilepsy with a focus on Epidiolex(R) , which is in
Phase 3 clinical development for the treatment of Dravet syndrome,
Lennox-Gastaut syndrome (LGS) and Tuberous Sclerosis Complex (TSC).
GW has a deep pipeline of additional cannabinoid product candidates
which includes clinical development across a variety of compounds
for both orphan and non-orphan indications.
Epilepsy Drug Development Programs
GW's epilepsy franchise centers around two product candidates,
Epidiolex, a liquid formulation of pure plant-derived cannabidiol
(CBD), and GWP42006 (CBDV). GW is currently pursuing the
development of CBD for a series of individual orphan
epilepsy-related indications providing GW with significant new
market opportunities. GW retains all rights to commercialize any
and all products that evolve from these programs.
Epidiolex
GW is undertaking a formal development program for Epidiolex in
the field of severe, drug-resistant childhood epilepsy with initial
focus on conducting formal development programs in the treatment of
three indications - Dravet syndrome, LGS and TSC. The Company has
to date received Orphan Drug Designation from the U.S. Food and
Drug Administration (FDA) for Epidiolex for the treatment of both
Dravet syndrome and LGS. Additionally, GW has received Fast Track
Designation from the FDA and Orphan Designation from the European
Medicines Agency (EMA) for Epidiolex for the treatment of Dravet
syndrome.
Epidiolex development in Dravet syndrome
GW commenced a Phase 2/3 clinical trial of Epidiolex for Dravet
syndrome in October 2014. This trial is designed as a two-part
randomized double-blind, placebo-controlled parallel group dose
escalation, safety, tolerability, pharmacokinetic and efficacy
trial of single and multiple doses of Epidiolex to treat Dravet
syndrome in children who are not responding adequately to other
anti-epileptic drugs. The first part of this trial was completed in
February 2015, and included a dose-ranging pharmacokinetic and
safety evaluation in a total of 34 patients over a 3 week treatment
period.
Following a satisfactory review of the Part A data by an
independent panel, Part B of the trial commenced in March 2015.
Part B is a Phase 3 pivotal placebo-controlled safety and efficacy
evaluation of Epidiolex (at a dose of 20mg/kg per day) over a 14
week treatment period. Originally expected to recruit 100 patients,
this trial reached a total of 120 patients randomized. In April
2015, GW commenced an additional dose-ranging Phase 3 trial in
Dravet syndrome which is recruiting 150 patients. This
placebo-controlled trial differs from the first Phase 3 trial in
that it includes two Epidiolex dose arms, at 20mg/kg and at
10mg/kg. Both of these studies will be the largest known controlled
trials in Dravet syndrome.
GW expects to report top-line results from the Phase 2/3 pivotal
safety and efficacy study in March 2016 and results from the second
Phase 3 trial in the second half of 2016. The primary measure of
efficacy in both trials will be the comparison between Epidiolex
and placebo in the percentage change in number of monthly
convulsive seizures (reported tonic-clonic, tonic, clonic and
atonic seizures) during the 14 week treatment period (which
includes 2 weeks dose titration) compared with the 4 week baseline
observation period.
Epidiolex development in LGS
February 10, 2016 07:00 ET (12:00 GMT)
On 29 and 30 December 2015, following the exercise and sale of
vested share options on behalf of Dr. Geoffrey Guy and Chris Tovey,
previously announced on 21 December, the Group received gross
proceeds from the sale of option shares of GBP0.1 million and
GBP4.5 million respectively. Having deducted the GBP0.6 million
option exercise price due to be retained by the Company and having
deducted taxation totalling GBP2.2 million, the net proceeds were
paid to Dr. Guy and Mr Tovey in January 2016.
As at 31 December, the liability to pay GBP1.8 million to these
Directors is included within other payables, together with the
taxation liability of GBP2.2 million.
12. Contingent liabilities
As at 31 December 2015 certain fees associated with ongoing
capital expenditure have been estimated. The final fees payable are
expected to be agreed and paid when construction is completed,
scheduled for the second quarter of the year ending 30 September
2016. The Group estimates that there is a possible contingent
liability for incremental fees of up to GBP0.4 million (30
September 2015: GBP0.4 million) of capital expenditure.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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February 10, 2016 07:00 ET (12:00 GMT)
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