GW Pharmaceuticals Presents Nabiximols U.S. Development and Commercial Strategy
June 30 2020 - 7:00AM
GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the
Group), a world leader in the science, development, and
commercialization of cannabinoid prescription medicines, today
announces the Company’s strategy for bringing its pipeline product
nabiximols to the U.S. market. This strategy includes multiple
opportunities for the submission of an initial New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA), the earliest
of which could occur in 2021. GW will host a webcast today to
provide insight into the U.S. Phase 3 clinical program and
commercial opportunity for nabiximols.
“We are excited to present the details of our
clinical program and regulatory strategy for nabiximols, which we
believe support the potential for a substantial near-term
commercial opportunity in the U.S. Following constructive meetings
with the FDA, we are now commencing a Phase 3 clinical program that
provides multiple opportunities for an NDA submission, including as
early as 2021”, stated Justin Gover, GW’s Chief Executive Officer.
“Beyond the initial target indication of MS spasticity, our Phase 3
clinical program is designed to achieve a broad spasticity label
over time. This development strategy, together with the long-term
exclusivity potential of nabiximols, provides GW with confidence
that this product should represent a significant value driver for
GW.”
Highlights of GW’s nabiximols U.S.
clinical development strategy:MS Spasticity
Clinical program
- Three positive Phase 3 MS spasticity trials already completed
outside of the U.S.
- Five new MS Spasticity Phase 3 trials are expected to commence
in H2 2020 (2) and H1 2021 (3), any one of which we believe could
enable a NDA submission
- Phase 3 muscle tone studies – placebo-controlled cross-over
design
- N=52; Expected start: Q4 2020
- N=190; Expected start: Q1 2021
- N=36 (nabiximols responders); Expected start: Q1 2021
- Phase 3 spasm frequency studies – placebo-controlled parallel
group
- N=450; Expected start: Q4 2020
- N=~200 (nabiximols responders); Expected start: Q2 2021
Spinal Cord Injury (SCI) spasticity
clinical program
- Three SCI trials are expected to be initiated in 2020 and 2021
- N=~100 (observational clinical discovery study); Expected
start: Q4 2020
- N=~100 (muscle tone in nabiximols responders);
Placebo-controlled parallel group design. Expected start: Q2
2021
- N=~400 (spasm frequency); Placebo-controlled parallel group
design. Expected start: H2 2021
This
second spasticity indication may lead to broad anti-spasticity
labeling and
usage. Post
Traumatic Stress Disorder (PTSD) clinical program
- We are also exploring the potential of nabiximols to reduce
sleep disturbance symptoms, as well as anxiety and irritability, in
patients with PTSD
- A Phase 2/3 study in PTSD will have approximately 325 subjects
and is anticipated to be initiated in H1 2021
GW will host a webcast today, June 30th, 2020
from 10:00am-12:00pm EDT. Justin Gover, GW’s Chief Executive
Officer, will host this event. The presentation will feature
external medical and research experts as well as GW
executives. A replay will be available for soon after the
live presentation. Both the live webcast link and the archive will
be available on GW’s corporate website at www.gwpharm.com on the
Investor section homepage.
About NabiximolsNabiximols is
expected to enter pivotal Phase 3 development in the United States
in the second half of 2020. The U.S. commercial rights are owned by
GW. GW anticipates developing multiple indications for nabiximols
with an initial focus on spasticity. The initial target indication
will be for the treatment of MS spasticity, to be followed by
Spinal Cord Injury spasticity and Post Traumatic Stress Disorder,
or PTSD.
Nabiximols is a complex botanical medicine
formulated from extracts of the cannabis plant that contains the
principal cannabinoids THC and CBD and also contains minor
constituents, including other cannabinoid and non-cannabinoid plant
components, such as terpenes, sterols, and triglycerides. The
product is administered as a mouth spray.
Nabiximols is known as Sativex® outside of the
United States and is commercially available for the treatment of MS
spasticity in numerous countries. These approvals were based on
multiple pivotal trials conducted in Europe1.
1: Markova et al, International Journal of Neuroscience 2019;
Novotna et al, European Journal of Neurology 2011; Collin et al,
European Journal of Neurology 2007
About GW Pharmaceuticals plc and
Greenwich Biosciences, Inc.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. The Company’s
lead product, EPIDIOLEX® (cannabidiol) oral solution, is
commercialized in the U.S. by its U.S. subsidiary Greenwich
Biosciences for the treatment of seizures associated with
Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two
years of age or older. This product has received approval in the
European Union under the tradename EPIDYOLEX®. The Company has
submitted applications in both the U.S. and Europe to expand the
indication for Epidiolex to include seizures associated with
Tuberous Sclerosis Complex (TSC), for which it has reported
positive Phase 3 data, and is carrying out a Phase 3 trial in Rett
syndrome. The Company has a deep pipeline of additional cannabinoid
product candidates, in particular nabiximols, for which the Company
is advancing multiple late-stage clinical programs in order to seek
FDA approval in the treatment of spasticity associated with
multiple sclerosis and spinal cord injury, as well as for the
treatment of PTSD. The Company has additional cannabinoid product
candidates in Phase 2 trials for autism and schizophrenia. For
further information, please visit www.gwpharm.com.
Forward-looking statement This
press release contains forward-looking statements that reflect GW's
current expectations regarding future events, including
statements regarding the timing of clinical trials, the timing of
regulatory filings and approvals, the timing and outcomes of
regulatory or intellectual property decisions, and the clinical
benefits and commercial potential of nabiximols (marketed as
Sativex® outside the US). Actual events could differ materially
from those projected herein and depend on a number of factors,
including (inter alia), the risks and uncertainties which 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 |
|
Stephen Schultz, VP Investor Relations (U.S.) |
917 280 2424 / 401 500 6570 |
U.S. Media
Enquiries:Sam Brown Inc. Healthcare
Communications |
|
Christy CurranMike Beyer |
615 414 8668312 961 2502 |
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