GW Pharmaceuticals plc Announces the Sale of Priority Review Voucher for $105M
March 18 2019 - 7:30AM
GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the
Group), the world leader in the development and commercialization
of cannabinoid prescription medicines, today announced that GW
Research Ltd. has entered into a definitive agreement to sell its
Rare Pediatric Disease Priority Review Voucher (PRV) for
$105,000,000. GW was awarded the voucher under a U.S. Food
and Drug Administration (FDA) program intended to encourage the
development of treatments for rare pediatric diseases. GW Research
Ltd. received the PRV when EPIDIOLEX® (cannabidiol) was approved by
the FDA for the treatment of seizures associated with
Lennox-Gastaut Syndrome or Dravet syndrome, two rare, severe
childhood-onset epilepsies. The transaction remains subject to
customary closing conditions, including anti-trust review.
“Having successfully developed and launched
EPIDIOLEX as the first plant-derived cannabinod medicine approved
by the FDA, GW is advancing a pipeline of additional cannabinoid
products to address patient needs across a range of therapeutic
areas,” stated Justin Gover, GW’s Chief Executive Officer. “The
sale of the PRV provides an important source of non-dilutive
capital to help advance our pipeline and to continue to invest in
the EPIDIOLEX commercial launch in both the U.S. and Europe.”
About the Rare Pediatric Disease
Priority Review Voucher ProgramThe program is intended to
encourage development of new drug and biological products for
prevention and treatment of certain rare pediatric diseases. A PRV
may be issued to the sponsor of a rare pediatric disease product
application and would entitle the holder to priority review of a
single New Drug Application or Biologics License Application, which
reduces the target review time and could lead to an expedited
approval. The sponsor receives the PRV upon approval of the rare
pediatric disease product application and it can be sold without
limitation, subject to applicable FDA requirements for filing and
use.
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. GW, along with
its U.S. subsidiary Greenwich Biosciences, has received U.S. FDA
approval for EPIDIOLEX (cannabidiol) oral solution for the
treatment of seizures associated with Lennox-Gastaut syndrome (LGS)
or Dravet syndrome in patients two years of age or older and which
is now available by prescription in the U.S. The Company has
submitted a regulatory application in Europe for the adjunctive
treatment of seizures associated with LGS and Dravet syndrome. The
company continues to evaluate EPIDIOLEX in additional rare epilepsy
conditions and currently has an ongoing clinical trial in tuberous
sclerosis complex (TSC). 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 U.S. 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,
glioblastoma, and schizophrenia. For further information, please
visit www.gwpharm.com.
Forward-looking statementsThis
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 and outcomes of regulatory or intellectual property
decisions, the relevance of GW products commercially
available and in development, the clinical benefits of EPIDIOLEX
(cannabidiol) oral solution and Sativex (nabiximols) and the safety
profile and commercial potential of EPIDIOLEX and Sativex.
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 10-KT filed on February 28, 2019.
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 |
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U.S. Media Enquiries:Sam Brown Inc.
Healthcare Communications |
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Christy CurranMike Beyer |
615
414 8668312 961 2502 |
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EU Media Enquiries:FTI
Consulting |
|
Ben
Atwell/Andrew Ward |
+44
(0) 20 727 1000 |
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