GW Pharmaceuticals Reacquires Full Rights to Develop and Commercialize Sativex® in U.S.
13 December 2017 - 11:00PM
GW Pharmaceuticals plc (Nasdaq:GWPH) (“GW” or “the Company”), a
biopharmaceutical company focused on discovering, developing and
commercializing novel therapeutics from its proprietary cannabinoid
product platform, today announces the termination of its previous
license agreement with Otsuka Pharmaceutical Co., Ltd. in relation
to Sativex® (nabiximols) in the U.S. As a result, GW has now
reacquired full ownership of the development and commercialization
rights to the product in the U.S. market without making any upfront
payment to Otsuka. GW has agreed to make contingent milestone
payments to Otsuka, the first of which would become due upon FDA
approval of Sativex and thereafter additional payments would become
due upon the achievement of certain annual sales thresholds of
Sativex in the United States.
“We are pleased to have amicably reached this
agreement with Otsuka, which enables GW to develop, seek approval
for, and commercialize Sativex in the United States,” stated Justin
Gover, GW’s CEO. “We have previously conducted several positive
Phase 2 and 3 trials for Sativex and believe that this product
represents an important new late-stage pipeline opportunity for GW
in the U.S. market.”
Sativex is an oromucosal spray of a formulated
extract that contains the principal cannabinoids cannabidiol (CBD)
and delta-9-tetrahydrocannabinol (THC) in a 1:1 ratio. Sativex is
currently approved in 29 countries outside the U.S. for the
treatment of spasticity in patients with multiple sclerosis. GW and
Otsuka originally signed a licensing agreement in 2007 under which
GW granted Otsuka an exclusive license to develop and market
Sativex in the U.S. The two companies conducted a clinical trials
program in the treatment of cancer pain, in which the trials did
not meet the primary endpoint.
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 epilepsy with a focus on
Epidiolex (cannabidiol), for which GW has submitted an NDA to the
FDA for the adjunctive treatment of LGS and Dravet syndrome. The
Company continues to evaluate Epidiolex in additional 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. The Company has a deep pipeline of additional cannabinoid
product candidates which includes compounds in Phase 1 and 2 trials
for glioblastoma, 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 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
Sativex® (nabiximols) and the safety profile and commercial
potential of 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
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: |
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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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