LONDON, May 7, 2013
/PRNewswire/ -- GW Pharmaceuticals plc (Nasdaq: GWPH, AIM:
GWP, "GW" or the "Company"), a biopharmaceutical company focused on
discovering, developing and commercializing novel therapeutics from
its proprietary cannabinoid product platform, announces that it has
received commercialization approval for its prescription medicine
Sativex® in Italy. A
full marketing authorization has been granted by the authorities in
Italy for the treatment of
moderate to severe spasticity in Multiple Sclerosis (MS) patients
who have not responded adequately to other anti-spasticity
medications. This license to market Sativex® in
Italy comes by way of the
publication of Sativex® in the Italian Official Journal
(Gazzetta Ufficiale) and reflects that regulatory, pricing and
reimbursement approvals are now in place for an expected commercial
launch in September by GW's partner, Almirall S.A. The reimbursed
price of the medicine granted by the authorities in Italy is consistent with the reimbursed
Sativex® price in Spain.
The publication of Sativex® in the Italian Official
Journal triggers a €250,000 milestone payment from Almirall to
GW.
"The approval in Italy brings
the total to 21 countries that have approved Sativex®
for use in the treatment of MS spasticity," stated Justin Gover, Chief Executive Officer of GW. "In
granting reimbursement approval for Sativex®, we
appreciate the foresight of the Italian authorities in recognizing
the value of a medicine that treats a particularly debilitating
symptom of MS that is not adequately treated with currently
available medications. We now look forward to working with our
partners Almirall towards commercial launch in this important
market in a few months' time."
About GW Pharmaceuticals plc
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 commercialized the world's first plant-derived
cannabinoid prescription drug, Sativex®, which is approved for the
treatment of spasticity due to multiple sclerosis in 20 countries.
Sativex is also in Phase 3 clinical development as a potential
treatment of pain in people with advanced cancer. This Phase 3
program is intended to support the submission of a New Drug
Application for Sativex in cancer pain with the U.S. Food and Drug
Administration and in other markets around the world. GW has
established a world leading position in the development of
plant-derived cannabinoid therapeutics and has a deep pipeline of
additional cannabinoid product candidates, including two distinct
compounds, GWP42004 and GWP42003, in Phase 2 clinical development
for Type 2 diabetes and ulcerative colitis, respectively, and at
least two additional programs expected to enter Phase 1 and Phase 2
clinical trials in the next 12 months. For further information,
please visit www.gwpharm.com
Forward-looking statements
This news release may contain forward-looking statements that
reflect GWs current expectations regarding future events, including
statements regarding regulatory clearance of GW's products.
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 the GW's research strategies, the applicability of the
discoveries made therein, the successful and timely completion of
uncertainties related to the regulatory process, and the acceptance
of Sativex® and other products by consumer and
medical professionals. A further list and description of risks,
uncertainties and other risks associated with an investment in GW
can be found in GW's filings with the U.S. Securities and Exchange
Commission, including its most recent Form F-1. 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.
SOURCE GW Pharmaceuticals plc