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RNS Number : 3567A
GW Pharmaceuticals PLC
19 March 2013
Update on Sativex(R) in Germany
Porton Down, UK, 19 March 2013: GW Pharmaceuticals plc (AIM:
GWP, "GW"), the specialty pharmaceutical company focused on
cannabinoid science, today provides an update on pricing
negotiations in Germany for Sativex(R) being conducted by GW's
licensing partner, Almirall S.A. ("Almirall").
In June 2012 the German Federal Joint Committee (G-BA), the
national reimbursement authority, determined that Sativex provides
added benefit over current treatment options in the treatment of
spasticity in multiple sclerosis (MS). The next step in the process
has been for Almirall to negotiate a price for Sativex with the
German National Association of Statutory Health Insurance Funds.
After several months of inconclusive discussions, Almirall recently
attended a meeting with an arbitration board. The outcome of this
meeting, which was communicated to Almirall today, was the
determination of a price significantly lower than the reimbursed
Sativex price in other European countries. Sativex is one of
several recent examples of new medicines that have not been
appropriately valued by the new German reimbursement system.
The decision in Germany is in distinct contrast to the price
agreed in every other European country to date, where pricing
reflects the value that Sativex brings to patients with an unmet
need. Our partners, Almirall, consider the German price to be
unacceptable and plan to take all necessary steps to challenge the
decision, which may include suspension or withdrawal of supply in
Germany, whilst they pursue a reasonable solution. Almirall is
committed to maintaining the success and value of the Sativex
franchise across Europe.
Sativex is now approved in 20 countries, in eight of which
commercialisation has now commenced - UK, Spain, Germany, Denmark,
Norway, Sweden, Canada and Israel. The 12 additional countries in
which Sativex has received regulatory approval are Austria, Czech
Republic, Belgium, Finland, Iceland, the Netherlands, Luxembourg,
Poland, Portugal, Slovakia, New Zealand and Australia. Launches in
most of these countries are expected to take place in the next
twelve months. In addition to the 20 countries which have formally
approved, we are awaiting product licences in two further countries
(Italy and Ireland) that have recommended approval. Regulatory
applications have also been submitted in Switzerland and seven
countries in the Middle East.
"Sativex has an excellent record of achieving appropriate price
levels in all other countries to date and we are confident that the
ongoing global commercial prospects for Sativex outside of Germany
are unchanged," stated Justin Gover, GW's Chief Executive Officer.
"The recently introduced pricing and reimbursement system in
Germany has been presented as a means of recognising innovative new
medicines that provide added value over existing treatment options.
Despite Sativex being a clear example of such a medicine, as
recognised in other markets, the German system appears to be
neglecting the interests of patients and jeopardising
pharmaceutical companies' ability to provide German patients with
access to new treatments. Sativex is one of several examples of new
medicines that have not been appropriately valued by the German
reimbursement system. Almirall is now taking all necessary steps to
maintain the success and value of the Sativex franchise across
Europe."
Since the introduction of Sativex in mid-2011 it is estimated
that approximately 3,000 German patients are currently receiving
treatment with Sativex and this number has been growing steadily.
Sativex treats patients with MS spasticity, who have failed to
respond adequately to conventional anti-spasticity drugs. Sativex
helps patients who are often significantly hindered in their
day-to-day lives by MS-induced spasticity to partially regain their
mobility, freedom and quality of life.
"The new price decision in Germany is inappropriate for an
innovative treatment option for severely suffering patients who
currently do not have other options and no longer covers the
financing of the product. We will evaluate all possible options and
further steps for Sativex as Almirall believes Germany should
continue as a relevant country for innovative medicines", stated
Farid Taha, Managing Director of Almirall Hermal GmbH.
Sativex is the world's first plant-derived cannabinoid
prescription drug. In addition to MS spasticity, Sativex is also in
Phase III clinical development as a potential treatment of pain in
people with advanced cancer. The cancer pain indication represents
the initial target indication for Sativex in the United States. In
addition to Sativex, GW 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 programmes in epilepsy and glioma expected to enter
clinical trials in the next 12 months.
For GW's financial year ended 30 September 2013, we expect to
account for a provision of GBP0.8 million to reflect the impact of
this pricing decision, which we are required to apply to sales in
Germany from July 2012, and product sales will be lower than
previously expected. Cash and cash equivalents at 31 December 2012
was GBP27.6 million.
GW will make further announcements in relation to this
development when appropriate.
Enquiries:
GW Pharmaceuticals plc (Today) +44 20 7831 3113
Justin Gover, Chief Executive Officer (Thereafter) +44 1980
557000
Stephen Schultz, VP Investor Relations +1 401 500 6570
FTI Consulting +44 20 7831 3113
Ben Atwell / Simon Conway / John Dineen
Peel Hunt LLP +44 207 418 8900
James Steel / Vijay Barathan
About GW Pharmaceuticals plc
Founded in 1998, GW is 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 clinical trials in
the next 12 months. For more information, please visit the
Company's website at www.gwpharm.com
This news release may contain forward-looking statements that
reflect GWs current expectations regarding future events, including
development and regulatory clearance of the 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(R) and other products by consumer and medical
professionals.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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