GW Pharmaceuticals plc Announces Sativex® Launch in Italy
LONDON, July 8, 2013
LONDON, July 8,2013 /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, is pleased to note the announcement
from its partner Almirall S.A. that Sativex® is now available in Italy as a
prescription medicine for use in the treatment of moderate to severe
spasticity in Multiple Sclerosis (MS) patients who have not responded
adequately to other anti-spasticity medications. The launch follows receipt of
full marketing authorization for Sativex® by the Italian health authorities in
May. The medicine is reimbursed by the Italian authorities as a Class H
(hospital dispensed) medicine. The reimbursed price of the medicine granted by
the authorities in Italy is consistent with the reimbursed Sativex® price in
"As one of the largest markets in Europe, the launch of Sativex® in Italy is a
key milestone in the commercialization of this important new medicine. Italy
represents yet another addition to the growing number of countries in Europe
in which Sativex® is now available to treat MS spasticity, a particularly
debilitating symptom of MS that is not adequately treated with currently
available medications," stated Justin Gover, Chief Executive Officer of GW.
"With a total of 21 countries that have now approved Sativex^® for use in the
treatment of MS spasticity, and a further 9 countries in which regulatory
submissions are ongoing, we look forward to a series of further commercial
launches over the coming twelve months."
The full text of Almirall's announcement is below. (NOTE: the following press
release issued by Almirall S.A. is translated into English for the convenience
of the reader. Some variation may have occurred in this translation.)
Almirall Announces the Commercial Launch of Sativex® in Italy
oThe first medicine containing cannabinoids for the treatment of spasticity
in multiple sclerosis (MS) is available in Italy.
oThe new medicine, comprised of two primary active components, THC
(delta-9-tetrahidrocannabinol) and CBD (cannabidiol), is administered as
an oromucosal spray and contains cannabinoids which are extracted from the
cannabis sativa plant (C. sativa) grown and processed under strictly
oSativex has demonstrated its efficacy in MS patients suffering from
spasticity not adequately controlled by traditional anti-spasticity
medications by mitigating symptoms which include muscle stiffness, painful
spasms and cramps, bladder problems and sleep disturbance^1.
Milan, 8 July 2013 - HCPs and patients now have an extra weapon to fight
against spasticity, one of the most common symptoms associated with MS and one
of the main causes of disability linked to this disease. Beginning in July,
Sativex® will be available on prescription as the first specific treatment for
moderate to severe spasticity in MS patients who have not adequately responded
to other anti-spasticity medications. Sativex®, which is reimbursed in H Class
(Hospital), is available in hospital pharmacies within MS Centers. In order to
monitor therapeutic accuracy and appropriateness, a National Register has been
established in which patients treated with Sativex will be enrolled.
"In our country" - declares Giancarlo Comi, Professor of Neurology Universita
Vita-Salute San Raffaele - "the majority of patients suffering from MS must
cope with the problem of spasticity which not only limits their capacity to
walk but often causes sleep disturbance, muscle stiffness, painful spasms and
cramps thus making it difficult to complete simple tasks of daily activities.
The availability of Sativex^®, which can reduce these troublesome symptoms,
offers a brighter perspective to these patients," concludes Comi.
Sativex® is an endocannabinoid modulator comprised of two primary active
components, THC (delta-9-tetrahidrocannabinol) and CBD (cannabidiol) which are
extracted from the plant C. sativa, grown and cultivated in glasshouses at a
secure location under closely controlled growing conditions. Sativex® is
administered as an oromucosal spray enabling flexible dosage, according both
to individual response and the specific symptoms of each patient, and can be
easily taken by patients who have difficulties swallowing.
"Sativex®"- declares Carlo Pozzilli, Professor of Neurology, Universita di
Roma "La Sapienza" -"is the first medicine containing cannabinoids extracted
from the plant C. sativa to undergo clinical trials in accordance with
European legislation and to demonstrate efficacy and safety for the treatment
of spasticity in MS. Its primary components, THC and CBD" - continues Pozzilli
- "interact with human endocannabinoid receptors CB1 and CB2 by modulating the
motor and pain pathways, improving spasticity without causing muscle weakness.
The medicine," - concludes Pozzilli - "is generally well tolerated, does not
cause the side effects associated with the use of crude, herbal cannabis, and
does not create dependence."
In Italy, it is estimated that 75% of MS patients suffer from spasticity, a
symptom which impacts their quality of life and the quality of life of their
family and caregivers. Clinical evidence has demonstrated that Sativex^®, due
to its efficacy on spasticity, leads to improved quality of life and to
greater patient independence from the help of their relatives and
"Consistent with Almirall's objective to provide innovative therapeutic
solutions,"- declares Javier Garcia, Chief Executive Officer of Almirall
ltalia - "we are pleased to make Sativex® available in Italy. As the first new
medicine approved for the treatment of spasticity in MS patients, Sativex
addresses the unmet needs of patients and the requirements of HCPs."
Sativex has been approved in 21 Countries in the world and it is already
commercialized in 6 other European countries including Germany, Spain, and the
United Kingdom. Sativex has been developed by GW Pharmaceuticals plc.
Almirall holds the marketing rights to this medicine in Europe (except for the
1 Patient leaflet.
2 GW Pharmaceuticals. Cannabinoid Science: Cannabinoid Compounds. Available
at: http://www.gwpharm.com/types-compounds.aspx(Last accessed: 03/06/13).
Almirall is a pharmaceutical company engaged in producing valuable drugs from
its R&D, external partnerships, licences and cooperations. In 2012 Almirall
invested more than 23% of its turnover in R&D. Through the research on
innovative drugs we aim at becoming a relevant player in respiratory diseases,
dermatology with a strong interest in gastroenterology and in pain. With about
3,000 employees in 22 countries, Almirall had a total turnover of 900 million
Euros in 2012. The Company was founded in 1943 and it is based in Barcelona,
Spain. It is listed at Spanish exchange (ticker ALM). For further information
please visit the website www.almirall.com.
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 21 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
This news release may contain forward-looking statements that reflect GWs
current expectations regarding future events, including statements regarding
the timing of clinical trials, the relevance of GW products commercially
available and in development, the size of Sativex market opportunities, and
the 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^® 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 the prospectus
related to the Nasdaq offering filed by GW with the SEC on May 1, 2013.
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
Contact: GW Pharmaceuticals plc, Justin Gover, CEO, +44 1980 557000; Stephen
Schultz, VP Investor Relations, + 1 401 500 6570; FTI Consulting, Ben Atwell /
Simon Conway / John Dineen (European media enquiries), +44 20 7831 3113;
Robert Stanislaro (US media enquiries), +1 212 850 5657; Trout Group, LLC (US
investor relations) Seth Lewis / Todd James, +1 646 378 2900; Peel Hunt LLP
(UK Nominated Adviser and Broker), James Steel / Vijay Barathan, +44 20 7418
Press spacebar to pause and continue. Press esc to stop.