Health Canada Grants Full Approval of Sativex
August 31 2010 - 1:01AM
UK Regulatory
TIDMGWP
RNS Number : 8106R
GW Pharmaceuticals PLC
31 August 2010
Health Canada Grants Full Approval of Sativex
For the Treatment of Spasticity Due to Multiple Sclerosis
Porton Down, UK; Toronto, Canada - August 31, 2010 - GW Pharmaceuticals plc
(AIM: GWP) and Bayer Inc., a subsidiary of Bayer AG, today announced that Health
Canada has approved Sativex [delta-9-tetrahydrocannabinol 27 mg/mL (from
Tetrabinex - cannabis sativa L. extract) and cannabidiol 25 mg/mL (from
Nabidiolex - cannabis sativa L. extract)] as adjunctive treatment for
symptomatic relief of spasticity in adult patients with multiple sclerosis (MS).
Sativex is the first cannabinoid medicine derived from whole plant extracts
from the cannabis sativa plant containing both delta-9-tetrahydrocannabinol and
cannabidiol. This means that people in Canada with MS experiencing the
debilitating symptoms of spasticity, such as painful spasms and cramps, will now
have a new treatment option in addition to standard therapy.
The MS spasticity indication has received a full marketing authorization, or
Notice of Compliance (NOC), from Health Canada. Sativex is useful as adjunctive
treatment for symptomatic relief of spasticity in adult patients with MS who
have not responded adequately to other therapy and who demonstrate meaningful
improvement during an initial trial of therapy. In addition to this new NOC,
Health Canada approved Sativex in 2005 under its Notice of Compliance with
Conditions (NOC/c) policy as adjunctive treatment for the symptomatic relief of
neuropathic pain in adult patients with multiple sclerosis, and granted a
further NOC/c approval in 2007 as adjunctive analgesic treatment in adult
patients with advanced cancer who experience moderate to severe pain during the
highest tolerated dose of strong opioid therapy for persistent background
pain.1
"Health Canada's approval of a third indication for Sativex demonstrates the
broad applications of this medicine," said Dr. Shurjeel Choudhri, Chief Medical
Officer and Head, Medical and Scientific Affairs, Bayer Inc. "Sativex meets a
significant unmet medical need by improving the symptoms of spasticity in
patients with MS who have failed to respond to current anti-spasticity
medication. We believe that this approval represents an important step forward
in the available treatment options for the MS patient population in Canada."
Dr Stephen Wright, R&D Director, GW, said: "Following recent approvals in the UK
and Spain, Canada is now the third major country to approve Sativex for
symptomatic relief of spasticity in adult patients with MS. This regulatory
approval has come several months earlier than anticipated and GW looks forward
to working with Bayer to develop the marketing strategy for this new indication.
We are delighted that the international regulatory program for Sativex is
continuing its positive momentum."
1 Sativex Product Monograph, August 2010, p.6
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About Sativex
A product resulting from the pioneering research efforts of UK-based GW
Pharmaceuticals plc and marketed in Canada by Bayer HealthCare Pharmaceuticals,
Sativex contains active ingredients called 'cannabinoids', which are extracted
from cannabis plants grown and processed under strictly controlled conditions.
Cannabinoids react with cannabinoid receptors that are distributed throughout
the central nervous system and in immune cells.2
The principal active cannabinoid components of Sativex are THC and CBD, a
non-psychoactive cannabinoid. The ratio of THC to CBD in Sativex is 2.7mg:2.5mg
per spray, ensuring a standardized dose is delivered each time it is used.3
Standard marketing authorisation:4
Sativex is useful as adjunctive treatment for symptomatic relief of spasticity
in adult patients with multiple sclerosis (MS) who have not responded adequately
to other therapy and who demonstrate meaningful improvement during an initial
trial of therapy.
Marketing authorization with conditions:4
Sativex may be useful as adjunctive treatment for the symptomatic relief of
neuropathic pain in adult patients with MS.
Marketing authorization with conditions:4
Sativex may be useful as adjunctive analgesic treatment in adult patients with
advanced cancer who experience moderate to severe pain during the highest
tolerated dose of strong opioid therapy for persistent background pain.
Marketing authorizations with conditions reflect the promising nature of the
clinical evidence which are to be confirmed with further studies.
Treatment-emergent adverse events in clinical trials with Sativex which
occurred with a greater than 10 per cent frequency in patients with MS included
fatigue and dizziness. In patients with pain in cancer, these adverse events
included nausea, neoplasm progression, somnolence and dizziness. In most
patients, adverse events have resolved without treatment, and some with a
reduction of dosage of Sativex .5
Sativex is a registered trade mark of GW Pharmaceuticals and GW Pharmaceuticals
is the Marketing Authorisation holder for Sativex .
2 Health Canada. "Approval of SATIVEX(R) with Conditions Fact Sheet." Available
at
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/sativex_fs_fd
091289-eng.php (last accessed 26/08/10)
3 Sativex Product Monograph - August 2010, p. 52
4 Sativex Product Monograph - August 2010, p. 1
5 Sativex Product Monograph - August 2010, p.13-19
About MS
Multiple sclerosis (MS) is a degenerative neurological condition, which is
associated with a wide range of distressing and disabling signs and
symptoms.6 MS is the most common disabling disease of the CNS affecting young
adults and is usually diagnosed between the ages of 20 and 40 years..MS is twice
as common in women than in men.7 An estimated 55,000-75,000 Canadians have MS.8
About spasticity
Spasticity is a common symptom associated with Multiple Sclerosis (MS)9 and is a
major contributor to disability.10 It is caused by damage to the nerves in the
central nervous system which carry messages instructing muscles how to move
resulting in an involuntary muscle overactivity.11
In a survey, 84% of people with MS reported symptoms of spasticity12. Moderate,
severe or total spasticity is reported in 34% of individuals.11 Symptoms include
loss of mobility, painful spasms, stiffness and / or weakness of muscles.10 As a
consequence an individual may have difficulty in walking, picking up objects,
washing, dressing and other everyday activities involving movement.9 In addition
to causing a great deal of distress to the person with MS, mood, self-image and
motivation can also be affected.13
6 Health Canada. "Approval of SATIVEX(R) with Conditions Fact Sheet." Available
at
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/sativex_fs_fd
091289-eng.php (last accessed 26/0810)
7 Multiple Sclerosis Trust. MS Explained. 2008. Available at
http://www.mstrust.org.uk/information/publications/msexplained (Last accessed:
26/08/10)
8 MS Society of Canada. Available at
http://mssociety.ca/en/information/ms_what.htm (last accessed 26/08/10)
9 Multiple Sclerosis Trust. Multiple Sclerosis Information for Health and Social
Care Professionals. 2007. Available at
http://www.mstrust.org.uk/downloads/ms_information_for_hps.pdf (Last accessed:
26/08/10).
10 Beard S, et al. Health Technol Assess 2003;7(40)
11 Multiple Sclerosis Trust. Spasticity and Spasms factsheet. November 2009
12 Rizzo MA, et al. Prevalence and treatment of spasticity reported by multiple
sclerosis patients. Multiple Sclerosis 2004;10:589/595
13 Multiple Sclerosis International Federation. Spasticity in MS. MS in focus.
Issue 12. 2008. Available at http://www.msif.org/docs/MSinFocusIssue12EN.pdf
(Last accessed: 26/08/10).
About Bayer Inc.
Bayer Inc. (Bayer) is a Canadian subsidiary of Bayer AG, an international
research-based group with core businesses in health care, crop science and
innovative materials. Headquartered in Toronto, Ontario, Bayer Inc. operates the
Bayer Group's HealthCare and MaterialScience businesses in Canada. Bayer
CropScience Inc., headquartered in Calgary, Alberta operates as a separate legal
entity in Canada. Together, the companies play a vital role in improving the
quality of life for Canadians - producing products that fight diseases,
protecting crops and animals, and developing high-performance materials for
applications in numerous areas of daily life. Canadian Bayer facilities include
the Toronto headquarters and offices in Montréal and Calgary.
Bayer Inc. has approximately 800 employees across Canada and had sales of $853
million CDN in 2009. Globally, the Bayer Group had sales of over 31 billion Euro
in 2009. Bayer Inc. invested approximately $50 million CDN in research and
development in 2009. Worldwide, the Bayer Group spent the equivalent of over 2.7
billion Euro in 2009 in R&D. For more information, go to www.bayer.ca.
About GW Pharmaceuticals
GW was founded in 1998 and is listed on the AiM, a market of the London Stock
Exchange. Operating under licence from the UK Home Office, the company
researches and develops cannabinoid pharmaceutical products for patients who
suffer from a range of serious ailments, in particular MS and cancer pain. GW
has assembled a large in-house scientific team with expertise in cannabinoid
science as well as experience in the development of both plant based
prescription pharmaceutical products and medicines containing controlled
substances. GW occupies a world leading position in cannabinoids and has
developed an extensive international network of the most prominent scientists in
the field.
For further information, please visit www.gwpharm.com
This news release may contain forward-looking statements that reflect GW's
current expectations regarding future events, including the clinical development
and regulatory clearance of its 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 GW's research strategies, the applicability of the discoveries made
therein, the successful and timely completion of clinical studies, including
with respect to Sativex and GW's other products, the uncertainties related to
the regulatory process, and the acceptance of Sativex and other products by
consumers and medical professionals.
This new release may contain forward-looking statements based on current
assumptions and forecasts made by Bayer Group or subgroup management. Various
known and unknown risks, uncertainties and other factors could lead to material
differences between the actual future results, financial situation, development
or performance of the company and the estimates given here. These factors
include those discussed in Bayer's public reports which are available on the
Bayer website at www.bayer.ca. The company assumes no liability whatsoever to
update these forward-looking statements or to conform them to future events or
developments.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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