Innovative Treatment Option for Cancer Pain Now Available in Canada



    TORONTO, Aug. 7 /CNW/ - Today, Bayer Inc., a subsidiary of Bayer AG, and
GW Pharmaceuticals announced that Health Canada has approved SATIVEX(R), a
cannabis derived pharmaceutical treatment, 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. SATIVEX, the only pharmaceutical product derived from
components of the cannabis plant, is administered through a spray into the
patient's mouth.
    Health Canada has approved SATIVEX with conditions, under the Notice of
Compliance with Conditions (NOC/c) policy. This authorization reflects the
promising nature of the clinical evidence which will be confirmed with further
studies. Products approved under Health Canada's NOC/c policy have
demonstrated promising benefit, are of high quality and possess an acceptable
safety profile based on a benefit/risk assessment for the approved use.
    In 2005, Health Canada approved SATIVEX for the treatment of neuropathic
pain in adults with multiple sclerosis (MS), also under the Notice of
Compliance with Conditions (NOC/c) policy.
    SATIVEX is a buccal spray composed primarily of
delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), a non-psychoactive
cannabinoid. The product is standardized by both composition and dose. SATIVEX
is thought to act via cannabinoid receptors that are distributed throughout
the central nervous system and in immune cells(1). These receptors are
distributed throughout the pain pathways of the nervous system, and their
activation is known to reduce pain in relevant pain models.
    "Cancer pain is not managed as well as it could be and the resources
available to manage cancer pain effectively are still somewhat limited.
Cannabinoids have an important role in treating complex cancer pain
particularly neuropathic pain and demonstrate a positive effect with current
treatment options," said Dr. Lawrence Librach, Director of the Temmy Latner
Centre for Palliative Care at Mount Sinai Hospital and Vice President of the
Canadian Hospice Palliative Care Association.
    "Bayer HealthCare is committed to putting the needs of patients first and
is very pleased that SATIVEX can now be used to manage cancer pain in Canada,"
said Philip Blake, president and CEO, Bayer Inc. "Health Canada's approval of
SATIVEX is further recognition of the important role this medicine can play in
effective pain treatment."
    Dr. Geoffrey Guy, GW's chairman, commented: "GW is delighted to receive
Health Canada's regulatory approval for SATIVEX in the relief of cancer pain.
SATIVEX has been shown to provide important pain relief to the most high need
patients with advanced cancer. We are pleased to be able to offer the prospect
of an improved quality of life for people who previously had little such
opportunity."

    Cancer Statistics in Canada

    According to the Canadian Cancer Society, an estimated 159,900 new cases
of cancer and 72,700 deaths will occur in Canada this year alone. On average,
each week 3,075 Canadians will be diagnosed and 1,398 will die of cancer.

    Advanced Cancer in Canada

    Advanced cancer is one that may have spread to other places in the body
beyond its origin and usually cannot be cured or controlled with treatment.
Sixty to 90 per cent of patients with advanced cancer will experience moderate
to severe pain, regardless of age, gender and whether or not they are
hospitalized(2),(3),(4). For these patients, pain will interfere with their
sleep, daily activities, enjoyment of life, work capacity, and social
relations(5).

    How SATIVEX Works

    SATIVEX is administered through a spray pump under the tongue or on the
inside of the cheek, providing reliable, self-administered pain relief. The
spray formulation allows for more flexible dosing than an oral tablet.

    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
Ottawa and Calgary. Bayer Inc. has approximately 1,000 employees across Canada
and had sales of over $910 million CDN in 2006. Globally, the Bayer Group had
sales of over 28 billion Euro in 2006.
    Bayer Inc. invested approximately $47 million CDN in research and
development in 2006. Worldwide, the Bayer Group spends the equivalent of over
2 billion Euro in 2006 in R&D.

    About GW Pharmaceuticals

    GW was founded in 1998 and listed on the AiM, a market of the London
Stock Exchange, in June 2001. Operating under license from the UK Home Office,
the company researches and develops cannabinoid pharmaceutical products that
alleviate pain and other neurological symptoms in patients who suffer from
serious ailments. GW has assembled a team of over 100 scientists with
extensive experience in developing 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.

    ------------------------
    (1) Health Canada. "Approval of SATIVEX(R) with Conditions Fact Sheet."
    Last accessed 16 December 2005. Available at
    http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-
    avis/conditions/sativex_factsheet_e.html
    (2) Cleeland CS, et al. Multidimensional measurement of cancer pain:
    comparisons of US and Vietnamese patients. J Pain Symptom Manage
    1988;3:23-7
    (3) Cleeland CS, et al. Dimensions of the impact of cancer pain in a four
    country sample: new information from multidimensional scaling. Pain
    1996;67:267-73.
    (4) Stjernsward, J Clark, D. Palliative medicine: a global perspective.
    In: D Doyle, GWC Hanks N Cherny, KC Calman (eds) Oxford Textbook of
    Palliative Medicine Third ed. Oxford: Oxford University Press. 2003.
    (5) Maunsell E, et al. A brief pain diary for ambulatory patients with
    advanced cancer: acceptability and validity. Cancer 2000;88:2387-97.





For further information:

For further information: Veritas Communications: Rob McEwan, (416)
482-2248; Bayer Inc.: Alison Bing, (416) 240-5298; GW Pharmaceuticals plc: Dr.
Geoffrey Guy, Chairman; Justin Gover, Managing Director; Mark Rogerson, Press
& PR, +44 (0)1980 557000


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