Sativex(R) receives Qualifying Notice for approval in Canada for the relief of Cancer Pain



    PORTON DOWN, UK, and TORONTO, June 19 /CNW/ - GW Pharmaceuticals plc
(AIM: GWP) and Bayer HealthCare Pharmaceuticals announce that Health Canada,
the Canadian regulatory agency, has issued a Qualifying Notice for the
approval of Sativex(R) in the relief of cancer pain. Sativex is already
approved and marketed in Canada as adjunctive treatment for the symptomatic
relief of neuropathic pain in Multiple Sclerosis ("MS") in adults. This
approval was granted under the NOC/c policy.
    GW filed the application in October 2006 with Health Canada under the
Notice of Compliance with conditions (NOC/c) policy. The approved indication
will be "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". Health Canada has
completed its regulatory review in line with its 200 day review target.
    Sativex has been developed by UK-based GW Pharmaceuticals and is
exclusively marketed in Canada by Bayer.
    Under the NOC/c process, the issue of a Qualifying Notice confirms that
Sativex qualifies to be considered for approval in cancer pain and sets out
the conditions and post-approval undertakings upon which the marketing
authorization for Sativex in this indication can be granted. The conditions
for the approval of Sativex in cancer pain are in accordance with standard
guidance provided by the regulator for NOC/c approvals and include a
commitment to ongoing clinical research. This process is identical to that
under which Sativex is already approved in the MS neuropathic pain indication.
    GW is required to respond and accept the conditions within 30 days.
Following this, Health Canada will review this response, subject to a 30 day
review target. Should the response be acceptable, Health Canada can then be
expected to proceed to finalise the marketing authorisation.
    Dr Geoffrey Guy, GW's Chairman, said, "We are delighted to receive this
Qualifying Notice from Health Canada and look forward to receiving regulatory
approval for Sativex in the relief of cancer pain in the next few months. This
additional regulatory approval represents a further step in our broad-based
regulatory strategy for Sativex, which is designed to secure approvals for
this important new medicine across a range of separate therapeutic indications
in countries across the world over the coming years."
    Philip Blake, President and CEO of Bayer Inc., said, "Pain is one of the
most debilitating and feared symptoms of advanced cancer. The approval of
Sativex for the treatment of these high need patients is further recognition
of the value of this important medicine and we shall now actively commence our
launch plans for this indication."

    Sativex in Cancer Pain

    GW has completed a positive Phase III study in Europe in 177 patients
with cancer pain. The trial was a multi-center double-blind, randomized,
placebo-controlled parallel group study. Patients in the study had advanced
cancer and were experiencing pain that was not responding adequately to strong
opioid medication (e.g. morphine). In addition to study medication, all
patients remained on their existing opioid and other analgesic medication
during the trial. In this study, Sativex achieved a statistically significant
improvement in comparison with placebo in pain as measured on a numerical
rating scale (p=0.014), a primary endpoint of the study. A responder analysis
showed that 43 per cent of patients on Sativex showed a greater than 30 per
cent improvement in their pain (p=0.024).
    Cancer-related pain can be defined as pain caused by cancer, by cancer
treatment such as surgery, radiation therapy or chemotherapy, or by the side
effects of treatment. Severe pain is experienced by at least two thirds of
patients with advanced disease. It is estimated that between 14 per cent and
47 per cent of these patients will achieve inadequate pain relief from opioid
based approaches and will continue to suffer pain.(i)
    Dr Paul Daeninck, Director, Symptom Management Group for Cancer Care
Manitoba and Assistant Professor, Depts of Internal Medicine and Family
Medicine, University of Manitoba, said, "Pain remains a significant unmet
medical need for many patients with cancer, who may be unable to gain adequate
pain relief from even the best use of existing strong opioid medicines.
Furthermore, a proportion of patients are simply unable to tolerate opioids in
doses that may be required to relieve their pain. In short, there is a clear
need for effective new analgesics. The results with Sativex show that it can
provide additional pain relief to this group of patients and may represent an
important new option in the treatment of cancer pain."
    In 2006, the United States Food and Drug Administration (FDA) accepted an
Investigational New Drug (IND) Application for Sativex to enter into Phase III
clinical trials in the U.S. for the treatment of cancer pain. The first U.S
trial is due to commence in the next few months.

    Notes to editors:

    Sativex

    Sativex is a buccal spray composed primarily of 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.(ii) These receptors are distributed throughout the
pain pathways of the nervous system, and their activation is known to reduce
pain in relevant pain models.
    In 2005, Health Canada approved Sativex for the symptomatic relief of
neuropathic pain in adults with Multiple Sclerosis. This approval was granted
under the NOC/c policy.

    Notice of Compliance with Conditions (NOC/c) policy

    The NOC/c policy applies to drug submissions intended for the treatment,
prevention or diagnosis of a serious, life-threatening or severely
debilitating illness or condition for which there is no existing therapy
available on the Canadian market which possesses a similar therapeutic profile
or for which the new submission demonstrates a significant improvement in the
benefit/risk profile over alternate available products.
    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. The promising
nature of the clinical evidence is to be confirmed with further studies.

    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 licence from the UK Home Office,
the Company is developing cannabis-derived pharmaceutical products for
patients with multiple sclerosis, neuropathic pain, cancer pain, spinal cord
injury, rheumatoid arthritis, and other severe medical conditions.
    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 is dedicated to developing
treatment options that alleviate pain and other neurological symptoms in
patients who suffer from serious ailments.
    For further information, please visit the Company's website:
www.gwpharm.com

    About Bayer HealthCare

    Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's
leading, innovative companies in the healthcare and medical products industry.
The company combines the global activities of the Animal Health, Consumer
Care, Diabetes Care, and Pharmaceuticals divisions. Bayer HealthCare
Pharmaceuticals comprises the following business units: Women's Healthcare,
Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and
Oncology. The company's aim is to discover and manufacture products that will
improve human health worldwide by diagnosing, preventing and treating
diseases.

    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.

    
    --------------------------
    (i)  Zech DF, Grond S, Lynch J et al. Validation of WHO guidelines for
         cancer pain relief - a 10 year prospective study. Pain 1995; 63: 65-
         76.).
    (ii) 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_fact
sheet_e.html.
    





For further information:

For further information: GW Pharmaceuticals plc: Dr Geoffrey Guy,
Chairman, Justin Gover, Managing Director, Today: +44 (0)20 7831 3113;
Financial Dynamics: David Yates, Ben Atwell, Tel: +44 (0)20 7831 3113; Bayer
Inc.: Alison Bing, Tel: (416) 240-5298

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