Sativex® receives Qualifying Notice for approval in Canada for the relief of Cancer Pain

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Oct 22, 2007

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® 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.

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