GW Pharmaceuticals plc and Bayer HealthCare, Pharmaceuticals Division - Canada (Bayer) announce that GW has submitted a regulatory application in Canada for Sativex to seek approval for a new indication for the treatment of pain in patients with advanced cancer that has not been adequately relieved by opioid medications.

This submission follows a formal pre-submission meeting recently held with Health Canada outlining the evidence of effectiveness of Sativex in this very seriously ill patient population. Following this meeting, Health Canada advised that, on the basis of the clinical data presented, that a submission for consideration under the Notice of Compliance with Conditions (NOC/c) policy could be made.

Dr Geoffrey Guy, GW's chairman, said, "This regulatory submission 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."

GW has completed a positive phase III study in Europe in 177 patients with cancer pain. The trial was a multi-centre 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.

Dr Jeremy Johnson, Principal Investigator for GW's completed cancer pain study and Medical Director, Severn Hospice, UK, 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."

Philip Blake, President and CEO of Bayer Inc., said "Pain is one of the most debilitating and feared symptoms of advanced cancer and once Sativex is approved for this indication, we look forward to making it available to these patients."

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. Canada became the first country in the world to approve Sativex, a novel prescription pharmaceutical product derived from components of the cannabis plant shown to have therapeutic properties. This approval was granted under the 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.

Earlier this year, the United States Food and Drug Administration (FDA) accepted an Investigational New Drug (IND) Application for Sativex to enter directly into phase III clinical trials in the US for the treatment of cancer pain.

Sativex has been developed by UK-based GW Pharmaceuticals plc and is exclusively marketed in Canada by Bayer HealthCare, Pharmaceuticals Division.