Porton Down, UK, 19 October 2006: GW Pharmaceuticals plc (AIM: GWP) (“GW” or “the Company”) 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-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 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 U.S. 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.
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GW Pharmaceuticals plc Today: +44 (0)20 7831 3113
Dr Geoffrey Guy, Chairman
Justin Gover, Managing Director
Financial Dynamics Tel: +44 (0)20 7831 3113
David Yates / Ben Atwell
Lori Ann Horrigan Tel: 001 416 240 5252
Notes to editors:
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. T he 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.
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.
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, offices in Ottawa and Calgary , as well as a manufacturing facility in Sarnia , Ontario . Bayer Inc. has approximately 930 employees across Canada and had sales of $981 million Canadian in 2005. Globally, the Bayer Group had sales of about 27.4 billion Euro in 2005.
Bayer Inc. invested approximately $38.1 million Canadian in research and development in 2005. Worldwide, the Bayer Group spends the equivalent of 1.9 billion Euro in 2005 in R&D.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group 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 our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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® with Conditions Fact Sheet.” Last accessed 16 December 2005. Available athttp://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/sativex_factsheet_e.html.