Health Canada Approves Sativex® For Cancer Pain

 

Health Canada Approves Sativex® For Cancer Pain

7  August  2007

GW Pharmaceuticals plc (AIM: GWP) and Bayer Inc., a subsidiary of Bayer AG, today announce that Health Canada has approved Sativex®, 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) under the 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.1These receptors are distributed throughout the pain pathways of the nervous system, and their activation is known to reduce pain in relevant pain models.

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.”

“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.”

“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.

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. Based on current incidence rates, 39 per cent of Canadian women and 44 per cent of men will develop cancer during their lifetimes. Cancer is the leading cause of premature death - or early death - in Canada: 1,006,000 potential years were lost in 2003 as a result of cancer. This represents 32 per cent of the potential years of life lost resulting from all causes of death.2

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.3,4,5For these patients, pain will interfere with their sleep, daily activities, enjoyment of life, work capacity, and social relations.6

Data Demonstrates Promising Efficacy
The efficacy of Sativex has been demonstrated in a double-blind placebo controlled parallel group study in patients with cancer pain. 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 pain relief, in comparison with placebo. The study further showed that in patients with advanced cancer who were already taking the strongest available pain treatments, more than four of ten patients taking Sativex were able to achieve a further clinically important reduction in pain.7

Principal Components
A product resulting from the pioneering research efforts of UK-based GW Pharmaceuticals plc and marketed in Canada by Bayer HealthCare Pharmaceuticals, Sativex was first indicated in Canada in 2005 as adjunctive treatment for the symptomatic relief of neuropathic pain in MS. Sativex contains Tetranabinex®and Nabidiolex®, extracts of chemically and genetically characterised Cannabis sativa L. plants (hemp plants). Its principal active cannabinoid components are THC and CBD.8 The ratio of THC to CBD in Sativex is 2.7mg:2.5mg per spray, ensuring a standardized dose is delivered each time it is used.8

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.

Sativex and Side-Effects
In clinical trials, the most frequent side-effects included nausea, fatigue, dizziness and application site reactions. Side-effects were usually mild or moderate in severity and often resolved with down-titration or interruption of treatment.9

1Health Canada. "Approval of SATIVEX(R) with Conditions Fact Sheet." Last accessed December 16 2005. Available athttp://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/sativex_fs_fd_091289_e.html
2Canadian Cancer Society. General Cancer Stats for 2007http://www.cancer.ca/ccs/internet/standard/0,2283,3172_14423__langId-en,00.html
3Cleeland CS, et al. Multidimensional measurement of cancer pain: comparisons of US and Vietnamese patients.J Pain Symptom Manage1988;3:23-7.
4Cleeland CS, et al. Dimensions of the impact of cancer pain in a four country sample: new information from multidimensional scaling.Pain1996;67:267-73.
5Stjernsward, 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.
6Maunsell E, et al. A brief pain diary for ambulatory patients with advanced cancer: acceptability and validity.Cancer2000;88:2387-97.
7Sativex Product Monograph – June 2007.
8Sativex Product Monograph – June 2007.
9Sativex Product Monograph – June 2007.

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 visitwww.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.