Multiple Sclerosis - Canada Approves Cannabis Derived Pharmaceutical Treatment, Sativex(reg)

Main Category: Multiple Sclerosis
Article Date: 22 Apr 2005 - 16:00 PDT


Health Canada has approved Sativex(reg) (Cannabis sativa L. extract) a new drug developed as adjunctive treatment for the symptomatic relief of neuropathic pain in adults with multiple sclerosis (MS). Canada becomes 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. Sativex is administered via a spray into the 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.

"Effective pain control and management are extremely important in a disease like MS," said Dr. Allan Gordon, Neurologist and Director of the Wasser Pain Management Centre, Mount Sinai Hospital, Toronto, Ontario. "The approval of Sativex in Canada reflects the urgent need for additional treatment options in the field of neuropathic pain in MS."

Neuropathic pain

Pain is a common symptom of MS occurring in up to 86 per cent of people with MS. Neuropathic or nerve pain can occur spontaneously or can be provoked by touch, temperature or movement. It is estimated that 50 per cent of people with MS suffer from chronic neuropathic pain. , , The most common descriptions of neuropathic pain are of freezing, cold or burning sensations usually of the limbs and most often of the lower extremities. Many individuals with neuropathic pain respond inadequately to current treatment options. ,

"It's hard to explain to someone who has never felt this type of pain. It's like being plugged into an electric socket all the time," said Steve Walsh, who suffers from MS and has lived with neuropathic pain for five years. "At times, putting on clothes or anything touching me can be too much to take," he added.

Data demonstrates efficacy

While there is no complete cure for MS or neuropathic pain, a double-blind placebo controlled parallel group study demonstrated that Sativex provided significantly greater pain relief than placebo. Sativex also significantly reduced pain-related sleep disturbance.8

Principal components

A product resulting from the pioneering research efforts of UK-based GW Pharmaceuticals plc and marketed in Canada by Bayer HealthCare, Pharmaceuticals Division, Sativex is the first product indicated in Canada as adjunctive treatment for the symptomatic relief of neuropathic pain in MS.

Its principal active cannabinoid components are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). The ratio of THC to CBD in Sativex is 2.7 mg : 2.5 mg per spray, ensuring a standardized dose is delivered each time it is used.

"The approval of Sativex is good news for the Canadian MS community. People living with MS and neuropathic pain need new options to address their pain. Sativex will likely be welcomed by the many people with MS, whose quality of life has been further compromised with neuropathic pain," said Dr. William J. McIlroy, National Medical Advisor, MS Society of Canada.

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, well suited to the variable nature of neuropathic pain experienced by people with MS.

"Because Sativex is designed for self-administration, this allows for flexible dosing and puts the patient in control of their pain," said Dr. Gordon. "This is very important since pain severity varies between different patients and even in the same patient at different times."

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.8

Sativex is expected to be available through Canadian pharmacies by late Spring 2005.

Multiple sclerosis (MS) in Canada

MS is a disease of the central nervous system and is the most common neurological disease affecting young adults in Canada. Approximately 50,000

Canadian men and women have the disease and each day approximately three more people are diagnosed. MS is most often diagnosed in people between the ages of 20 to 40 years of age.

About Bayer HealthCare AG

Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the health care and medical products industry. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro.

The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Bayer HealthCare employed 35,300 people worldwide in 2004.

Bayer HealthCare's aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.

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.

About GW Pharmaceuticals plc

GW Pharmaceuticals plc is licensed by the UK Home Office to undertake a pharmaceutical research and development program to develop non-smoked cannabis-based prescription medicines. GW's shares are publicly traded on AiM, a market on the London Stock Exchange.

Full details of GW and the company's clinical trials program can be found at http://www.gwpharm.com. GW's clinical research program is being carried out by a team of pharmaceutical professionals experienced in drug development and, in particular, the development of plant-based medicines and drug delivery systems.

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.

FOR FURTHER INFORMATION, PLEASE CONTACT:

IN WESTERN CANADA/PRAIRIES:
Sousie Tsotskos
Cohn & Wolfe
TEL: (416) 324-2069 ext. 4066
sousie_tsotskos@ca.cohnwolfe.com

IN ONTARIO:
Alanna Fox
Cohn & Wolfe
TEL: (416) 324-2069 ext. 4078
alanna_fox@ca.cohnwolfe.com

IN QUEBEC:
Sylvie Tessier
Cohn & Wolfe
TEL: (514) 845-2257 ext. 232
sylvie_tessier@mtl.cohnwolfe.com

IN MARITIMES/NEWFOUNDLAND:
Kate Morrison
Cohn & Wolfe
TEL: (416) 324-2069 ext. 4059
kate_morrison@ca.cohnwolfe.com

IN EUROPE:
Mark Rogerson
for GW Pharmaceuticals
TEL: 011-44-1980-557-000
CELL: 011-44-7885-638-810
mvlrog@aol.com

BAYER INC.
Lori Ann Horrigan
Tel: (416) 240-5252 or 1-800-440-5473
lori-ann.horrigan.b@bayer.com

References:
Ehde DM et al. Multiple Sclerosis 2003; 9; 605-611.
Archibald CJ, et al. Pain 1994; 58:89-93.
Sketris IS, et al. Clinical Therapeutics 1996; 18(2):303-318.
Moulin DE, et al. Neurology 1988;38:1830-1834.
Multiple Sclerosis International Federation http://www.msif.org/print.rm?id=10188
Harden N and Cohen M. Journal of Pain Symptom Management 2003; 25 (5 Suppl): S12-S17.
New Directions in Neuropathic Pain: Focusing Treatment on Symptoms and Mechanisms. Royal Society of Medicine Press Ltd.: 2000.
Sativex Product Monograph - April 2005
http://www.mssociety.ca

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