New Marijuana-Derived Drug Approved in Canada
U.S. Marketing Effort On The Horizon

G.W. Pharmaceuticals announced in an Apr. 19, 2005 press release that Sativex, a marijuana-derived drug for pain management, has been approved for treatment of Multiple Sclerosis in Canada:


"Health Canada has approved Sativex® (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 [read about Sativex's rejection by U.K. regulators]. 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. 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....

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....

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....

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. Sativex is expected to be available through Canadian pharmacies by late Spring 2005."
Apr. 19, 2005 G.W. Pharmaceuticals



G.W. Pharmaceuticals had previously announced its plans to market Sativex in the United States, as stated in its Feb. 28, 2005 press release:


"GW announces that it is accelerating its strategy to enter the United States market by retaining experts in pharmaceutical development and regulatory affairs.

In its preliminary results statement of 19 January 2005, GW announced that it would embark on a regulatory programme in the US for its lead product, Sativex. The Company considers that the breadth of data now available will enable initiation of discussions with the Food & Drug Administration (FDA) for an Investigational New Drug application in the US....

Dr. Geoffrey Guy, Executive Chairman of GW, commented: 'The US is the world’s most significant pharmaceutical market. In order for GW to be successful in this market, it is important for the Company to gather together an appropriate team and resources. Over the last few years, GW has been working to build a support base in the US and we are excited about the prospect of working alongside a range of experts to assist our efforts. We are delighted that our plans have met with such a positive response from our founder US shareholders, who have extensive experience in this sector, and welcome their increased equity participation in the Company.'"
Feb. 28, 2005 G.W. Pharmaceuticals