GW Pharmaceuticals announces that Health Canada, the Canadian regulatory authority, has issued a Qualifying Notice for the approval of Sativex®, a cannabis-based medicinal extract product.
Sativex will initially be indicated in Canada for the relief of neuropathic pain in Multiple Sclerosis (“MS”).
GW filed its Sativex application with Health Canada under the Notice of Compliance with conditions (NOC/c) policy. The Qualifying Notice confirms that Sativex qualifies to be considered for approval and sets out the conditions and post-approval undertakings upon which the marketing authorization for Sativex can be granted. The conditions for Sativex’s approval are in accordance with standard guidance provided by the regulator for NOC/c approvals and include a commitment to ongoing clinical research.
The regulatory submission for Sativex was filed with Health Canada in May 2004. Health Canada has completed its regulatory review in line with its 200 day review target.
GW is required to respond and accept the conditions within 30 days. Following this, Health Canada review this response, subject to a 30 day review target. Should the response be acceptable, Health Canada can then be expected to proceed to finalise the marketing authorisation.
Sativex has been developed by GW and will be exclusively marketed in Canada by the Pharmaceuticals Division of Bayer HealthCare.
Sativex is a whole plant medicinal cannabis extract containing TetranabinexTM(tetrahydrocannabinol or THC) and NabidiolexTM(cannabidiol or CBD) as its principal components. The medicine is administered by means of a spray into the mouth.
Approximately 50,000 people in Canada are diagnosed with MS.
Following the initial approval for Sativex in the relief of neuropathic pain in MS, GW expects to make further applications in Canada for the use of Sativex in additional indications, including pain in other conditions.
Dr Geoffrey Guy, Executive Chairman of GW, said, “We are delighted to receive this Qualifying Notice from Health Canada and look forward to receiving regulatory approval for Sativex in Canada in the early part of 2005. This approval will be a major milestone for GW and for people with Multiple Sclerosis who have long awaited a prescription cannabis-based medicine for the treatment of neuropathic pain. We view Canada as an important target market for Sativex and look forward to working towards product launch with our partner Bayer.
“Health Canada has processed its regulatory review in just seven months and we are grateful to them for this rapid turnaround time. Sativex will be the first prescription cannabis-based medicine and we believe that the pragmatism shown by Health Canada in their review reflects a welcome recognition of the clinical need in MS patients for Sativex.”
- Ends -
GW Pharmaceuticals pl: + 44 1980 557000
Dr Geoffrey Guy, Executive Chairman
Mark Rogerson, Press and PR + 44 7885 638810
Weber Shandwick SquareMile: + 44 20 7067 0700
Notes to Editors
GW Pharmaceuticals plcis licensed by the UK Home Office to undertake a pharmaceutical research and development programme to develop non-smoked cannabis-based prescription medicines. Full details of GW and the company’s clinical trials programme can be found at www.gwpharm.com
GW’s clinical research programme 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. GW’s team is also supported by a number of prominent scientific advisers in this field in Europe and North America.
This news release may contain forward-looking statements that reflect the Company's current expectations regarding future events, including the clinical development and regulatory clearance of the Company's 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 the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, including with respect to Sativex and the Company's other products, the uncertainties related to the regulatory process, and the acceptance of Sativex and other products by consumers and medical professionals.