Porton Down, UK, 20 July 2007: GW Pharmaceuticals plc (AIM: GWP) announces that it has chosen to withdraw its current regulatory application for Sativex in Europe and that it expects to resubmit an application for approval in 2008. This follows constructive and detailed discussions with regulatory authorities in which they have provided a clear path to approval for Sativex in the treatment of MS Spasticity.
MS Spasticity Application
In September 2006, GW filed an application for Sativex under the decentralised procedure in four European countries (UK, Spain, Denmark, Netherlands) for the relief of MS Spasticity. GW has been able to resolve successfully all the major questions raised by the regulators during this process except one, and at a meeting with the UK assessors this week, it became clear that this outstanding issue requires the generation of additional data. As European regulatory rules do not permit the introduction of new data as part of the current process, GW has elected to withdraw and resubmit its application.
The current regulatory application process has confirmed that quality and safety data are already sufficient to support a marketing authorisation of Sativex. The regulators have also confirmed that existing efficacy data provide statistically significant evidence and “could in principle lead to a positive risk benefit conclusion”. In addition, regulators have recognised that a large proportion of otherwise treatment-resistant patients respond to Sativex by obtaining clinically meaningful improvements in spasticity.
Sativex provides benefit to the most high need MS patients who have no further therapeutic options available. The regulator’s outstanding clarification relates to the fact that in a clinical trial context, the benefit obtained by “responders” can be masked by looking at the mean improvement across the whole studied patient population, which comprises both responders and non-responders. The regulators therefore wish to be able to identify Sativex responders in the first 4 weeks of treatment and to confirm that the improvements gained by such responders over a further 12 week period is significantly greater than placebo.
As part of the current regulatory process, GW performed analyses of existing data showing that responders can be reliably identified after 4 weeks and that, after 12 weeks, the difference from placebo is clinically important and highly statistically significant (p=0.015). The regulators view this as acceptable evidence of efficacy in principle but consider these analyses technically to be “post-hoc” since they were performed at the regulator’s request following completion of the trials. They require such data to be produced as part of a prospectively planned analysis and hence GW will undertake an additional study to re-confirm this result prior to resubmitting its regulatory application.
The regulators have given GW clear guidance as to the design of the further study required, which differs from a conventional Phase III design. The study is expected to start recruiting patients in the next few months, with the results due in the second half of 2008. The regulators have specified a novel “enriched design” which first identifies responders over a 4 week period, and then focuses on analysing the effect of Sativex vs placebo on those responders over a further period of time.
GW’s clinical plans for the next twelve months have for some time included a further MS Spasticity trial and the regulator’s specific design requirements will therefore be incorporated into the planned study. This study is already within GW’s budget for 2008, will not result in any increase in rate of R&D expenditure above current levels and will be financed from existing cash resources, which today stand at £19.5m.
Sativex Resubmission
There are two potential opportunities for early re-submission in Europe next year. In the indication of MS Neuropathic Pain, a second pivotal Phase III trial completes in early 2008 which could lead to a regulatory filing in this indication at that time. Since this is a distinct indication from MS Spasticity, the outstanding issue identified as part of this recent application would not be relevant. In the event that GW does not submit for this indication, the second opportunity is to resubmit for MS Spasticity later in 2008 following completion of the new study outlined above.
Dr Stephen Wright, R&D Director, said, “We are encouraged that the regulators see Sativex as providing useful efficacy and that they accept our quality and safety data as sufficient for approval. This regulatory application has provided us with a clear route to approval for Sativex in the relief of MS Spasticity. We have received detailed and constructive guidance from the regulators on how to satisfy their single outstanding requirement and are confident that we can address this.
“We expect to re-submit our application to the regulators in Europe in 2008, either in the indication of MS Neuropathic Pain or MS Spasticity. Elsewhere, we look forward to receiving final regulatory approval in Canada for the Cancer Pain indication in the coming weeks and our first large scale clinical trials in the US are scheduled to commence in the late summer.”
Professor Mike Barnes, President of the World Federation of Neuro-rehabilitation, Professor of Neurological Rehabilitation and Consultant Neurologist, University of Newcastle, said, “The data clearly show that Sativex provides valuable and much needed relief of MS Spasticity. Indeed, this medicine is able to treat some of the highest need MS patients, who currently have no further treatment options available. It is regrettable and unnecessary in my view, and in the view of other prominent members of the MS treatment community, that the regulators require GW to generate further data to show what we already know – that Sativex is a safe and efficacious treatment for people with MS.”
Dr Geoffrey Guy, GW Chairman, said, “We recognise that it is taking longer than we had hoped for Sativex to obtain approval in Europe. Each step, however, has been one of progress towards achieving this goal. Whilst we complete these final steps, we will continue to respond to the needs of people with MS by ensuring Sativex remains available under our named patient prescription programme.”
There will be a conference call for analysts today at 8.30am BST. Analysts should contact Gemma Cross Brown at Financial Dynamics on +44 (0) 20 7831 3113 for details. There will be a live audio web cast of this call, which will be accessible on the press releases page in the investor relations section of the GW website (www.gwpharm.com). A recording of this call will be available on the GW website later today.
Enquiries:
GW Pharmaceuticals plc Today: +44 20 7831 3113
Dr Geoffrey Guy, Chairman Thereafter: +44 1980 557000
Justin Gover, Managing Director
Mark Rogerson, Press and PR Tel: +44 7885 638810
Financial Dynamics Tel: +44 20 7831 3113
David Yates, Ben Atwell
About Sativex
Sativex is being developed for approval in four target indications (MS Spasticity, MS Neuropathic Pain, Cancer Pain and Peripheral Neuropathic Pain). Each of these indications provides a distinct regulatory opportunity and is supported by a specific clinical development programme.
In Canada, Sativex is approved for the relief of MS Neuropathic Pain and has also received a Qualifying Notice from the Canadian regulators for a further approval in the relief of Cancer Pain. Final approval of the Cancer Pain indication is expected shortly.
In the United States, the lead indication for Sativex is Cancer Pain and, following a series of positive meetings with the Food & Drug Administration (FDA), late stage trials in that country are about to commence.
GW has to date entered into three Sativex license agreements – with Otsuka in the US, with Bayer HealthCare in the UK and Canada, and with Almirall in Europe (ex-UK). These agreements together have yielded financial terms to GW totaling $51m of signature fees, up to $376m of milestone payments as well as significant long term supply price provisions.
About GW
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 visit www.gwpharm.com
This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including development and regulatory clearance of the GW'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 GW's research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex and other products by consumer and medical professionals.
