Porton Down, UK, 17 March 2006 - GW Pharmaceuticals plc (AIM: GWP) today announces preliminary results from a Phase III study of Sativex® in the relief of spasticity in people with Multiple Sclerosis (MS). This study is one of a number of Phase III studies which are currently taking place to support approval of Sativex across Europe in a range of target indications.
To listen to the conference call that took place at 08:30 on 17 March 2006, hosted by Justin Gover, please download the audio file.
GW to evaluate optimal regulatory filing strategy with marketing partners
Analysis of the per protocol population (those patients that complied with the study protocol) showed a positive and statistically significant improvement in the primary outcome measure (p<0.05). Analysis of the Intention to Treat (ITT) population (all study patients regardless of whether they complied with the protocol) was in favour of Sativex but not to a degree that reached statistical significance (p>0.05).
Dr Stephen Wright, R&D Director at GW, said:
"The study supports the significant positive data already generated from previous GW studies in people with MS who have failed to respond to currently available anti-spasticity treatments. This is a high need patient population and we are considering the regulatory impact of this new study in light of the different outcomes of the two statistical analyses and in the context of our overall regulatory strategy for Sativex. Whilst this study may provide GW with a regulatory route in Europe for the spasticity indication, the bulk of our positive clinical data relates to neuropathic pain. We have two further Phase III neuropathic pain studies due to report later this year and we need to consider with our marketing partners the relative benefits of awaiting that data before submitting the next regulatory filing."
The trial reported today was a randomized placebo-controlled parallel group study in 335 people with spasticity due to MS. All patients entering the study were taking best available anti-spasticity medication and remained on such medication through the trial. Hence, any improvements seen in the trial were obtained over and above currently available treatment. The primary outcome measure was the improvement in spasticity as measured on a 0-10 numeric rating scale. The duration of treatment in the study was 14 weeks.
In this trial, the primary endpoint, and two key secondary endpoints (the Responder Analysis and the Carer Global Impression of Change), in the per protocol analysis achieved statistical significance, whereas the outcomes in the ITT analysis were positive but non-significant. The lack of significance in the ITT analysis was not due to a lack of effect of Sativex, but rather was due to a larger than expected placebo response, thus reducing the size of the difference between the two groups. Had the placebo response been the same as in GW’s previous completed Phase III spasticity study, the ITT analysis in this new study would also have been statistically significant.
Separately, a pooled analysis across the three Sativex MS spasticity studies now completed, incorporating a total of 652 patients, shows Sativex to be significantly superior to placebo (p<0.05).
As in previous studies, adverse event data in this latest trial showed the medicine to be generally well tolerated.
Professor Mike Barnes, Professor of Neurological Rehabilitation, University of Newcastle, and President of the World Federation of neuro-rehabilitation, said:
“This study explored the effects of Sativex in a high need patient population who, by definition, had exhausted all available anti-spasticity medication and yet remained in need of treatment. As a clinician, the positive per protocol result confirms to me that Sativex has a valuable role in treating those patients for whom there are no further treatment options available."
Sativex is approved and marketed in Canada in the indication of MS neuropathic pain. In the last eighteen months, GW has put in place a substantial Phase III clinical programme for global regulatory success for Sativex in multiple indications. In addition to MS spasticity, the following Phase III trials are ongoing or planned:
two Phase III peripheral neuropathic pain studies, due to complete later this year
a further Phase III trial in MS neuropathic pain due to complete in mid-2007
a Phase III clinical programme for the treatment of cancer pain
Dr Geoffrey Guy, Executive Chairman of GW, said:
"This study is one of several studies included within our comprehensive Phase III clinical programme for Sativex across multiple indications including neuropathic pain and spasticity in multiple sclerosis, peripheral neuropathic pain and cancer pain. GW's regulatory strategy in Europe is directed towards approval of Sativex in all the major countries and not just the UK. On this basis, GW, together with our marketing partners and the relevant regulatory authorities, will evaluate the relative strengths of a regulatory submission for the relief of spasticity or neuropathic pain. We will proceed so that the next regulatory filing in Europe has the maximum chance of success across the indications and across the major markets.
"GW has recently achieved a number of significant milestones. Sativex is now approved in Canada for the relief of neuropathic pain in MS. In the US, the FDA has permitted Sativex to enter directly into Phase III trials and in Continental Europe, GW has signed an exclusive marketing agreement with Almirall Prodesfarma for Sativex. The Company continues to make excellent progress towards realising its global ambitions."
There will be a conference call for analysts today at 8.30am. Please contact Gemma Cross Brown at Financial Dynamics on +44 (0) 20 7831 3113 for details. A recording of this call will be accessible on the press releases page in the investor relations section of the GW website (www.gwpharm.com) later this morning.
GW Pharmaceuticals plc Today: +44 (0)20 7831 3113
Dr Geoffrey Guy, Executive Chairman Thereafter: + 44 (0)1980 557000
Justin Gover, Managing Director
Mark Rogerson, Press and PR Tel: + 44 (0)7885 638810
Financial Dynamics Tel: +44 (0)20 7831 3113
David Yates, Sarah MacLeod
Notes to Editors
Phase III Statistical Analyses
Analysis based on the intention to treat a subject, rather than on whether the subject actually took the treatment as intended. The analysis includes all subjects allocated to a treatment group irrespective of their compliance with the planned course of treatment.
Per Protocol Analysis
The set of data generated by subjects who complied with the study protocol not only in terms of their medical condition and use of background medication, but also who took the study treatment as prescribed.
About Sativex® Phase III Trials Programme
GW’s ongoing Phase III trials programme has been the subject of formal regulatory advice in Europe and North America and is designed to obtain approvals for Sativex across global markets in the following indications. This programme remains unchanged and is summarized below:
Peripheral neuropathic pain
Two Phase III studies in the peripheral neuropathic pain indication are due to complete before the end of this year. The first study (in patients with pain due to diabetic neuropathy) is expected to report results in Q3 2006 and the second study (in patients with pain characterized by the presence of allodynia) is due to report results at the end of 2006. These studies meet formal pan-European regulatory guidelines in the indication of peripheral neuropathic pain and would support a filing in this indication in Europe.
Neuropathic pain in MS
This indication is approved in Canada. A further Phase III MS neuropathic pain trial, to complement the positive Phase III study already completed, will provide data for a filing in this indication in Europe. The trial is due to start next quarter and is expected to complete in mid-2007.
General neuropathic pain
The three studies listed above will together provide a regulatory package in Europe for the broad indication of general neuropathic pain.
Spasticity in MS
GW has previously reported two positive MS spasticity studies, including a pivotal Phase III study in 189 patients. The study reported today represents the second pivotal Phase III study in this indication.
The FDA has recently accepted an IND for Sativex to commence Phase III trials in the US for this indication. The first trial is due to commence this year. US development will also contribute to a future European filing in this indication.
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 is developing cannabis-derived pharmaceutical products for patients with multiple sclerosis, neuropathic pain, cancer pain, spinal cord injury, rheumatoid arthritis, and other severe medical conditions.
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 is dedicated to developing treatment options that alleviate pain symptoms in patients who suffer from serious ailments.
For further information, please visit the Company’s website:www.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 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 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.