11 Mar 2009 13:12
GW REPORTS HIGHLY STATISTICALLY SIGNIFICANT RESULTS IN SATIVEX® PIVOTAL PHASE III STUDY IN MS SPASTICITY
Expected Milestone Payment from Almirall of £8m
Porton Down, UK, 11 March 2009: GW Pharmaceuticals plc (GWP:AIM) today announces positive preliminary results from a pivotal Phase III double-blind randomised placebo-controlled study of Sativex® in patients with spasticity due to Multiple Sclerosis (MS), who have achieved inadequate spasticity relief with existing therapies. This study was requested by the UK regulator in order to gain approval in this indication and following today's results, GW will file a regulatory submission in Q2 09.
This Phase III study used an enriched design whereby 573 patients initially received Sativex for 4 weeks in a single blind manner (Phase A), following which Sativex responders (n=241) were randomized to continue on Sativex or switch to placebo for a further 12 weeks in a double-blinded manner (Phase B). During the randomized period, patients were not permitted to adjust their dose. This study is the largest study GW has undertaken and recruitment was achieved in just ten months using 52 hospital sites in five countries - UK, Spain, Italy, Czech Republic and Poland.
The prospectively defined primary efficacy endpoint of the study - the difference between the mean change in spasticity severity of Sativex vs Placebo in Phase B - was highly statistically significantly in favour of Sativex (p=0.0002). The numeric difference between the two groups as measured on a Numeric Rating Scale was 0.84 units from a baseline of 3.89, greater than that achieved in previous studies. The difference between Sativex and placebo was also significant for a number of secondary endpoints. 74% of Sativex patients achieved an improvement of greater than 30% in their spasticity score over the entire study versus 51% on placebo (p=0.0003). In addition, statistically significant improvements were also seen in spasm frequency (p=0.005), sleep disturbance (p
The study provides further evidence of Sativex's reassuring safety profile. The adverse event data in this study was superior to previous Sativex studies - an improvement which resulted from the modified dose titration regimen employed in the study.
Following these positive results, GW will submit a regulatory application in Q2 09 in the UK and, subject to discussion with Almirall, other selected European countries. Upon approval, Sativex will be marketed exclusively in the UK by Bayer HealthCare and in the rest of Europe by Almirall.
Dr Stephen Wright, GW's R&D Director, said: "This Phase III study is a resounding success and provides further evidence that Sativex provides meaningful efficacy for people with spasticity due to MS. In the last six months, GW has reported three positive Sativex studies incorporating a design modified from previous studies and we are delighted that this new approach is producing such consistent positive results. We will file a European regulatory submission in Q2 09 and look forward to progressing the review during 2009."
Milestone Payment
GW also announces today that it has signed an amendment to the Sativex licence agreement with Almirall. This amendment provides for the potential milestone payment to be received following this study result to reach £8m. The £8m milestone will become due upon Almirall electing to include a country within their licensed territory (Europe excluding UK) as part of the forthcoming regulatory submission to the UK. This decision is expected to be made within the next month.
Justin Gover, GW's Managing Director, said, "GW has a history of maintaining a strong financial position and this increased potential milestone payment represents an attractive opportunity to further consolidate this position. We are delighted by the ongoing support and enthusiasm of our licensing partners for the commercial potential of Sativex."
There will be a conference call for analysts today at 2.30pm and the corresponding presentation will be available on the investor relations section of the GW website (www.gwpharm.com). Analysts should contact Juliet Edwards at Financial Dynamics on 020 7269 7125 for details. A recording of this meeting will be available on the GW website later today.
Enquiries:
| GW Pharmaceuticals plc | (Today) + 44 20 7831 3113 |
| Dr Geoffrey Guy, Executive Chairman | (Thereafter) + 44 1980 557000 |
| Justin Gover, Managing Director | |
| Financial Dynamics | + 44 20 7831 3113 |
| David Yates / John Dineen | |
| Investec Bank plc | + 44 20 7597 4000 |
| Patrick Robb |
Notes to Editors
Sativex Prescription Use
Sativex is approved and marketed in Canada for the treatment of cancer pain and MS neuropathic pain. In addition, Sativex is available on prescription in the UK on a "named patient" basis and has to date been exported to 22 countries around the world.
Sativex and MS Spasticity
Spasticity (spasms and stiffness) is one of the most common symptoms of MS occurring in as many as three-quarters of people with MS. Spasticity can affect many aspects of daily life, such as walking and sitting. Sativex aims to treat high need patients who have previously failed to gain adequate benefit from currently available anti-spasticity treatments
The indication of MS spasticity has been the sole focus of previous discussions with European regulatory authorities. The trial reported today was specifically requested by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), prior to obtaining approval for Sativex.
Prior to the study reported today, GW had accumulated a body of clinical data in approximately 700 patients with MS spasticity, including two pivotal Phase III trials as well as two supportive trials.
In February 2009, GW reported positive results from a placebo-controlled randomized withdrawal study of Sativex® in patients with spasticity due to MS. This study showed that Sativex provides meaningful long term efficacy for people with spasticity due to MS, and will be important additional feature of the efficacy and safety data to be submitted in the forthcoming regulatory application.
GW expects to file a regulatory submission in Q2 09. Upon UK approval, GW will receive a £10m milestone payment from Bayer. On approval in Spain, GW will receive a further £2.5m payment from Almirall.
Sativex and Cancer Pain
Over one-third of patients with cancer, and more than three-quarters of those with advanced disease, have chronic pain. Currently available opioid therapies do not yield sufficient relief in a substantial proportion of these patients and there is a clear need for new treatments.
Cancer pain is the lead indication for the development of Sativex in the United States. GW has completed a positive Phase II cancer pain study in Europe in 177 patients and is now carrying out a 336 patient Phase IIb/III study in collaboration with its partner, Otsuka Pharmaceutical Co. Ltd. Upon approval, Sativex will be exclusively marketed in the US by Otsuka.
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 for patients who suffer from a range of serious ailments, in particular multiple sclerosis and cancer pain. GW has assembled a large in-house scientific team with expertise in cannabinoid science as well as experience in the development of 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.