GWP.L Regulatory News (GWP)

3 Oct 2006 07:01

GW Pharmaceuticals PLC03 October 2006 GW Pharmaceuticals PLC SATIVEX(R) DATA PRESENTED AT ECTRIMS EUROPEAN MULTIPLE SCLEROSIS CONGRESS Porton Down, UK, 3 October 2006 - GW Pharmaceuticals plc (AIM: GWP) announcestoday that results from two Phase III studies of Sativex(R) were presented atEurope's leading multiple sclerosis (MS) conference, the 22nd Congress of theEuropean Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS),which took place in Madrid, Spain, from 27 - 30 September. The outcome of thestudies in spasticity and bladder dysfunction, both symptoms of MS, were firstreported by GW earlier this year. The MS spasticity study, which evaluated 337 patients over a 15 week period,showed a significant reduction in symptoms of spasticity in patients in the 'perprotocol' population (i.e. those patients who complied with the study protocol)with advanced MS who had severe levels of spasticity despite ongoing treatmentwith the best available anti-spasticity medications. In addition 36% of thesepatients reported at least a 30% improvement in their spasticity symptoms whichwas also statistically significant(1). The 'intention to treat' population (allpatients who entered the study, some of whom may have violated the protocol)showed a trend towards Sativex but this did not reach statistical significance.Sativex-treated patients also reported improvements in secondary endpoints suchas sleep assessments at clinic visits; a timed 10 metre walk, quality of lifemeasures, spasm severity and bladder symptoms. Benefits were also reported bycarers who noticed overall improvements in the Sativex group. Professor Christine Collin, lead investigator in the study and Consultant inNeurological Rehabilitation Medicine based at The Royal Berkshire and Battle NHSTrust, Reading commented, "This study shows encouraging results in a patientpopulation with a high level of unmet medical need. It demonstrates thatSativex can reduce spasticity in these difficult to treat patients who havefailed to gain enough improvement in their spasticity from the best currentlyavailable medication. Furthermore, when these results are pooled with a previoussimilar trial giving a total population of over 520 MS patients with spasticity,significant benefits in favour of Sativex were seen, in the whole intention totreat population." A second Phase III study presented at ECTRIMS and short-listed for a prize bythe scientific committee, investigated Sativex in the management of bladderproblems in people with MS. Bladder problems are a very common feature in up to75% of people with MS experiencing dysfunction including increased frequency andurgency of urination and increased incontinence(2). This study in 135 patientssuffering with urinary incontinence, not wholly relieved by their existingtreatment, demonstrated that Sativex had a positive impact on the symptoms ofover-active bladder with 84% in the Sativex treated group vs. 58% of the placebogroup reporting improvements in bladder dysfunction(3). Statisticallysignificant improvements were seen in nocturia (urination during the night),number of voids per day and patients' opinion of bladder symptom severity. Sativex contains the cannabinoids D9-tetrahydrocannabinol (THC) and cannabidiol(CBD) and is formulated as an oromucosal spray which is administered by sprayinginto the mouth and allows flexible dosing which is ideally suited to thevariable nature of MS. Each spray of Sativex delivers a fixed dose of 2.7mg THCand 2.5mg CBD. Sativex was generally well tolerated in both studies(1,3). Sativex is licensed in Canada and has recently been submitted for regulatoryapproval in selected European countries. Enquiries:GW Pharmaceuticals plcDr Geoffrey Guy, Executive Chairman Tel: + 44 (0)1980 557000Justin Gover, Managing Director Financial Dynamics Tel: +44 (0)20 7831 3113David Yates, Sarah MacLeod Notes to Editors About GW Pharmaceuticals plc GW was founded in 1998 and listed on the AiM, a market of the London StockExchange, in June 2001. Operating under licence from the UK Home Office, theCompany is developing cannabis-derived pharmaceutical products for patients withmultiple 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 indeveloping both plant-based prescription pharmaceutical products and medicinescontaining controlled substances. GW is dedicated to developing treatmentoptions that alleviate pain and other neurological symptoms in patients whosuffer from serious ailments. For further information, please visit the Company's website: www.gwpharm.com References 1. Collin C, Ambler Z et al. A randomised study of Sativex(R) in patientswith symptoms of spasticity due to multiple sclerosis. Poster 412 presented atthe 22nd Congress of the European Committee for Treatment and Research inMultiple Sclerosis (ECTRIMS) 2. http://www.mssociety.org.uk/about_ms/symptoms/bladder/bladder_problems.html 3. de Ridder D, Constantinescu C et al. Randomised controlled study ofcannabis based medicine (Sativex(R)) in patients suffering from multiplesclerosis associated detrusor overactivity. Poster 411 presented at the 22ndCongress of the European Committee for Treatment and Research in MultipleSclerosis (ECTRIMS) This information is provided by RNS The company news service from the London Stock Exchange