GWP.L Regulatory News (GWP)

13 Dec 2007 14:01

GW Pharmaceuticals PLC13 December 2007 GW Welcomes Move by UK Regulator to Provide More Information for Sativex(R) Prescribers Porton Down, UK; 13 December 2007: GW Pharmaceuticals plc (AIM: GWP) welcomesthe publication today by the UK regulator, the Medicines & Healthcare productsRegulatory Agency (MHRA) of a Public Information Report on Sativex(R), GW'scannabinoid spray medicine. The MHRA has taken this unprecedented step due to its view of the "huge publicinterest" in Sativex and the fact that approximately 1400 patients in the UKhave so far received the medicine on prescription on a named patient basis. Newpatients continue to be prescribed Sativex every day. Hence, the MHRA considersthat it is in the public interest for potential prescribers to have furtherinformation on the medicine. Dr Geoffrey Guy, Chairman, said, "We welcome the MHRA's appreciation of thepublic interest in Sativex and recognition of the extent of prescription use ofSativex in the UK. We continue to receive enquiries from UK physicians andpatients on a daily basis and this report will serve to provide them with moreinformation about the medicine and its use." Dr Guy added, "As we have previously announced, there is an outstanding efficacyissue to be resolved prior to full regulatory approval for Sativex in the reliefof Multiple Sclerosis spasticity. This issue, detailed in the report, is beingaddressed through an additional Phase III clinical trial, which commencedrecently." Enquiries: GW Pharmaceuticals plc Today: +44 20 7831 3113 Dr Geoffrey Guy, Chairman Thereafter: + 44 1980 557000Justin Gover, Managing DirectorMark Rogerson, Press and PR Tel: + 44 7885 638810 Financial Dynamics Tel: +44 20 7831 3113 David Yates Notes to Editors Further Information on the Public Information Report Report Conclusions The Report confirms previous statements by GW that the major issue to beovercome prior to approval of Sativex for the relief of spasticity in peoplewith Multiple Sclerosis relates to the provision of specific additional efficacydata. Key summary conclusions of the Report are: • All pharmaceutical points raised during the procedure have been resolved satisfactorily. • There are no preclinical objections to the granting of a marketing authorisation. • The safety profile is considered acceptable in principle for the proposed patient population and indication, providing sufficient efficacy is demonstrated. • The remaining efficacy issue is to carry out a prospectively planned study to confirm GW's "post hoc analyses supporting an argument that non responders can be identified in a 4 week therapeutic trial, and that the mean treatment effect in the remaining patients who would continue to receive treatment, would be clinically significant." In addition to the guidance disclosed in the assessment report on the additionalrequired clinical trial, GW has separately received formal "Scientific Advice"from MHRA on the company's protocol design and statistical analysis plan. Safety Information The safety information detailed in the report is consistent with that alreadycontained in the Canadian Product Monograph, which is approved by Health Canadafor Sativex in the relief of neuropathic pain in MS and cancer pain, as well asthe information which has previously been provided to UK physicians whocurrently prescribe Sativex on a named patient basis. Expert Statement The Report includes a consensus statement by a panel of independent clinicalexperts specialising in the treatment and rehabilitation of people with MS andin clinical trial design, who were asked to review and comment on the Sativexdata and the MHRA's assessment thereof. This panel was chaired by Lord Walton ofDetchant, an eminent British neurologist and past president of the Royal Societyof Medicine and the General Medical Council of Great Britain. The statementconcludes: "We conclude that Sativex meets a currently unmet medical need in patients wherethere is no other conservative treatment option. It is our view that Sativexshould be licensed and become available on prescription for patients withspasticity due to multiple sclerosis, and we urge the MHRA to do so." Full Report The full report can be found on the MHRA website: www.mhra.gov.uk About Sativex Sativex is composed primarily of two cannabinoids: CBD (cannabidiol) and THC(delta 9 tetrahydrocannabinol). Sativex is administered as a metered doseoro-mucosal spray; each 100uL spray contains 2.7mg THC and 2.5mg CBD. TheSativex formulation is standardized by both composition and dose and is suppliedin small spray vials. The components of Sativex have been shown to bind tocannabinoid receptors that are distributed throughout the central nervous systemand in immune cells. Sativex is already approved and marketed in Canada as adjunctive treatment forthe symptomatic relief of neuropathic pain in MS, and for the relief of cancerpain. Health Canada has approved Sativex under its Notice of Compliance withconditions (NOC/c) policy. In the US, the lead indication for Sativex is cancer pain. On 26 November, GWand its US licensing partner, Otsuka, announced that the first US Phase II/IIIcancer pain trial had been initiated. GW has to date entered into three Sativex license agreements - with Otsuka inthe US, with Bayer HealthCare in the UK and Canada, and with Almirall in Europe(ex-UK). About GW GW was founded in 1998 and listed on the AiM, a market of the London StockExchange, in June 2001. Operating under license from the UK Home Office, thecompany researches and develops cannabinoid pharmaceutical products thatalleviate pain and other neurological symptoms in patients who suffer fromserious ailments. GW has assembled a team of over 100 scientists with extensiveexperience in developing both plant-based prescription pharmaceutical productsand medicines containing controlled substances. GW occupies a world leadingposition in cannabinoids and has developed an extensive international network ofthe most prominent scientists in the field. For further information, pleasevisit www.gwpharm.com This news release may contain forward-looking statements that reflect GWscurrent expectations regarding future events, including development andregulatory clearance of the GW's products. Forward-looking statements involverisks and uncertainties. Actual events could differ materially from thoseprojected herein and depend on a number of factors, including (inter alia), thesuccess of the GW's research strategies, the applicability of the discoveriesmade therein, the successful and timely completion of uncertainties related tothe regulatory process, and the acceptance of Sativex(R) and other products byconsumer and medical professionals. This information is provided by RNS The company news service from the London Stock Exchange