GWP.L Regulatory News (GWP)

5 Sep 2006 07:00

GW Pharmaceuticals PLC05 September 2006 GW Pharmaceuticals plc GW Files Sativex(R) for Approval in Selected European Countries for MS Spasticity Porton Down, UK, 5 September 2006 - GW Pharmaceuticals plc (AIM: GWP) ("GW" or "the Company") today announces that it has filed a regulatory submission inselected European countries for Sativex(R), its cannabinoid spray medicine. Thefiling is for the symptomatic relief of spasticity in people with multiplesclerosis (MS), a patient group with a significant unmet medical need. The filing has been made under the "decentralised procedure" in the UK, Spain,Denmark and the Netherlands. Under this procedure, the UK is acting asReference Member State and will consult with the three other countries. Ifsuccessful, a filing under the decentralised procedure would lead to thesimultaneous approval of Sativex in these countries for the MS spasticityindication. Upon approval, Sativex will be marketed in the UK by Bayer HealthCare and in therest of Europe by Almirall. Commenting on today's announcement, Dr Stephen Wright, GW's R&D Director, said: "We now have a sizeable body of positive clinical data to support the efficacyand safety of Sativex in MS spasticity. This is a complex data package and wehave therefore reviewed the complete dossier with our marketing partners anddiscussed it in detail with a number of European regulators. These meetings haveprovided constructive and positive feedback. The conclusion of GW and itsmarketing partners, taking into account the views of the regulators, as well asthe unmet needs of this target patient group, is that this body of data warrantsserious regulatory evaluation." Dr Geoffrey Guy, Executive Chairman of GW, added: "This filing is one element of a broad-based regulatory strategy for Sativex,which is designed to maximise the opportunities for Sativex as well as to managethe risks associated with its development. Beyond the filing today in MSspasticity, the Phase III clinical trials programme continues and will providefurther sets of clinical data to support additional regulatory filings inseparate indications. This approach is aimed at creating several independentopportunities to obtain regulatory approvals for Sativex in the coming years." There will be a conference call for analysts today at 9.00am. Please contactGemma Cross Brown at Financial Dynamics on +44 (0) 20 7831 3113 for details. Arecording of this call will be accessible on the press releases page in theinvestor relations section of the GW website (www.gwpharm.com) later today. Enquiries:For GW: GW Pharmaceuticals plc Today: +44 (0)20 7831 3113 Dr Geoffrey Guy, 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, Ben Atwell For Bayer: Sylvia Barber Tel: +44 (0)1635 563607 For Almirall: Weber Shandwick Healthcare Tel: +44 (0)20 7067 0000 Natalie Murphy, Brian Tjugum Notes to Editors Background to the submission The current submission is supported by a body of clinical data in approximately700 patients with MS spasticity, and includes two pivotal Phase III trials aswell as two supportive trials. Data from the first pivotal trial, which showedpositive results across all primary analyses, were announced in June 2004 andreviewed by the UK regulatory authority. The UK regulators subsequently advisedthat this single pivotal trial would need to be supplemented by a furtherpivotal clinical study in MS spasticity in order to obtain a product licence forSativex in this indication. The second pivotal trial in MS spasticity, the results of which were reported inMarch 2006, showed a consistent positive treatment effect to the first pivotaltrial. A pooled analysis of the full spasticity data-set also showed a positiveeffect for Sativex in this patient population. In the second pivotal trial, theper protocol analysis achieved statistical significance, whereas the outcome inthe Intention to Treat (ITT) analysis was positive but non-significant. GWtherefore stated at that time that it wished to consult with a number ofdifferent regulatory authorities in Europe, as well as with its Europeanmarketing partners, Bayer and Almirall, to determine whether it should moveforward with a filing in this indication. In the last few months, a series of positive meetings have taken place withofficials from selected target European regulatory authorities. These meetingswere attended by GW as well as its marketing partners and were aimed atproviding advice as to the appropriateness of the data package for regulatorysubmission. These meetings are based on a preliminary view of the data and, assuch, any advice provided is always subject to a detailed assessment in anyfuture application. As a result of these meetings, GW and its marketing partnerswere in full agreement that the regulatory dossier should be submitted at thistime. Regulatory strategy for Sativex This regulatory submission is part of a comprehensive strategy to secureregulatory approvals for Sativex across multiple indications in Europe, NorthAmerica and the rest of the world. In addition to MS spasticity, Sativex is alsoin Phase III trials for three further separate indications: peripheralneuropathic pain, MS neuropathic pain and cancer pain. It is intended that, inaccordance with conventional regulatory requirements, each regulatory submissionfor each target indication is supported by two pivotal Phase III clinicaltrials. Indication: MS Neuropathic Pain Sativex is approved in Canada in the indication of MS Neuropathic Pain underHealth Canada's Notice of Compliance with conditions policy. GW has recently commenced a second pivotal Phase III study in this indication.This study supplements a completed positive pivotal Phase III study as well as anumber of supportive studies. This second pivotal study, which is expected toreport results in approximately one year, is intended to complete a data packageto support a regulatory submission in Europe in this indication. In addition,the study will be submitted to the Canadian regulators in order to achieve afull Notice of Compliance. Indication: Peripheral Neuropathic Pain GW is now completing two pivotal Phase III studies in this indication, which aredue to report results at the end of this year. These studies, together with anumber of completed positive supportive studies, are intended to provide a datapackage to support a regulatory submission in Europe in this indication. Indication: Cancer Pain In January 2006, GW received permission from the US regulatory authority, theFood and Drug Administration (FDA) to commence Phase III trials in the US in thecancer pain indication. This follows the results of a positive Phase III trialcarried out in Europe. Preparations to commence the first of two pivotal PhaseIII trials in this indication are well underway. Two pivotal Phase III trials inthis indication will be carried out to provide a regulatory submission in boththe US and in Europe. About GW Pharmaceuticals 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 About Almirall Almirall is a consolidated international pharmaceutical company that researches,develops and commercialises its own R&D and licensed drugs with the aim ofimproving people's health and quality of life. Almirall is to invest 750 million euros in R&D over the next five years. Thetherapeutic areas on which Almirall focuses its research resources are relatedto the treatment of asthma, COPD, psoriasis and rheumatoid arthritis. Almirall, whose headquarters are in Barcelona (Spain), has a staff of over 3200people, 500 of whom work in R&D and with approximately 1000 workinginternationally in Almirall's affiliate companies. Almirall's products are currently present in approximately 100 countries. Thecompany has direct presence in Europe and Latin America via affiliates. For further information please visit the website at: www.almirall.es About Bayer HealthCare AG Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world's leading,innovative companies in the health care and medical products industry. In 2004,the Bayer HealthCare subgroup generated sales amounting to some 8.5 billionEuro. The company combines the global activities of the divisions Animal Health,Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Since January 1,2006 the new Pharmaceutical Division consists of the former Biological Productsand Pharmaceutical Division and now comprises three business units: Haematology/Cardiology; Oncology and Primary Care. Bayer HealthCare employed 35,300 peopleworldwide in 2004. Bayer HealthCare's aim is to discover and manufacture innovative products thatwill improve human and animal health worldwide. The products enhance well-beingand quality of life by diagnosing, preventing and treating disease. This news release may contain forward-looking statements that reflect GW'scurrent expectations regarding future events, including the clinical developmentand regulatory clearance of 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 GW's research strategies, the applicability of the discoveries madetherein, the successful and timely completion of clinical studies, includingwith respect to Sativex and GW's other products, the uncertainties related tothe regulatory process, and the acceptance of Sativex and other products byconsumers and medical professionals. This information is provided by RNS The company news service from the London Stock Exchange