20th Jun 2006 07:01
GW Pharmaceuticals PLC20 June 2006 GW Pharmaceuticals plc ("GW" or "the Group") Interim Results For The Six Months Ended 31 March 2006 Porton Down, UK, 20 June 2006: GW Pharmaceuticals plc (AIM: GWP), the developerand manufacturer of a range of new medicines based on cannabis and othercontrolled drugs, announces its interim results for the six months ended 31March 2006. GW today is also hosting a research and development (R&D) day foranalysts and investors. HIGHLIGHTS • FDA permits Sativex to enter directly into US Phase III trials in cancer pain. First Phase III trial to commence around the end of 2006. US licensing discussions for Sativex have commenced • Licence agreement signed in December 2005 with Almirall to market Sativex in Europe (excluding the UK) • Results announced of a third Phase III MS spasticity study showing significant positive results in the per protocol analysis. Regulatory advice meetings being held to consider possibility of MS spasticity submission in Europe. Decision to be taken in second half of 2006 • Programme of Phase III trials continues. Two further Phase III peripheral neuropathic pain trials fully recruited and due to report results by end of 2006. Phase III MS neuropathic pain trial to commence Q3 2006 • Revenues for six months to 31 March 2006 of £0.73m, including £0.5m relating to commercial sales of Sativex in Canada, Spain and the UK • Net loss for the period of £6.2m (2005: £5.1m), in line with expectation • Cash and short term deposits at 31 March 2006 of £25.4m Dr Geoffrey Guy, Executive Chairman of GW, said: "GW is now generating product sales revenues in Canada, Spain and the UK. Inaddition, we are increasingly excited by the prospects for Sativex in the USfollowing the FDA's permission to enter directly into Phase III trials. GW has abroad development and regulatory strategy for Sativex which provides multipleopportunities over the next few years to continue to obtain product approvals invarious indications across Europe, North America and beyond. In the nearer term,we will continue our regulatory discussions in Europe to determine the initialtarget indication for our next regulatory filing, report results of two furtherEuropean Phase III studies and start our first pivotal study in the US. Withthese important value drivers to come, we believe the prospects for GW areextremely encouraging." An analyst presentation of the interim results and an R&D day are being heldtoday from 09.30 at Financial Dynamics, Holborn Gate, 26 Southampton Buildings,London WC2A 1PB. Please contact Gemma Cross Brown at Financial Dynamics on +4420 7269 7125 for details. An audio webcast of the presentation will be availableon GW's website at www.gwpharm.com later this afternoon. Enquiries: GW Pharmaceuticals plc (20/06/06) + 44 20 7831 3113Dr Geoffrey Guy, Executive Chairman (Thereafter) + 44 1980 557000Justin Gover, Managing Director Financial Dynamics + 44 20 7831 3113David Yates / Sarah Macleod GW Pharmaceuticals plc ("GW" or "the Group") Interim Results For The Six Months Ended 31 March 2006 During the first half of the year, GW met two primary strategic objectives insigning a license agreement for Sativex in Europe and gaining approval from theFood & Drug Administration (FDA) for Sativex to enter directly into late stagePhase III clinical trials in the United States. These milestones serve tobroaden significantly GW's strategic outlook and to highlight the Group'sexpanded territorial ambitions for the approval of Sativex over the next fewyears. In Europe, GW is currently evaluating its regulatory options for Sativexin the indication of Multiple Sclerosis (MS) spasticity and in parallel iscontinuing to progress its neuropathic pain programme. In the US, preparationsare underway for the start of the first pivotal Phase III study around the endof this year. GW's developmental, regulatory and commercial outlook is moreinternational in scope than ever before. REGULATORY STRATEGY The Group's regulatory strategy is to provide multiple opportunities over thenext few years to obtain approvals for Sativex across various indications and ina range of markets. GW has a programme of Phase III trials ongoing which have been implemented inconsultation with regulatory authorities, as well as independent clinical andregulatory consultants, and are designed to supplement the positive data alreadygenerated. Their outcome will determine the timing of regulatory submissions inthe various indications and in the various territories. Proof of efficacy hasalready been established in previous late-stage studies and these new studiescontribute to the evidence generation in support of Sativex. At each point of new data being available, GW will be in a position to discusswith its marketing partners and with regulatory authorities whether the datapackage warrants a regulatory submission or whether further clinical data wouldbe desirable before seeking approval. Indeed, irrespective of each set of trialresults, GW and its partners are likely to carry out further trials in thesetarget indications over the next few years in order to supplement globallyapprovable regulatory packages and to provide more data to support the marketingof the product post approval. GEOGRAPHIC REVIEW United States In January 2006, GW announced that the FDA had granted permission for Sativex toenter directly into Phase III clinical trials in the US. The achievement of thisgoal represents one of the most important events in GW's history. The prospectsfor the Group, which had hitherto been focused solely on the UK and Europe, nowincorporate the world's largest pharmaceutical market. Further, this decisionby the FDA provides clear testimony to the quality of GW's team of scientistsand to the extent of data generated over recent years. The proposed initial target indication for Sativex in the US is the relief ofpain in cancer patients who have failed to obtain adequate relief frommaintenance opioid analgesia. This indication is supported by data from ourcompleted positive European Phase III cancer pain trial. In the US, GW willconduct two Phase III cancer pain trials prior to making a regulatory submissionto the FDA. The two US Phase III studies will each be 250 patient, double-blind, randomizedplacebo controlled studies evaluating the effect of Sativex in relieving averagedaily pain, reducing the use of breakthrough opioid medications, improving thequality of sleep and relevant aspects of quality of life among other outcomemeasures. The first Phase III trial protocol has been subject to written FDAadvice and has been agreed with the principal investigator, Dr Russell K.Portenoy. Dr Portenoy is Chairman of the Department of Pain Medicine andPalliative Care at Beth Israel Medical Center, New York City, and one of theworld's leading experts in the field. Preparations for the Phase III studies are proceeding according to plan and thefirst patient is expected to enter the first study at around the end of 2006, orearly 2007. A US regulatory submission could reasonably be expected to occur24-36 months after the start of the Phase III programme. The US development planalso includes other smaller scale supporting studies, a number of which havecommenced in recent months. In April 2006, the FDA issued a statement outlining its position that there wasno evidence to support the safety and efficacy of "smoked marijuana" as amedicine. This statement is entirely consistent with GW's approach and with thedevelopment of Sativex. GW has long stated that the medicinal properties ofcannabinoids can and should only be demonstrated through a full developmentprogramme of a pharmaceutical product presented in an appropriate dosage formand conducted according to internationally recognised regulatory standards.Sativex meets all such requirements. As announced in January, GW intends to seek a US licensing partner for Sativexin parallel with the start of US development activities. Discussions withpotential partners are now underway and proceeding in line with GW'sexpectations. Canada Sativex is approved in Canada as an adjunctive treatment for symptomatic reliefof neuropathic pain in adults with MS. The product was approved under HealthCanada's Notice of Compliance with Conditions (NOC/c) policy. This policy isapplied to products which are considered by Health Canada to address a seriousmedical condition for which there are no currently approved products, and wherethe data to date reflect promising clinical evidence. The "condition" element ofthe approval is the need for a confirmatory Phase III study to further verifythe clinical benefit. In line with guidance provided by GW in January, total in-market sales for 2006are expected to reflect a similar sales rate as seen in the latter six months of2005. Feedback from the market continues to be positive with consistent patternsof safety and efficacy as experienced during the clinical trials. Thecommercial picture at this stage reflects the limitations of the NOC/c approvaland the lack of reimbursement by the public health system. We expect thissituation to change once the "condition" element of the NOC/c approval islifted, which will follow completion of a planned MS neuropathic pain trial inthe second half of 2007. GW is currently exploring opportunities to expand the regulatory approval inCanada to other indications. Discussions have been held with Health Canada abouta possible NOC/c application for Sativex in the treatment of cancer pain. Europe In December 2005, GW entered into an exclusive agreement with AlmirallProdesfarma S.A. ("Almirall"), Spain's largest pharmaceutical company, to marketSativex in Europe (excluding the UK). In the UK, Sativex has already beenexclusively licensed to Bayer HealthCare. Under the terms of the agreement, GW has maintained a significant share of longterm product revenues in addition to a £12 million signature fee. Including thissignature fee, milestones payable may total up to £46 million. GW isresponsible for completing the development of Sativex in the three initialtarget indications of MS symptoms (neuropathic pain and spasticity), neuropathicpain and cancer pain. In addition, Almirall and GW expect to collaborate on thedevelopment of Sativex in other indications. It is anticipated that Almirallwill contribute to the cost of development of new indications. The licensed territory includes the members of the European Union (excluding theUK), EU accession countries, as well as Switzerland, Norway and Turkey. Incountries where Almirall has no direct presence at the time of product launch,the companies shall jointly agree the appointment of distribution partners. Insuch countries, GW may elect to distribute the product itself. Spain In November 2005, GW reached agreement with the Health Department of TheRegional Government of Catalonia in Spain to supply Sativex to up to 600patients suffering from MS and a number of other conditions under acompassionate access programme. The programme has been approved by the SpanishMinistry of Health and the Catalan Health Department has approved a specificbudget to pay for GW to supply the medicine. Patients being entered into the programme have a range of medical conditions,including spasticity in MS, neuropathic pain in MS, neuropathic pain from otheretiologies, and anorexia-cachexia in cancer patients undergoing chemotherapy.There are six participating hospital centres, incorporating 22 investigatingunits. The first patient entered the programme in January 2006 and patients arecontinuing to be enrolled. GW, Almirall and the Catalan Health Department arevery pleased with the response to this programme by opinion leaders andpatients. Half the patients to be included are cancer patients withanorexia-cachexia. At the outset of the programme, the Catalan HealthDepartment decided that these patients would start to be enrolled in the secondhalf of 2006. This remains the intention and it is therefore likely thatpatients will be continuing on this programme beyond the end of 2006. UK GW was informed by the UK Home Office in November 2005 that Sativex may beimported from Canada to satisfy its prescription to individual patients in theUK as an unlicensed medicine. This development is in response to enquiries froma number of UK doctors and individual patients who have been in contact with theHome Office to request access to Sativex. Under relevant UK legislation, thebasis on which Sativex may be imported is the clinical judgement of doctors inrelation to specific nominated patients. In the UK, Sativex remains a Schedule 1 controlled drug, possession of whichrequires a Home Office licence. At the time of the announcement in November, theHome Office stated that it would be developing a licensing regime to fit thesecircumstances. Since that time, the Home Office has facilitated the arrangementsfor doctors, pharmacists and patients to possess the drug without therequirement to be individually licensed. This initiative by the Home Officegreatly simplifies the process for those patients who are in possession of anamed patient prescription. As a result of these developments, Sativex is now being supplied on a namedpatient basis to certain patients in the UK who are in receipt of aprescription. The Home Office licences mean that Sativex may be supplieddirectly from the UK manufacturers without need for export to and re-import fromCanada. GW charges for provision of the medicine under these circumstances. R&D REVIEW GW is today holding an R&D day which will provide an update on the Group'sprimary research into the potential of cannabinoids, early stage clinicalresearch which may enhance GW's development pipeline in the coming years, aswell as the Sativex clinical programme and regulatory strategy. Presenters willinclude: - Professor Roger Pertwee, Professor of Neuropharmacology, University of Aberdeen and GW's Director of Pharmacology- Dr Philip Robson, Director, GW's Cannabinoid Research Institute and Senior Research Fellow, Department of Psychiatry, University of Oxford- Dr Stuart Ratcliffe, Director of Pain Research, St Bartholomew's and the London Hospitals- Dr Stephen Wright, GW's R&D Director Symptoms of MS - Spasticity Headline results were announced in March 2006 of a Phase III study in the reliefof spasticity in people with MS. Analysis of the per protocol population (those patients that complied with thestudy protocol) showed a positive and statistically significant improvement inthe primary outcome measure (p0.05). The lack of significance in the ITT analysis was not due to a lack of effect ofSativex, but rather was due to a larger than expected placebo response, thusreducing the size of the difference between the two groups. Had the placeboresponse been the same as in GW's previous completed Phase III spasticity study,the ITT analysis in this new study would also have been statisticallysignificant. This study supports the positive data already generated from previous GW PhaseIII studies and enhances the data package beyond that assessed in the previousUK regulatory process. A pre-specified pooled analysis across the three PhaseIII Sativex MS spasticity studies now completed, incorporating a total of 666patients, shows Sativex to be significantly superior to placebo (pRelated Shares:
GWP.L