30th Jan 2007 07:01
GW Pharmaceuticals PLC30 January 2007 GW Pharmaceuticals plc ("GW" or "the Group") PRELIMINARY RESULTS Porton Down, UK, 30 January 2007: GW Pharmaceuticals plc (AIM: GWP), thedeveloper and manufacturer of a range of new cannabinoid medicines, includingSativex(R), announces its preliminary results for the year ended 30 September2006. Operational Highlights • Sativex regulatory submission filed in four European countries for the relief of Spasticity in Multiple Sclerosis • European (ex-UK) licence agreement signed with Almirall, including £12m signature fee. Launch preparations now underway • Sativex regulatory submission filed in Canada to extend approval to the treatment of Cancer Pain • FDA permitted Sativex to enter directly into US Phase III trials in Cancer Pain, allowing late stage US development to commence during 2007 • US Sativex licensing discussions progressing on track • Further encouraging data from Phase III trials in MS Spasticity and Neuropathic Pain • Phase III MS Neuropathic Pain trial recruiting on track Financial Highlights • Balance sheet strengthened with net cash inflow for the year of £6.8m. Significant inflows include Almirall signature fee and £8.1m US equity financing • Cash and short term deposits at 30 September 2006 of £19.9m, ahead of guidance • Revenues of £1.98m, including £1.35m relating to commercial sales of Sativex. £12m Almirall signature fee to be recognised as revenue over 15 years • Net loss of £11.9m, in line with expectation Dr Geoffrey Guy, Executive Chairman of GW, said: "During 2006, GW made good progress in advancing the clinical and regulatoryprogramme for Sativex in all its target indications. Having achieved approval inCanada in 2005, this year we filed regulatory submissions in four Europeancountries for MS Spasticity and also sought to further expand the Canadianlicence though a filing in Cancer Pain. In the United States, we receivedpermission from the FDA to enter directly into late stage development. We alsosaw further encouraging Phase III data showing that Sativex producesimprovements over and above current treatments that are highly meaningful to theeveryday lives of patients. "We look forward to an exciting 2007 in which we will seek to sign a US licenseagreement, commence late stage US trials, progress the ongoing regulatorysubmission in Europe, expand our existing market in Canada, and advance earlystage cannabinoid research programmes. With Sativex continuing to show greatpromise and significant potential newsflow anticipated this year, GW continuesto make strong progress." An analyst presentation of the preliminary results is being held today at 09.30at Financial Dynamics, Holborn Gate, 26 Southampton Buildings, London WC2A 1PB.Please contact Gemma Cross Brown at Financial Dynamics on +44 20 7269 7125 fordetails. An audio webcast of the presentation will be available on the investorrelations section of GW's website at www.gwpharm.com later this afternoon. Enquiries: GW Pharmaceuticals plc (30/01/07) + 44 20 7831 3113Dr Geoffrey Guy, Executive Chairman (Thereafter) + 44 1980 557000Justin Gover, Managing Director Financial Dynamics + 44 20 7831 3113David Yates / Nicola Daley GW Pharmaceuticals plc ("GW" or "the Group") Preliminary Results For The Year Ended 30 September 2006 REGULATORY STRATEGY Over the last few years, GW has broadened its clinical trials programme forSativex. With late stage trials either planned or underway in each of theCompany's four chosen target markets in the key geographic regions, GW hasdeveloped a robust clinical and regulatory programme. The Group's regulatory strategy is to provide multiple opportunities over thenext few years to obtain approvals for Sativex across various indications in anumber of geographic markets. The strategy is currently focused on fourspecific targeted therapeutic indications, each of which represents a distinctregulatory opportunity and each of which requires a distinct set of clinicalefficacy data. These indications are as follows: • MS Spasticity • MS Neuropathic Pain • Peripheral Neuropathic Pain • Cancer Pain GW has generated a large body of positive efficacy data to support the proposeduse of Sativex to address these high need patient populations. GW continues itsprogramme of Phase III trials in order to supplement the existing data and tounderpin its regulatory strategy of securing approvals in both Europe and NorthAmerica. Each Phase III trial is implemented in consultation with regulatoryauthorities, marketing partners, as well as independent clinical and regulatoryconsultants. At each point of new data being available, GW discusses with its marketingpartners and with regulatory authorities whether the data package warrants aregulatory submission or whether further clinical data would be desirable beforeseeking approval. In the last year, this strategy has led to regulatorysubmissions in Europe for MS Spasticity and in Canada for Cancer Pain. GW andits partners are likely to carry out further trials in these target indicationsover the next few years in order to supplement globally approvable regulatorypackages and to provide more data to support the marketing of the product postapproval. Beyond Sativex, we continue to invest in early stage cannabinoid research toselect and develop our next product candidates. Cannabinoids provide a wealth ofexciting therapeutic opportunity and it is the Group's intention to build on ourworld leading research position by advancing other products into clinical trialsand through to regulatory approvals over the coming years. GEOGRAPHIC REVIEW Europe In September 2006, GW announced it had filed a regulatory submission in selectedEuropean countries for Sativex for the symptomatic relief of spasticity inpeople with 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. The decision to proceed with a submission followed a series of constructivemeetings with officials from selected target European regulatory authorities.These meetings were attended by GW as well as its marketing partners and wereaimed at providing advice as to the appropriateness of the data package forregulatory submission. These meetings were based on a preliminary view of thedata and, as such, any advice provided is always subject to a detailedassessment in any future application. Nevertheless, as a result of thesemeetings, GW and its marketing partners were in full agreement to submit. In December 2005, Sativex was licensed exclusively to Almirall, Spain's largestpharmaceutical company, in Europe (ex-UK). The agreement provided for GW tomaintain a significant share of long term product revenues in addition to a £12msignature fee and total further milestones of up to £34m. In the UK, Sativex hasalready been exclusively licensed to Bayer HealthCare. Having now filed the regulatory submission, both Almirall and Bayer areadvancing their launch plans. Upon approval of the current filing in the selected four countries, theregulatory strategy is to expand the MS Spasticity indication into otherEuropean countries through the mutual recognition procedure. The rules do notpermit a parallel regulatory application in any other indication whilst the MSSpasticity review is ongoing. Hence, GW's regulatory strategy for otherindications is to continue to build the clinical evidence base whilst we awaitcompletion of the European MS Spasticity regulatory process. Following this, GWwill have the opportunity to extend the approval into other indications, such asneuropathic pain. United States At the beginning of 2006, GW announced that the FDA had granted permission forSativex to enter directly into Phase III clinical trials in the US. Thisdecision by FDA resulted from the extent of quality, safety and efficacy datagenerated by GW in Europe. 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 European Phase III Cancer Pain trial in 177 patients. In this study,Sativex achieved a statistically significant improvement in comparison withplacebo in pain as measured on a numerical rating scale (p=0.014), a primaryendpoint of the study. A responder analysis showed that 43% of patients onSativex showed a greater than 30% improvement in their pain (p=0.024) GW has made important progress during 2006 in the US. The Company's strategy hasbeen to first obtain IND status, to then put in place the necessary DrugEnforcement Administration (DEA) licences and in parallel work on the clinicalresearch logistics necessary to commence US development. GW has made progresstowards obtaining the key DEA licences necessary to carry out US development,has selected contract research organisations for various clinical studies, andalso signed up key US investigator sites. From a regulatory perspective, GW held a further "end of Phase II meeting" withthe FDA during the summer to ensure that the key aspects of work necessary tomeet the FDA's requirements for approval were agreed upon. This meeting achievedits objectives and the relationship with the FDA remains highly constructive. The principal investigator of the first US clinical trial is Dr Russell K.Portenoy, Chairman of the Department of Pain Medicine and Palliative Care atBeth Israel Medical Center, New York City, and one of the world's leadingexperts in his field. As stated previously, GW intends to seek a US licensing partner for Sativex inparallel with the start of US development activities. The progress ofdiscussions with potential partners is in line with our previous expectationsand proceeding well. Whilst GW has already embarked on aspects of the USdevelopment plan, it is likely that the large clinical trials will commence oncethe US licensing agreement is concluded. 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 in April 2005. Thispolicy is applied to products which are considered by Health Canada to address aserious medical condition for which there are no currently approved products,and where the data to date reflect promising clinical evidence. The "condition"element of the approval is the need for a confirmatory Phase III study tofurther verify the clinical benefit. In Summer 2006, GW stated that it was exploring opportunities to expand theregulatory approval in Canada to other indications. In October 2006, GWsubmitted a regulatory application in Canada for Sativex to seek approval for anew indication for the treatment of pain in patients with advanced cancer thathas not been adequately relieved by opioid medications. This submission followeda formal pre-submission meeting with Health Canada outlining the evidence ofeffectiveness of Sativex in this very seriously ill patient population.Following this meeting, Health Canada advised that, on the basis of the clinicaldata presented, a submission for consideration under the NOC/c could be made. Feedback from the market continues to be positive with consistent patterns ofsafety and efficacy as experienced during the clinical trials. In line withprevious GW guidance, the sales rate continues to be similar to previousperiods. The commercial picture at this stage is limited due to nature of theNOC/c approval and the lack of reimbursement by the public health system. Weexpect this situation to change once the "condition" element of the NOC/capproval is lifted following the availability of additional supporting data. Thefirst opportunity for this may occur follow completion of an ongoing MSNeuropathic Pain trial in the second half of 2007. 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. Originally intended to be a one year programme for 2006, GW supplied furtherproduct immediately prior to the financial year end and the clinical programmeis now continuing into 2007. The Catalan Health Department have issued publicstatements announcing that they are very pleased with the response to thisprogramme by opinion leaders and patients. In October 2006, the Health Committeeof Catalonia presented initial results, which concluded that 65 per cent of theparticipants have experienced an improvement of quality of life and a decreasein pain. 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 those with anorexia-cachexia in cancer 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. Of the total 600 patients envisaged, half are due tobe cancer patients with anorexia-cachexia and this enrolment has yet to start. UK GW has long considered one of its most important medical imperatives to be toprovide a means for UK patients to access Sativex on prescription. In early2006, we achieved this objective when the Home Office permitted the prescriptionof Sativex to individual patients in the UK as an unlicensed medicine. Thisdevelopment was in response to enquiries from a number of UK doctors andindividual patients who have been in contact with the Home Office to requestaccess to Sativex. Under relevant UK legislation, the basis on which Sativex maybe prescribed is the clinical judgement of doctors in relation to specificnominated patients. The Home Office licences cover physicians, pharmacists andpatients in the UK, and hence permit access to Sativex without the need for anyconsultation with the Home Office. As a result of these developments, Sativex is now being supplied on a namedpatient basis to patients in the UK who are in receipt of a prescription. Thisincludes patients who have previously been on clinical trials, as well as otherpatients who have been recommended to take Sativex by their physician. The Home Office licences mean that Sativex may be supplied directly from the UKmanufacturing site and dispensed by local pharmacies. GW charges for provisionof the medicine under these circumstances. SATIVEX CLINICAL TRIALS PROGRAMME MS Spasticity Preliminary results were announced in March 2006 of a Phase III study in therelief of 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). This study supported the positive data already generated from previous GW PhaseIII studies and enhanced 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, showed Sativex to be significantly superior to placebo (pRelated Shares:
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