19th Jan 2005 07:00
GW Pharmaceuticals PLC19 January 2005 Embargoed until 0700 19 January 2005 GW Pharmaceuticals plc ("GW" or "the Group") Preliminary Results for the Year Ended 30 September 2004 GW Pharmaceuticals plc, the company which develops and manufactures a range ofnew medicines based on cannabis and other controlled drugs, announces itspreliminary results for the year ended 30 September 2004. Highlights •Qualifying notice received for first regulatory approval of Sativex(R) in Canada •UK regulatory approval process for Sativex ongoing. Medicines Commission hearing expected within six months •Positive results from Phase III clinical trial in cancer pain (announced separately today) •Further positive results from Phase III clinical trials in neuropathic pain and spasticity in Multiple Sclerosis •Positive results from Phase II clinical trial in rheumatoid arthritis •Patient recruitment complete for two further Phase III trials. Results due in first half of 2005 •Further regulatory filings planned in 2005, including a US IND application •Second generation Advanced Dispensing System methadone technology developed and operational •Net loss for the year to 30 September 2004 of £13.7m (2003: £8.1m) •Cash and short term deposits at 30 September 2004 of £17.8m Dr Geoffrey Guy, Executive Chairman, commented: "This has been a year ofsignificant achievement. Although the UK regulatory process for Sativex has beenslower than anticipated, we were delighted in December 2004 to receive noticethat Sativex qualifies for approval in Canada. We therefore expect shortly toachieve our first regulatory approval, a key milestone in the history of GW. Inaddition, we have announced a series of positive results from clinical trials,including three new Phase III trials, which further enhance the wealth ofefficacy data to support the potential of Sativex. "Regarding the UK regulatory process, we have now resolved all quality andsafety issues and we remain determined to resolve the one outstandingefficacy-related issue at the Medicines Commission. The outcome of thisCommission hearing should be known in the summer. "With our first approval imminent as well as the breadth of positive clinicaldata which continues to be generated, we have good reason to be excited aboutthe year ahead. We expect 2005 to be the year of our first product launch, atime of restored momentum, as well as a financial turning point as we start togenerate commercial revenues from product sales." A presentation for analysts is taking place today at 09.30 at Weber ShandwickSquare Mile, Fox Court, 14 Gray's Inn Road, London WC1. An audio webcast of thepresentation will be available on GW's website at www.gwpharm.com from 15.00today. Enquiries: GW Pharmaceuticals plc (19/01/05) 020 7067 0700Dr Geoffrey Guy, Chairman (Thereafter) 01980 557000Justin Gover, Managing Director Weber Shandwick Square Mile 020 7067 0700Kevin Smith / Sarah MacLeod Embargoed until 0700 19 January 2005 GW Pharmaceuticals plc ("GW" or "the Group") Preliminary Results for the Year Ended 30 September 2004 Managing Director's Review Last year saw intense regulatory and clinical trials activity, and ended withthe exciting news that a Qualifying Notice has been received for the approval ofSativex in Canada. With each new clinical trial, we find more reasons forencouragement about the commercial potential of our products. Including today'sannouncement of positive results from our cancer pain trial, we completed threepositive Phase III trials during the last calendar year. In the UK, we considerthat we have a compelling case for the regulator to approve Sativex and will befocusing on achieving a successful outcome to the final part of this processduring the coming months. Canada GW filed the regulatory application for Sativex in Canada in May 2004 and wewere delighted to receive a Qualifying Notice for approval just seven monthslater, earlier than expected. In recognition of the clinical need amongst peoplewith Multiple Sclerosis (MS), Health Canada, the Canadian regulator, hasreviewed the Sativex dossier with speed and pragmatism. Over this period, we and our partners Bayer have been working closely on theregulatory process as well as preparing for launch. We look forward to anintense period of pre-launch and launch activity over the next few months. Thereare 50,000 people with MS in Canada and there is widespread recognition andunderstanding of the medicinal properties of cannabis. We therefore considerCanada to be an ideal market for the world's first launch of Sativex. Following the initial approval for Sativex in the relief of neuropathic pain inMS, GW expects to make further applications in Canada for the use of Sativex inadditional indications, including pain in other conditions. UK In the past twelve months, a great deal of focus has been placed on the UKregulatory process. For a medicine to be granted a product licence, it mustsatisfy the three criteria of quality, safety and efficacy. Having initiallyreceived questions from the MHRA in respect of 46 different issues, we wereinformed in December 2004 that there are no quality or safety concerns thatwould prevent an approval, but there is one issue outstanding related toefficacy - an "uncertainty" as to the clinical relevance of the statisticallysignificant effect seen in a clinical trial in MS spasticity. Although the regulators have now stated that a further positive confirmatorystudy in spasticity would enable grant of a product licence, GW considers thatthe submitted data package already addresses this single outstanding issue. Forthis reason, we have elected to seek a hearing at the Medicines Commission, thesenior advisory body to the MHRA. This hearing can be expected to take place bysummer 2005. If it is successful, Sativex will immediately proceed to be granteda product licence in the UK. In parallel, GW is now close to commencing thefurther confirmatory study requested, subject to final methodology discussionswith the regulator. Further Regulatory Activity In light of the extent of GW's positive clinical data, the grant of theQualifying Notice for approval in Canada and the single limited outstandingissue in the UK regulatory process, GW plans to commence the preparation ofregulatory documentation in 2005 for the submission of additional regulatoryapplications. This may include applications for additional indications in Canada, UK and elsewhere. In addition, GW now considers that the breadth of data issufficient to obtain an IND (Investigational New Drug) in the United States andis now commencing US regulatory activity with a view to requesting a pre-INDmeeting with the Food & Drug Administration shortly. Clinical Trials This has been perhaps GW's most successful year to date in terms of clinicalresults. We have reported positive results from three Phase III clinical trialsin MS spasticity, neuropathic pain and cancer pain. These three trials,including a total of nearly 500 patients, are amongst our largest studies todate and each supports separate market opportunities. In addition, we havegenerated positive data from a Phase II trial in rheumatoid arthritis, the firstever controlled clinical trial of a cannabis-based medicine in the treatment ofarthritis. In these trials, as well as all previous trials, all patients had failed toachieve an adequate response on existing medication, and remained on theirexisting medication during the course of the trial. Hence, improvements seen areover and above those obtained with existing available medications, and thepatient group studied is one with a very high clinical need. In total, GW's clinical trials have to date incorporated over 1500 subjects.When we first embarked on our clinical trials programme in 1999, one would notperhaps have expected that so many avenues of research would yield positiveresults. Yet, this has indeed turned out to be the case. The more we researchinto the medicinal properties of cannabis and cannabinoids, the greater ourenthusiasm for the potential of our research programme. Phase III Trials As reported in a separate announcement today, positive results have beenachieved from a Phase III trial in 177 patients with cancer whose pain is notadequately controlled on existing strong opioid treatments (e.g. morphine).Sativex was significantly superior to placebo (p=0.014) in relieving pain, aprimary endpoint in the study. This improvement was achieved over and abovepatients' existing opioid and other analgesic medication, which they continuedto take during the trial. These data provide further demonstration of the broadpotential of this product, not only in its initial MS and neuropathic painmarkets, but also in cancer and potentially other types of chronic pain. In June, GW reported positive results from its largest MS Phase III trial. Thisstudy focused on the symptom of spasticity (spasms and stiffness), which is oneof the most common symptoms of MS, occurring in as many as three-quarters ofpeople with MS. This trial of 189 MS patients showed that Sativex wassignificantly superior to placebo in relieving spasticity (pRelated Shares:
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