GWP.L Regulatory News (GWP)

16 Dec 2005 15:14

GW Pharmaceuticals PLC16 December 2005 For Immediate Release 16 December 2005 GW Pharmaceuticals plc ("GW" or "the Company") Statement In Response To The Verdict Of The Inquest Into The Death Of Mrs Rene Anderson During the course of this week, an inquest has taken place in Sheffield into thedeath of Mrs Rene Anderson. Mrs Anderson, a 69 year old diabetic, died in March2004. One of the factors in her case, which has received media attention, isthat she had taken part in a Sativex clinical trial over a three week periodduring October 2003. In his verdict at the end of the inquest today, the Coroner stated that "MrsAnderson died on 3rd March 2004 in the Northern General Hospital as aconsequence of prolonged immobility following an illness for which she had beenadmitted on 28th October 2003. On the balance of probabilities, an idiosyncraticreaction to a trial drug (either alone or in combination with other medications)was at least a significant contributory factor to the initiation of thisillness." While the case is very sad by its nature, GW does not believe it raises any newor additional safety concerns about Sativex. The term idiosyncratic reaction was defined by the Coroner as unusual,unexpected and individual. For this reason GW believes it has no wider relevancefor patients or for the medicine. Importantly: • Mrs Anderson took a very low dose of the medicine over a very limited period of time. • Confusion is listed on the product information as an effect that can be associated with Sativex, and in the rare cases where it has been observed it has been fully reversed on withdrawal. • Mrs Anderson's immobility was unresolved despite over four months of hospital care and complicated by a wide range of other drugs. Dr Stephen Wright, R&D Director of GW, said: "GW Pharmaceuticals extends itscondolences to the relatives and friends of Mrs Rene Anderson. This was a uniquecase. Whatever the sad cause of Mrs Anderson's death, it does not mean thatSativex is dangerous for patients even if it may have been one of severalfactors to have caused Mrs Anderson's initial confusion. "All relevant information concerning this case was passed to the regulatoryauthorities at the time according to standard procedures and has been includedin all safety information subsequently provided to clinicians and regulators.Since that time, Sativex has successfully undergone rigorous clinical assessmentas to safety and quality, and has been licensed as a medicine in Canada. We donot believe that this case has any negative consequences for the regulatoryprogress of Sativex. "The extensive safety data on Sativex is very reassuring. GW has been carryingout clinical trials in patients with serious and life-threatening diseasesincluding multiple sclerosis, cancer, and diabetes mellitus since 1999. Morethan 2,000 patients have taken part in the company's clinical trials, generatingmore than 1,000 patient-years of exposure. Within this experience, Sativex hasconsistently shown itself to be safe and well-tolerated by patients." - Ends - Enquiries: GW Pharmaceuticals plcMark Rogerson, Press and PR + 44 7885 638810 Weber Shandwick Square MileKevin Smith/Rachel Taylor + 44 20 7067 0700 Notes to Editors The inquest into the death of Mrs Rene Anderson commenced on 12 December 2005.Mrs Anderson was 69 years old with a 25 year history of diabetes mellitus, andalso suffered from resistant hypertension, clinically significant depression andhyperlipidaemia. She died in March 2004. One of the factors in her case, which has received media attention, is that MrsAnderson had taken part in a Sativex clinical trial over a three week periodduring October 2003. Mrs Anderson's total exposure to Sativex extended to atotal of 42 doses (a total of less than four days worth for a typical patient).During October 2003, Mrs Anderson developed confusion and other intoxicationeffects and stopped taking Sativex. At the end of October 2003, a full fourmonths before her death, a urine test confirmed that there was no presence ofcannabinoids in her body. A further period of four months of hospital inpatient care passed prior to MrsAnderson's death in March 2004 after pneumonia and kidney failure, during whichtime she received numerous medications under the direction of various doctors. There were a number of other potential causes of confusion in this patient. MrsAnderson was also taking a wide range of other medication both before and afterher brief involvement in the Sativex trial, including tramadol, haloperidol,nitrazepam, simvastin, citalopram, losartan, frusemide, atenolol and doxazosin.All these medicines have side effects of their own, and a number list confusionon the product label. There are over 50 prescription medicines which listconfusion as a side effect. This information is provided by RNS The company news service from the London Stock Exchange