Pfizer Ends Clinical Trials for the CETP,Torcetrapib (Illuminate) Due to Safety Concerns

This just in, from Espicom's Cardiovascular Drug News.  The drug's development reportedly involved an investment of $800 million, and the class of drugs (cholesterol ester transfer proteins) was expected to become a "gold standard":  On 2nd December, the independent Data Safety Monitoring Board (DSMB) monitoring the ILLUMINATE morbidity and mortality study for torcetrapib recommended terminating the trial due to an imbalance of mortality and cardiovascular (CV) events. Pfizer has confirmed that it is stopping all torcetrapib clinical trials, has informed the FDA and is in the process of notifying all clinical investigators in the program, as well as other regulatory authorities. At the end of October, the cholesterol ester transfer protein (CETP) inhibitor attracted attention due to a negative outcome from the preliminary results of Phase III heterozygous familial hypercholesterolaemia trials in combination with the company's established statin, Lipitor (atorvastatin), with patients in the combination therapygroup experiencing an increase in systolic blood pressure versus those taking atorvastatin alone. The company stated at the time its belief that this would not alter the favourable clinical profile of torcetrapib+atorvastatin (T/A) in the treatment of CV disease and underscored that the studies were far from complete. Overall lipid results from all the completed trials were positive, generally showing that T/Asignificantly increased HDL cholesterol by 55 to 60 per cent and lowered LDL cholesterol by 10 to 15 per cent over atorvastatin alone (leading to a combined reduction in LDL-C of 50 to 60 per cent). At its recent research and development meeting, Pfizer highlighted T/A and CETP research as the most important new development in CV medicine in years. Dr John LaMattina, President of Pfizer Global Research and Development, commented that the category "has the potential to change theface of cardiovascular medicine" and that at the end of its comprehensive program, the company expected to have a medicine with "unparalleled efficacy in raising HDL, lowering LDL and with an anti-atherosclerosis indication". The top-line results of the three pivotal imaging trials wereexpected during the first quarter of 2007, in addition to results of some additional Phase III lipid studies. Pfizer has, however, terminated ILLUMINATE and in fact, ended the development program for this compound, with participating patients being advised to stop taking the study medication immediately. According to Espicom's latest Pharmaceutical Companies Analysis report, Pfizer was investing approximately US$800 million in the development of T/A. Dr Philip Barter, Director of the Heart Research Institute in Australia and Chairman of the Steering Committee overseeing the ILLUMINATE study, clarified how surprised those blinded to the safety data were by the DSMB's information, stating that it was "totally unexpected and disappointing." At 1.40pm CET on 4th December, Pfizer's share price was EUR 18.00 in Frankfurt, down by 12.83 per cent from the previous day. The company's CEO, Jeffrey B Kindler, confirmed that despite the setback, Pfizer's financial guidance for 2006 is unchanged and that its previously-announced plan for transforming the company will now be accelerated, with a focus on core R&D, manufacturing and commercial operations, as well as procurement and other areas. Espicom's Cardiovascular Drug Discoveries had predicted that this CT had the potential to become the new gold standard treatment by 2010, and that by 2012, sales could have reached around US$6.8 billion. Source: Cardiovascular Drug News For further information on this and other articles featured in Cardiovascular Drug News visit: http://www.espicom.com/prodcat.nsf/structure/SourceLanding?EditDocument&Referer=FM02EB&ProductCode=00000032 For further information and to order your copy of Cardiovascular Drug Discoveries go to: http://www.espicom.com/prodcat.nsf/structure/SourceLanding?EditDocument&Referer=FM02EB&ProductCode=00001315