Cholesterol drug failure hits Pfizer
pharmafile | December 4, 2006 | News story | Research and Development, Sales and Marketing |Â Â Â
Pfizer has suffered a major blow with its decision to cancel late-stage pipeline torcetrapib following safety concerns.
Torcetrapib, which raises 'good' HDL cholesterol, was to be combined in a single pill with Pfizer's current top-seller Lipitor, but new trial data results indicated the drug increased risk of heart disease and death among patients.
Analysts had predicted that if successful, torcetrapib could have reached peak sales of $20 billion, and its cancellation leaves a major hole in the company's future revenues.
Pfizer described the development as "totally unexpected and disappointing" and saw its share price dip 13% in early trading.
Dr Philip Barter, director of the Australian Heart Research Institute and chairman of the steering committee overseeing the study, said: "Based on all the evidence we have seen regarding torcetrapib and in light of prior study results, we were very surprised by the information received from the Data Safety Monitoring Board (DSMB), the only body with access to the unblinded safety data."
He added: "We believed the study was coming along as expected and this new information was totally unexpected and disappointing, given the potential benefits of this drug."
Pfizer's chief executive, Jeffrey Kindler, commented: "While the DSMB information we received was both surprising and disappointing, our focus is on the best interests of patients and making sure all this information is communicated to appropriate medical and regulatory authorities as quickly as possible."
Scrapping torcetrapib is the latest blow in a difficult two years for Pfizer. During this time, a number of its key drugs have gone off patent and it has suffered decreasing sales for a number of its products.
Kindler, who took over as chief executive in late summer, stressed: "With regard to our business, we understand the challenge that this represents and we will respond quickly and aggressively to it. It is important to put this information in the context of both our commitment to transform Pfizer and our overall product and financial strength."
Pfizer recently announced a 20% cut in its US salesforce and has now followed this with a fundamental review of its R&D strategy.
It intends to launch four new experimental drug candidates each year, starting in 2011 and will also aim to generate six new products per year through external deals, beginning in 2010.
Kindler added: "Pfizer's substantial financial strength will enable it to continue to invest in a wide range of pipeline opportunities across a diverse range of therapeutic areas, capitalising on the largest pipeline in its history. It will bring forward these major, new product opportunities as aggressively as possible."
