Pfizer hit by “totally unexpected and disappointing” drug trial results

Pfizer, the world’s largest pharmaceutical company, has expressed dismay and surprise over the safety findings for an investigational new drug touted to be a blockbuster replacement for Lipitor, the world’s best-selling statin.

The company has announced that it is stopping all clinical trials for torcetrapib after regulatory authorities reported an “imbalance of mortality and cardiovascular events”.

Pfizer has said that it is in the process of contacting all clinical investigators for the Illuminate study to tell patients to stop taking their treatment immediately. In addition, the development programme for the drug has been terminated.

Dr Philip Barter, who oversaw the study, said he thought that the trials were progressing smoothly, making the new data about deaths “totally unexpected and disappointing”.

Jeffrey B Kindler, chief executive officer of Pfizer, also expressed dismay over the findings of regulatory authorities, although he emphasised the strength of Pfizer’s product pipeline, noting that effort to transform the company would be “accelerated” in response to the setback.

“With regard to our business, we understand the challenge that this represents and we will respond quickly and aggressively to it,” he stated.

“It is important to put this information in the context of both our commitment to transform Pfizer and our overall product and financial strength,” he said.

Last month, Pfizer had said that the preliminary results for a phase III trial involving an torcetrapib/atorvastatin treatment had proved “very positive”. Although a slight increase in systolic blood pressure was observed for patients using the drug, Dr Joseph Feczko, Pfizer’s chief medical officer, said that this would be unlikely to alter its “favourable” clinical profile.

The early indications are that Pfizer’s shares could suffer a large fall on receipt of the news.