Pfizer's hopes for cholesterol blockbuster dashed

Pfizer has abandoned its PCSK9 cholesterol drug bococizumab, saying late-stage clinical data shows it became less effective over time, and was less safe than rivals.

The company also announced in its third quarter results statement that sales of its biggest-selling cancer drug, Ibrance, had fallen short of expectations.

Following the patent expiry of its Lipitor (atorvastatin), at one time the world’s biggest selling drug, Pfizer had been searching for a cholesterol-lowering drug to replace it.

With Praluent (alirocumab) and Repatha (evolovumab), Sanofi and Amgen have managed to market a new generation of cholesterol drugs for people with inherited high cholesterol levels – and Pfizer was looking to develop its own drug to compete in the PCSK9 inhibitor class.

Pfizer had completed six studies of bococizumab, which according to GlobalData forecasts could have generated sales of $2.2 billion in 2023 if approved.

But Pfizer said the clinical profile across the trials includes an “unanticipated attenuation of low-density lipoprotein cholesterol (LDL-C) lowering over time”, as well as higher rates of injection site reactions compared with rivals in the same class.

The company will record the cost of ending development as a charge equivalent to around $0.04 per share in its fourth quarter results.

Pfizer had previously reported that four of the six trials in the phase 3 SPIRE programme had been successful.

In two remaining trials bococizumab had also been effective in adults with primary hyperlipidemia and mixed dyslipidemia, and the drug was generally safe and well tolerated in both trials.

Pfizer will also halt two ongoing cardiovascular outcome studies, SPIRE-1 and SPIRE-2.

In its Q3 results, Pfizer said Ibrance generated sales of $550 million, missing a consensus forecast of $576 million. Its Lyrica pain drug also fell short at $1.05 billion, missing a forecast of $1.28 billion, although its Prevnar vaccine, with sales of $1.54 billion, exceeded forecasts of $1.48 billion.