Pfizer ($PFE) is to dump all work on its proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) bococizumab due to weak data and an “evolving treatment and market landscape for lipid-lowering agents.”
The shock announcement, made alongside its financials this morning, comes as the New York Big Pharma found that bococizumab “is not likely to provide value to patients, physicians, or shareholders” after its ability to lower LDL-C weakened over time and increased the risk of some adverse events.
After combing over its data and having a deeper look at the market, Pfizer will also halt its entire development program for the med, including the two ongoing cardiovascular outcome studies. The drug had been in late-stage development for its potential to lower LDL-C and improve cardiovascular outcomes.
Things had looked good as recently as June, when Pfizer released positive data from two more trials for its new experimental anticholesterol drug as the three-way dual for the PCSK9 inhibitor market heated up.
The U.S. pharma giant said two more Phase III bococizumab trials met their primary endpoints in patients who are at high risk of heart problems and those with genetically high cholesterol levels after besting placebo at 12 weeks.
These latest data built on another positive set of trial data published back in April, which also met their testing goals.
The SPIRE-HR and SPIRE-FH studies were the third and fourth of six SPIRE lipid-lowering studies to be completed, all of which were designed to be used toward regulatory filing.
In a statement, Pfizer said after looking over these data, “Pfizer has observed an emerging clinical profile that includes an unanticipated attenuation of low-density lipoprotein cholesterol (LDL-C) lowering over time, as well as a higher level of immunogenicity and higher rate of injection-site reactions with bococizumab than shown with the other agents in this class.”
PCSK9 inhibitors work by blocking the protein that degrades LDL receptors on the liver that remove LDL cholesterol from the blood. By blocking PCSK9’s ability to work, more receptors are available to get rid of LDL cholesterol from the blood and, as a result, lower LDL cholesterol levels. The company has also been reported to be working on a pill version and a vaccine in this franchise area.
This will see Pfizer drop out of the race for market share with Amgen ($AMGN) and Regeneron ($REGN)/Sanofi ($SNY), which have both already gained marketing approvals with their injectable PCSK9 inhibitors in Repatha (evolocumab) and Praluent (alirocumab), respectively. Analysts had seen these meds making $3 billion at peak.
“As a company, we understand that developing new and important medicines for patients is a critical, but difficult undertaking,” said Dr. James Rusnak, chief development officer for Cardiovascular and Metabolic Diseases, Pfizer Global Product Development. "Accordingly, we continually evaluate our development programs as data emerge to support prudent decisions that provide value both to the patients we serve and our shareholders. We are disappointed by this outcome, but remain committed to investing in innovation, concentrating our pipeline on areas where we can bring transformational therapies to address unmet needs, including in patients with cardiovascular and metabolic diseases. We thank the investigators, their patients, and support staff who have participated in this important research program.”
Pfizer will also take a financial hit, with the co saying it will have a negative impact of around $0.04 per share on both a GAAP and adjusted basis. Pfizer also announced it has ditched a Phase II IL-6 Crohn’s candidate, as well as three Phase I tests for meds in smoking cessation, schizophrenia and a cancer biologic. The pharma was down around 2% premarket this morning.