Pfizer (PFE) has abandoned its PCSK9 inhibitor program to treat cholesterol. The company is ending its development of bococizumab SPIRE Phase III, as well as its two remaining Phase III SPIRE-1 and SPIRE-2 trials.
PCSK9 inhibitors are a new class of drugs developed to treat high cholesterol. So far, the class is represented by Regeneron (REGN) and Sanofi (SNY)’s Praluent and Amgen (AMGN)’s Repatha. Neither drug, which is extremely expensive compared to current standard-of-care statins, have performed as well as hoped, clearly a factor in Pfizer’s decision.
Pfizer indicates that over the six studies of bococizumab, it doesn’t show as much lowering of cholesterol levels over time as hoped, that patients were showing more of an immune response than predicted, and there were more side effects that desirable.
“As a company, we understand that developing new and important medicines for patients is a critical, but difficult undertaking,” said James Rusnak, chief development officer, Cardiovascular and Metabolic Diseases, Pfizer Global Product Development, in a statement. “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.”
The company further indicated that the termination of the program was likely to have a negative 4-cent-per-share effect on its earnings per share, and was recording it as a Research and Development charge in the fourth quarter, as well as putting it into its updated 2016 financial guidance