Pfizer to discontinue two ongoing cardiovascular studies

Pfizer announced today the discontinuation of the global clinical development program for bococizumab, its investigational Proprotein Convertase Subtilisin Kexin type 9 inhibitor (PCSK9i).

The company said that the totality of clinical information now available for bococizumab, taken together with the evolving treatment and market landscape for lipid-lowering agents, indicates that bococizumab is not likely to provide value to patients, physicians, or shareholders. As a result, Pfizer has decided to discontinue the development program, including the two ongoing cardiovascular outcome studies.

With the completion of six bococizumab lipid-lowering studies, 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. The goal of treating elevated cholesterol is to reduce the occurrence of cardiovascular events such as heart attacks and stroke, which requires long-term effective and durable cholesterol-lowering, explained the company.

“As a company, we understand that developing new and important medicines for patients is a critical, but difficult undertaking. 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,” said James Rusnak, MD, PhD, Chief Development Officer, Cardiovascular and Metabolic Diseases, Pfizer Global Product Development. “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.”

“To honor the altruism of trial participants, and to maximize the clinical and scientific knowledge derived from the halted trials, Pfizer has committed to ensuring that the data will be made available to study leaders for independent analysis and prompt public presentation. We believe the available data will allow us to test the core scientific questions posed by the overall program which is in the best interest of patients who volunteered in these clinical trials, and for patients worldwide who suffer from heart disease,” stated Paul M. Ridker, MD, Co-chair Executive Committee, SPIRE clinical trials program and director for Cardiovascular Disease Prevention, Brigham and Women’s Hospital.

Pfizer estimates that the discontinuation of the bococizumab development program will have a negative impact of approximately $0.04 per share on both a GAAP and adjusted basis. Pfizer will record this as a Research and Development charge in the fourth quarter of 2016 and is incorporating this estimated impact into its updated 2016 financial guidance, which will be provided in conjunction with its third quarter earnings release to be issued this morning.