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Pfizer shuts down development of PCSK9 inhibitor


NEW YORK — Pfizer has discontinued the global clinical development program around its investigational high cholesterol treatment bococizumab, the company announced Tuesday, noting that because of information available about the treatment and the current market landscape, it wasn’t likely to create value for patients, doctors or shareholders. 


Pfizer said that over the course of six studies, bococizumab showed an unanticipated attenuation of LDL cholesterol lowering over time, a lower immunogenicity and a higher rate of reactions at the injection site than other agents in the class of drugs. The treatment would have joined a small class of drugs known as PCSK9 inhibitors, which currently contains Amgen’s Repatha and Sanofi and Regeneron’s Praluent. 


“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 Dr. James Rusnak,  Pfizer Global Product Development’s chief development officer, cardiovascular and metabolic Diseases. “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 expects the discontinuation to have a $0.04 per share impact on a GAAP and adjusted basis. Pfizer said it would record it as a research and development charge in the fourth quarter of 2016, and it is incorporating the impact into its updated 2016 guidance. 


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