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The Pulse of the Pharmaceutical Industry
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.
The list pricing for the two drugs exceeded $14,000 per year. Statins are typically priced at about $50 per month. Payers have been skeptical that the high price is worth it for the typical patient with high cholesterol, although for patients with a rare genetic version of hypercholesterolemia that don’t respond to statins, the industry appears willing to pay for it.
Pfizer, taking into account those issues as well as other problems with its own drug that would make breaking into the market difficult, chose to terminate the program and write it off as an R&D expense.
Which leaves the company with what Caroll calls “one of the weakest late-stage pipelines in Big Pharma.”
Seamus Fernandez, an analyst with Leerink, wrote, “This removes an important Phase III pipeline product for Pfizer while eliminating a major potential competitor for Amgen and Sanofi/Regeneron.”
Pfizer, for its part, has said it plans to release the data from the trials as soon as possible for independent analysis. “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,” said Paul Ridker, co-chair of the Executive Committee, SPIRE clinical trials program and director for Cardiovascular Disease Prevention at Brigham and Women’s Hospital, in a statement.
Sorry. No data so far.