Pfizer backs out of PCSK9 development
- Along with third quarter earnings Tuesday, Pfizer disclosed has abandoned further development of its PCSK9 inhibitor bococizumab.
- The big pharma has been waffling about staying in the space, indicating previously they were losing interest in the once-hot class. Pfizer announced last quarter it would discontinue the development of its oral PCSK9 inhibitor.
- "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," Pfizer said in a statement.
PCSK9 inhibitors were once a highly anticipated class of cholesterol drugs, watched closely by analysts and investors who saw them as the next big blockbusters.
Yet the two PCSK9 drugs already on the market have failed to gain traction due to high price tags, inconvenient administration and a niche patient population. The drugs, sold by Amgen and the Sanofi, Regeneron team, have faced major pushback from payers, while physicians often have to go through substantial paperwork to justify prescriptions
On top of all of those obstacles, the cholesterol market is currently saturated by low-cost generic statins, most of which actually work well for a large share of patients.
Pfizer has tested bococizumab in six Phase 3 trials and shown the drug is highly effective in lowering "bad" cholesterol, or LDL-C. While that sounds positive, there has been some controversy over whether lowering LDL-C is effective in actually decreasing the risk of heart problems.
In its statement Tuesday, the company noted there was high-immunogenicity and high injection site reactions in some of the bococizumab trials.
Pfizer had two cardiovascular outcomes studies in the works — both of which would require years of study, thousands of patients and lots of cash. Both studied have now been halted due to this decision, ostensibly saving Pfizer some money.
Elsewhere, The Medicines Co. continues to push ahead with its PCSK9 synthesis inhibitor.
- Pfizer Statement
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