Earlier this month, Pfizer dumped development of a new cholesterol-lowering drug candidate that had not lived up to expectations in a late-phase trial. Now Pfizer is dumping much of the €400 million plant expansion in Ireland it was planning to support it.
With the decision not to proceed with the proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) bococizumab, the New York drugmaker will not need the 371,300-square-foot expansion of its Grange Castle biologics manufacturing unit or the 300 or so jobs that would have brought, the Irish Times reported today.
A company spokeswoman pointed out in an email today that Pfizer had never confirmed an expansion, only that it had submitted plans for one to authorities in Ireland. It said today it will still do a smaller version of the expansion for production of other drugs at the massive site, where it currently employs about 1,100 workers.
“Following the decision to discontinue the development of bococizumab, part of the potential expansion for which the planning permission was sought will not now go ahead,” she said. “Expansion in relation to other incoming products will continue as planned, involving investment, recruitment and new technology.”
When Pfizer confirmed last summer that it was contemplating a $423 million expansion of the facility, it said the project would be completed in two phases, adding 200 jobs to Pfizer’s Ireland operations with the initial phase and another 100 jobs upon completion of the second.
That changed when the drug giant announced this month that it found that bococizumab “is not likely to provide value to patients, physicians, or shareholders” after data showed its ability to lower LDL-C weakened over time and increased the risk of some adverse events. It said that “taken together with the evolving treatment and market landscape for lipid-lowering agents,” it had decided to discontinue the development program, including the two ongoing cardiovascular outcome studies.
That leaves the field to Amgen and partners Sanofi and Regeneron, which already have PCSK9 cholesterol-fighters Repatha and Praluent on the market. But the “market landscape” Pfizer referred to includes the fact that payers have slapped prior-authorization hurdles on the drugs and uptake has not been what was originally anticipated. Many doctors say they're waiting for more data that would show whether Praluent and Repatha significantly cut the risk of cardiovascular events such as heart attacks, data that would change their thinking on use significantly.