After years of manufacturing woes, Pfizer appeared to turn a corner earlier this year for its growing sterile injectables portfolio. But even with signs trending upward, Pfizer is preparing to exit an Australian site specializing in those drugs as part of a global reorganization effort.
Pfizer will walk away from its more than 50-year-old facility in Perth, Australia—and jeopardize 470 jobs—as the company undergoes a “thorough evaluation” of its global manufacturing chain, a Pfizer spokeswoman said Monday.
The New York-based drugmaker expects to wind down operations at the Perth site by the end of 2023 and fully exit the facility in the first quarter of 2024. The facility specializes in sterile injectable manufacturing and mostly supplies drugs to the Australian and New Zealand markets, according to Pfizer’s website.
The plant also produces a range of oncology products that are exported globally; in all, the plant churns out 120 million doses annually.
With the Perth site closed, Pfizer will transfer that manufacturing to its Melbourne, Australia facility and other overseas plants, the spokeswoman said.
As for the 470 workers, Pfizer is “committed to keeping them informed of the site exit process,” but the spokeswoman did not specify the details of that plan.
Pfizer’s exit from Perth comes at a crucial time as the drugmaker looks to spin off its flagging Upjohn generics unit into a merger with Mylan expected to close later this year.
Meanwhile, the company’s sterile injectables portfolio only recently turned a corner after a series of disastrous manufacturing setbacks left much of the drugmaker’s portfolio undersupplied for years. In April, CEO Albert Bourla said remediation and modernized manufacturing investments allowed the company to stock 90% of its portfolio.
In March, Pfizer distributed seven-and-a-half times the baseline demand of 30 of its sterile injectable products to cover back orders, including the shipping of 10 drugs at more than double demand, Bourla said. In certain cases, Pfizer delivered sterile injectables at more than five times demand, showing the drugmaker’s newfound ability to ship its portfolio at scale.
In all, Pfizer’s sterile injectables portfolio revenue grew 15% in the first quarter from the same time period the previous year.
Those recent gains came years after the FDA blasted Pfizer’s facility in sterile injectables facility in McPherson, Kansas—a 2015 pickup from its $15 billion Hospira buyout.
In 2016, the FDA cited Pfizer for a number issues at the McPherson site and followed up with a 2017 warning letter and 2018 inspection that noted many of the same concerns.
A May 2016 inspection alerted the company to problems, but a 2017 warning letter made it clear the FDA was not satisfied with Pfizer’s efforts to solve those issues at that point. A 10-page Form 483 in August 2018 included eight observations, seven of which were repeats.
Those most recent mistakes came after Pfizer said it had invested $800 million in its injectables operations through 2018.
Oct 19, 2020