In February last year, the US Food and Drug Administration (FDA) issued a warning letter to Pfizer’s fill and finish facility in McPherson, Kansas.
The facility was one of a number Pfizer added to its network when it acquired Hospira for $17bn in 2015 and is now part of its contract manufacturing business CentreOne.
But according to the firm, the FDA upgraded the status of the facility this month to Voluntary Action Indicated (VAI), following an inspection last October.
“The change to VAI status will lift the compliance hold that the FDA placed on approval of pending applications and is an important step toward resolving the issues cited in the February 2017 FDA Warning Letter,” the firm said.
The status lift also bodes well for Novartis subsidiary Sandoz and partner Momenta which contracts Pfizer to fill/finish their generic version of Teva’s Copaxone (glatiramer acetate injection) from the plant. The warning delayed approval of their product Glatopa 40 mg last year, but in a statement yesterday Momenta said the FDA upgrade puts the product on course for approval and launch in the first half of 2018.
Sterile injectable shortages
Pfizer continues to remediate compliance problems across the former Hospira network.
The firm’s fourth quarter suffered from a 10% operational decline due to shortages of Hospira legacy sterile injectable products “largely driven by capacity constraints and technical issues,” John Young, group president of Pfizer Innovative Health said on a results call yesterday.
“As we said during the Hospira acquisition, we were aware that there are manufacturing issues that were confirmed during the due-diligent process, but we have a robust action plan in place and we believe that we’ll make progress during 2018 towards reducing sterile injectable shortages and that will include investing capital in those specific plans,” he told stakeholders.
And Pfizer is set to have access to capital to invest in its US manufacturing network, CEO Ian Read confirmed on the call, thanks to the ‘Tax Cuts and Jobs Act,’ signed into law by president Donald Trump on December 22.
The Act is allowing multinationals to repatriate cash from overseas, and already fellow Big Pharma firms J&J and AbbVie have hinted at multi-billion dollar investments in their US networks over the coming years.
“After evaluating the expected positive net impact, the new tax code will have on Pfizer, we have decided to take several actions,” Read told stakeholders.
“Over the next five years, we plan to invest approximately $5bn in capital projects in the US including the strengthening of our manufacturing presence in the US.”