- Pfizer said it is making progress in resolving some of the legacy manufacturing issues it inherited with its 2015 acquisition of Hospira, even though the drugmaker was recently hit with a new warning letter from the Food and Drug Administration.
- In that letter, the regulator cited an array of GMP violations at Pfizer's McPherson, Kansas facility, which had been inspected in May and June of last year.
- "The actual inspections were recently of Hospira," Pfizer CEO Ian Read explained on an earnings call earlier this week. "They were within, I believe the first nine months of our acquisition, so the data in the [Form] 483s are based on a view of the plan as one and a half years ago or one year ago."
Pfizer has had difficulties bringing Hospira's manufacturing facilities into compliance with the FDA. The drugmaker's continued problems come amid stepped-up oversight from the FDA of manufacturing standards, which has impacted approval of a number of drugs in recent quarters.
"We're obviously disappointed of the outcome of recent regulatory inspections at some of our manufacturing facilities, including McPherson," said John Young, head of Pfizer's Essential Health unit.
"We are making all of the investments necessary to satisfy the items identified during the recent inspections, and our goal is to have these issues remediated in timely fashion."
Interestingly, the warning letter issued to Pfizer's McPherson facility could delay approval of Momenta Pharmaceutical's generic version of Teva's blockbuster Copaxone (glatiramer acetate).
Momenta has developed the 40 mg generic Copaxone copy in partnership with Novartis' Sandoz unit, which in turn contracted fill/finish manufacturing for the drug to Pfizer. While approval may be dependent on successful remediation of the GMP concerns at McPherson, Momenta believes it could still win approval this year — potentially hitting Teva's bottom line.