A year ago today, Lonza got a warning letter from the FDA questioning whether it could stand behind the potency and purity of APIs being manufactured at its plant in Hopkinton, MA.
At the time, French drug company Ipsen, and the Japan-based Eisai, both of which bought APIs from the Swiss contract manufacturer, let the world know they were working with Lonza and the FDA to insure ongoing supplies of their drugs. In February, however, Ipsen told shareholders that it would take a write-down on its growth failure treatment Increlex because of "uncertainties on the supply" from Lonza. It said, however, that "The FDA should be carrying out further plant inspection shortly."
However, yesterday, on the anniversary of its first announcement, Ipsen sent out another declaration that it is still working with the FDA and Lonza, but assured "that it has avoided an interruption in U.S. supply of Increlex."
A Lonza spokeswoman simply responded to FiercePharmaManufacturing via email: "As announced today by Ipsen, Lonza and Ipsen are working together with FDA in the supply of U.S. patients with this important drug." She was unable to provide insight into when issues there may be resolved.
When FDA inspectors wrote up their observations, they focused on problems they found with failed batches of Eisai's cancer drug, Ontak, saying the company didn't investigate what caused the failures in potency and purity. But the FDA noted that if the problems were not fixed, they potentially could affect Increlex.
- here's the announcement
Lonza trouble may trigger big write-down at Ipsen
FDA slams manufacturing shortfalls at Daiichi unit