A Lonza plant in the U.S. has been struggling for 18 months to get its manufacturing practices back up to FDA expectations. But the shortcomings are now leading to shortages for one of its key clients.
French drugmaker Ipsen says shortages of its orphan drug Increlex appear inevitable because of ongoing issues at Lonza plant in the U.S. The drug is used to treat a rare condition in children called IGF-1 deficiency, which results in them being very short for their age.
Late last month, Alexion Pharmaceuticals ($ALXN) assured investors it was on top of the issues with its pricey rare-disease drug Soliris. But the FDA report indicates that Alexion has had trouble figuring out the source of the contamination and so adequately attacking it.
CMO Lonza has signed a three-year, $6.9 million agreement with NIH's Center for Regenerative Medicine, signing on to supply stem cells for research purposes.
Lonza, the API and chemical giant, has been struggling to reduce manufacturing costs, particularly at its massive plant in Visp, Switzerland, where it has slashed 400 jobs. But CEO Richard Ridinger says more restructuring is in the cards.
Targeted drugs are becoming the focus of a growing number of companies, and manufacturers are responding by building more antibody drug conjugate manufacturing capacity.
The Swiss API and chemical company Lonza thinks it has found the solution to capacity issues at its massive facility in Visp, Switzerland: Make more product. In particular, make more antibody drug conjugates (ADCs).
Lonza will take the job ax to nearly 14% of the jobs at its massive API manufacturing site in Visp, Switzerland as efforts to cut costs there continue.
Three years after Teva Pharmaceutical Industries ($TEVA) and Switzerland's Lonza joined forces to develop a few blockbuster biosimilars, one of their lead programs has hit an unexpected roadblock.
On the anniversary of its announcement of problems with Lonza's supply of APIs, 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."