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 ($IPN) says supply interruptions of its orphan drug Increlex appear inevitable because of ongoing issues at a Lonza API plant in Hopkinton, MA, which is the subject of a 2011 warning letter. The drug is used to treat IGF-1 deficiency, a rare condition in children, which results in them being very short for their age. Ipsen said last week that doctors and patients can expect supply interruptions to begin appearing in the U.S. immediately and in Europe and the rest of the world by the third quarter. It said Lonza is working closely with the FDA "to address these issues," but that it did not expect the supply problems to be resolved before the end of this year.
In the September 2011 warning letter, FDA inspectors focused on problems they observed with failed batches of an API for Ontak, a cancer drug from Japanese drugmaker Eisai. They said the company didn't investigate what caused the failures in potency and purity. The letter also criticized the plant's quality control unit for releasing lots of the Ontak API even though they did not meet revised specifications for the level of a chemical used in the manufacturing process.
The FDA noted in the warning letter that if problems were not fixed, they potentially could affect Increlex. And then they did. Seven months ago, Ipsen said problems were cropping up but that it believed it could manage supplies to keep Increlex available to patients. Last week, however, Ipsen indicated the manufacturing problems hadn't gotten the best of its efforts to keep the drug in the supply chain. Ipsen last year sold €28.3 million ($36.8 million) worth of Increlex.
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