Aptevo, a recent spinoff from Emergent BioSolutions, says it believes manufacturing issues that interrupted production of its coagulation factor IX treatment for hemophilia B have been solved and it expects to have Ixinity back on the market early in the second quarter.
The Seattle, WA-based drugmaker reported in November that CMC Biologics, its exclusive supplier for the bulk drug supply of the sterile drug, was having problems getting it to meet specifications. But the company said on Wednesday that routine manufacturing has now resumed.
“We have identified the root cause of the out-of-specification BDS result that led to the supply interruption for Ixinity and have implemented the necessary corrective measures to support resuming commercial production,” Aptevo CEO Marvin L. White said in a statement.
The company reported in its quarterly filing in November that it had ordered nine lots of the lyophilized powder for solution for intravenous injection from CMC but the CMO had been able to get only one lot to meet specs. It was being produced at CMC Biologics' facility in Bothell, Washington.
In October, Aptevo gave the FDA a heads-up that it expected a supply interruption but suggested an alternate supply plan, which the FDA turned down. Aptevo said it had to write off $2.9 million in unsaleable inventory that was in the process of being manufactured.
Aptevo was the biosciences division of Emergent, a Gaithersburg, Maryland-based company that primarily develops and produces vaccines and drugs to counter biological and chemical threats and emerging infectious diseases. The company said it decided to spin off its biosciences operations so each group could focus on what it does best.
One of the drugs that Aptevo took with it was Ixinity, which Emergent had picked up in 2013 with its $222 million buyout of Winnipeg, Manitoba-based Cangene at a time when Emergent’s leaders thought the company should branch out from its focus on bioterrorism.
Two other drugmakers also reported interruptions of drug supplies last year after their API producers ran into difficulties. One of those was Allergan, which notified the FDA in August that GlaxoSmithKline was having trouble producing the API for superbug antibiotic Avycaz at a GSK plant in Verona, Italy. Allergan believed that setback would be resolved in the first quarter of 2017. It remains on the FDA drug shortages list.
Before that, Boston-based Keryx Biopharmaceuticals reported that a production glitch had led to the depletion of supplies of its kidney drug Auryxia. It expected that problem to be resolved by year-end 2016. It is not on the FDA drug shortages list.