Keryx's announced halt in a US Securities and Exchange Commission (SEC) filing last night, explaining that its unnamed CMO had reported problems converting the active pharmaceutical ingredient (API) into the finished product.
Boston based Keryx added that the stoppage will interrupt supplies going on to say it is working with a second contract manufacturing organisation in a bid to restore supplies before the end of 2016.
The drug is an iron-based compound that binds phosphate and forms non-absorbable complexes. It is used to lower phosphate levels in patients suffering from kidney diseases.
It was approved by the US Food and Drug Administration (FDA) in 2014.
Keryx CEO Greg Madison told investors during the firm's second quarter earnings call that: “In the past few months we began experiencing difficulties converting active pharmaceutical ingredients to finished drug product, which resulted in variable yields.
“We have been managing supply levels efficiently even with the increased demand generated by our field team in the second quarter. Last week our CMO notified us that a production issue reoccurred in its latest run and they agreed to stop production to identify the problem."
Madison said Keryx has been working to add a second CMO since 2014, explaining that the company in question has already produced Auryxia.
"The finished tablets already on hand coupled with the additional production runs scheduled with this manufacturer we believe would allow us to come back to the market during the fourth quarter pending FDA approval of the site."
Keryx licensed worldwide rights, excluding certain Asian countries, to develop and market ferric citrate from Taiwan-based Panion & BF Biotech in 2005.
Under the deal, Panion is eligible to receive royalty payments based on net sales, as well as a manufacturing fee for product manufactured for use in the licensed territory.
A Panion spokesman told us “All the [Auryxia] API is manufactured by us. The actual tablets are manufactured locally in their respective regions.”
Keryx signed a manufacturing services agreement with Norwich Pharmaceuticals in 2014.
The firm did not respond to a request for comment.
In 2007 Panion licensed Japanese development and commercialization rights for ferric citrate to Japan Tobacco and its subsidiary Torii Pharmaceutical Co.
JT and Torii received manufacturing and marketing approval for ferric citrate in January 2014 and launched the product the following May as Riona.