Keryx announced the US Food and Drug Administration (FDA) had cleared Patheon to make Auryxia in a SEC filing last night. The Boston firm said Patheon will help it make the drug available to wholesalers in due course.
CEO Greg Madison said: “Getting a second drug product manufacturer approved was an important step to ensuring long-term supply of Auryxia is consistently available to patients.”
Keryx has not disclosed details of its original contract manufacturer.
Auryxia is Keryx’s only drug.
According to an SEC filing Keryx signed a manufacturing services agreement with Norwich Pharmaceuticals in 2014.
Auryxia 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 disease and has been available in the US since 2014 when it was approved by the FDA.
In August, Keryx announced supplies of the drug would be interrupted explaining, in an SEC filing, that an unnamed contractor had encountered problems converting the active pharmaceutical ingredient (API) into the finished product.
At the time the firm also said it was working with a second contractor – Patheon – to restore supplies.
Keryx licensed US rights to develop and market ferric citrate from Panion & BF Biotech in 2005.
Under the deal, Panion receives royalty payments based on net sales, as well as a manufacturing fee for product manufactured for use in the licensed territory.
Earlier this year a Panion spokesman told us “All the [Auryxia] API is manufactured by us. The actual tablets are manufactured locally in their respective regions.”
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.
Since this article was published Keryx has confirmed it will continue to work with Norwich.
Spokeswoman Amy Sullivan told us “our original CMO, Norwich, experienced an issue converting API to drug product. This led to the supply interruption that we announced on August 1st.
“We have expanded our drug product manufacturing capability, with the approval of Patheon … We now have two approved drug product manufacturers for Auryxia in the US” she said, adding “We are working with Norwich to remedy the issue and resume commercial production at their facility.”