Keryx: Patheon and Norwich sites will ensure supply of iron-based Auryxia

By Dan Stanton

- Last updated on GMT

Image: iStock/yezry
Image: iStock/yezry

Related tags Pharmacology Pharmaceutical drug

Keryx Biopharmaceuticals will continue to work with Norwich Pharmaceuticals despite bringing Patheon on board to manufacture Auryxia (ferric citrate).

Last August, Keryx announced an interruption in the supply of its 2014 FDA-approved medication Auryxia after its contract manufacturing organisation (CMO) reported problems in converting the active pharmaceutical ingredient (API) into the finished product.

But in a conference call discussing fourth quarter results last week, management revealed supply of the kidney disease drug is now stable following the clearance in November​ of a second drug product manufacturer for Auryxia, Patheon.

“The capacity that we have in our supply chain at this time with Patheon is certainly sufficient now and for the foreseeable future,”​ CEO Gregory Madison told shareholders. “We got plenty of capacity coming out of both Patheon sites to supply the marketplace.”

"However with the market opportunity that we believe exist in IDA [iron deficiency anemia], ultimately down the road there will be additional capacity that’s needed."

Neither Keryx nor Patheon replied at the time of going to press to a request for further details.

Madison also spoke about the CMO that was subject to last year’s production problems, Norwich Pharma Services with which it signed a manufacturing services agreement in 2014​.

“So we continue to work with Norwich. They are definitely part of our plans for 2017​,” he said, adding he expects the CMO to come back online before the end of the year.

Auryxia is an iron-based compound that binds phosphate and forms non-absorbable complexes, used to lower phosphate levels in patients suffering from kidney disease.

The drug is Keryx’s only commercial product, with the US rights to develop and market it licensed from Panion & BF Biotech in 2005.

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