The master manufacturing services and supply agreement will see Switzerland-based Siegfried make “GMP-grade quantities” of the active pharmaceutical ingredient (API) - ferric citrate - for Keryx until at least the end of 2021.
According to the announcement, Siegfried will “perform certain manufacturing activities at its manufacturing facilities in Saint Vulbas, France and Pennsville, New Jersey as well as to manufacture and supply GMP-grade quantities of the proprietary active pharmaceutical ingredient.”
The contract comes weeks after Biovectra Inc announced Keryx had contracted it to make ferric citrate at its facility in Charlottetown, PEI, Canada.
A Siegfried spokesman told us "Biovectra and Siegfried will supply the API and Patheon will manufacture the drug product."
This was confirmed by a Keryx spokeswoman, who told us, "We have been working with our manufacturing partners to expand manufacturing capacity for Auryxia. The contracts filed with both Seigfried and BioVectra expand API capacity with both organizations, who currently manufacture API for Keryx. These are and have been our only two API manufacturers for commercial product.
She added, "this capacity expansion is needed with the recent approval we received for an additional indication for Auryxia in the US as a treatment for iron deficiency anaemia for adults with chronic kidney disease. "
Hyperphosphatemia
Auryxia is an iron-based compound that binds phosphate and forms non-absorbable complexes. Doctors use the drug to lower phosphate levels in patients suffering from chronic kidney disease (CKD).
The US Food and Drug Administration (FDA) approved Auryxia for the treatment of hyperphosphatemia in CKD patients in 2014 with the European Medicines Agency clearing it in 2015.
Last year, the FDA also approved it for the treatment of iron deficiency anaemia in CKD patients not on dialysis.
Panion & BF Biotech
Keryx licensed US rights to develop and market ferric citrate from Panion & BF Biotech, the drug’s originator, in 2005 in return for a fee for production of the API and sales royalties.
A Panion representative told us the API is produced using technology developed by his firm, explaining, “no matter which company Keryx chooses to make such Ferric Citrate API, it will still be our technology.”
In 2007, Keryx sub-licensed Japanese development and commercialization rights 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.
Keryx Auryxia supply
In 2014, Keryx firm hired Norwich Pharmaceuticals to convert the API into the finished product for clinical development.
In 2016, the US firm contracted Patheon to make the drug after Norwich encountered problems processing the ingredient that interrupted supply.
The Keryx spokeswoman told us "We will have three Patheon sites manufacturing Auryxia tablets, and have terminated our agreement with Norwich."