BioVectra Inc., an innovative global contract development and manufacturing organization (CDMO), announced a long-term supply agreement with Keryx Biopharmaceuticals, Inc., to manufacture Ferric Citrate, the active pharmaceutical ingredient (API) in Auryxia® tablets, a medicine approved for the treatment of two common complications of chronic kidney disease.
BioVectra Inc. brings over 45 years of contract development and manufacturing experience to the partnership, including working with Keryx to manufacture Ferric Citrate API since 2003. BioVectra will prepare for the anticipated growth in the long-term Ferric Citrate API supply needs by expanding production capacity at their headquarters facility in Charlottetown, PEI, Canada.
“This partnership is a pivotal step in our journey as BioVectra. It is a shining example of the innovation, talent and determination we have cultivated in the Atlantic Canada region. We take great pride in serving the needs of global partners and the patients they are treating,” said BioVectra President, Oliver Technow. “We are very pleased to bring an agreement of this magnitude, creating highly skilled jobs, to Charlottetown, PEI. It is another terrific accomplishment for bioscience in Atlantic Canada.”
“With the recent U.S. FDA approval of Auryxia for a second indication, it is critical that we have sufficient manufacturing capacity to support anticipated future prescription demand,” said Melissa Bradford-Klug, Chief Business Officer of Keryx Biopharmaceuticals. “BioVectra has been manufacturing the active pharmaceutical ingredient in Auryxia since 2003 and we believe they will be a great partner as we continue to expand the supply chain for Auryxia.”
“This partnership illustrates what BioVectra does best. Since Keryx first approached us for clinical supply nearly 15 years ago, we have collaborated on Auryxia’s clinical phases, registration, and commercial launch to a point where we are expanding capacity to meet increased market demand,” said Vice President of Business Development, Heather Delage. “We look forward to continuing to be an important part of Keryx’s long-term strategic supply chain.”
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, Inc., with headquarters in Boston, Massachusetts, is focused on the development and commercialization of innovative medicines that provide unique and meaningful advantages to people with kidney disease. The Keryx team consists of approximately 200 committed people working with passion to advance the care of people with this complex disease. This dedication has resulted in two FDA-approved indications for Keryx’s first medicine, Auryxia® (ferric citrate) tablets. For more information about Keryx, please visit www.keryx.com.
BioVectra is a CDMO that serves pharmaceutical and biotech companies with full-service cGMP outsourcing solutions for intermediates and active pharmaceutical ingredients. An innovative and reliable service partner with a strong regulatory history, BioVectra has over 45 years of experience specializing in:
- GMP Microbial Fermentation & Purification
- Complex Chemistry
- Process & Analytical Development
For more information about BioVectra, please visit www.biovectra.com.