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Bayer has appointed Cardinal Health as US-based contract manufacturer for Xofigo (radium Ra 223 dichloride) injection, and Cardinal Health will build a dedicated facility.
Bayer HealthCare and Cardinal Health announced, on Dec. 18, 2014, the signing of a 15-year agreement for the contract manufacturing of Xofigo (radium Ra 223 dichloride). As part of the agreement, Cardinal Health will build a 64,000-ft2 facility in Indianapolis, Indiana that will be dedicated exclusively to the manufacturing of Xofigo. Product manufactured at this facility will primarily be distributed in the US and Canada.
The manufacturing facility will be built near and leverage the capabilities of Cardinal Health's existing Indianapolis radiopharmacy, which is one of the two US locations authorized by Bayer HealthCare to distribute Xofigo. Cardinal Health is the sole distributor of Xofigo in the US.
Xofigo is an alpha-particle-emitting radioactive therapeutic agent for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease. Bayer HealthCare is developing and marketing Xofigo worldwide. The current manufacturing site in Norway will continue to be responsible for global supply of the product.
Bayer started the preparations for a second manufacturing site soon after the first marketing authorization for Xofigo was obtained in May 2013. The new Cardinal Health manufacturing facility, slated for completion in 2017, will be built and equipped for the unique manufacturing needs of Xofigo. The facility will be supported by approximately 85 employees, including specialized manufacturing roles, chemists, engineers, and other professional positions.
Source: Cardinal Health