Under the agreement, Cardinal Health will build a state-of-the art, 64,000 square foot facility in Indianapolis, which will be dedicated exclusively to the manufacturing of Xofigo. Product manufactured at this facility will primarily be distributed in the US and Canada.
The new manufacturing facility, slated for completion in 2017, will be built and equipped for the unique manufacturing needs of Xofigo, the companies said, though neither responded to a request for more comment. The new space will be supported by approximately 85 employees, including specialized manufacturing roles, chemists, engineers and other professionals.
The manufacturing facility will be built near and leverage the capabilities and talent 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 (CRPC), symptomatic bone metastases and no known visceral metastatic disease. The current manufacturing site in Norway will continue to be responsible for global supply of the product, Bayer said in a statement.
"This new agreement presents us with an excellent opportunity to leverage our unmatched expertise in the nuclear pharmacy industry to expand access to a therapeutic agent," said Tiffany Olson, president of Cardinal Health's Nuclear Pharmacy Services business. "We look forward to continuing to strengthen our relationship with Bayer HealthCare, and to developing innovative services to expand the use of radiopharmaceuticals in the United States and Canada."
Bayer had started the preparations for a second manufacturing site soon after the first marketing authorization for Xofigo was obtained in May 2013, the company said.
"Cardinal Health has played a pivotal role in distributing Xofigo to medical facilities since the product's launch in the US in May 2013," said Shannon Campbell, VP and general manager of oncology, Bayer HealthCare. "Cardinal Health's proven track record in radiopharmaceuticals and their experience with Xofigo make them a formidable choice for helping to expand our manufacturing capabilities in North America."