A German radiation therapy manufacturer said it will acquire a business unit from Oxford’s Biocompatibles Inc., which voluntarily suspended operations in May after federal regulators noted problems with its manufacturing process documentation.
Biocompatibles, which is owned by BTG International, will sell its prostate cancer implant business to Eckert & Ziegler AG’s medical division for $5 million, the latter company announced.
In an April 30 letter posted on the U.S. Food & Drug Administration’s website, a New England district regulator wrote to Biocompatibles that the FDA had found problems with the company’s manufacturing process for its radioactive brachytherapy needle sets, which include prostate needles pre-filled with coated radioactive seeds.
“Eckert & Ziegler is now acquiring the division and hopes to remedy these shortcomings quickly so that it can resume delivery,” Eckert said in a statement.
The company hopes to win back previous customers lost as a result of the shutdown. In the meantime, it expects to incur unforeseen additional costs of $1.6 million until the implant business can be resumed.
Biocompatibles is the fourth-largest provider of the implants in the United States and had 2012 sales of approximately $10.7 million, Eckert said.
