DEERFIELD, Ill., August 31, 2010 - In response to Halozyme's update on the HYLENEX recall and associated progress, Baxter today issued the following comments.
Baxter has completed its investigation of particulate matter observed in select vials of HYLENEX recombinant (hyaluronidase human injection), the subject of a May 2010 recall of the product. The results indicated that the root cause was incompatibility between the product formulation and the glass vial (a process known as delamination), unrelated to Baxter's fill and finish manufacturing activities. There is no indication that Baxter's manufacturing operations and processes were the cause of the particulate matter. All batches were processed according to approved manufacturing specifications and met all acceptance criteria prior to Halozyme's release of the product.
Baxter will work with Halozyme on potential regulatory and commercial paths forward, including presenting information to the U.S. Food and Drug Administration.
Today, Halozyme also withdrew a breach of contract notice it had delivered to Baxter in May. Baxter strongly disagreed with Halozyme's previous assertions, firmly believing that the company was in full compliance with its obligations. We are pleased that this situation has been resolved.