Halozyme Therapeutics, Inc. today announced the delivery of a notice of breach to Baxter Healthcare Corporation due to Baxter’s failure to provide HYLENEX® (hyaluronidase human injection) in accordance with the terms of the parties’ existing development and supply contracts. Baxter recently informed Halozyme that certain materials produced by Baxter are not in compliance with the requirements of the HYLENEX agreements. This noncompliance, along with Halozyme’s concerns over the quality and capabilities of Baxter’s manufacturing operations, has led Halozyme to deliver the notice of breach. In the event that Baxter is unable to remedy all material breaches within 120 days, Halozyme may terminate the HYLENEX relationship.
No medical events have been reported in connection with noncompliant HYLENEX product. Halozyme is working with the U.S. Food and Drug Administration and Baxter to ensure patient safety. Halozyme and Baxter are actively investigating both the causes and the extent of these manufacturing issues.
Halozyme believes that Baxter’s manufacturing deficiencies are specific to the 150U HYLENEX product. Neither the rHuPH20 bulk enzyme nor any other products containing the enzyme are believed to be affected.
