Halozyme finishes Hylenex manufacturing probe, strategizes market relaunch

Halozyme completes Hylenex manufacturing probe

SAN DIEGO — Halozyme Therapeutics Inc. said Tuesday it completed an investigation into manufacturing problems behind its Hylenex product and has drawn up a corrective action plan and market relaunch strategy.

Hylenex is used to help the body increase the absorption of fluids, in order to boost injected drugs and to increase the absorption of fluids and drugs administered under the skin. The drug was launched in the United States in 2009 for use in pediatric rehydration.

In May, Baxter International Inc. voluntarily recalled all lots of Hylenex because of glass particles found in vials of the product. Baxter, based in Deerfield, Ill., makes Hylenex for San Diego-based Halozyme.

Baxter said in a separate statement that the problem was caused by an incompatibility between the drug and the glass vial.

“There is no indication that Baxter’s manufacturing operations and processes were the cause of the particulate matter,” he said.

To date, no adverse medical events have been reported in connection with the withdrawn Hylenex product.

Halozyme and Baxter are completing materials for a meeting with the Food and Drug Administration over the reintroduction strategy. Halozyme said it has lifted the breach of contract notice it sent Baxter in May.

Shares of Halozyme fell a penny to $7.18 in Tuesday morning trading, while Baxter shares fell 23 cents to $42.97.