Halozyme gets FDA OK for Hylenex; Baxter preps for launch

By E. Janene Geiss

Philadelphia, Dec. 5 - Halozyme Therapeutics, Inc. and Baxter Healthcare Corp. announced Monday that the U.S. Food and Drug Administration has approved Halozyme's Hylenex for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs.

Baxter will market and sell Hylenex, a proprietary recombinant hyaluronidase human injection, in the United States, according to a joint news release.

"This is a landmark achievement for Halozyme. We believe Hylenex will help enhance the practice of medicine by offering health care providers and their patients a human recombinant product as an adjuvant to increase the absorption of other injected drugs," Jonathan Lim, Halozyme's chairman and chief executive officer, said in the release.

Bayer said it is preparing to launch Hylenex.

"We look forward to using our expertise and strong channels to successfully launch Hylenex, allowing patients in many clinical settings to benefit from the product manufactured with this promising technology," Daniel Tasse, general manager of Baxter's anesthesia, critical care and oncology business, said in the release.

Results from a clinical trial conducted to support the Hylenex New Drug Application demonstrated no allergic reactions to Hylenex and significantly reduced injection site discomfort, officials said.

The double-blinded clinical study compared Hylenex to a saline control in 100 human volunteers. These volunteers were injected intradermally with Hylenex in one forearm and saline control in the other forearm, and evaluated for allergic responses and injection site side effects. The data showed injection-site discomfort - stinging, burning, other discomfort - of 28% in the saline arm and 3% in the Hylenex arm, officials said.

Halozyme is a San Diego biopharmaceutical company dedicated to developing and commercializing recombinant human enzymes for the infertility, ophthalmology and oncology communities.

Baxter, based in Deerfield, Ill., is the principal U.S. operating subsidiary of Baxter International Inc., a biotechnology company that develops medical devices and pharmaceuticals.

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