Halozyme expects to complete enrollment in Infuse-Morphine trial in fourth quarter

By Jennifer Lanning Drey

Eugene, Ore., Sept. 7 - Halozyme Therapeutics, Inc. plans to complete enrollment in its clinical trial of subcutaneous administration of morphine with Hylenex in the fourth quarter, said Jonathan Lim, president and chief executive officer of Halozyme, during a presentation at the Roth New York Conference on Thursday.

Hylenex is approved for use as a spreading agent to accelerate the delivery of fluids and drugs.

The Infuse-Morphine study is designed to determine the time to maximal blood levels of morphine after subcutaneous administration with and without Hylenex and maximal blood levels after intravenous administration of morphine. The study, which began in February, is also assessing safety and tolerability.

"Hylenex for subcutaneous rather than IV infusion represents a fundamentally new route of administration," Lim said.

The commercial launch of Hylenex will initially target patients being treated in hospice situations and with palliative medicines since administering Hylenex does not require a skilled caregiver. The company believes the technology may allow patients to remain in their homes longer, Lim said.

"Hylenex can potentially transform outpatient symptom management," he said.

Halozyme is preparing to recruit and train a dedicated sales force for Hylenex, and the company expects a full-scale commercial launch of the product in early 2007.

Halozyme began implementing plans for a targeted launch of Hylenex in the first quarter with Baxter Healthcare Corp. The launch plans involve using post-marketing trials to continue to build a clinical foundation, Lim said.

The company plans to begin clinical trials of Hylenex in conjunction with antibiotic, antipsychotic and anti-nausea medications, Lim added.

"These will form the solid foundation for our launch plans," he said.

Halozyme is a biopharmaceutical company that develops and commercializes recombinant human enzymes for infertility, ophthalmology and oncology.

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