Roche conducts third Phase 1 clinical trial utilizing Halozyme’s Enhanze Technology

Sep 10 2009

Halozyme Therapeutics, Inc. (Nasdaq: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced that the first patient was dosed in a Phase 1 pharmacokinetic clinical trial using Enhanze™ Technology (rHuPH20, recombinant human hyaluronidase) in a subcutaneous formulation of a Roche biologic. This biologic represents the third Roche proprietary compound directed to an exclusive target to enter the clinic as part of the Halozyme Roche collaboration. Initiation of the clinical trial has triggered a milestone payment under the agreement.

“The initiation of the third Phase 1 clinical trial by Roche since December 2008 utilizing our rHuPH20 enzyme further underscores their commitment and belief in the commercial potential of Halozyme’s technology,” said Jonathan Lim, M.D., Halozyme’s President and CEO. “We value Roche’s clinical expertise and ability to move multiple programs forward.”

Halozyme Roche Collaboration

In December 2006, Halozyme entered into an agreement with Roche to apply Halozyme’s proprietary Enhanze Technology to selected biological therapeutic compounds from Roche. Under the terms of the agreement, Roche made an initial payment to Halozyme for the application of its recombinant human enzyme, rHuPH20, to three pre-defined biologic targets exclusive to Roche. In December 2008, Roche selected a fourth biologic target followed by selection of a fifth target in June 2009 and has the option to exclusively develop and commercialize rHuPH20 with an additional eight potential targets. Pending the successful achievement of a series of clinical, regulatory, and sales events, Roche may pay Halozyme additional milestones as well as royalties on potential future product sales. Under the collaboration, Roche has access to Halozyme’s expertise in developing and applying rHuPH20 to Roche biologics directed at multiple targets. Roche obtained a worldwide, exclusive license to develop and commercialize product combinations of rHuPH20 and Roche compounds resulting from the collaboration.

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