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Halozyme Therapeutics Announces Initiation of Phase 1 Clinical Trial with Roche Biologic

-- First patient dosed in trial with third Roche biologic formulated with Halozyme’s recombinant human hyaluronidase enzyme --

-- Halozyme to receive milestone payment --

SAN DIEGO--(BUSINESS WIRE)--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.

About Halozyme Therapeutics, Inc.

Halozyme is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company's portfolio of products and product candidates is based on intellectual property covering the family of human enzymes known as hyaluronidases and additional enzymes that affect the extracellular matrix. Halozyme’s Enhanze™ Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Roche to apply Enhanze Technology to Roche’s biological therapeutic compounds for up to 13 targets and with Baxter BioScience to apply Enhanze Technology to Baxter’s biological therapeutic compound, GAMMAGARD LIQUID. Halozyme’s research pipeline candidates target significant areas of unmet medical need. For more information visit www.halozyme.com.

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation,┬ástatements concerning Roche’s progress under the collaboration and the potential achievement of various milestones) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company's reports on Forms 10-K, 10-Q, and other filings with the Securities and Exchange Commission.

Source: Halozyme Therapeutics, Inc.

Halozyme
Robert H. Uhl
Senior Director, Investor Relations
858-704-8264
ruhl@halozyme.com

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