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Halozyme Therapeutics Announces Roche Begins Phase 1 Clinical Trial With Second Biologic

Key Takeaway: Halozyme Therapeutics announced that Roche has begun a Phase 1 clinical trial using its Enhanze Technology for a new biologic target. This marks the second trial initiated by Roche in a short period, highlighting their efficient development approach. The collaboration could yield additional milestone payments and royalties for Halozyme, contingent on successful outcomes.

Market Sentiment Analysis

POSITIVE FACTORS

  • Roche has initiated a second clinical trial quickly, showcasing efficiency.
  • Halozyme's Enhanze Technology is being applied to multiple targets.
  • The collaboration may lead to significant milestone payments and royalties.

CONCERNS & RISKS

  • The success of the collaboration depends on achieving clinical and regulatory milestones.
  • Forward-looking statements involve risks and uncertainties that could impact results.

Full Press Release Details

SAN DIEGO, Jan. 15, 2009 (GLOBE NEWSWIRE) -- Halozyme Therapeutics, Inc. (Nasdaq:HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced that Roche has dosed the first patient in a Phase 1 pharmacokinetic clinical trial with a subcutaneous formulation using Enhanze(tm) Technology of a biologic directed to a second Roche exclusive target. This has triggered a milestone payment under the agreement.
"This is the second clinical trial initiated by Roche within a short timeframe and illustrates the rapid and efficient approach Roche is taking to develop different biologicals simultaneously with Enhanze Technology," said Jonathan Lim, M.D., Halozyme's President and CEO.
Halozyme Roche Collaboration
In December 2006, Halozyme entered into an agreement with Roche to apply Halozyme's proprietary Enhanze Technology to Roche's biological therapeutic compounds. Under the terms of the agreement, Roche paid Halozyme an initial payment for the application of its recombinant human enzyme, rHuPH20, to three pre-defined Roche biologic targets. In December 2008, Roche selected a fourth biologic target and has the option to exclusively develop and commercialize rHuPH20 with an additional nine 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 targets. Roche obtained a worldwide, exclusive license to develop and commercialize product combinations of rHuPH20 and Roche target 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(tm) 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 visitwww.halozyme.com.
The Halozyme Therapeutics, Inc. logo is available athttp://www.globenewswire.com/newsroom/prs/?pkgid=5750
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements 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.

Frequently Asked Questions

What is the purpose of the Phase 1 trial?

The Phase 1 trial aims to evaluate a subcutaneous formulation of a biologic using Enhanze Technology.

How many targets can Roche develop with Halozyme's technology?

Roche has the option to develop up to 13 targets using Halozyme's Enhanze Technology.

What milestone was triggered by this trial?

The initiation of the trial triggered a milestone payment under the collaboration agreement.

What is Enhanze Technology?

Enhanze Technology is a drug delivery platform designed to enhance the absorption of biologics.

Last updated: Jan 15, 2009