Halozyme Begins Phase 2 Clinical Trial of Insulin-PH20 in Type 2 Diabetic Patients

SAN DIEGO--(BUSINESS WIRE)--Jul. 14, 2009-- Halozyme Therapeutics, Inc. (Nasdaq:HALO) today announced the commencement of patient dosing in a Phase 2 clinical study of Insulin-PH20 in patients with Type 2 Diabetes Mellitus. This randomized cross-over design study is designed to compare the postprandial glycemic excursions following a standardized test meal after treatment with either insulin lispro+PH20 or regular insulin+PH20 relative to treatment with lispro (Humalog) alone.

"This study is designed to confirm in type 2 diabetes patients the benefit of reduced postprandial hyperglycemia observed in a previous Phase 2 study conducted in type 1 diabetes patients for which interim results were reported earlier this year," explained Douglas Muchmore, M.D., Halozyme's vice president of clinical development for endocrinology. "Unlike the previous study where identical doses of lispro were given with and without PH20 to facilitate a direct pharmacokinetic comparison, the doses of each of the three drugs will be titrated independently in this study to directly compare the glycemic response under optimum treatment conditions."

This Phase 2 study will investigate the pharmacokinetics (PK) and glucodynamics of insulin lispro+PH20 and regular insulin+PH20 versus lispro alone. The primary endpoint of this study is the glycemic excursion over the first 4 hours. Secondary endpoints include the comparison of optimum doses of insulin required for glycemic control, as well as various PK, PD and safety endpoints. A number of clinical trials investigating Halozyme's Insulin-PH20 are currently underway and more trials are planned.

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 therapeutics for up to 13 targets and with Baxter BioScience to apply Enhanze Technology to Baxter's biological therapeutic compound, GAMMAGARD LIQUID™. The product candidates in Halozyme's research pipeline target multiple areas of significant unmet medical need. For more information visit https://www.halozyme.com.

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In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, (i) statements concerning the design of clinical trials and (ii) initiation of future clinical trials) 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 Therapeutics, Inc.Robert H. UhlSenior Director, Investor [email protected]