Halozyme Study Results Show Faster Insulin Absorption when Administered in Combination with a Wide Range of PH20 Enzyme Concentrations

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Wed Oct 21, 2009 1:30pm EDT

-- Faster Absorption and Greater Peak Concentrations Reported for Combinations
of PH20 with Regular Insulin and Insulin Lispro Compared to Either Insulin Alone
-- 

-- Effects of Insulin Were Accelerated with the Addition of PH20 as Measured by
Glucodynamic Endpoints -- 
SAN DIEGO--(Business Wire)--
Halozyme Therapeutics, Inc. (Nasdaq:HALO) today announced dose response study
results that demonstrated faster insulin absorption and increased peak insulin
concentrations after co-administration of its recombinant hyaluronidase enzyme
(rHuPH20 or PH20) with regular human insulin and with insulin lispro. The
enhanced absorption effects were observed at clinically relevant insulin doses
across a broad range of PH20 concentrations. In addition, study results also
showed accelerated insulin action as measured by glucose infusion rates in this
euglycemic glucose clamp study. The company presented these results today at the
International Diabetes Federation Congress in Montreal. 

"This study has demonstrated faster insulin absorption for varying insulin doses
and PH20 concentrations. Even at relatively low insulin doses and low
concentrations of PH20, the faster insulin absorption produced an acceleration
of the effects of insulin," said Doug Muchmore, M.D., vice president,
endocrinology clinical development. "This dose response study allowed us to
determine the optimal enzyme concentration, an important milestone in the
development of our ultrafast insulin program, which has already been useful in
the design of ongoing clinical trials." 

The study enrolled healthy volunteers in cohorts of four subjects who received
either 3U or 12U of regular insulin or 1.5U or 6U of insulin lispro, without
PH20 and with five different concentrations of PH20 during a total of six clamp
procedures. The results demonstrated that PH20 is a potent enhancer of insulin
absorption over a wide range of concentrations, 0.3 to 80 micrograms per mL,
with an optimum effect at about 5 micrograms per mL. Observed adverse events
were generally mild, and PH20 was well tolerated when co-injected with either
regular human insulin or insulin lispro. 

The goal of Halozyme`s ultrafast insulin program is to develop a best-in-class
insulin product in comparison to the current standard of care analog products
that participate in the growing $3 billion prandial insulin market. Halozyme is
developing two different products in parallel to explore a maximum range of
value creating opportunities: recombinant human insulin formulated with PH20
(Insulin-PH20), and a rapid acting insulin analog formulated with PH20
(Analog-PH20). With a more rapidly absorbed, faster acting insulin product,
Halozyme seeks to demonstrate one or more significant improvements relative to
existing treatment, such as improved glycemic control, less hypoglycemia, and
less weight gain. A number of Phase 1 and Phase 2 clinical pharmacology trials,
and registration trial-enabling treatment studies are ongoing or planned, that
will investigate the various attributes of Halozyme`s insulin product
candidates. A multidose crossover treatment study in type 1 patients is
currently underway that compares regular insulin with PH20 to Humalog® (insulin
lispro), where patients self-administer each test drug for three months. Results
are expected in 3Q10. 

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
www.halozyme.com. 

Safe Harbor Statement

In addition to historical information, the statements set forth above include
forward-looking statements (including, without limitation, statements concerning
(i) program goals, (ii) product characteristics, (iii) other clinical trials,
and (iv) clinical trial results and the conclusions drawn from such 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.

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



Copyright Business Wire 2009

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