SAN FRANCISCO, June 9 /PRNewswire-FirstCall/ -- Halozyme Therapeutics,
Inc. (Nasdaq: HALO), a biopharmaceutical company developing and
commercializing products targeting the extracellular matrix, today announced
new Phase I data for the company's diabetes mellitus program at the American
Diabetes Association's 68th Scientific Sessions. The data showed that
combining the company's proprietary recombinant human hyaluronidase enzyme
(rHuPH20) with Humulin R(R) (regular insulin human) or Humalog(R) (insulin
lispro) yielded pharmacokinetics and glucodynamics that better mimicked
physiologic prandial (mealtime) insulin release and activity than Humulin R or
Key pharmacokinetic (PK) and glucodynamic (GD) improvements observed in
the study include:
-- Significantly faster systemic absorption of each insulin, starting with
the first observation time point of three minutes after injection
-- Significantly faster and greater glucose lowering activity early after
-- Significantly greater peak insulin levels for the same dose
-- Significantly lower variability of key PK and GD variables across
-- rHuPH20 in combination with Humulin demonstrated statistically
significant improvement across all parameters when compared to Humalog
By making mealtime insulins faster, i.e., shifting insulin exposure and
glucose lowering activity to earlier times and away from late postprandial
times, combination with rHuPH20 yielded a profile of insulin kinetics and
activity more like that of natural, endogenous prandial insulin release.
Diabetes mellitus is an increasingly prevalent, costly condition
associated with substantial morbidity and mortality. Attaining and
maintaining normal blood sugar levels to minimize the long term clinical risks
is a key treatment goal for diabetic patients. The timing of insulin
administration with meal ingestion is critical to effective control of blood
sugar levels. An ideal insulin would closely mimic normal physiologic mealtime
"If these insulin kinetics can be replicated in studies with diabetic
patients, the co-formulation of rHuPH20 with recombinant insulin products may
close the gap between currently available therapies and endogenous physiologic
insulin release," explained Richard C. Yocum, MD, Vice President of Clinical
Development and Medical Affairs at Halozyme. "The potential benefits of such
a combination include better overall glycemic control and simplified injection
rHuPH20 is the active ingredient in an FDA-approved product for use as an
adjuvant to increase the dispersion and absorption of other injected drugs.
Halozyme plans to conduct additional clinical trials in its insulin
development program, including a study in diabetic patients later in 2008.
The Phase I crossover, euglycemic clamp study was conducted in 26 healthy
male volunteers. The study had two stages: the first stage compared the PK and
GD of Humalog injected subcutaneously (SC) with and without rHuPH20, and the
second stage compared the PK and GD of Humulin R injected SC with and without
Compared to Humalog and Humulin R alone, rHuPH20 had the following effects
on PK and GD:
-- The median time to maximal insulin concentration (Tmax) decreased
significantly: 54% for Humalog (p = 0.0006) and 64% for Humulin R (p =
-- Insulin concentration increased rapidly and substantially. At 3
minutes, when the first post-injection sample was taken, the increase
was 335% for Humalog (p = 0.03) and 2,400% for Humulin R (p < 0.0001).
-- The mean maximal insulin concentration (Cmax) was substantially
increased: 90% for Humalog (p = 0.0003) and 142% for Humulin R (p <
-- The increase in systemic insulin exposure, expressed as the mean area
under the curve (AUC) was significant over the first 30 minutes, when
insulin release drives meal ingestion metabolism: 277% for Humalog (p =
0.0008) and 730% for Humulin R (p < 0.0001).
-- The mean AUC from 4 to 6 hours after injection, when insulin still
entering the circulation may lead to post-prandial hypoglycemia, showed
a substantial decrease: 41% for Humalog (p < 0.0001) and 48% for
Humulin R (p < 0.0001).
-- The glucose infusion rate (GIR) AUC from 0 to 1 hour after injection
(corresponding to the time of initial meal digestion) increased
meaningfully: 102% for Humalog (p = 0.0001) and 142% for Humulin R (p <
-- GIR AUC from 4 to 6 hours, a time when insulin may lead to post-
prandial hypoglycemia, was substantially reduced: 29% for Humalog (p =
0.0020) and 26% for Humulin R (p = 0.0265)
-- The inter-subject variability for both PK and GD parameters, as
quantitated by the coefficient of variation (CV) and used as an
indication of predictability, improved when rHuPH20 was co-
administered. For example for insulin PK:
-- The CV for Tmax was reduced by 54% for Humalog and 12% for Humulin
-- The CV for Cmax was reduced by 27% for Humalog and 24% for Humulin
-- The co-injection of Humulin R, a regular insulin, with rHuPH20
demonstrated reduced Tmax, and tGIRearly50% as well as increased Cmax
relative to the fast-acting analog Humalog alone (without rHuPH20):
-- The insulin Tmax for Humulin R with rHuPH20 was 43% shorter than for
Humalog alone (p = 0.02).
-- The insulin Cmax for Humulin R with rHuPH20 was 43% greater than for
Humalog alone (p = 0.046).
-- The tGIRearly50% for Humulin R with rHuPH20 was 31% shorter than for
Humalog alone (p = 0.0004).
-- All injections were well-tolerated, with no serious or severe adverse
events (AEs). No injection with rHuPH20 resulted in any AE assessed as
related to rHuPH20.
The study results were presented in full at the American Diabetes
Association's 68th Scientific Sessions in San Francisco as a late breaking
abstract. The poster from the ADA presentation is available on Halozyme's
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing
products targeting the extracellular matrix for the drug delivery, metabolism,
oncology and dermatology markets. The company's portfolio of products and
product candidates is based on intellectual property covering the family of
human enzymes known as hyaluronidases. The company's Enhanze(TM) Technology
is a novel drug delivery platform designed to increase the absorption and
dispersion of biologics. Its key partnerships are with Roche to apply Enhanze
Technology to Roche's biological therapeutic compounds for up to 13 targets
and with Baxter to apply Enhanze Technology to Baxter's biological therapeutic
compound, GAMMAGARD LIQUID 10%. In addition, the company has received FDA
approval for two products: Cumulase(R), for use in in-vitro fertilization, and
HYLENEX, for use as an adjuvant to increase the absorption and dispersion of
other injected drugs and fluids. HYLENEX is partnered with Baxter
International Inc. The Company also has a number of different enzymes in its
portfolio that are targeting significant areas of unmet need.
Safe Harbor Statement
In addition to historical information, the statements set forth above
include forward-looking statements (including, without limitation, statements
concerning (i) the potential benefits of co-formulating rHuPH20 with insulin
and an insulin analog and (ii) plans to conduct additional 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.
CONTACT: Robert H. Uhl, Senior Director, Investor Relations of
Halozyme, +1-858-704-8264, firstname.lastname@example.org; or Karen Sparks, x275,
email@example.com, or Joleen Schultz, x215, firstname.lastname@example.org, both of
Web site: http://www.halozyme.com