MUNICH, Germany, March 10 /PRNewswire-FirstCall/ -- Halozyme Therapeutics,
Inc. (Nasdaq: HALO), a biopharmaceutical company developing and
commercializing products based on the extracellular matrix, today announced
new safety and pharmacokinetic data from a second generation manufacturing
process for its recombinant human PH20 enzyme (rHuPH20). The data from three
studies were presented at the European Federation for Pharmaceutical Sciences
meeting for Development of Safe Protein Therapeutics: Preclinical, Clinical
and Regulatory Issues.
The objectives of the presented studies were to investigate the
intravenous (IV) and subcutaneous (SC) safety assessment of rHuPH20
administered at significantly higher doses to non-human primates than
previously examined. rHuPH20 from a first generation manufacturing process
has been utilized in a different formulation with lower concentrations for SC
injection as an adjuvant to increase absorption and dispersion of other
injected drugs and for SC fluid administration.
Second generation rHuPH20 is produced by a new manufacturing process
optimized for productivity and product safety. Once commercialized, it is
expected to result in greater than 90% reduction in cost of goods relative to
the product produced by the first generation process.
The use of rHuPH20 at higher concentrations in formulations may
potentially facilitate the conversion from IV to SC administration of
therapeutic proteins by allowing increased injection volumes and local
dispersion and absorption of SC co-injected therapeutic proteins into the
systemic circulation. The findings of the presented studies were as follows:
-- In a pharmacokinetic (PK) dose-range finding study, doses up to
3,600,000 U/kg (30 mg/kg) were well-tolerated following either IV or SC
-- Daily administration of rHuPH20 for one week was well tolerated via
either IV or SC delivery at a daily bolus dose of 600,000 U/kg
(5 mg/kg). No test article-related changes were observed in any
toxicology parameters and no systemic enzyme accumulation was observed.
-- A 3-month interim analysis from an ongoing 39-week chronic toxicity
study with weekly dosing up to 240,000 U/kg revealed no changes in
standard toxicity parameters or in male fertility assessment.
"These studies further expand the safety database for rHuPH20 in both dose
and duration, and support the potential use of rHuPH20 from Halozyme's new
manufacturing process in chronic applications," said Walter Bee, PhD,
Halozyme's Vice President of Preclinical Development. "We anticipate that
this toxicology package will be supportive of our current and future
Enhanze(TM) Technology partners' regulatory applications."
About Enhanze Technology
Enhanze Technology is Halozyme's proprietary drug delivery technology
based on recombinant human hyaluronidase (rHuPH20), a recombinant form of the
naturally occurring human enzyme being investigated for its ability to break
down hyaluronic acid (HA), the space-filling "gel"-like substance that is a
major component of tissues throughout the body. When combined or
co-formulated with certain injectable drugs, Enhanze(TM) Technology can act as
a "molecular machete" to facilitate the penetration and dispersion of these
drugs by temporarily opening flow channels under the skin. Molecules as large
as 200 nanometers may pass freely through the perforated extracellular matrix,
which recovers its normal density within approximately 24 hours, leading to a
drug delivery platform which does not permanently alter the architecture of
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing
products based on the extracellular matrix for the drug delivery, 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 safety of the company's rHuPH20 enzyme and (ii) any impact
on the regulatory applications for any third-party) 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: David A. Ramsay, Chief Financial Officer of Halozyme
Therapeutics, Inc., +1-858-704-8260, firstname.lastname@example.org; or Karen Sparks,
ext. 275, email@example.com, or Joleen Schultz, ext. 215, firstname.lastname@example.org,
both for Halozyme Therapeutics, Inc., +1-858-455-5500/
Web site: http://www.halozyme.com