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
-- 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 the skin.
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
Halozyme Contact Media Contacts
David A. Ramsay Karen Sparks / Joleen Schultz
Chief Financial Officer Mentus
(858) 704-8260 (858) 455-5500, x275/x215
|SOURCE Halozyme Therapeutics, Inc.|
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