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
|SOURCE Halozyme Therapeutics, Inc.|
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