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Halozyme Therapeutics' Enhanze Technology Large Protein Molecule,Therapeutic Clinical Trial Results Presented at the 34th Annual,Meeting of the Controlled Release Society

- Co-Injection of rHuPH20 with Humira Estimated to Increase the Maximal Steady State Subcutaneous Bioavailability from 64% to 100% -

SAN DIEGO, July 09, 2007 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. , a biopharmaceutical company developing and commercializing recombinant human enzymes, today announced that final results of the Enhanze(TM) Technology clinical trial demonstrating improved absorption and bioavailability of a representative commercially-available large protein molecule therapeutic (LPMT) were presented at the 34th Annual Meeting of the Controlled Release Society in Long Beach, California. Enhanze Technology is Halozyme's enzyme-based drug delivery platform based on recombinant human PH20 hyaluronidase (rHuPH20). The abstract describing this trial was rated by the Controlled Release Society as having notable high scientific quality and was designated for a podium presentation, which included a recently completed modeled population pharmacokinetic (PK) analysis used to estimate the effect of steady state co-administration of rHuPH20 with the LPMT.

This clinical trial, sponsored and funded solely by Halozyme, compared the PK, safety, and tolerability of an LPMT agent subcutaneously (SC) injected first without Enhanze Technology (rHuPH20) and then with rHuPH20 in 15 patients. The representative LPMT selected for this trial was HUMIRA(R) (adalimumab), based on the product being readily commercially available, well-recognized, labeled for SC route of administration, and for which a validated assay for PK profiling could be developed. The open-label cross-over study used escalating doses of rHuPH20 (ranging from 1,600 U to 12,800 U) and a fixed dose of HUMIRA (40 mg) injected every two weeks. Patients with rheumatoid arthritis on maintenance HUMIRA were crossed-over to a single SC injection of HUMIRA co-injected with rHuPH20, and the two injections were compared with regard to PK and s
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