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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

afety. HUMIRA is a registered trademark of Abbott Laboratories.

The data from this clinical trial support the study hypothesis that rHuPH20 increases the relative bioavailability of the SC injected HUMIRA:

    -- For the primary endpoint of area under the curve (AUC) for adalimumab

       plasma concentration, the AUC over the 14 days following administration

       was higher when the HUMIRA was co-injected with rHuPH20 compared to the

       HUMIRA injection without rHuPH20 for 100% (15/15) of the patients in

       the study.


    -- The modeled population PK analysis estimated a 59% maximal increase in

       the relative SC bioavailability of adalimumab at steady state if

       co-injected with rHuPH20; thus, the reported reference 64% SC absolute

       bioavailability HUMIRA injected alone was estimated to increase to 100%

       when co-injected with rHuPH20, achieving essentially complete

       absorption.


    -- The modeled PK analysis estimated that a high dose of rHuPH20 (at least

       6,400 U) was required to assure the maximal rHuPH20 effect.


    -- Injection of rHuPH20 with HUMIRA was well tolerated at all rHuPH20 dose

       levels, without dose-limiting toxicity, premature withdrawals, or

       serious adverse events.  Of the total of five adverse events reported

       in this study, two were assessed as having no association with either

       study drug (basal cell carcinoma and urinary tract infection).  The

       remaining three events consisted of mild injection site erythema

       (redness) that occurred on the day of the co-injection and resolved

       within one or two days.

As a spreading agent, hyaluronidase has traditionally been used to accelerate the delivery of drugs and fluids, including local anesthetics, other co-injected drugs, and contrast agents, and for subcutaneous fluid replacement. Although a large body of clinical experience supports the benefits and safety of using
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