New Model Provides Insights Into Intravenous and Subcutaneous Immunoglobulin Pharmacokinetics in Patients With Primary Immunodeficiencies

KING OF PRUSSIA, Pa., March 19, 2011 /PRNewswire/ — CSL
Behring today announced the development of an innovative
pharmacokinetic (PK) model that allows the absorption,
distribution, metabolism, and elimination of subcutaneous (SC)
immunoglobulin G (IgG) following administration to be simulated
with a high degree of accuracy and precision. The new PK model
provides a novel means of simulating the mechanism by which SC IgG
is transported after it is injected into the subcutaneous tissue.
Data from the model, which was developed by CSL Behring in
collaboration with researchers at Cardiff University, Keele
University, and Prism Ideas Ltd, were described in both a poster
presentation and an oral presentation at the 2011 American Academy
of Allergy, Asthma and Immunology annual meeting.

The current understanding of the clinical implications of SC
versus intravenous (IV) dosing of IgG in primary immunodeficiency
(PI) patients is limited. In addition, little is known about where
SC IgG travels within the body after it is administered and how
long it remains there. This information defines IgG’s
pharmacokinetic (PK) profile and could affect the volume and
frequency of IgG dosing for PI patients.

“At CSL Behring we are continually searching for and identifying
ways of improving treatment for patients with primary
immunodeficiencies,” said Martin Bexon, M.D., Program Director,
Global Clinical Research and Development at CSL Behring. “This
model increases our knowledge of how SC IgG is distributed
throughout the body and has the potential to help us further
optimize a dosing schedule that balances the convenience and
therapeutic value of Hizentra for PI patients.”

The new PK model, presented at this meeting in both a poster
(Bexon et al; Poster 46; Session 2203) and an oral presentation
(Jolles et al; Session 4602) describes a complex system of
continuous interactions between extravascular (tissue) and
intravascular (blood) compartments that help

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