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Baxter and Halozyme Announce Collaboration for Development of Subcutaneous GAMMAGARD LIQUID(TM) Administration Using Enhanze(TM) Technology
Date:9/10/2007

lozyme's proprietary drug delivery technology based on rHuPH20, a recombinant form of the naturally occurring human enzyme approved by FDA for its ability to break down hyaluronic acid, 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 Technology can 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 that does not permanently alter the architecture of the skin.

About Baxter's GAMMAGARD LIQUID(TM) 10%

GAMMAGARD LIQUID 10% (known as KIOVIG(TM) in Europe) is indicated for the treatment of primary immunodeficiency disorders associated with defects in immune system. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Important Safety Information for the United States

GAMMAGARD LIQUID 10% is contraindicated in patients with known anaphylactic or severe hypersensitivity responses to Immune Globulin (Human). Patients with severe selective IgA deficiency (IgA < 0.05 g/L) may develop anti-IgA antibodies that can result in a severe anaphylactic reaction.

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and th
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SOURCE Baxter International Inc.
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