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Shire Pharmaceuticals Group PLC

Drug Names(s): Subcutaneous Human Immune Globulin with Enhanze Technology/hyaluronidase, Gammagard Liquid HYQ

Description: BioMedTracker has separate drug profiles for the intravenous and subcutaneous formulationsof Gammagard, including the subcutaneous formulations with and without Halozyme's Enhanze (recombinant hyaluronidase). Please also see Gammagard and Gammagard (Subcutaneous).

Baxter and Halozyme are developing GAMMAGARD LIQUID 10% administered subcutaneously using Enhanze Technology.

GAMMAGARD preparation of a broad spectrum of immunoglobulins (antibodies) derived from large pools of human plasma, which can be used for antibody replacement.

Enhanze Technology is a proprietary drug delivery platform using Halozyme’s enzyme, rHuPH20. When co-formulated with other injectable drugs, Enhanze Technology may 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 extracellular matrix, which recovers its normal density within approximately 24 hours, leading to a drug delivery platform which does not permanently alter the architecture of the skin. The principal focus of the Enhanze Technology platform is the use of rHuPH20 to facilitate subcutaneous or intramuscular routes of administration for large molecule biological therapeutics.

Deal Structure: Baxter and Halozyme
In September 2007, Baxter and Halozyme Therapeutics announced that the Companies have entered into an agreement to apply Halozymes Enhanze Technology to the development of a subcutaneous route of administration for Baxters GAMMAGARD LIQUID 10%. Under the terms of the agreement, Baxter will provide Halozyme an initial upfront payment of $10 million. Pending successful completion of a series of regulatory and sales milestones, Baxter may make further milestone payments totaling $37 million to Halozyme. Baxter also will assume development, manufacturing, clinical, regulatory, sales and marketing costs. Halozyme will be responsible for the supply of the recombinant human hyaluronidase (rHuPH20) enzyme that provides the basis for Enhanze Technology. Upon regulatory approval, Halozyme will also receive royalties on GAMMAGARD LIQUID 10% administered subcutaneously using Enhanze Technology both in kits and in co-formulations.

Baxter and...See full deal structure in Biomedtracker

Partners: Halozyme Therapeutics, Inc.

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