Baxter International Inc. and Halozyme Therapeutics, Inc. jointly announced that they have entered into an agreement to apply Halozyme's proprietary enhanze technology to the development of a subcutaneous route of administration for Baxter's gammagard liquid 10 per cent [Immune Globulin Intravenous (Human)] (IGIV) (known as Kiovig in Europe). For patients using gammagard liquid 10 per cent - currently administered intravenously - subcutaneous administration with enhanze technology may increase overall convenience and improve the dispersion of the therapy.
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 and 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 per cent administered subcutaneously using Enhanze Technology both in kits and in co-formulations.
"We believe our technology can enhance the clinical benefits that biologics have already been shown to provide. We are very excited to expand our relationship with Baxter so that they may make this important product available to as many people as possible worldwide as a way to simplify the delivery of medications and fluids and, ultimately, provide a more comfortable patient experience," said Jonathan Lim, managing director, president and CEO, Halozyme.
Baxter's gammagard liquid 10 per cent is a large molecule therapy made from human plasma that is indicated for the treatment of primary immunodeficiency disorders associated with defects in immune system. Enhanze Technology is Halozyme's proprietary drug delivery technology based on rHuPH20. rHuPH20 is a form of human enzyme that temporarily clears space in the matrix of tissues underlying the two outer layers of the skin to increase absorption and spreading of injected drugs.
"By using enhanze technology to facilitate a subcutaneous route of administration for gammagard liquid, patients with immunodeficiency disorders could benefit from access to home therapy that may potentially allow full IV dosing with the convenience of subcutaneous delivery," said Hartmut J. Ehrlich, managing director, vice president of global research and development for Baxter's BioScience business. "This partnership represents Baxter's ongoing scientific innovation and investment in enhancing administration of gammagard liquid therapy", he added.
In February 2007, Baxter and Halozyme expanded their ongoing collaboration to commercialize product combinations of Hylenex recombinant (hyaluronidase human injection) with certain Baxter proprietary and non-proprietary small molecule therapies. Hylenex is a formulation of rHuPH20, supplied by Halozyme, indicated to facilitate the absorption and dispersion of other injected drugs or fluids. Hylenex is manufactured by Baxter Healthcare Corporation for Halozyme.