DEERFIELD, Ill. and SAN DIEGO, Sept. 10 BaxterInternational Inc. (NYSE: BAX) and Halozyme Therapeutics, Inc. (Nasdaq: HALO)announced today they have entered into an agreement to apply Halozyme'sproprietary Enhanze(TM) Technology to the development of a subcutaneous routeof administration for Baxter's GAMMAGARD LIQUID(TM) 10% [Immune GlobulinIntravenous (Human)] (IGIV) (known as KIOVIG(TM) in Europe). For patientsusing GAMMAGARD LIQUID 10% -- currently administered intravenously --subcutaneous administration with Enhanze Technology may increase overallconvenience and improve the dispersion of the therapy.
Under the terms of the agreement, Baxter will provide Halozyme an initialupfront payment of $10 million. Pending successful completion of a series ofregulatory and sales milestones, Baxter may make further milestone paymentstotaling $37 million to Halozyme. Baxter also will assume development,manufacturing, clinical, regulatory, sales and marketing costs. Halozyme willbe responsible for the supply of the recombinant human hyaluronidase (rHuPH20)enzyme that provides the basis for Enhanze Technology. Upon regulatoryapproval, Halozyme will also receive royalties on GAMMAGARD LIQUID 10%administered subcutaneously using Enhanze Technology both in kits and in co-formulations.
Baxter's GAMMAGARD LIQUID 10% is a large molecule therapy made from humanplasma that is indicated for the treatment of primary immunodeficiencydisorders associated with defects in immune system. Enhanze Technology isHalozyme's proprietary drug delivery technology based on rHuPH20. rHuPH20 is aform of human enzyme that temporarily clears space in the matrix of tissuesunderlying the two outer layers of the skin to increase absorption andspreading of injected drugs.
"By using Enhanze Technology to facilitate a subcutaneous route ofadministration for GAMMAGARD LIQUID, patients with immunodeficiency disorderscould benefit from access to home therapy that may potentially allow full IVdosing with the convenience of subcutaneous delivery," said Hartmut J.Ehrlich, MD, vice president of global research and development for Baxter'sBioScience business. "This partnership represents Baxter's ongoing scientificinnovation and investment in enhancing administration of GAMMAGARD LIQUIDtherapy."
"We believe our technology can enhance the clinical benefits thatbiologics have already been shown to provide. We are very excited to expandour relationship with Baxter so that they may make this important productavailable to as many people as possible worldwide as a way to simplify thedelivery of medications and fluids and, ultimately, provide a more comfortablepatient experience," said Jonathan Lim, MD, president and CEO of Halozyme.
In February 2007, Baxter and Halozyme expanded their ongoing collaborationto commercialize product combinations of HYLENEX(TM) 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 ofother injected drugs or fluids. HYLENEX is manufactured by Baxter HealthcareCorporation for Halozyme.
About Enhanze(TM) Technology
Enhanze Technology is Halozyme's proprietary drug delivery technologybased on rHuPH20, a recombinant form of the naturally occurring human enzymeapproved by FDA for its ability to break down hyaluronic acid, the space-filling "gel"-like substance that is a major component of tissues throughoutthe body. When combined or co-formulated with certain injectable drugs,Enhanze Technology can facilitate the penetration and dispersion of thesedrugs by temporarily opening flow channels under the skin. Molecules as largeas 200 nanometers may pass freely through the perforated extracellular matrix,which recovers its normal density within approximately 24 hours, lead