Phase 3 trial begins for Gammagard liquid plus rHuPH20 in primary immunodeficiency patients

Baxter International Inc. and Halozyme Therapeutics, Inc. gas announced the start of a Phase 3 clinical trial of Baxter's Gammagard Liquid [Immune Globulin Intravenous] 10% (IGIV), marketed as KIOVIG in the European Union, with Halozyme's recombinant human hyaluronidase enzyme (rHuPH20, Enhanze Technology) for the treatment of primary immunodeficiency (PID).

The purpose of this clinical trial is to evaluate the safety and efficacy and gain regulatory approval for the treatment of PID using Gammagard Liquid and rHuPH20 via subcutaneous (under the skin) injection at a single site.

Gammagard Liquid is currently administered intravenously (IV). Subcutaneous (SC) administration of Gammagard Liquid with Enhanze Technology is an investigational study and when approved could allow patients to receive a full monthly dose in a single injection site in their home setting.

"Baxter's work with Halozyme represents a commitment to innovation and, in particular, to advancing patient care with Gammagard Liquid," said Hartmut J. Ehrlich, M.D., vice president of Global Research and Development for Baxter's BioScience business.

"Entering Phase III clinical development is an important achievement for our hyaluronidase enzyme and for our collaboration with Baxter. We are pleased with the progress that has been made since our alliance began in September 2007," stated Jonathan Lim, M.D., President and CEO of Halozyme. "We look forward to continuing our strong working relationship with the Baxter team and to further advance this program."

This Phase III clinical study is a prospective, open-label, non-controlled design that will be conducted in 10-20 centers in the U.S. and Canada. The trial will evaluate the efficacy of Gammagard Liquid administered SC with rHuPH20 in the prevention of acute serious bacterial infections and will also assess pharmacokinetic parameters of SC and rHuPH20 compared to intravenous administration.

About Gammagard Liquid

Gammagard Liquid is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Important Safety Information

Gammagard Liquid 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 the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number.

Glycine, an amino acid, is used as a stabilizer. Gammagard Liquid does not contain sucrose.

Gammagard Liquid is made from human plasma. It may carry a risk of transmitting infectious agents, viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Components used in the packaging of this product are latex-free.

Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity, hypercoagulable disorders, and prolonged periods of immobilization.

IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis.

Aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.

Various mild and moderate reactions, such as headache, fever, fatigue, chills, flushing, dizziness, urticaria, wheezing or chest tightness, nausea, vomiting, rigors, back pain, chest pain, muscle cramps, and changes in blood pressure may occur with infusions of Immune Globulin Intravenous (Human).

For full prescribing information, please visit: http://www.baxter.com/