BOSTON, November 7, 2011 - Baxter International Inc. (NYSE:BAX) today announced the presentation of its phase III study data for HyQ, an investigational combination immunoglobulin (IG) product for use in patients with primary immunodeficiencies (PI). The study evaluated efficacy and safety as well as the pharmacokinetics, infusion volumes, intervals, and rates compared to patients' previous intravenous immunoglobulin (IGIV) administration. Results from the study were presented on Saturday, Nov. 5, during the American College of Allergy, Asthma and Immunology annual meeting in Boston.
"In addition to a reduced rate of serious bacterial infections, the phase III study data suggest potentially useful attributes of HyQ, such as the possibility for a three or four week dosing schedule with single-site, self-administered infusions, which patients may appreciate," said Mark Stein, MD, Medical Director of Allergy Associates of the Palm Beaches, and investigator in the phase III trial.
The phase III prospective, open-label study enrolled 89 patients with PI in the United States and Canada, and evaluated the effectiveness of HyQ in the prevention of infections and measured other secondary endpoints including tolerability. Study participants received recombinant human hyaluronidase (rHuPH20) administered subcutaneously, followed by IG 10 percent infused subcutaneously through the same needle at a dose of 108 percent of the patient's previously prescribed IG dose (administered intravenously).
The majority of patients infused their HyQ dose in a single site and nearly 98 percent of infusions were completed without changes in infusion rate due to tolerability. The most common local adverse reactions were discomfort/pain, erythema, swelling/edema and pruritus. Systemic adverse events occurred in 8.3 percent of HyQ infusions compared to 25 percent of IGIV infusions in the control arm.
In HyQ treated patients, serious validated bacterial infections (SBIs) occurred at an annualized rate of 0.025, which is lower than the threshold set by the FDA of less than 1.0 annually, and the annual rate of all infections was 2.97. Further, HyQ was bioequivalent to IGIV at 108 percent of the IV dose at 3- or 4-week intervals. HyQ provided a lower peak IG concentration compared to IGIV, similar to weekly IGSC, with trough levels similar to every three or four-week IGIV treatment. Baxter has submitted applications for marketing approval of HyQ in the United States and in Europe, both of which have been accepted for review by the regulatory authorities.
"These data support the potential clinical benefits of HyQ that, if approved, will make it an attractive therapeutic option for physicians and their patients with primary immunodeficiencies," said Professor Hartmut Ehrlich, vice president, R&D, Baxter's BioScience business.
HyQ is a combination product that includes IG and recombinant human hyaluronidase, which are packaged as a kit. IG provides the therapeutic effect of HyQ and the recombinant human hyaluronidase facilitates the dispersion and absorption of the IG. The IG is a 10% solution that is prepared from large pools of human plasma and contains a broad spectrum of antibodies. The recombinant human hyaluronidase facilitates the increased bioavailability of IG by temporarily increasing the permeability of the subcutaneous tissue.
HyQ is being developed by Baxter using a recombinant human hyaluronidase technology platform licensed from Halozyme Therapeutics, Inc.
About Primary Immunodeficiency
Primary immunodeficiency (PI) comprises more than 150 diseases of the immune system. According to the Immune Deficiency Foundation, at least 250,000 persons in the United States have one of the primary immunodeficiency disorders. IG supplies a broad spectrum of IG antibodies against a wide variety of bacterial and viral agents, thereby preventing infections or fighting them when they occur.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
This release includes forward-looking statements concerning HyQ. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: actions of regulatory bodies and other governmental authorities; satisfaction of regulatory and other requirements; and other risks identified in the company's most recent filing on Form 10-K and other SEC filings, all of which are available on the company's website. The company does not undertake to update its forward-looking statements.