DEERFIELD, Ill., March 2, 2012 - Baxter International Inc. (NYSE: BAX) today announced the presentation of additional long-term data supporting the clinical profile of HyQ, its investigational combination product for use in patients with primary immunodeficiencies (PI). The company also introduced HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], as the submitted brand name for the investigational product, previously referred to as HyQ. Posters and oral presentations regarding the HyQvia clinical program will be given during the 2012 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual meeting in Orlando.
"The HyQvia clinical program has been focused on obtaining long-term data about this new facilitated subcutaneous immunoglobulin therapy, including safety, efficacy, tolerability, and pharmacokinetic data," said Prof. Hartmut J. Ehrlich, M.D., vice president of global research and development in Baxter's BioScience business. "This information may be used to inform physicians in making the most appropriate treatment choice for their patients."
Selected study data of interest:
- Safety and Pharmacokinetics of Facilitated-Subcutaneous Infusion of Immune Globulin (Human), 10% and Recombinant Human Hyaluronidase (IGHy) in a Phase III Extension Study in Patients With Primary Immunodeficiency Disease (Melamed, Oral session 4602-764, Monday, March 5, 2:00 pm)
- Pharmacokinetics (PK) of Human Immunoglobulin 10% (IgG) Administered Intravenously (IGIV), Subcutaneously (IGSC) or Facilitated Subcutaneously with Recombinant Human Hyaluronidase (IGHy) in a Subset of Patients with Primary Immunodeficiency Disease (Stein, Poster session 2203-55, Monday, March 5, 9:45 am)
- Tolerability and Efficacy of Facilitated-Subcutaneous Infusion of Immune Globulin (Human), 10% and Recombinant Human Hyaluronidase (IGHy) in a Subset of Study Patients With Primary Immunodeficiency Disease (Wasserman, Poster session 2203-56, Saturday, March 3, 9:45 am)
HyQvia is a combination product that includes Immune Globulin (IG) Infusion 10% (Human) and Recombinant Human Hyaluronidase, which are packaged as a kit. IG provides the therapeutic effect of HyQvia 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.
HyQvia is being developed by Baxter using a recombinant human hyaluronidase technology platform licensed from Halozyme Therapeutics, Inc. The therapy is under review by regulatory bodies in the United States, Europe and Canada.
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.
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, 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, including with respect to related clinical efforts and its future brand name. 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: safety, efficacy, tolerability and pharmacokinetic data; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.