Baxter and Halozyme Announce Positive Opinion for HyQvia for Treatment of Primary and Secondary Immunodeficiencies in the European Union

Baxter International

and Halozyme Therapeutics

today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (EMA CHMP) has granted a Positive Opinion to Baxter for the use of HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary immunodeficiencies. The product is a combination of human normal immunoglobulin (IGSC, 10%) and recombinant human hyaluronidase, which facilitates the dispersion and absorption of the IGSC. ''This recommendation supports our efforts to improve the overall quality of care for patients. This therapy, when approved by the European Commission, would offer patients the option to administer their therapy at home, in a single subcutaneous site every three to four weeks, resulting in potentially lower systemic adverse reactions compared to intravenous treatments,'' said Ludwig Hantson, Ph.D., president of Baxter's BioScience business. ''We look forward to introducing HyQvia as a new patient-friendly therapeutic option for immunodeficient patients.'' The application was based on results from a phase III, prospective, open-label, non-controlled design clinical trial, which evaluated the safety and effectiveness of HyQvia in the prevention of acute serious bacterial infections, and the pharmacokinetic parameters compared to immunoglobulin administered intravenously. The objective of the study was to infuse a 3-or 4-week dose of the therapy in a single subcutaneous site. The acute serious bacterial infection rate in the study was 0.025 per patient per year, which is below the required efficacy threshold of 1.0 (serious bacterial infections per patient per year). In the tolerability assessment of HyQvia, the most frequently reported adverse reactions were infusion site reactions (20% of infusions), headache (3% of infusions), fatigue (1% of infusions) and pyrexia (fever) (1% of infusions). Upon receiving marketing authorization from the European Commission, Baxter plans to launch HyQvia in selected countries in the European Union later this year. ''Recognizing that the path to approval for any biologic is a long journey, I would like to thank and congratulate the teams at Halozyme and Baxter who have worked tirelessly to advance this therapeutic option for patients,'' said Gregory I. Frost, Ph.D., president and chief executive officer, Halozyme Therapeutics. About HyQvia HyQvia is a product consisting of human normal immunoglobulin (IGSC, 10%) and recombinant human hyaluronidase (licensed from Halozyme Therapeutics). The two components are packaged together as a dual vial unit: IGSC provides the therapeutic effect and the recombinant human hyaluronidase facilitates the dispersion and absorption of the IGSC, increasing the bioavailability. The IGSC is a 10% solution that is prepared from human plasma consisting of at least 98% IgG, which contains a broad spectrum of antibodies. HyQvia is indicated as replacement therapy in adults (≥ 18 years) in primary immunodeficiency syndromes and in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. Important Safety Information HyQvia should not be used by women who are pregnant, or are planning to become pregnant, or are breast-feeding. About Immunodeficiency Disorders Primary Immunodeficiencies (PI) are a group of more than 175 disorders in which part of the body's immune system is missing or does not function properly. Normally, the immune system protects the body from pathogenic microorganisms like bacteria, viruses, and fungi, which can cause infectious diseases. When any part of a person's immune system is absent or dysfunctional, they are more likely to become infected and may take longer to recover from infections. When a defect in the immune system is inherited, it is called primary, or inherited, immune deficiency. It is estimated that as many as six million children and adults are affected by PI worldwide. Secondary immunodeficiencies develop as a result of a variety of conditions such as malignancies, particularly those of the haematopoietic and lymphoreticular systems, metabolic disease and/or malnutrition. Furthermore, burns or severe infection can also cause defective immune function and poor antibody response. In particular, immunoglobulin therapies are used to treat hypogammaglobulinaemia associated with chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM). These patients may benefit from immunoglobulin replacement therapy in addition to standard treatment of their primary disease. About Baxter International Inc. Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with haemophilia, 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. About Halozyme Therapeutics Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company's research focuses primarily on a family of human enzymes, known as hyaluronidases, that increase the absorption and dispersion of biologics. Halozyme's pipeline addresses therapeutic areas, such as diabetes, oncology and dermatology that have significant unmet medical need. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Baxter, ViroPharma, Intrexon, and Pfizer. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com. This release includes forward-looking statements concerning HyQvia, including expectations regarding the launch of HyQvia in the European Union. 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: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; and other risks identified in Baxter's and Halozyme's most recent filings on Form 10-K and other SEC filings, all of which are available on Baxter's and Halozyme's websites respectively. Baxter and Halozyme do not undertake to update their forward-looking statements.