Press release from Business Wire
Baxter Receives Marketing Authorization for HyQvia in European Union
Tuesday, May 21, 2013
Baxter Receives Marketing Authorization for HyQvia in European Union09:00 EDT Tuesday, May 21, 2013
BRUSSELS (Business Wire) -- Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc., (NASDAQ:HALO) today announced that the European Commission has granted Baxter marketing authorization in all European Union (EU) Member States for the use of HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary immunodeficiencies.
''HyQvia offers patients with primary and secondary immunodeficiencies the ability to administer their treatment in a single subcutaneous site every three to four weeks. This represents an important advance for patients who are managing a chronic disease as HyQvia combines key benefits of intravenous and subcutaneous administration into one product,'' said Ludwig Hantson, Ph.D., president of Baxter's BioScience business. ''We look forward to introducing HyQvia in the coming weeks to support physicians and adult immunodeficient patients in Europe.''
Baxter will introduce HyQvia in select countries during 2013 and plans to expand the launch to other EU countries in 2014.
''We are delighted that these patients who depend on immunoglobulin replacement treatment will have access to HyQvia,'' said Gregory I. Frost, Ph.D., president and chief executive officer, Halozyme Therapeutics.
The product is a combination of human normal immunoglobulin (IGSC, 10%) and recombinant human hyaluronidase, which facilitates the dispersion and absorption of the IGSC. The application was based on results from a phase III, prospective, open-label, non-controlled multi-center 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 treatment in a single subcutaneous site.
The rate of validated acute serious bacterial infections 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).
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 Risk Information
HyQvia should not be used by patients with a hypersensitivity to human immunoglobulins, especially in very rare cases of IgA deficiency when the patient has antibodies against IgA. HyQvia should not be used by patients with a systemic hypersensitivity to hyaluronidase or recombinant human hyaluronidase. HyQvia should not be used by patients with a hypersensitivity to any of the excipients, including glycine.
HyQvia must not be given intravenously.
HyQvia should not be used by women who are pregnant, or are planning to become pregnant, or are breast-feeding.
Patients should be closely monitored and carefully observed for any adverse reactions throughout the infusion period, particularly patients starting with HyQvia treatment. In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. The treatment required depends on the nature and severity of the adverse reaction. In case of shock, standard medical treatment for shock should be implemented.
Thromboembolic events (e.g. myocardial infarction, cerebral vascular accident, deep vein thrombosis, and pulmonary embolism), renal dysfunction/failure, aseptic meningitis syndrome, and hemolysis have been observed with IG 10% administered intravenously and cannot be excluded with use of HyQvia. Thrombotic events and haemolysis have also been reported in association with the subcutaneous administration of immunoglobulin products.
Human normal immunoglobulin and human serum albumin (stabilizer of the recombinant human hyaluronidase) are produced from human plasma and may carry a risk of transmitting infectious agents.
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 treatment 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.
Baxter Media Contacts
Brian Kyhos, (224) 948-5353
Deborah Spak, (224) 948-5353
Baxter Investor Contacts
Mary Kay Ladone, (224) 948-3371
Clare Trachtman, (224) 948-3085
Halozyme Media Contact
Nurha Hindi, 310-633-9434
Halozyme Investor Contact
Kurt Gustafson, 858-704-8272