Baxter Submits Amended BLA to U.S. FDA for HyQvia for Primary Immunodeficiency

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DEERFIELD, Ill., and SAN DIEGO, DECEMBER 2, 2013-Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc. (NASDAQ:HALO) announced today that Baxter has completed submission of an amended biologics license application (BLA) to the United States Food and Drug Administration (FDA) to re-initiate the review process for approval of HyQvia [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] facilitated subcutaneous infusion for the treatment of adult patients with primary immunodeficiency (PI).

HyQvia is a combination of human immune globulin (IG) and recombinant human hyaluronidase. Baxter and Halozyme submitted additional preclinical data that was requested from the FDA in 2012, and expect a six-month review period.

"We believe that if approved, HyQvia may become a valuable option for patients with immune deficiency as it allows for the delivery of a full dose of immunoglobulin often in a single site every three to four weeks, in the comfort of a patient's home," said Ludwig Hantson, Ph.D., president of Baxter's BioScience business. "As a long-standing leader in the IG market, we are committed to continually developing new treatment options like HyQvia that have the potential to make a meaningful difference in the way patients are treated."

The original BLA submission for HyQvia 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, rate of adverse reactions and the pharmacokinetic parameters compared to immunoglobulin administered intravenously. In the tolerability assessment of HyQvia, the most frequently reported adverse reactions for patients who received HyQvia were local infusion site reactions (such as pain or discomfort, redness, swelling, and itching) and headache, nausea, fatigue and fever.

HyQvia was approved and launched in a number of European countries in the second half of 2013.

About HyQvia
HyQvia is a product consisting of human normal immunoglobulin (IG 10%) and recombinant human hyaluronidase (licensed from Halozyme Therapeutics). The IG provides the therapeutic effect and the recombinant human hyaluronidase facilitates the dispersion and absorption of the IG administered subcutaneously, increasing its bioavailability. The IG 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 in Europe as replacement therapy in adults (> 18 years) with primary immunodeficiency syndromes and in myeloma or chronic lymphocytic leukaemia (CLL) 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 immune deficiency. It is estimated that as many as six million children and adults are affected by PI worldwide.

About Baxter
Baxter International Inc. (NYSE: BAX), 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.

About Halozyme
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, which increase the absorption and dispersion of biologics, drugs and fluids. Halozyme's pipeline addresses therapeutic areas, including diabetes, oncology and dermatology that have significant unmet medical need. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer, Baxter, and Intrexon. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com  and follow us on www.twitter.com/HALOTherapeutic .

This release includes forward-looking statements concerning HyQvia, including expectations with regard to pending regulatory review in the US and its potential impact on patients. 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 approval and other requirements; actions of regulatory bodies and other governmental authorities; product quality or patient safety issues; changes in law and regulations; and other risks identified in each of the company's most recent filings on Form 10-K and other SEC filings, all of which are available on their respective websites. Neither Baxter nor Halozyme undertakes to update its forward-looking statements.

News Source : Baxter Submits Amended BLA to U.S. FDA for HyQvia for Primary Immunodeficiency

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