GAMMAGARD LIQUID is currently administered intravenously (IV). Subcutaneous (SC) administration of GAMMAGARD LIQUID with Enhanze Technology is an investigational study and when approved could allow patients to receive a full monthly dose in a single injection site in their home setting.
"
"Entering Phase III clinical development is an important achievement for
our hyaluronidase enzyme and for our collaboration with
This Phase III clinical study is a prospective, open-label, non-controlled
design that will be conducted in 10-20 centers in the U.S. and
About GAMMAGARD LIQUID
GAMMAGARD LIQUID is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
Important Safety Information
GAMMAGARD LIQUID is contraindicated in patients with known anaphylactic or severe hypersensitivity responses to Immune Globulin (Human). Patients with severe selective IgA deficiency (IgA < 0.05 g/L) may develop anti-IgA antibodies that can result in a severe anaphylactic reaction.
Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number.
Glycine, an amino acid, is used as a stabilizer. GAMMAGARD LIQUID does not contain sucrose.
GAMMAGARD LIQUID is made from human plasma. It may carry a risk of transmitting infectious agents, viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Components used in the packaging of this product are latex-free.
Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity, hypercoagulable disorders, and prolonged periods of immobilization.
IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis.
Aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.
Various mild and moderate reactions, such as headache, fever, fatigue, chills, flushing, dizziness, urticaria, wheezing or chest tightness, nausea, vomiting, rigors, back pain, chest pain, muscle cramps, and changes in blood pressure may occur with infusions of Immune Globulin Intravenous (Human).
For full prescribing information, please visit: http://www.baxter.com/products/biopharmaceuticals/downloads/gamliquid_PI.pdf
About
Baxter International Inc. 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,
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing
products targeting the extracellular matrix for the endocrinology, oncology,
dermatology, and drug delivery markets. The company's portfolio of products
and product candidates is based on intellectual property covering the family
of human enzymes known as hyaluronidases. The company's Enhanze(TM)
Technology is a novel drug delivery platform designed to increase the
absorption and dispersion of biologics. Its key partnerships are with Roche to
apply Enhanze Technology to Roche's biological therapeutic compounds for up to
13 targets and with
Safe Harbor Statement
In addition to historical information, the statements set forth above
include forward-looking statements (including, without limitation, statements
concerning the potential regulatory approval and the benefits of administering
rHuPH20 with GAMMAGARD) that involve risk and uncertainties that could cause
actual results to differ materially from those in the forward-looking
statements. The forward-looking statements are also identified through use of
the words "believe," "enable," "may," "will," "could," "intends," "estimate,"
"anticipate," "plan," "predict," "probable," "potential," "possible,"
"should," "continue," and other words of similar meaning. Actual results could
differ materially from the expectations contained in forward-looking
statements as a result of several factors, including regulatory approval
requirements and competitive conditions. These and other factors that may
result in differences are discussed in greater detail in the companies'
reports on Forms 10-K, 10-Q, and other filings with the Securities and
Exchange Commission. Neither
Halozyme Contact Robert H. Uhl Senior Director, Investor Relations (858) 704-8264 ruhl@halozyme.com Baxter Contacts Chris Bona (847) 948-2815 Laura Grossmann (847) 948-3026
SOURCE Halozyme Therapeutics, Inc.