DEERFIELD, Ill. and SAN DIEGO, Jan. 5 BaxterInternational Inc. and Halozyme Therapeutics, Inc. (Nasdaq: HALO) todayannounced the start of a Phase III clinical trial of Baxter's GAMMAGARD LIQUID[Immune Globulin Intravenous] 10% (IGIV), marketed as KIOVIG in the EuropeanUnion, with Halozyme's recombinant human hyaluronidase enzyme (rHuPH20,Enhanze(TM) Technology) for the treatment of primary immunodeficiency (PID).The purpose of this clinical trial is to evaluate the safety and efficacy andgain regulatory approval for the treatment of PID using GAMMAGARD LIQUID andrHuPH20 via subcutaneous (under the skin) injection at a single site.
GAMMAGARD LIQUID is currently administered intravenously (IV).Subcutaneous (SC) administration of GAMMAGARD LIQUID with Enhanze Technologyis an investigational study and when approved could allow patients to receivea full monthly dose in a single injection site in their home setting.
"Baxter's work with Halozyme represents a commitment to innovation and, inparticular, to advancing patient care with GAMMAGARD LIQUID," said Hartmut J.Ehrlich, M.D., vice president of Global Research and Development for Baxter'sBioScience business.
"Entering Phase III clinical development is an important achievement forour hyaluronidase enzyme and for our collaboration with Baxter. We are pleasedwith the progress that has been made since our alliance began in September2007," stated Jonathan Lim, M.D., President and CEO of Halozyme. "We lookforward to continuing our strong working relationship with the Baxter team andto further advance this program."
This Phase III clinical study is a prospective, open-label, non-controlleddesign that will be conducted in 10-20 centers in the U.S. and Canada. Thetrial will evaluate the efficacy of GAMMAGARD LIQUID administered SC withrHuPH20 in the prevention of acute serious bacterial infections and will alsoassess pharmacokinetic parameters of SC and rHuPH20 compared to intravenousadministration.
About GAMMAGARD LIQUID
GAMMAGARD LIQUID is indicated for the treatment of primaryimmunodeficiency disorders associated with defects in humoral immunity. Theseinclude but are not limited to congenital X-linked agammaglobulinemia, commonvariable immunodeficiency, Wiskott-Aldrich syndrome, and severe combinedimmunodeficiencies.
Important Safety Information
GAMMAGARD LIQUID is contraindicated in patients with known anaphylactic orsevere hypersensitivity responses to Immune Globulin (Human). Patients withsevere selective IgA deficiency (IgA < 0.05 g/L) may develop anti-IgAantibodies that can result in a severe anaphylactic reaction.
Immune Globulin Intravenous (Human) products have been reported to beassociated with renal dysfunction, acute renal failure, osmotic nephrosis, anddeath. Patients predisposed to acute renal failure include patients with anydegree of pre-existing renal insufficiency, diabetes mellitus, age greaterthan 65, volume depletion, sepsis, paraproteinemia, or patients receivingknown nephrotoxic drugs. Especially in such patients, IGIV products should beadministered at the minimum concentration available and the minimum rate ofinfusion practicable. While these reports of renal dysfunction and acute renalfailure have been associated with the use of many of the licensed IGIVproducts, those containing sucrose as a stabilizer accounted for adisproportionate share of the total number.
Glycine, an amino acid, is used as a stabilizer. GAMMAGARD LIQUID does notcontain sucrose.
GAMMAGARD LIQUID is made from human plasma. It may carry a risk oftransmitting infectious agents, viruses, and theoretically, theCreutzfeldt-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 atrisk may include those with a history of atherosclerosis, multiplecardiovascular risk factors, advanced age, impaired cardiac output, and/orknown or suspected hyperviscosity, hypercoagulable disorders, and prolongedperiods of immobilization.
IGIV products can contain blood group antibodies that may cause a positivedirect antiglobulin reaction and, rarely, hemolysis.
Aseptic meningitis syndrome (AMS) has been reported to occur infrequentlyin association with IGIV treatment. Discontinuation of IGIV treatment hasresulted 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 bloodpressure 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
Baxter International Inc. develops, manufactures and markets products thatsave and sustain the lives of people with hemophilia, immune disorders,infectious diseases, kidney disease, trauma, and other chronic and acutemedical conditions. As a global, diversified healthcare company, Baxterapplies a unique combination of expertise in medical devices, pharmaceuticalsand biotechnology to create products that advance patient care worldwide.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializingproducts targeting the extracellular matrix for the endocrinology, oncology,dermatology, and drug delivery markets. The company's portfolio of productsand product candidates is based on intellectual property covering the familyof human enzymes known as hyaluronidases. The company's Enhanze(TM)Technology is a novel drug delivery platform designed to increase theabsorption and dispersion of biologics. Its key partnerships are with Roche toapply Enhanze Technology to Roche's biological therapeutic compounds for up to13 targets and with Baxter to apply Enhanze Technology to Baxter's biologicaltherapeutic compound, GAMMAGARD LIQUID 10%. In addition, the company hasreceived FDA approval for two products: Cumulase(R), for use in in-vitrofertilization, and HYLENEX, for use as an adjuvant to increase the absorptionand dispersion of other injected drugs and fluids. HYLENEX is partnered withBaxter International Inc. Halozyme also has a number of different enzymes inits portfolio that target significant areas of unmet medical need. For moreinformation visit http://www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth aboveinclude forward-looking statements (including, without limitation, statementsconcerning the potential regulatory approval and the benefits of administeringrHuPH20 with GAMMAGARD) that involve risk and uncertainties that could causeactual results to differ materially from those in the forward-lookingstatements. The forward-looking statements are also identified through use ofthe words "believe," "enable," "may," "will," "could," "intends," "estimate,""anticipate," "plan," "predict," "probable," "potential," "possible,""should," "continue," and other words of similar meaning. Actual results coulddiffer materially from the expectations contained in forward-lookingstatements as a result of several factors, including regulatory approvalrequirements and competitive conditions. These and other factors that mayresult in differences are discussed in greater detail in the companies'reports on Forms 10-K, 10-Q, and other filings with the Securities andExchange Commission. Neither Baxter nor Halozyme undertakes to update itsforward-looking statements.Halozyme Contact Robert H. Uhl Senior Director, Investor Relations (858) 704-8264 [email protected]
Baxter Contacts Chris Bona (847) 948-2815 Laura Grossmann (847) 948-3026
SOURCE Halozyme Therapeutics, Inc.