Pivotal Phase III Study for Subcutaneous Administration of Immunoglobulins Fully Enrolled
DEERFIELD, Ill. & SAN DIEGO--(BUSINESS WIRE)--Jul. 15, 2009--
Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc.
(Nasdaq:HALO) today announced completion of patient enrollment in the
Phase III pivotal study of GAMMAGARD LIQUID [Immune Globulin Intravenous
(Human) 10%] (also known as KIOVIG outside of the United States) with
rHuPH20 (recombinant human hyaluronidase enzyme) for the treatment of primary
immunodeficiency disorder (PID). Patients will receive monthly
subcutaneous (SC) injections of Halozyme’s rHuPH20 with Baxter’s GAMMAGARD
“The achievement of complete Phase III enrollment is an important
milestone of Baxter’s work with Halozyme to offer patients more advanced
treatment options,” said Hartmut J. Ehrlich, M.D., vice president of
Global Research and Development for Baxter’s BioScience business.
“I am pleased with the efficiency and dedication Baxter has demonstrated
toward our collaboration and their exemplary ability to manage and carry
out the clinical objectives,” stated Jonathan Lim, M.D., Halozyme’s
president and CEO. “Completion of patient enrollment in this Phase III
registration study marks a significant and timely accomplishment for the
GAMMAGARD LIQUID-rHuPH20 development program.”
This Phase III clinical trial is a prospective, open-label,
non-controlled design underway in 15 centers in the U.S. and Canada. The
study will evaluate the safety and efficacy of GAMMAGARD LIQUID
administered SC with rHuPH20 in the prevention of acute serious
bacterial infections over 12 months and will also assess pharmacokinetic
parameters of SC GAMMAGARD LIQUID with rHuPH20 compared to intravenous
(IV) administration of GAMMAGARD LIQUID alone. Patient Quality of Life
(QOL) parameters will also be measured. Subcutaneous administration of
GAMMAGARD LIQUID with rHuPH20 in this investigational study will
determine if it will allow PID patients to receive a full monthly dose
in a single injection site in the home setting. GAMMAGARD LIQUID is
currently only approved for IV administration. Additional information
about this Phase III study can be found at clinicaltrials.gov.
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
Immune Globulin Intravenous (Human) products have been reported to be
associated with renal dysfunction, acute renal failure, osmotic
nephrosis, and death. IGIV products should be administered at the
minimum concentration available and the minimum rate of infusion
practicable in at risk patients.
GAMMAGARD LIQUID is made from human plasma. It may carry a risk of
transmitting infectious agents, e.g. viruses, and theoretically, the
Creutzfeldt-Jakob disease (CJD) agent. Some viruses, such as B19V or
hepatitis A, are particularly difficult to remove or inactivate.
GAMMAGARD LIQUID should only be administered intravenously.
Immediate anaphylactic and hypersensitivity reactions are a remote
IGIV products can contain blood group antibodies which may act as
hemolysins and induce in vivo coating of red blood cells with
immunoglobulin causing a positive direct antiglobulin reaction and,
rarely, hemolysis. Hemolytic anemia can develop subsequent to IGIV
therapy due to enhanced red blood cell sequestration.
There have been reports of noncardiogenic pulmonary edema (Transfusion
Related Acute Lung Injury [TRALI]) in patients administered IGIV.
Thrombotic events have been reported in association with IGIV. The
potential risks and benefits of IGIV should be weighed against those of
Aseptic meningitis syndrome (AMS) has been reported to occur
infrequently in association with GAMMAGARD LIQUID treatment.
Discontinuation of IGIV treatment has resulted in remission of AMS
within several days without sequelae.
For full prescribing information, please visit:
Baxter International Inc., 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 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 and
additional enzymes that target the extracellular matrix. Halozyme’s
Enhanze™ Technology is a novel drug delivery platform
designed to increase the absorption and dispersion of biologics. The
company has key partnerships with Roche to apply Enhanze Technology to
Roche’s biological therapeutics for up to 13 targets and with Baxter
BioScience to apply Enhanze Technology to Baxter’s biological
therapeutic compound, GAMMAGARD LIQUID™. The product
candidates in Halozyme’s research pipeline target multiple areas of
significant unmet medical need. For more information visit www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above
include forward-looking statements (including, without
limitation, statements concerning the GAMMAGARD-rHuPH20 clinical
development program) 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 each company's reports on
Forms 10-K, 10-Q, and other filings with the Securities and Exchange
Source: Halozyme Therapeutics, Inc.
Baxter Media Contacts
Chris Bona, 847-948-2815
Baxter Investor Contacts
Kay Ladone, 847-948-3371
Clare Trachtman, 847-948-3085
Robert H. Uhl, Senior Director, Investor Relations,