DEERFIELD, Ill. and SAN DIEGO, Jan 05, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Baxter
International Inc. and Halozyme Therapeutics, Inc. (Nasdaq: HALO) today
announced the start of a Phase III clinical trial of Baxter's GAMMAGARD LIQUID
[Immune Globulin Intravenous] 10% (IGIV), marketed as KIOVIG in the European
Union, 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 and
gain regulatory approval for the treatment of PID using GAMMAGARD LIQUID and
rHuPH20 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 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.
"Baxter's work with Halozyme represents a commitment to innovation and, in
particular, to advancing patient care with GAMMAGARD LIQUID," said Hartmut J.
Ehrlich, M.D., vice president of Global Research and Development for Baxter's
"Entering Phase III clinical development is an important achievement for
our hyaluronidase enzyme and for our collaboration with Baxter. We are pleased
with the progress that has been made since our alliance began in September
2007," stated Jonathan Lim, M.D., President and CEO of Halozyme. "We look
forward to continuing our strong working relationship with the Baxter team and
to further advance this program."
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 Canada. The
trial will evaluate the efficacy of GAMMAGARD LIQUID administered SC with
rHuPH20 in the prevention of acute serious bacterial infections and will also
assess pharmacokinetic parameters of SC and rHuPH20 compared to intravenous
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
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
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:
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, 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. 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 Baxter to apply Enhanze Technology to Baxter's biological
therapeutic compound, GAMMAGARD LIQUID 10%. In addition, the company has
received FDA approval for two products: Cumulase(R), for use in in-vitro
fertilization, and HYLENEX, for use as an adjuvant to increase the absorption
and dispersion of other injected drugs and fluids. HYLENEX is partnered with
Baxter International Inc. Halozyme also has a number of different enzymes in
its portfolio that target significant areas of unmet medical need. For more
information visit http://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 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 Baxter nor Halozyme undertakes to update its
Robert H. Uhl
Senior Director, Investor Relations
SOURCE Halozyme Therapeutics, Inc.