Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics,
Inc., (NASDAQ:HALO) today announced that the United States Food and
Drug Administration (FDA) approved Baxter’s subcutaneous treatment
for adult patients with primary immunodeficiency (PI), HYQVIA
[Immune Globulin Infusion 10% (Human) with Recombinant Human
Hyaluronidase].
HYQVIA is the first subcutaneous immune globulin (IG) treatment
approved for PI patients with a dosing regimen requiring only one
infusion up to once per month (every three to four weeks) and one
injection site per infusion to deliver a full therapeutic dose of
IG. The majority of PI patients today receive intravenous infusions
in a doctor’s office or infusion center, and current subcutaneous
IG treatments require weekly or bi-weekly treatment with multiple
infusion sites per treatment.
''Patients with PI value treatments that offer efficacy, safety
and tolerability. Since each person with PI responds differently to
treatment, having options that meet these individual needs is
critically important,'' commented Marcia Boyle, President and
Founder of the Immune Deficiency Foundation. ''We commend Baxter
for its significant commitment and investment in the development of
HYQVIA.''
''The availability of HYQVIA has a significant impact on the
treatment of PI, allowing for effective delivery of a full
therapeutic dose of IG less frequently than other subcutaneous
treatments (up to once a month), while maintaining the efficacy,
safety and tolerability profile that is most important for
patients,'' said Ludwig Hantson, Ph.D., President of Baxter
BioScience. ''This approval highlights the support of the patient
community for new treatment options.''
''Today’s FDA approval of HYQVIA is a significant milestone for
Halozyme as it represents the first U.S. approved Biologics License
Application which utilizes our rHuPH20 platform,'' commented Dr.
Helen Torley, President and Chief Executive Officer of Halozyme.
''I would like to thank the talented teams at both Halozyme and
Baxter for their dedication to bring a new treatment alternative to
PI patients managing a life-long disease.''
Baxter expects to launch HYQVIA in the U.S. in the coming weeks.
HYQVIA was approved in Europe in 2013 for adults (≥18 years) with
primary immunodeficiency syndromes and myeloma or chronic
lymphocytic leukemia (CLL) with severe secondary
hypogammaglobulinemia and recurrent infections. It is currently
being prescribed in several European countries, including Germany,
Netherlands, Sweden, Norway, Denmark, Ireland and Italy.
About HYQVIA
HYQVIA is an immune globulin with a recombinant human
hyaluronidase indicated for the treatment of Primary
Immunodeficiency (PI) in adults.
HYQVIA is a product consisting of Immune Globulin Infusion 10%
(Human) (IG 10%) and Recombinant Human Hyaluronidase (developed by
Halozyme Therapeutics). The IG component, a 10% solution that is
prepared from large pools of human plasma consisting of at least
98% IgG, contains a broad spectrum of antibodies and provides the
therapeutic effect. The Recombinant Human Hyaluronidase of HYQVIA
increases dispersion and absorption of the Immune Globulin Infusion
10% (Human).
Important Risk Information
Thrombosis may occur with immune globulin products, including
HYQVIA. Risk factors may include advanced age, prolonged
immobilization, hypercoagulable conditions, history of venous or
arterial thrombosis, use of estrogens, indwelling vascular
catheters, hyperviscosity, and cardiovascular risk factors.
Thrombosis may occur in the absence of known risk factors. For
patients at risk of thrombosis, administer HYQVIA at the minimum
dose and infusion rate practicable. Ensure adequate hydration in
patients before administration. Monitor for signs and symptoms of
thrombosis and assess blood viscosity in patients at risk of
hyperviscosity.
HYQVIA is contraindicated in patients who have a history of
anaphylactic or severe systemic reactions to the administration of
IgG; in IgA-deficient patients with antibodies to IgA and a history
of hypersensitivity; and in patients with known systemic
hypersensitivity to hyaluronidase or Recombinant Human
Hyaluronidase of HYQVIA. Severe hypersensitivity reactions may
occur, even in patients who have tolerated previous treatment with
IgG. Patients with antibodies to IgA are potentially at greater
risk of developing potentially severe hypersensitivity and
anaphylactic reactions. Non-neutralizing antibodies to the
recombinant human hyaluronidase component may develop. The
potential exists for such antibodies to cross-react with endogenous
PH20, which is known to be expressed in adult male testes,
epididymis, and sperm. It is unknown whether these antibodies may
interfere with fertilization in humans. The clinical significance
of these antibodies is unknown.
Aseptic Meningitis Syndrome (AMS) has been reported to occur
with IgG products, including Immune Globulin Infusion 10% (Human)
administered intravenously and subcutaneously. Discontinuation of
IgG treatment has resulted in remission of AMS within several days
without sequelae. The syndrome usually begins within several hours
to two days following intravenously administered IgG, perhaps more
frequently in association with high dose (2 g/kg) intravenously
administered IgG.
IgG products, including HYQVIA, contain blood group antibodies
which may act as hemolysins and induce in vivo coating of red
blood cells (RBC) with IgG. These antibodies may cause a positive
direct antiglobulin reaction and hemolysis. Acute intravascular
hemolysis has been reported following intravenously administered
IgG, including Immune Globulin Infusion 10% (Human) administered
intravenously, and delayed hemolytic anemia can develop due to
enhanced RBC sequestration.
Acute renal dysfunction/failure, acute tubular necrosis,
proximal tubular nephropathy, osmotic nephrosis, and death may
occur upon use of IgG products administered intravenously,
especially those containing sucrose. HYQVIA does not contain
sucrose. Periodic monitoring of renal function and urine output is
particularly important in patients judged to be at increased risk
for developing acute renal failure.
Infusion into or around an infected area can spread a localized
infection. Do not infuse HYQVIA into these areas due to potential
risk of spreading a localized infection. Non-cardiogenic pulmonary
edema (TRALI) may occur with intravenously administered IgG and has
been reported to occur with Immune Globulin Infusion 10% (Human)
administered intravenously. TRALI is characterized by severe
respiratory distress, pulmonary edema, hypoxemia, normal left
ventricular function, and fever.
Because the Immune Globulin Infusion 10% (Human) of HYQVIA is
made from human plasma, it may carry a risk of transmitting
infectious agents, e.g., viruses, the variant CJD (vCJD) agent, and
theoretically, the Creutzfeldt-Jakob disease (CJD) agent. This also
applies to unknown or emerging viruses and other pathogens. No
cases of viral transmission or CJD have been associated with
HYQVIA.
After infusion of IgG, the transitory rise of the various
passively transferred antibodies in the patient’s blood may yield
false positive serological testing results, with the potential for
misleading interpretation. Passive transmission of antibodies to
erythrocyte antigens (e.g., A, B, and D) may cause a positive
direct or indirect antiglobulin (Coombs’) test. Common adverse
reactions observed in clinical trials in >5% of subjects were:
local reactions, headache, antibody formation against recombinant
human hyaluronidase (rHuPH20), fatigue, nausea, pyrexia, and
vomiting.
Please see accompanying full prescribing information,
including boxed warning for HYQVIA at:
http://www.baxter.com/downloads/healthcare_professionals/products/HYQVIA_PI.pdf.
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops,
manufactures and markets products that save and sustain the lives
of people with hemophilia, immune disorders, cancer, 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
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
oncology, diabetes, and dermatology that have significant unmet
medical need. The Company markets Hylenex® recombinant
(hyaluronidase human injection) and has partnerships with Roche,
Pfizer, and Baxter. Halozyme is headquartered in San Diego. For
more information on how we are innovating, please visit our
corporate website at www.halozyme.com.
This release includes forward-looking statements concerning
HYQVIA, including expectations with regard to its planned
commercial launch in the US. 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: actions of regulatory bodies and
other governmental authorities; satisfaction of regulatory and
other requirements; changes in laws and regulations; product
quality or supply or patient safety issues; 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.
Baxter Media ContactBrian Kyhos224-948-5353 or
media@baxter.comorBaxter Investor ContactsMary Kay Ladone,
224-948-3371Clare Trachtman, 224-948-3085orHalozyme Media /
Investor ContactSchond GreenwayHalozyme
Therapeutics858-704-8352ir@halozyme.com
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