Baxter Media Contact Baxter Investor Contacts Halozyme Media / Investor Contact

Baxter Media Contact
Brian Kyhos
224-948-5353 or [email protected]
Baxter Investor Contacts
Mary Kay Ladone, 224-948-3371
Clare Trachtman, 224-948-3085
Halozyme Media / Investor Contact
Schond Greenway
858-704-8352
[email protected]
BAXTER LAUNCHES HYQVIA IN THE UNITED STATES FOR ADULT PATIENTS
WITH PRIMARY IMMUNODEFICIENCY
DEERFIELD, Ill., October 20, 2014 – Baxter International Inc. (NYSE:BAX) and
Halozyme Therapeutics, Inc., (NASDAQ:HALO) today announced the launch and first
shipments of HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant
Human Hyaluronidase], Baxter’s subcutaneous immunoglobulin treatment for adult
patients with primary immunodeficiency (PI) in the United States. The treatment was
approved by the U.S. Food and Drug Administration (FDA) in September of this year.
“HYQVIA will have a significant impact on the treatment of primary
immunodeficiency. It will be a welcomed addition to the therapeutic options in my
practice, particularly for patients who are seeking less frequent dosing, but still desire
the efficacy and tolerability associated with subcutaneous treatment,” said Richard L.
Wasserman, M.D., Ph.D, clinical professor of pediatrics at University of Texas
Southwestern Medical School and clinical investigator on the HYQVIA clinical trial.
BAXTER LAUNCHES HYQVIA IN THE UNITED STATES FOR ADULT PATIENTS WITH
PRIMARY IMMUNODEFICIENCY – PAGE TWO
HYQVIA is the first subcutaneous immune globulin (IG) treatment approved for
adult PI patients that allows a full monthly dose of IG to be administered with only one
injection site and one infusion each month (once every three to four weeks depending
on their established dosing regimen).
“With our swift commercial introduction, we look forward to sharing HYQVIA with
adult PI patients seeking an option with less frequent dosing than current subcutaneous
treatments without compromising efficacy, safety and tolerability. The goal of HYQVIA is
to allow people with PI to feel less like patients by reducing the treatment burden
associated with weekly dosing and multiple injection sites per dose,” said Ludwig
Hantson, Ph.D., President of Baxter BioScience.
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
available 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).
BAXTER LAUNCHES HYQVIA IN THE UNITED STATES FOR ADULT PATIENTS WITH
PRIMARY IMMUNODEFICIENCY – PAGE THREE
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.
BAXTER LAUNCHES HYQVIA IN THE UNITED STATES FOR ADULT PATIENTS WITH
PRIMARY IMMUNODEFICIENCY – PAGE FOUR
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.
BAXTER LAUNCHES HYQVIA IN THE UNITED STATES FOR ADULT PATIENTS WITH
PRIMARY IMMUNODEFICIENCY – PAGE FIVE
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.
BAXTER LAUNCHES HYQVIA IN THE UNITED STATES FOR ADULT PATIENTS WITH
PRIMARY IMMUNODEFICIENCY – PAGE SIX
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
BAXTER LAUNCHES HYQVIA IN THE UNITED STATES FOR ADULT PATIENTS WITH
PRIMARY IMMUNODEFICIENCY – PAGE SEVEN
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 impact to patients. 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 Baxter's most recent filing on Form 10K and other SEC filings, all of which are available on Baxter's website. Baxter does not
undertake to update its forward-looking statements.
###