Baxter Receives Marketing Authorization for HyQvia in European Union
BRUSSELS -- May 21, 2013
Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc.,
(NASDAQ:HALO) today announced that the European Commission has granted Baxter
marketing authorization in all European Union (EU) Member States for the use
of HyQvia (solution for subcutaneous use) as replacement therapy for adult
patients with primary and secondary immunodeficiencies.
''HyQvia offers patients with primary and secondary immunodeficiencies the
ability to administer their treatment in a single subcutaneous site every
three to four weeks. This represents an important advance for patients who are
managing a chronic disease as HyQvia combines key benefits of intravenous and
subcutaneous administration into one product,'' said Ludwig Hantson, Ph.D.,
president of Baxter’s BioScience business. ''We look forward to introducing
HyQvia in the coming weeks to support physicians and adult immunodeficient
patients in Europe.''
Baxter will introduce HyQvia in select countries during 2013 and plans to
expand the launch to other EU countries in 2014.
''We are delighted that these patients who depend on immunoglobulin
replacement treatment will have access to HyQvia,'' said Gregory I. Frost,
Ph.D., president and chief executive officer, Halozyme Therapeutics.
The product is a combination of human normal immunoglobulin (IGSC, 10%) and
recombinant human hyaluronidase, which facilitates the dispersion and
absorption of the IGSC. The application was based on results from a phase III,
prospective, open-label, non-controlled multi-center clinical trial, which
evaluated the safety and effectiveness of HyQvia in the prevention of acute
serious bacterial infections, and the pharmacokinetic parameters compared to
immunoglobulin administered intravenously. The objective of the study was to
infuse a 3-or 4-week dose of the treatment in a single subcutaneous site.
The rate of validated acute serious bacterial infections in the study was
0.025 per patient per year, which is below the required efficacy threshold of
1.0 (serious bacterial infections per patient per year). In the tolerability
assessment of HyQvia, the most frequently reported adverse reactions were
infusion site reactions (20% of infusions), headache (3% of infusions),
fatigue (1% of infusions) and pyrexia (fever) (1% of infusions).
HyQvia is a product consisting of human normal immunoglobulin (IGSC, 10%) and
recombinant human hyaluronidase (licensed from Halozyme Therapeutics). The two
components are packaged together as a dual vial unit: IGSC provides the
therapeutic effect and the recombinant human hyaluronidase facilitates the
dispersion and absorption of the IGSC, increasing the bioavailability. The
IGSC is a 10% solution that is prepared from human plasma consisting of at
least 98% IgG, which contains a broad spectrum of antibodies.
HyQvia is indicated as replacement therapy in adults (≥ 18 years) in primary
immunodeficiency syndromes and in myeloma or chronic lymphocytic leukaemia
with severe secondary hypogammaglobulinaemia and recurrent infections.
Important Risk Information
HyQvia should not be used by patients with a hypersensitivity to human
immunoglobulins, especially in very rare cases of IgA deficiency when the
patient has antibodies against IgA. HyQvia should not be used by patients with
a systemic hypersensitivity to hyaluronidase or recombinant human
hyaluronidase. HyQvia should not be used by patients with a hypersensitivity
to any of the excipients, including glycine.
HyQvia must not be given intravenously.
HyQvia should not be used by women who are pregnant, or are planning to become
pregnant, or are breast-feeding.
Patients should be closely monitored and carefully observed for any adverse
reactions throughout the infusion period, particularly patients starting with
HyQvia treatment. In case of adverse reaction, either the rate of
administration must be reduced or the infusion stopped. The treatment required
depends on the nature and severity of the adverse reaction. In case of shock,
standard medical treatment for shock should be implemented.
Thromboembolic events (e.g. myocardial infarction, cerebral vascular accident,
deep vein thrombosis, and pulmonary embolism), renal dysfunction/failure,
aseptic meningitis syndrome, and hemolysis have been observed with IG 10%
administered intravenously and cannot be excluded with use of HyQvia.
Thrombotic events and haemolysis have also been reported in association with
the subcutaneous administration of immunoglobulin products.
Human normal immunoglobulin and human serum albumin (stabilizer of the
recombinant human hyaluronidase) are produced from human plasma and may carry
a risk of transmitting infectious agents.
About Immunodeficiency Disorders
Primary Immunodeficiencies (PI) are a group of more than 175 disorders in
which part of the body’s immune system is missing or does not function
properly. Normally, the immune system protects the body from pathogenic
microorganisms like bacteria, viruses, and fungi, which can cause infectious
diseases. When any part of a person's immune system is absent or
dysfunctional, they are more likely to become infected and may take longer to
recover from infections. When a defect in the immune system is inherited, it
is called primary, or inherited, immune deficiency. It is estimated that as
many as six million children and adults are affected by PI worldwide.
Secondary immunodeficiencies develop as a result of a variety of conditions
such as malignancies, particularly those of the haematopoietic and
lymphoreticular systems, metabolic disease and/or malnutrition. Furthermore,
burns or severe infection can also cause defective immune function and poor
antibody response. In particular, immunoglobulin therapies are used to treat
hypogammaglobulinaemia associated with chronic lymphocytic leukaemia (CLL) and
multiple myeloma (MM). These patients may benefit from immunoglobulin
replacement treatment in addition to standard treatment of their primary
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures
and markets products that save and sustain the lives of people with
haemophilia, 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, that increase the absorption and dispersion of biologics.
Halozyme’s pipeline addresses therapeutic areas, such as diabetes, oncology
and dermatology that have significant unmet medical need. The Company markets
Hylenex® recombinant (hyaluronidase human injection) and has partnerships with
Roche, Baxter, ViroPharma, Intrexon, and Pfizer. Halozyme is headquartered in
San Diego, CA. 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 regarding the launch of HyQvia in the European Union. 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: satisfaction of regulatory and other
requirements; actions of regulatory bodies and other governmental authorities;
changes in laws and regulations; and other risks identified in Baxter's and
Halozyme's most recent filings on Form 10-K and other SEC filings, all of
which are available on Baxter's and Halozyme's websites respectively. Baxter
and Halozyme do not undertake to update their forward-looking statements.
Baxter Media Contacts
Brian Kyhos, (224) 948-5353
Deborah Spak, (224) 948-5353
Baxter Investor Contacts
Mary Kay Ladone, (224) 948-3371
Clare Trachtman, (224) 948-3085
Halozyme Media Contact
Nurha Hindi, 310-633-9434
Halozyme Investor Contact
Kurt Gustafson, 858-704-8272
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