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Baxter and Halozyme Announce Positive Opinion for HyQvia for Treatment of Primary and Secondary Immunodeficiencies in the

  Baxter and Halozyme Announce Positive Opinion for HyQvia for Treatment of
  Primary and Secondary Immunodeficiencies in the European Union

Business Wire

LONDON -- March 22, 2013

Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc.,
(NASDAQ:HALO) today announced that the European Medicines Agency’s Committee
for Medicinal Products for Human Use (EMA CHMP) has granted a Positive Opinion
to Baxter for the use of HyQvia (solution for subcutaneous use) as replacement
therapy for adult patients with primary and secondary immunodeficiencies.  The
product is a combination of human normal immunoglobulin (IGSC, 10%) and
recombinant human hyaluronidase, which facilitates the dispersion and
absorption of the IGSC.

''This recommendation supports our efforts to improve the overall quality of
care for patients. This therapy, when approved by the European Commission,
would offer patients the option to administer their therapy at home, in a
single subcutaneous site every three to four weeks, resulting in potentially
lower systemic adverse reactions compared to intravenous treatments,'' said
Ludwig Hantson, Ph.D., president of Baxter’s BioScience business. ''We look
forward to introducing HyQvia as a new patient-friendly therapeutic option for
immunodeficient patients.''

The application was based on results from a phase III, prospective,
open-label, non-controlled design 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 therapy in a single subcutaneous site. The acute serious
bacterial infection rate 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). Upon receiving marketing authorization from the
European Commission, Baxter plans to launch HyQvia in selected countries in
the European Union later this year.

''Recognizing that the path to approval for any biologic is a long journey, I
would like to thank and congratulate the teams at Halozyme and Baxter who have
worked tirelessly to advance this therapeutic option for patients,'' said
Gregory I. Frost, Ph.D., president and chief executive officer, Halozyme
Therapeutics.

About HyQvia

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 Safety Information

HyQvia should not be used by women who are pregnant, or are planning to become
pregnant, or are breast-feeding.

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 therapy in addition to standard treatment of their primary
disease.

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.

Contact:

Baxter Media Contacts
Brian Kyhos, (224) 948-4210
Deborah Spak, (224) 948-2349
or
Baxter Investor Contacts
Mary Kay Ladone, (224) 948-3371
Clare Trachtman, (224) 948-3085
or
Halozyme Media Contact
Nurha Hindi, 310-633-9434
Nurha.Hindi@hkstrategies.com
or
Halozyme Investor Contact
Kurt Gustafson, 858-704-8272
ir@halozyme.com
 
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