DEERFIELD, Ill. and SAN DIEGO, Sept. 10 /PRNewswire-FirstCall/ -- Baxter
International Inc. (NYSE: BAX
) and Halozyme Therapeutics, Inc. (Nasdaq: HALO
announced today they have entered into an agreement to apply Halozyme's
proprietary Enhanze(TM) Technology to the development of a subcutaneous route
of administration for Baxter's GAMMAGARD LIQUID(TM) 10% [Immune Globulin
Intravenous (Human)] (IGIV) (known as KIOVIG(TM) in Europe). For patients
using GAMMAGARD LIQUID 10% -- currently administered intravenously --
subcutaneous administration with Enhanze Technology may increase overall
convenience and improve the dispersion of the therapy.
Under the terms of the agreement, Baxter will provide Halozyme an initial
upfront payment of $10 million. Pending successful completion of a series of
regulatory and sales milestones, Baxter may make further milestone payments
totaling $37 million to Halozyme. Baxter also will assume development,
manufacturing, clinical, regulatory, sales and marketing costs. Halozyme will
be responsible for the supply of the recombinant human hyaluronidase (rHuPH20)
enzyme that provides the basis for Enhanze Technology. Upon regulatory
approval, Halozyme will also receive royalties on GAMMAGARD LIQUID 10%
administered subcutaneously using Enhanze Technology both in kits and in co-
Baxter's GAMMAGARD LIQUID 10% is a large molecule therapy made from human
plasma that is indicated for the treatment of primary immunodeficiency
disorders associated with defects in immune system. Enhanze Technology is
Halozyme's proprietary drug delivery technology based on rHuPH20. rHuPH20 is a
form of human enzyme that temporarily clears space in the matrix of tissues
underlying the two outer layers of the skin to increase absorption and
spreading of injected drugs.
"By using Enhanze Technology to facilitate a subcutaneous route of
administration for GAMMAGARD LIQUID, patients with immunodeficiency disorders
could benefit from access to home therapy that may potentially allow full IV
dosing with the convenience of subcutaneous delivery," said Hartmut J.
Ehrlich, MD, vice president of global research and development for Baxter's
BioScience business. "This partnership represents Baxter's ongoing scientific
innovation and investment in enhancing administration of GAMMAGARD LIQUID
"We believe our technology can enhance the clinical benefits that
biologics have already been shown to provide. We are very excited to expand
our relationship with Baxter so that they may make this important product
available to as many people as possible worldwide as a way to simplify the
delivery of medications and fluids and, ultimately, provide a more comfortable
patient experience," said Jonathan Lim, MD, president and CEO of Halozyme.
In February 2007, Baxter and Halozyme expanded their ongoing collaboration
to commercialize product combinations of HYLENEX(TM) recombinant
(hyaluronidase human injection) with certain Baxter proprietary and non-
proprietary small molecule therapies. HYLENEX is a formulation of rHuPH20,
supplied by Halozyme, indicated to facilitate the absorption and dispersion of
other injected drugs or fluids. HYLENEX is manufactured by Baxter Healthcare
Corporation for Halozyme.
About Enhanze(TM) Technology
Enhanze Technology is Halozyme's proprietary drug delivery technology
based on rHuPH20, a recombinant form of the naturally occurring human enzyme
approved by FDA for its ability to break down hyaluronic acid, the space-
filling "gel"-like substance that is a major component of tissues throughout
the body. When combined or co-formulated with certain injectable drugs,
Enhanze Technology can facilitate the penetration and dispersion of these
drugs by temporarily opening flow channels under the skin. Molecules as large
as 200 nanometers may pass freely through the perforated extracellular matrix,
which recovers its normal density within approximately 24 hours, leading to a
drug delivery platform that does not permanently alter the architecture of the
About Baxter's GAMMAGARD LIQUID(TM) 10%
GAMMAGARD LIQUID 10% (known as KIOVIG(TM) in Europe) is indicated for the
treatment of primary immunodeficiency disorders associated with defects in
immune system. These include but are not limited to congenital X-linked
agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich
syndrome, and severe combined immunodeficiencies.
Important Safety Information for the United States
GAMMAGARD LIQUID 10% 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 10% does not contain sucrose.
Components used in the packaging of this product are latex-free.
GAMMAGARD LIQUID 10% is made from human plasma. It may carry a risk of
transmitting infectious agents, e.g. viruses, and theoretically, the
Creutzfeldt-Jakob disease (CJD) agent.
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 go to
Important Safety Information for HYLENEX(TM) recombinant
Hypersensitivity to hyaluronidase or any other ingredient in the
formulation is a contraindication to the use off this product. Discontinue
HYLENEX recombinant (hyaluronidase human injection) if sensitization occurs.
Hyaluronidase should not be used to enhance the absorption and dispersion of
dopamine and/or alpha agonist drugs. Hyaluronidase should not be injected into
or around an infected or acutely inflamed area because of the danger of
spreading a localized infection. Hyaluronidase should not be used to reduce
the swelling of bites or stings. Hyaluronidase should not be applied directly
to the cornea. Hyaluronidase should not be used for intravenous injections
because the enzyme is rapidly inactivated.
Furosemide, the benzodiazepines and phenytoin have been found to be
incompatible with hyaluronidase. The most frequently reported adverse
experiences have been local injection site reactions. Hyaluronidase has been
reported to enhance the adverse events associated with co-administered drug
product. Allergic reactions (urticaria or angioedema) have been reported in
less than 0.1% of patients receiving hyaluronidase. Anaphylactic-like
reactions following retrobulbar block or intravenous injections have occurred,
rarely. When hyaluronidase is added to a local anesthetic agent, it hastens
the onset of analgesia and tends to reduce the swelling caused by local
infiltration, but the wider spread of the local anesthetic solution increases
its absorption; this shortens its duration of action and tends to increase the
incidence of systemic reaction. Edema has been reported most frequently in
association with hypodermoclysis.
The full prescribing information for HYLENEX should be consulted prior to
prescription or administration. For full HYLENEX prescribing information,
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, assists healthcare
professionals and their patients with the treatment of complex medical
conditions, including cancer, hemophilia, immune disorders, kidney disease and
trauma. The company applies its expertise in medical devices, pharmaceuticals
and biotechnology to make a meaningful difference in patients' lives.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing
products based on the extracellular matrix for the drug delivery, oncology,
and dermatology markets. The company's portfolio of products is based on
intellectual property covering the family of human enzymes known as
hyaluronidases. The company's Enhanze Technology is a novel drug delivery
platform designed to increase the absorption and dispersion of biologics. In
addition, the company received FDA approval for two products: Cumulase® and
HYLENEX, for use as an adjuvant to increase the absorption and dispersion of
other injected drugs and fluids. The company also has a number of different
enzymes in its portfolio that are targeting significant areas of unmet need.
This release includes forward-looking statements concerning the companies'
expectations related to the expanded relationship between Halozyme and Baxter.
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: the anticipated timing of
regulatory filings and the success of certain regulatory events regarding
gaining regulatory approval for the products described in this release
including those products under development; the effectiveness of the products
described in this release including those products under development; the
ability of Baxter to effectively capitalize on drug-delivery platform
opportunities in existing and new markets; demand for and market acceptance
for the products described in this release including those products under
development; the impact of competitive products and pricing, including generic
competition, drug re-importation and disruptive technologies; internal and
external factors that could impact commercialization; and other risks
discussed in each company's filings with the Securities and Exchange
Commission (SEC) that could cause actual results to differ materially from
those in the forward-looking statements. Each company's SEC filings are
available on its respective website. The companies do not undertake any
obligation to update any forward-looking statements as a result of new
information, future events, changes assumptions or otherwise, and all forward-
looking statements speak only as of the time when made. Actual results or
experience could differ materially from the expectations contained in the
HYLENEX recombinant, GAMMAGARD LIQUID and KIOVIG are trademarks of Baxter
Cumulase and Enhanze are trademarks of Halozyme Therapeutics, Inc.