Baxter and Halozyme Announce Collaboration For Development Of ...

Baxter and Halozyme Announce Collaboration For Development Of Su...neous GAMMAGARD LIQUID Administration using Enhanze Technology 

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Baxter and Halozyme Announce Collaboration For 

Development Of Subcutaneous GAMMAGARD LIQUID 

Administration using Enhanze Technology 

Development of New Route to Administer GAMMAGARD LIQUID 10% Could Make Home 

Therapy More Accessible; Collaboration Valued at Up To $47 Million 

DEERFIELD, Ill. and SAN DIEGO, Calif., September 10, 2007 – 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 Technology to the development of a 

subcutaneous route of administration for Baxter’s GAMMAGARD LIQUID 10% [Immune Globulin 

Intravenous (Human)] (IGIV) (known as KIOVIG 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-formulations. 

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 therapy.” 

“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 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. 

http://www.baxter.com/about_baxter/news_room/news_releases/2007/09-10-07-baxter_halozyme.html (1 of 4)10/23/2007 10:30:44 AM


About Enhanze 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 skin. 

About Baxter’s GAMMAGARD LIQUID 10% 

GAMMAGARD LIQUID 10% (known as KIOVIG 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 for GAMMAGARD LIQUID, please go to www.baxter.com/products/ 

biopharmaceuticals/downloads/gamliquid_PI.pdf 



Important Safety Information for HYLENEX 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 coadministered 

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, visit www.HYLENEX.com. 

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 reimportation 

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 forward-looking statements. 

HYLENEX recombinant, GAMMAGARD LIQUID and KIOVIG are trademarks of Baxter Healthcare 

Corporation. 

Cumulase and Enhanze are trademarks of Halozyme Therapeutics, Inc. 

For More Information 

Media Contacts 

Christopher Bona, (847) 948-2815 - Baxter 

Tarsis Lopez, (847) 940-5166 - Baxter 

Karen Sparks, (858) 455-5500, x275 - 

Halozyme 

Investor Contacts 

Mary Kay Ladone, (847) 948-3371 - Baxter 

Clare Trachtman, (847) 948-3085 - Baxter 

David A. Ramsay, (858) 794-8881 - Halozyme 

Don Markley, (310) 691-7100 - Halozyme 

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