DEERFIELD, Ill. and SAN DIEGO, Sept. 10 /PRNewswire-FirstCall/ -- Baxter International Inc. and Halozyme Therapeutics, Inc. 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- 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(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 skin.
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 http://www.gammagardliquid.com.
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, visit http://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(R) 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 forward-looking statements.
HYLENEX recombinant, GAMMAGARD LIQUID and KIOVIG are trademarks of Baxter Healthcare Corporation.
Cumulase and Enhanze are trademarks of Halozyme Therapeutics, Inc.
Baxter International Inc.