Healthcare Industry News: Hylenex
News Release - February 14, 2007
Halozyme and Baxter Expand Global HYLENEX CollaborationTotal Collaboration Valued at Up to $65 Million, Including a $20 Million Equity Investment in Halozyme
SAN DIEGO and DEERFIELD, Ill., Feb. 14 (HSMN NewsFeed) -- Halozyme Therapeutics, Inc. (Amex: HTI ) and Baxter Healthcare Corporation announced today they have expanded their existing Hylenex recombinant (hyaluronidase human injection) agreements to include the use of Hylenex recombinant with Baxter proprietary and non-proprietary small molecule drugs.
Under the terms of the agreements, Baxter will pay Halozyme an initial upfront payment of $10 million and will make a $20 million equity investment. Pending the successful completion of a series of regulatory and sales events, Baxter may make further milestone payments to Halozyme. Halozyme will also receive royalties on Hylenex recombinant as a standalone product and on any kits and co-formulations of Hylenex recombinant with Baxter or other non-proprietary small molecule drugs. The agreement does not include combinations of Hylenex recombinant with cytostatic and cytotoxic chemotherapeutic agents, the rights to which have been retained by Halozyme. In addition, Baxter will now assume all development, manufacturing, clinical, regulatory, sales and marketing costs.
"Hylenex recombinant is the first and only FDA-approved recombinant human hyaluronidase drug product, and we are very proud to expand our relationship with Baxter so that they may make this important drug 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.
"Hylenex recombinant offers an innovative drug delivery technology for small molecules and hydration fluids, and given Baxter's strong relationships with clinicians and channel strength, Baxter is well positioned to bring this technology to patients," said Daniel Tasse, general manager of Baxter Pharmaceuticals and Technologies, part of Baxter's Medication Delivery business. "Our priority this year is to continue to complete clinical trials, engage key opinion leaders and build clinical foundations with centers of excellence in a number of important clinical settings in preparation for our expanded Hylenex recombinant launch this year."
Hylenex recombinant (hyaluronidase human injection) is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs, as an adjuvant for subcutaneous fluid administration (hypodermoclysis), and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. Hyaluronidase is contraindicated in patients with hypersensitivity to hyaluronidase enzyme or any other ingredients in the formulation. Hyaluronidase should not be used to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs. Discontinue Hylenex recombinant if sensitization occurs. Hyaluronidase should not be applied directly to the cornea, and should not be injected around infected or acutely inflamed areas, nor used to reduce the swelling of bites or stings. Hyaluronidase should not be used for intravenous injections because the enzyme is rapidly inactivated. Furosemide, the benzodiazepines, and phenytoin are incompatible with hyaluronidase. Please see accompanying package insert for full Prescribing Information.
About Baxter Healthcare Corporation
Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX ). 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 recombinant human enzymes for the drug delivery, palliative care, oncology, and infertility 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(TM) Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. In addition, the company has received FDA approval for two products: Cumulase® and Hylenex recombinant, 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.
Safe Harbor Statement
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 is a trademark of Baxter International, Inc.
Cumulase and Enhanze are trademarks of Halozyme Therapeutics, Inc.
Source: Halozyme Therapeutics
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