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News Release

 
 

Halozyme Therapeutics and Baxter Healthcare Corporation Expand Relationship to Include European Union

 

 

SAN DIEGO, Calif. and DEERFIELD, Ill., August 8, 2005 – Halozyme Therapeutics, Inc. (AMEX: HTI), a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, and Baxter Healthcare Corporation (Baxter) announced today that Baxter has exercised its option to market, sell, and distribute Hylenex™ in the European Union. Hylenex is a local formulation of recombinant human hyaluronidase under development for use as a “spreading agent” to enhance the delivery of local anesthesia, contrast agents, and for subcutaneous fluid replacement (also called hypodermoclysis). Halozyme filed a New Drug Application in the United States for Hylenex on March 23, 2005 and will be filing for regulatory approval in the European Union.

 

In August 2004, Halozyme and Baxter first entered into an exclusive sales and marketing agreement under which Baxter and Halozyme are equal partners in the commercialization of Hylenex upon U.S. Food and Drug Administration (FDA) approval. Under the original terms of the agreement, Baxter will fill and finish Hylenex as well as market, distribute, and sell Hylenex in the United States and Puerto Rico. Halozyme also granted Baxter a right of first refusal for additional select developmental stage products and territories. The companies have now added the additional territory of the European Union to the partnership.

 

“Baxter's decision to expand our partnership to include the European Union is a strong validation of our Hylenex product's market opportunity,” said Jonathan Lim , MD, Halozyme's chairman and CEO. “ We are excited to have Baxter as a partner utilizing their world-class sales and marketing capabilities to help develop and commercialize Hylenex in Europe.”

 

“This product will bring significant benefit to patients in many clinical settings,” said Daniel Tassé, general manager for Baxter's Anesthesia, Critical Care and Oncology business. “We look forward to continuing to work with Halozyme to bring Hylenex to market.”

 

Halozyme's hyaluronidase (rHuPH20) is a recombinant form of the naturally occurring human enzyme and is being investigated for its ability to break down hyaluronic acid (HA), the space-filling gel-like substance that is a major component of tissues throughout the body. Hyaluronidase that is injected in the skin or in the muscle is being studied to determine if it can temporarily digest the HA gel to enhance the penetration and diffusion of other injected drugs or fluids.

 

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 dedicated to developing and commercializing recombinant human enzymes for the infertility, ophthalmology, and oncology communities. The company's portfolio of products under development is based on intellectual property covering the family of human enzymes known as hyaluronidases. Halozyme's recombinant human enzymes may replace current animal slaughterhouse-derived enzymes that carry potential risks of animal pathogen transmission and immunogenicity. The versatility of the first enzyme, rHuPH20, enables Halozyme to develop the product as a medical device, drug enhancement agent, and therapeutic biologic.

 
Safe Harbor Statement

 

In addition to historical information, statements set forth in this news release include forward-looking statements including, without limitation, statements concerning: anticipated timing of regulatory filings and the potential success in gaining regulatory approval for developmental products; the potential effectiveness of products under development; the potential benefits from collaborative relationships; the ability to effectively exploit drug-delivery platform opportunities in other markets; demand for and market acceptance for new and existing products; 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 factors discussed in each company's filings with the Securities and Exchange Commission that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words “believe,” “expect,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning, which are predictions of or indicate future events and trends and which do not relate to historical matters. 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.

For Additional Information

Halozyme Contacts:

     

Baxter Contacts:

 
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