SAN DIEGO, Calif. and DEERFIELD, Ill., March 30, 2005 – Halozyme Therapeutics, Inc. (AMEX: HTI), a development stage biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, and Baxter Healthcare Corporation announced today that they have expanded their relationship by signing a development and supply agreement for Enhanze SC™, Halozyme's recombinant human hyaluronidase enzyme (rHuPH20).
In August 2004, Halozyme Therapeutics and Baxter Healthcare Corporation signed an exclusive sales and marketing agreement, under which Baxter and Halozyme are equal partners in the commercialization of Enhanze SC™, upon Food and Drug Administration (FDA) approval. Upon approval of the therapeutic by the FDA, Baxter will fill and finish Enhanze SC ä as well as market, distribute, and sell it in the United States and Puerto Rico. Under terms of the agreement, Halozyme also will grant Baxter a right of first refusal for additional select developmental stage products and territories.
Enhanze SC™, the first product in Halozyme's Enhanze™ Technology portfolio, is a 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 (NDA) for Enhanze SC™ on March 23, 2005.
"This development and supply agreement builds upon our existing distribution agreement, and further solidifies our partnership with Baxter,” said Jonathan Lim, MD, Halozyme's Chairman and CEO. “Enhanze SC™ is an important product in our pipeline, and Baxter is an ideal partner to help us commercialize it.”
“This agreement is a logical extension of our current distribution relationship with Halozyme,” said Daniel Tassé, general manager for Baxter’s Anesthesia, Critical Care and Oncology business. “We will be able to provide enhanced value to customers by leveraging our manufacturing infrastructure, as well as our strong marketing channel in the Anesthesia and Critical Care market place.”
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 development stage 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-derived enzymes that carry potential risk 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.
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.