Healthcare Industry News: Halozyme Therapeutics
News Release - April 27, 2007
Baxter Introduces HYLENEX for Use in Ophthalmic Surgery
SAN DIEGO, April 27 (HSMN NewsFeed) -- Baxter Healthcare Corporation today announced availability of HYLENEX recombinant (hyaluronidase human injection) for the ophthalmology market for use in enhancing the absorption and dispersion of other injected drugs. HYLENEX is the first and only human recombinant hyaluronidase therapeutic product and is available from Baxter in one milliliter single-dose vials containing 150 units of hyaluronidase. The announcement was made at the American Society of Cataract and Refractive Surgery (ASCRS) and American Society of Ophthalmic Administrators (ASOA) joint Symposium held in San Diego, April 27 through May 2, 2007."The incorporation of animal-derived hyaluronidase into the anesthetic protocol for ophthalmic surgery has historically been shown to increase the speed of anesthetic onset, enhance the intensity and decrease the volume of drug required," said Scott Greenbaum M.D., clinical assistant professor, Department of Ophthalmology, New York University. "HYLENEX is a recombinant human protein produced using the latest in biotechnology manufacturing processes and its availability thus represents an important development for the ophthalmology community."
"As a recombinant protein, HYLENEX represents an advanced and more sustainable supply of hyaluronidase, circumventing the quality and supply problems that have historically been associated with animal-derived product," said Gregory Frost, Ph.D., vice president and chief scientific officer, Halozyme Therapeutics, Inc. "In addition, the use of a human protein derived from a recombinant source helps mitigate concerns over the potential for inter-species pathogen transmission and the potential for immunological reactions attributed to animal-derived product."
As HYLENEX is being introduced to the ophthalmology market, Baxter continues to develop its INFUSE clinical program, in which HYLENEX and other fluids or drugs are administered subcutaneously to patients. The INFUSE trials are evaluating the potential for Hylenex to offer an alternative route of administration for patients with difficult venous access.
HYLENEX is approved by the U.S. Food and Drug Administration for use as a spreading agent to increase the absorption and dispersion of other injected drugs and for subcutaneous hydration. HYLENEX was developed through an exclusive partnership with Halozyme Therapeutics, Inc. (Amex: HTI ).
About HYLENEX
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. 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 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.
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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.
Source: Baxter
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