Healthcare Industry News: rHuPH20
News Release - June 27, 2006
Halozyme and Baxter Announce Availability of Hylenex for Subcutaneous Delivery of Medications and FluidsCompanies Initially Target Hospice and Palliative Care Centers
SAN DIEGO, June 27 (HSMN NewsFeed) -- Halozyme Therapeutics, Inc. (Amex: HTI ) and Baxter Healthcare Corporation announced today the availability of Hylenex, a liquid injectable formulation of recombinant human hyaluronidase, in the United States.
"Hylenex is the first and only FDA-approved recombinant human hyaluronidase drug product, and we are proud to make it available to health care providers 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.
The companies will focus predominantly on making the product available to hospices and palliative care centers, where additional clinical trials are planned with morphine and other injectable medications.
"Our priority this year is to engage key opinion leaders and build clinical foundations with centers of excellence in hospice and palliative care, in preparation for a full commercial launch of Hylenex in early 2007," said Daniel Tasse, General Manager of Baxter's Anesthesia, Critical Care and Oncology business. "We will continue to study Hylenex in a clinical setting to help health care professionals fully realize the benefits this product offers in the subcutaneous administration of drugs and fluids."
In a Phase III-B clinical trial, Halozyme and Baxter studied the use of Hylenex with subcutaneous infusions of Lactated Ringer's solution using gravity flow without an infusion pump to achieve substantial flow rates with acceptable tolerability.
Hylenex was approved by the U.S. Food and Drug Administration on Dec. 2, 2005, for use as a spreading agent to increase the absorption and dispersion of other injected drugs and for subcutaneous hydration.
Hylenex recombinant (hyaluronidase human injection) is indicated for use as an adjuvant to increase the absorption and dispersion of other injected drugs, for hypodermoclysis, and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. Hylenex recombinant is contraindicated in patients with hypersensitivity to hyaluronidase enzyme or any other ingredient in the formulation. Warnings for the use of Hylenex consist of discontinuing Hylenex if sensitization occurs, and not using Hylenex to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs, for injection into or around an infected or acutely inflamed area because of the danger of spreading localized infection, to reduce the swelling of bites or stings, for application directly to the cornea, or for IV injections because the enzyme is rapidly inactivated. Precautions for the use of Hylenex consist of incompatibility with furosemide, benzodiazepines and phenytoin, and recommendation for consulting appropriate references to determine the usual precautions when considering administration of Hylenex with any drug (e.g., when epinephrine is injected along with hyaluronidase, the precautions for the use of epinephrine in cardiovascular disease, thyroid disease, diabetes, digital nerve block, ischemia of the fingers and toes, etc., should be observed). A preliminary skin test for hypersensitivity to Hylenex can be performed. 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 products. Edema has been reported most frequently in association with hypodermoclysis. Allergic reactions (uticaria 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. The full prescribing information for Hylenex should be consulted prior to prescription or administration. For full Hylenex prescribing information, visit www.hylenex.com or www.halozyme.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.
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. Halozyme's recombinant human enzymes may replace current animal slaughterhouse-derived extracts that carry potential risks of animal pathogen transmission and immunogenicity. The company has received FDA approval for two products: Cumulase®, the first and only recombinant human hyaluronidase for cumulus removal in the IVF process; and Hylenex for use as an adjuvant to increase the absorption and dispersion of other injected drugs. The versatility of the first enzyme, rHuPH20, enables Halozyme to develop the product as a medical device, drug enhancement agent, and therapeutic drug.
Safe Harbor Statement
In addition to historical information, statements set forth in this news release include forward-looking statements including, without limitation, statements concerning additional clinical trials, the timing of launch, and market acceptance of the product. The statements are based upon assumptions, including the following, that could cause actual results or experience to differ materially from the expectations contained in the forward-looking statements: anticipated timing of regulatory filings and the potential success in gaining regulatory approvals 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; the impact of competitive products; and other factors discussed in each company's filings with the Securities and Exchange Commission. 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.
Source: Halozyme Therapeutics
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