Halozyme Therapeutics, Inc. And Baxter Healthcare Corporation Announce FDA Approval Of Hylenex
SAN DIEGO, and DEERFIELD, Ill., Dec. 5 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, and Baxter Healthcare Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved Halozyme's Hylenex recombinant (hyaluronidase human injection) for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs. Baxter will market and sell Hylenex, a proprietary recombinant human hyaluronidase, in the United States.
"We are thrilled that the FDA has approved our first NDA filing," said Jonathan Lim, MD, Halozyme's Chairman and CEO. "This is a landmark achievement for Halozyme. We believe Hylenex will help enhance the practice of medicine by offering healthcare providers and their patients a human recombinant product as an adjuvant to increase the absorption of other injected drugs."
"We look forward to using our expertise and strong channels to successfully launch Hylenex, allowing patients in many clinical settings to benefit from the product manufactured with this promising technology," said Daniel Tasse, general manager of Baxter's Anesthesia, Critical Care and Oncology business. "We will continue to work with Halozyme to help clinicians fully realize the drug delivery and administration benefits this product offers."
Results from a clinical trial conducted to support the Hylenex NDA demonstrated no allergic reactions to Hylenex and significantly reduced injection site discomfort. The double-blinded clinical study compared Hylenex to a saline control in 100 human volunteers. These volunteers were injected intradermally with Hylenex in one forearm and saline control in the other forearm, and evaluated for allergic responses and injection site side effects. The data showed injection site discomfort (e.g., stinging, burning, other discomfort) of 28% in the saline arm and 3% in the Hylenex arm.
Hylenex recombinant (hyaluronidase human injection) is indicated for use as an adjuvant agent 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 ingredients in the formulation. The contraindications and warnings regarding the use of Hylenex should be recognized and adhered to prior to prescription or administration. For full prescribing information, visit www.halozyme.com or www.baxter.com.
About Baxter Healthcare Corporation
Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX - News). 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
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Halozyme Contacts Baxter Contacts Investors: Investors: David A. Ramsay Mary Kay Ladone Chief Financial Officer (847) 948-3371 (858) 794-8889 or firstname.lastname@example.org Clare Sullivan or (847) 948-3085 Don Markley Media: Lippert/Heilshorn & Associates Erin Gardiner (310) 691-7100 (847) 948-4210 email@example.com or Media: Cindy Resman Kathy W. Sweeney (847) 948-2815 Mentus (858) 455-5500, x230 firstname.lastname@example.org
Source: Halozyme Therapeutics, Inc.