SAN DIEGO, Feb. 2 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. , a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced it has initiated and dosed the first patient in a clinical trial of subcutaneous (SC) administration of morphine with Hylenex. Hylenex is a liquid injectable formulation that includes the active pharmaceutical ingredient, recombinant human hyaluronidase (rHuPH20). Morphine is a widely used drug for pain management and is currently approved for both intravenous and subcutaneous administration. More rapid absorption facilitated by Hylenex via the SC route of administration could shorten the time of onset for achieving effective pain relief for patients, without the burden of intravenous (IV) administration.
Hylenex is a recombinant human hyaluronidase approved for use as a spreading agent to accelerate the delivery of fluids and drugs, such as local anesthesics and other co-injected drugs, contrast agents, and for subcutaneous fluid replacement. Halozyme received FDA approval for Hylenex on December 2, 2005. The INcreased Flow Utilizing Subcutaneously-Enabled Morphine clinical trial, or INFUSE-Morphine study, is designed to determine the time to maximal blood levels of morphine after subcutaneous administration with and without Hylenex, maximal blood levels after intravenous administration of morphine, and to assess safety and tolerability. The double-blind, randomized, within-patient, placebo-controlled, crossover study will enroll up to 18 subjects.
About Hylenex
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.hylenex.com or www.halozyme.com.
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, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the Company’s products under development, product development plans, regulatory strategy, regulatory filing dates and clinical trials) 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,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company’s reports on Forms 10-KSB, 10-QSB and other filings with the Securities and Exchange Commission.
Halozyme Contact Investor Relations Contacts David A. Ramsay Don Markley / Zachary Bryant Chief Financial Officer Lippert/Heilshorn & Associates (858) 794-8889 (310) 691-7100 dramsay@halozyme.comdmarkley@lhai.com Media Contacts Kathy Sweeney / Joleen Schultz Mentus (858) 455-5500, x230/x215 kwitz@mentus.comjschultz@mentus.com
Halozyme Therapeutics, Inc.
CONTACT: David A. Ramsay, Chief Financial Officer of HalozymeTherapeutics, Inc., +1-858-794-8889, dramsay@halozyme.com; or InvestorRelations, Don Markley, dmarkley@lhai.com, or Zachary Bryant, both ofLippert/Heilshorn & Associates, +1-310-691-7100, for Halozyme Therapeutics,Inc.; or Media, Kathy Sweeney, ext. 230, kwitz@mentus.com, or JoleenSchultz, ext. 215, jschultz@mentus.com, both of Mentus, +1-858-455-5500,for Halozyme Therapeutics, Inc.
