SAN DIEGO, Oct. 10 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. , a biopharmaceutical company developing and commercializing recombinant human enzymes, today announced it has completed enrollment of a clinical trial of subcutaneous 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.
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, placebo-controlled, dose-comparison study reached its target enrollment of 12 evaluable subjects.
About Hylenex
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 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.
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(R), 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, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the development and commercialization of the Company’s products) 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-Q and other filings with the Securities and Exchange Commission.
Halozyme Contact Investor Relations Contacts David A. Ramsay Zachary Bryant Chief Financial Officer Lippert/Heilshorn & Associates (858) 794-8889 (310) 691-7100 dramsay@halozyme.comzbryant@lhai.com Media Contacts Joleen Schultz and Megan Swanland Riggs Mentus (858) 455-5500, x215 and x200 jschultz@mentus.commegan@mentus.com
Halozyme Therapeutics, Inc.
CONTACT: David A. Ramsay, Chief Financial Officer of HalozymeTherapeutics, Inc., +1-858-794-8889, dramsay@halozyme.com; or InvestorRelations, Zachary Bryant of Lippert/Heilshorn & Associates,+1-310-691-7100, zbryant@lhai.com, for Halozyme Therapeutics, Inc.; orJoleen Schultz, +1-858-455-5500 ext. 215, jschultz@mentus.com, or MeganSwanland Riggs, +1-858-455-5500 ext. 200, megan@mentus.com, both of Mentus,for Halozyme Therapeutics, Inc.
