Halozyme Therapeutics, Inc. (Amex: HTI), a development stage biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Cumulase(TM) for the treatment of oocytes to facilitate certain in vitro fertilization (IVF) procedures. The active pharmaceutical ingredient in Cumulase is the first and only recombinant human hyaluronidase approved in the United States for cumulus removal in the IVF process.
"We are thrilled to receive FDA 510(k) clearance to market our first product in the U.S.," said Jonathan Lim, MD, Halozyme's Chairman and CEO. "This achievement is a key milestone for our company and provides validation of our technology and our team's ability to develop and commercialize products based on recombinant human hyaluronidase."
Cumulase is an ex vivo formulation of rHuPH20 (recombinant human PH20 hyaluronidase) to replace bovine and ovine extracts currently used for the preparation of oocytes prior to IVF during the process of intracytoplasmic sperm injection (ICSI), in which the enzyme is an essential component. The enzyme strips away the hyaluronic acid that surrounds the oocyte, allowing the clinician to then perform ICSI, injecting the sperm into the oocyte. Cumulase provides the IVF specialist with a safer, purer and more reliable alternative to slaughterhouse-derived extracts.
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