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Halozyme Announces Janssen Submits Extension Application To European Medicines Agency For Subcutaneous Formulation Of DARZALEX® Utilizing ENHANZE® Technology
SAN DIEGO, July 19, 2019 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery
About this update from Halozyme Therapeutics, Inc.
[{"type":"text","content":"SAN DIEGO, July 19, 2019 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that Janssen-Cilag International NV (Janssen) has submitted an extension application to the European Medicines Agency (EMA) for the subcutaneous delivery of DARZALEX® (daratumumab) for patients with multiple myeloma.\n\"We are pleased that Janssen's filing follows quickly after its filing last week of a Biologics License Application (BLA) with the U.S. Food and Drug Administration,\" said Dr. Helen Torley, President and CEO. \"We are particularly excited that, pending approval by the EMA, a greater number of patients with multiple myeloma may soon have a new therapeutic option that offers the potential of DARZALEX® with a shorter administration time.\"\nJanssen's submission follows the announcement of positive results from its Phase 3 COLUMBA study, which investigated subcutaneously administered DARZALEX® in comparison to intravenous DARZALEX® in patients with relapsed and refractory multiple myeloma. Subcutaneous DARZALEX®, using ENHANZE® drug delivery technology, was found to be non-inferior to intravenous DARZALEX® with regard to the co-primary endpoints of overall response rate and Maximum Ctrough concentration on day 1 of the third treatment cycle prior to dose.\nAbout ENHANZE® TechnologyHalozyme's proprietary ENHANZE® drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.\nAbout HalozymeHalozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme's lead proprietary program, investigational drug pegvorhyaluronidase alfa (PEGPH20), applies a unique approach to targeting solid tumors, allowing increa...