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News Release - July 19, 2019
Halozyme Announces Janssen Submits Extension Application To European Medicines Agency For Subcutaneous Formulation Of DARZALEX(R) Utilizing ENHANZE(R) TechnologySAN DIEGO, July 19, 2019 -- (Healthcare Sales & Marketing Network) -- 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.
"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."
Janssen'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.
About ENHANZE® Technology
Halozyme'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.
Halozyme 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 increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for the treatment of several cancers and has the potential to be used in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx for its ENHANZE® drug delivery technology. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, the product development and approval efforts of Halozyme's ENHANZE® partners and statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery. These forward-looking statements also include statements regarding Halozyme's potential receipt of payments associated with future collaborative target nominations, achievement of certain milestones, and royalties on sales of commercialized products. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, 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 uncertainties concerning whether collaborative products are ultimately developed, approved or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review, unexpected regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.
DARZALEX® is a trademark of Janssen Pharmaceutica NV.
Source: Halozyme Therapeutics
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