Subject: FDA
FDA Approves Genentech's RITUXAN HYCELA, A Subcutaneous Rituximab Coformulated With Halozyme ENHANZE Technology
SAN DIEGO, June 22, 2017 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved Genentech's RITUXAN HYCELATM, a combination of rituximab and Halozyme's hyaluronidase human ENHANZE® technology, for subcutaneous injection in multiple blood cancer indications.
"We are pleased that RITUXAN HYCELA will now provide another treatment option for U.S. patients," said Dr. Helen Torley, president and chief executive officer. "RITUXAN HYCELA has the potential to reduce the treatment burden and administration time, and is an option preferred by many patients."
RITUXAN HYCELA has been approved for patients with follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia, and is expected to be available within one to two weeks. Including all approved indications, Roche reported total 2016 sales of rituximab in the United States of approximately $3.9 billion. Across all of its global collaboration and licensing agreements, Halozyme earns on average a mid-single-digit royalty on sales of products using the ENHANZE technology.
Today's approval was preceded by an FDA Oncologic Drug Advisory Committee in March that voted 11 to 0 in favor of the benefit/risk profile for rituximab/human hyaluronidase subcutaneous (under the skin) injection for patients in the proposed indications of follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia.
About Halozyme
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 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 metastatic pancreatic cancer, non-small cell lung cancer, gastric cancer, metastatic breast cancer and has potential across additional cancers 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 and Lilly for its ENHANZEtm 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, 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, potential royalties to be received on sales using ENHANZE technology formulation, the number of collaborative targets actually chosen, whether such products are ultimately developed or commercialized, whether milestones triggering milestone payments will be achieved and statements concerning facilitating more rapid delivery of injectable medications through subcutaneous delivery 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 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 unexpected expenditures and costs, unexpected results or delays in development, regulatory review and commercialization, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recently filed Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.
Contacts: Chris Burton
Jim Mazzola
858-704-8122
[email protected]
858-704-8352
[email protected]
SOURCE Halozyme Therapeutics, Inc.
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