SAN DIEGO, Nov. 3, 2016 /PRNewswire/ -- Halozyme Therapeutics,
Inc. (NASDAQ: HALO) today announced that the U.S. Food and Drug Administration (FDA) has accepted Genentech's Biologics License
Application for a subcutaneous formulation of rituximab in multiple blood cancer indications. This is a co-formulation with
Halozyme's proprietary recombinant human hyaluronidase enzyme (ENHANZE™ platform), approved and marketed under the
MabThera® SC brand in countries outside the U.S.
"We are excited to see Genentech and Roche taking steps to bring a subcutaneous formulation of rituximab to patients in
the United States," said Dr. Helen Torley, president and chief
executive officer. "If approved, this formulation has the potential to reduce administration time for patients and health care
practitioners."
Including all approved indications, Roche reported total 2015 sales of rituximab in the United
States of 3.76 billion CHF.
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 ENHANZE™ drug delivery platform. 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, 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 of product candidates and regulatory review,
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 Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on August 9, 2016.
Contacts:
Jim Mazzola
858-704-8122
ir@halozyme.com
Chris Burton
858-704-8352
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.