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 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, 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:
Jim
Mazzola
858-704-8122
ir@halozyme.com
Chris
Burton
858-704-8352
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.