SAN DIEGO, March 29, 2017 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company
developing novel oncology and drug-delivery therapies, today
announced that an Oncologic Drug Advisory Committee of the U.S.
Food and Drug Administration voted 11 to 0 that the benefit/risk of
rituximab/hyaluronidase for subcutaneous (under the skin) injection
was favorable for patients in the proposed indications of
follicular lymphoma, diffuse large B-cell lymphoma and chronic
lymphocytic leukemia. The FDA action date is June 26, 2017.
"We are pleased with the support from today's advisory
committee," said Dr. Helen Torley,
president and chief executive officer. "Upon approval, subcutaneous
rituximab would offer a new treatment option for U.S. patients that
could reduce the administration time for the rituximab portion of
their treatment to 5 to 7 minutes as compared with an hour and a
half or more for intravenous administration."
Efficacy, safety, pharmacokinetic and patient-reported outcome
data from five clinical studies presented by Genentech, a member of
the Roche Group, at today's advisory committee meeting supported
the rituximab SC application.
Rituximab co-formulated with Halozyme's recombinant human
hyaluronidase was approved in Europe in 2014 and is currently marketed as
the subcutaneous (SC) formulation of MabThera®
(rituximab) in approximately 50 countries worldwide.
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 PEGPH20, the possible method of action of
PEGPH20, its potential application to improve cancer therapies,
including in combination with ABRAXANE and gemcitabine, and
statements concerning future actions relating to the development of
PEGPH20, including receipt by the FDA of breakthrough therapy
designation) 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 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 most
recent Annual and Quarterly Reports 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.