SAN DIEGO, Feb. 28, 2019 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company
developing novel oncology and drug-delivery therapies, today
announced that Genentech, a member of the Roche Group, has received
approval from the U.S. Food and Drug Administration (FDA) for
Herceptin Hylecta™, a subcutaneous fixed-dose combination of
trastuzumab and hyaluronidase-oysk. Herceptin Hylecta™ is approved
for the treatment of certain people with HER2-positive early breast
cancer (node-positive, or node-negative and ER/PR-negative or with
one high-risk feature) in combination with chemotherapy and
HER2-positive metastatic breast cancer in combination with
paclitaxel or alone in people who have received one or more
chemotherapy regimens for metastatic disease. Herceptin Hylecta™ is
a co-formulation of trastuzumab with Halozyme's proprietary
recombinant human hyaluronidase enzyme (ENHANZE®
technology). Herceptin Hylecta™ is a ready-to-use formulation that
can be administered in two to five minutes, compared to 30 to 90
minutes for intravenous trastuzumab.
"We are delighted that Herceptin Hylecta™ has been approved in
the U.S. and that the potential for two- to five-minute
administration time will now be available to patients in most of
the major developed markets," said Dr. Helen Torley, president and chief executive
officer. "Herceptin Hylecta™ is the third product co-formulated
with ENHANZE to receive FDA approval, which represents an important
achievement."
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.
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
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, 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 potential
development and commercialization of products co-formulated with
ENHANZE® and statements concerning such products 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 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
recently filed Annual Report on Form 10-K and Quarterly Reports on
Form 10-Q filed with the Securities and Exchange Commission.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.