SAN DIEGO, Sept. 13, 2019 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company
developing novel oncology and drug-delivery therapies, today
announced that the global phase III FeDeriCa study conducted by
Genentech, a member of the Roche Group, met its primary endpoint.
The FeDeriCa study investigated a fixed-dose combination of
pertuzumab (Perjeta®) and trastuzumab
(Herceptin®) for subcutaneous administration using
Halozyme's ENHANZE® drug delivery technology in
combination with intravenous chemotherapy. The study results
demonstrated non-inferior levels of Perjeta® in the
blood (pharmacokinetics) compared to standard intravenous (IV)
infusion of Perjeta® plus Herceptin® and
chemotherapy in patients with HER2-positive early breast
cancer.
"The results of the phase III FeDeriCa study represent an
important development for our ENHANZE® drug delivery
technology," said Dr. Helen Torley,
President and CEO. "This is the first study to combine two
therapeutic antibodies as a single fixed-dose subcutaneous
formulation utilizing our ENHANZE® technology, thereby
providing patients with HER2-positive breast cancer the possibility
of a faster treatment option."
Subcutaneous administration of the fixed-dose combination of
Perjeta® and Herceptin® is approximately 8
minutes for the initial loading dose and approximately 5 minutes
for each subsequent maintenance dose. Intravenous administration is
approximately 150 minutes for the loading dose of
Perjeta® and Herceptin® using standard IV
formulations and between 60-150 minutes for subsequent maintenance
infusions for the combination.
The study also demonstrated that the safety profile of the fixed
dose subcutaneous combination of Perjeta® and
Herceptin® was consistent with the safety profile of
Perjeta® and Herceptin® administered
intravenously.
Full data from the FeDeriCa study will be submitted for
presentation at an upcoming medical meeting and to health
authorities worldwide, including the U.S. Food and Drug
Administration (FDA) and the European Medicines Agency (EMA).1
2
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.
Halozyme 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, and
statements concerning certain other potential benefits of
ENHANZE® including facilitating more rapid delivery of
injectable medications through subcutaneous delivery. These
forward-looking statements also include statements regarding the
product development efforts of Halozyme's ENHANZE®
partner. These forward-looking statements involve risks 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 uncertainties concerning whether
collaborative products are ultimately developed or commercialized,
unexpected expenditures and costs, unexpected results or delays in
development and regulatory review, unexpected regulatory approval
requirements, unexpected adverse events and competitive conditions.
These and other factors that may result in differences are
discussed in greater detail in Halozyme's most recent Annual and
Quarterly Reports filed with the Securities and Exchange
Commission. Except as required by law, Halozyme undertakes no duty
to update forward-looking statements to reflect events after the
date of this release.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com
1 European Medicines Agency. Summary of Product
Characteristics for Herceptin. [Internet; cited 2019 September].
Available from:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000278/WC500074922.pdf.
2 European Medicines Agency. Summary of Product
Characteristics for Perjeta. [Internet; cited 2019 September].
Available from:
https://www.medicines.org.uk/emc/product/2993/smpc.
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SOURCE Halozyme Therapeutics, Inc.