SAN DIEGO, June 29, 2020 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S.
Food and Drug Administration (FDA) has approved Roche's Phesgo™
(pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection, a
fixed-dose combination (FDC) of Perjeta® and
Herceptin® with Halozyme's ENHANZE®
technology, administered subcutaneously in combination with
intravenous (IV) chemotherapy, for the treatment of eligible
patients with early and metastatic HER2-positive breast cancer.
This is the first time a product has been approved combining two
monoclonal antibodies that can be administered by a single
subcutaneous injection utilizing Halozyme's ENHANZE®
technology.
"We are excited that HER2-positive breast cancer patients in the
U.S. will now have the option to receive this important therapy in
a meaningfully shorter period of time," said Dr. Helen Torley, president and chief executive
officer. "This subcutaneous delivery was shown to be preferred to
IV administration by 85% of patients in the PHranceSCa study due to
less time in the clinic and more comfortable treatment
administration. Phesgo™ is the second
product to receive FDA approval this year, and the first
demonstrating the ability to combine two monoclonal antibodies,
utilizing our ENHANZE® technology."
Phesgo™ is available in single-dose
vials and can be administered in approximately eight minutes for
the initial loading dose and approximately five minutes for each
subsequent maintenance dose.(1) This is compared to
approximately 150 minutes for a sequential infusion of a loading
dose of Perjeta® and Herceptin® using the
standard IV formulations, and between 60-150 minutes for subsequent
maintenance infusions of the two medicines.(2,3)
Phesgo™ can be administered by a healthcare
professional in a treatment center or at a patient's home.
The approval is based on results from the pivotal phase III
FeDeriCa study, which met its primary endpoint, with
Phesgo™ showing non-inferior levels of
Perjeta® in the blood during a given dosing interval
(Ctrough), when compared to IV administration of
Perjeta®. The safety profile of
Phesgo™ with chemotherapy was comparable to
IV administration of Perjeta® plus Herceptin®
and chemotherapy, and no new safety signals were identified,
including no meaningful difference in cardiac toxicity. The most
common adverse events in both arms were alopecia, nausea, diarrhea
and anemia.(1,4)
The phase II PHranceSCa study showed that 85% (136/160) of
people receiving treatment for HER2-positive breast cancer
preferred treatment under the skin to IV administration due to less
time in the clinic and more comfortable treatment
administration.(1)
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 is a biopharmaceutical company
bringing disruptive solutions to significantly improve patient
experiences and outcomes for emerging and established therapies.
Halozyme advises and supports its biopharmaceutical partners in key
aspects of new drug development with the goal of improving
patients' lives while helping its partners achieve global
commercial success. As the innovators of the ENHANZE®
technology, which can reduce hours-long treatments to a matter of
minutes, Halozyme's commercially-validated solution has positively
impacted more than 400,000 patient lives via four commercialized
products across more than 100 global markets. Halozyme and its
world-class partners are currently advancing multiple therapeutic
programs intended to deliver innovative therapies, with the
potential to improve the lives of patients around the
globe. Halozyme's proprietary enzyme rHuPH20 forms the basis
of the ENHANZE® technology and is used to
facilitate the delivery of injected drugs and fluids, potentially
reducing the treatment burden of other drugs to patients. Halozyme
has licensed its ENHANZE® technology to leading
pharmaceutical and biotechnology companies including Roche,
Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb,
Alexion and argenx. Halozyme derives revenues from these
collaborations in the form of milestones and royalties as the
Company's partners make progress developing and commercializing
their products being developed with ENHANZE®. 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 and
potentially lowering the treatment burden for patients. 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 including any potential delays
caused by the current COVID-19 global pandemic, unexpected
regulatory approval requirements, unexpected adverse events or
patient outcomes from being treated with the newly-approved
ENHANZE® co-formulated product referred to in this press
release, 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.
References:
(1) US Food and Drug Administration.
Prescribing information for Phesgo.
(2) US Food and Drug Administration. Prescribing Information for
Herceptin. [Internet; cited June
2020]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.pdf.
(3) US Food and Drug Administration. Prescribing Information for
Perjeta [Internet; cited June 2020].
Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125409s113s118lbl.pdf
(4) Tan A, et al. Subcutaneous administration of the fixed-dose
combination of trastuzumab and pertuzumab in combination with
chemotherapy in HER2-positive early breast cancer: primary analysis
of the phase III, multicenter, randomized, open-label, two-arm
FeDeriCa study. Presented at SABCS, 2019 Dec
10-14; San Antonio, Texas.
Abstract #PD4-07.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.