SAN DIEGO, July 12, 2021 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen
Biotech, Inc. (Janssen) received U.S. Food and Drug Administration
(FDA) approval of DARZALEX FASPRO® (daratumumab and
hyaluronidase-fihj) in combination with pomalidomide and
dexamethasone (Pd) for the treatment of adult patients with
multiple myeloma who have received at least one prior line of
therapy, including lenalidomide and a proteasome inhibitor. The
approval marks Janssen's sixth indication for DARZALEX
FASPRO® in the treatment of multiple myeloma. Findings
from the Phase 3 APOLLO study were recently published in The
Lancet Oncology.
"We are delighted that Janssen received this FDA approval for
DARZALEX FASPRO®, making it the first and only
FDA-approved subcutaneous anti-CD38 monoclonal antibody therapy
available in this combination," said Helen
Torley, president and chief executive officer at Halozyme.
"This introduces a new delivery option for multiple myeloma
patients in the U.S. being treated with this regimen."
DARZALEX FASPRO® is co-formulated with recombinant
human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE®
drug delivery technology.
This FDA approval for DARZALEX FASPRO® in combination
with Pd for patients with multiple myeloma after first or
subsequent relapse is supported by data from the Phase 3 APOLLO
study, which met its primary endpoint of improved progression-free
survival (PFS). For more information related the Phase 3 APOLLO
study findings, please view Janssen's press release.
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 touched
more than 500,000 patient lives via five 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, argenx, Horizon
Therapeutics and ViiV Healthcare. 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.
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, approved or commercialized for the
indications referred to in this press release, 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 ENHANZE® co-formulated treatment
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.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.