SAN DIEGO, May 1, 2020 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that its
collaborator Janssen Biotech, Inc. (Janssen) has received approval
from the U.S. Food and Drug Administration (FDA) for DARZALEX
FASPRO™ (daratumumab hyaluronidase human- fihj). DARZALEX
FASPRO™ is approved in four regimens across five indications
in multiple myeloma patients, including newly diagnosed,
transplant-ineligible patients as well as relapsed or refractory
patients.
"We are delighted that DARZALEX FASPRO™ has been approved
in the U.S. making it possible for patients diagnosed with multiple
myeloma to receive daratumumab (DARZALEX®) treatment in
3-5 minutes with a subcutaneous injection rather than through a
multi-hour intravenous infusion. This can reduce the treatment
burden for patients, significantly shortening the time required in
the physician clinic, hospital in-patient and out-patient treatment
centers," said Dr. Helen Torley,
president and chief executive officer. "We are also pleased with
the breadth of indications granted to DARZALEX FASPRO™,
which includes the majority of the indications granted for the IV
DARZALEX® formulation."
DARZALEX FASPRO™ is approved for the treatment of adult
patients with multiple myeloma: in combination with bortezomib,
melphalan and prednisone in newly diagnosed patients who are
ineligible for autologous stem cell transplant (ASCT); in
combination with lenalidomide and dexamethasone in newly diagnosed
patients who are ineligible for ASCT and in patients with relapsed
or refractory multiple myeloma who have received at least one prior
therapy; in combination with bortezomib and dexamethasone in
patients who have received at least one prior therapy; and as
monotherapy, in patients who have received at least three prior
lines of therapy including a proteasome inhibitor (PI) and an
immunomodulatory agent or who are double-refractory to a PI and an
immunomodulatory agent.
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, Inc. is a biopharma technology platform
company that provides innovative and disruptive solutions with the
goal of improving patient experience and outcomes. Our proprietary
enzyme rHUPH20 is used to facilitate the delivery of injected drugs
and fluids. We license our technology to biopharmaceutical
companies to collaboratively develop products that combine our
ENHANZE® drug delivery technology with the collaborators'
proprietary compounds. 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.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.