SAN DIEGO, April 30, 2020 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that
Janssen-Cilag International NV (Janssen) received a Committee
for Medicinal Products for Human Use (CHMP) Positive Opinion from
the European Medicines Agency (EMA) recommending approval of a
DARZALEX® (daratumumab) subcutaneous (SC) formulation
for the treatment of adult patients with multiple myeloma in
frontline and relapsed/refractory settings. The CHMP's
Positive Opinion for daratumumab SC formulation applies to all
current daratumumab indications including newly diagnosed and
transplant-ineligible patients, as well as relapsed or refractory
patients.
The DARZALEX® SC formulation utilizes Halozyme's
ENHANZE® drug delivery technology and reduces the
treatment time from several hours to approximately five minutes
with comparable efficacy to intravenous DARZALEX® and
lower rates of infusion-related reactions.
"We are excited that a subcutaneous formulation of
DARZALEX® is one step closer to transforming the
treatment experience for multiple myeloma patients and physicians
in the European Union," said Dr. Helen
Torley, president and chief executive officer. "Once
available, multiple myeloma patients may benefit from a shorter
infusion time when compared with a multi-hour intravenous
infusion."
The CHMP opinion is supported by data from Janssen's Phase 3
COLUMBA study, which investigated subcutaneously administered
DARZALEX® in comparison to intravenous
DARZALEX® in patients with relapsed and refractory
multiple myeloma, and the Phase 2 PLEIADES study. In the COLUMBA
study, subcutaneous DARZALEX®, using ENHANZE®
drug delivery technology, was found to be non-inferior to
intravenous DARZALEX® with regard to the co-primary
endpoints of overall response rate and maximum Ctrough
concentration on day 1 of the third treatment cycle prior to
dose.
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. 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, 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, 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.