SAN DIEGO, April 26, 2020 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced the submission of
a New Drug Application (NDA) to the Ministry of Health, Labour and
Welfare (MHLW) by Janssen Pharmaceutical K.K. (Janssen) seeking
approval of a new subcutaneous (SC) formulation of daratumumab, an
intravenous (IV) treatment approved for patients with multiple
myeloma.
"We are pleased to see this New Drug Application submission in
Japan, which builds on Janssen's
prior regulatory submissions in the U.S. and EU that are currently
under review," said Dr. Helen
Torley, president and chief executive officer. "We are
excited that patients with multiple myeloma in Japan may soon have a new therapeutic option
that can be administered with a shorter infusion time when compared
with a multi-hour intravenous infusion."
The NDA is supported by pivotal data from the Phase 3 COLUMBA
(MMY3012) study – a randomized open label study – that included a
non-inferiority comparison of daratumumab SC formulation versus
daratumumab IV administration in patients with multiple myeloma who
had received at least three prior lines of therapy including a
proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or
whose disease was refractory to both PI and IMiD. In addition to
non-inferiority, daratumumab SC showed a lower rate of
infusion-related reactions. Data from the Phase 2 PLEIADES
(MMY2040) study – a non-randomized open label study conducted in
newly diagnosed or relapsed or refractory multiple myeloma patients
– are also included in the NDA. The subcutaneous formulation of
daratumumab is co-formulated with Halozyme's ENHANZE®
drug delivery technology, based on recombinant human hyaluronidase
PH20 (rHuPH20).
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 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.