SAN DIEGO, Oct. 31, 2017 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company
developing novel oncology and drug-delivery therapies, today
announced that Janssen Biotech, Inc. has initiated the
first of three planned Phase 3 clinical trials evaluating a
subcutaneous (SC) delivery of Darzalex® (daratumumab)
with Halozyme's proprietary ENHANZE® technology.
The initial Phase 3 study is in amyloidosis patients, with
additional Phase 3 studies in multiple myeloma and smoldering
myeloma patients planned for near-term initiation.
The subcutaneous formulation of daratumumab has an estimated
administration time of approximately 5 minutes compared to the
multi-hour intravenous infusion, potentially offering new benefits
to patients, caregivers and health systems. Halozyme's ENHANZE
technology enables the administration of medications with an
injection under the skin rather than an infusion into a vein.
"Our goal has been to make the injection of life saving
medicines less disruptive to patients using Halozyme's ENHANZE
technology," said Dr. Helen Torley,
president and CEO of Halozyme. "These studies aim to demonstrate
the transformative potential of ENHANZE when combined with
Darzalex."
The Phase 3 study follows a Phase 1b clinical trial that
demonstrated the safety, pharmacokinetics and anti-tumor activity
of the subcutaneous formulation in relapsed or refractory multiple
myeloma patients.
Halozyme will receive a $15
million milestone payment from Janssen following dosing of
the third patient in a Phase 3 trial.
Darzalex is a human monoclonal antibody that targets CD38 on the
surface of cells and is in clinical development by Janssen in a
range of cancers and immune diseases.
Halozyme Collaboration with Janssen Biotech,
Inc.
In December 2014, Halozyme and Janssen entered
into a collaboration and license agreement. Under the terms
of the agreement, Halozyme has granted Janssen a worldwide license
to develop and commercialize products for up to five targets,
combining rHuPH20 with Janssen's proprietary compounds. CD38, which
is targeted by daratumumab, is the first of these five targets.
Halozyme is eligible to receive payments upon Janssen's achievement
of specified development, regulatory and sales-based milestones,
totaling up to $113 million per target. Halozyme is also
entitled to royalty payments based on net sales of products using
the ENHANZE technology.
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 is a
biotechnology company focused on developing and commercializing
novel oncology therapies that target the tumor microenvironment.
Halozyme's lead proprietary program, investigational drug PEGPH20,
applies a unique approach to targeting solid tumors, allowing
increased access of co-administered cancer drug therapies to the
tumor in animal models. PEGPH20 is currently in development for
metastatic pancreatic cancer, non-small cell lung cancer, gastric
cancer, metastatic breast cancer and has potential across
additional cancers in combination with different types of cancer
therapies. In addition to its proprietary product portfolio,
Halozyme has established value-driving partnerships with leading
pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen,
AbbVie, Lilly and Bristol-Myers
Squibb for its ENHANZE® drug delivery technology. Halozyme
is headquartered in San Diego. For
more information visit 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,
the number of collaborative targets actually chosen, whether such
products are ultimately developed or commercialized, whether
milestones triggering milestone payments will be achieved, and
statements concerning facilitating more rapid delivery of
injectable medications through subcutaneous delivery that involve
risk 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 unexpected expenditures and costs, unexpected results or
delays in development and regulatory review, 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 Quarterly Report on Form
10-Q 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.
Contacts:
Jim
Mazzola
858-704-8122
ir@halozyme.com
Chris Burton
858-704-8352
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.