SAN DIEGO, Nov. 4, 2015 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen
Biotech, Inc. has dosed the first patient in a clinical trial
evaluating subcutaneous (SC) delivery of daratumumab with
Halozyme's proprietary ENHANZE™ technology in multiple myeloma.
Daratumumab is an investigational human monoclonal antibody that
targets CD38 on the surface of multiple myeloma cells and is in
clinical development by Janssen using the intravenous route of
administration. Multiple myeloma is an incurable blood cancer that
starts in the bone marrow and is characterized by an excessive
proliferation of plasma cells. Multiple myeloma is the third most
common blood cancer in the United
States (U.S.), following only leukemia and lymphoma. In the
U.S., approximately 26,850 new patients will be diagnosed with
multiple myeloma and approximately 11,240 people will die from the
disease in 2015. Globally, it is estimated that 114,251 people will
be diagnosed and 80,019 will die from the disease.
The Janssen Phase 1b clinical trial will evaluate the safety,
pharmacokinetics and antitumor activity of a daratumumab by the
subcutaneous route of administration in approximately 128 patients
with relapsed or refractory multiple myeloma.
"We believe the transition from an IV to subcutaneous
formulation has the potential to provide benefits to patients and
health care professionals, including reduced administration time,"
said Dr. Helen Torley, president and
CEO of Halozyme. "We are pleased to partner with Janssen to bring
these potential benefits to multiple myeloma patients through the
development of daratumumab using our proprietary rHuPH20
platform."
Halozyme's ENHANZE technology is based on a proprietary
recombinant human enzyme rHuPH20 that targets hyaluronan, a
glycosaminoglycan, which is a chain of natural sugars found
throughout the body and as a component of the extracellular matrix,
to aid in the dispersion and absorption of other injected
therapeutic drugs.
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 to 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 received an initial payment of
$15 million, and is eligible to
receive additional payments upon Janssen's achievement of specified
development, regulatory and sales-based milestones, totaling up to
$566 million. Halozyme is also
entitled to royalty payments based on net sales of products using
the ENHANZE™ technology. Under the collaboration, Janssen will also
obtain access to Halozyme's expertise in developing and applying
rHuPH20 to Janssen targets and will obtain a worldwide, exclusive
license to develop and commercialize product combinations of
rHuPH20 and Janssen target compounds resulting from the
collaboration.
About ENHANZE™
ENHANZE™ is Halozyme's proprietary drug delivery platform based
on the Company's 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. This delivery has been shown in studies
to reduce health care practitioner time required for administration
and shorten time for drug administration. ENHANZE may also benefit
subcutaneous biologics by reducing the need for multiple
injections.
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. PEGPH20 is
currently in development for metastatic pancreatic cancer,
non-small cell lung 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 and AbbVie for its drug delivery platform, ENHANZE™, which
enables biologics and small molecule compounds that are currently
administered intravenously to be delivered subcutaneously. 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, 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 of product candidates
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
the Company's Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission on August
10, 2015.
Contacts:
Jim
Mazzola
858-704-8122
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.