SAN DIEGO, Oct. 29, 2015 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that the first
healthy subject has been dosed in a Phase 1 clinical trial
evaluating the safety, tolerability and pharmacokinetics of a
subcutaneous formulation of rivipansel, a compound discovered by
GlycoMimetics, Inc. and being developed by Pfizer Inc., using
Halozyme's ENHANZE™ formulation.
"The advancement of the first product candidate under our Pfizer
collaboration represents further progress and validates the
potential of our ENHANZE platform," said Dr. Helen Torley, Halozyme's president and chief
executive officer. "The growing number of products co-formulated
with ENHANZE that are entering the clinic or already marketed
represent, I believe, just the beginning of the potential that
exists to help an even broader population of partners and
patients."
The initiation of dosing triggered a $1
million milestone payment to Halozyme under the License and
Collaboration Agreement between Halozyme and Pfizer that was
entered into in 2012. Rivipansel is an investigational compound
under evaluation by Pfizer as an intravenous formulation in a Phase
3 study for the treatment of individuals hospitalized with
vaso-occlusive crisis of sickle cell disease.
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 throughout
the body and component of the extracellular matrix, to aid in the
dispersion and absorption of other injected therapeutic drugs.
About Sickle Cell Disease
Sickle cell disease (SCD) is
a genetic disease that, according to the U.S. Centers for Disease
Control and Prevention (CDC), affects millions of people throughout
the world, including an estimated 90,000 to 100,000 people in
the United States. Rather than
being round, smooth and flexible, the red blood cells of patients
with SCD become sickle-shaped, inflexible and adhesive. The
complications associated with SCD occur when these inflexible and
sticky cells occlude small blood vessels, which can then cause
severe and chronic pain throughout the body. Vaso-occlusive crisis,
one of the most severe complications of sickle cell disease, can
result in acute ischemic tissue injury at one or more sites, with
inflammation and pain of varying degrees of severity.
Halozyme Collaboration with Pfizer Inc.
In
December 2012, Halozyme and Pfizer
entered into a collaboration and license agreement, under which
Pfizer has a worldwide license to develop and commercialize
products combining Halozyme's rHuPH20 enzyme with Pfizer's
proprietary biologics directed at up to six targets. Targets may be
selected on an exclusive or non-exclusive basis. Under the terms of
the agreement, Pfizer paid Halozyme an upfront fee for the
application of its recombinant human enzyme, rHuPH20, to up to six
targets. To date, four specified exclusive targets have been
chosen, and Pfizer has the right to elect two additional targets in
the future upon payment of additional fees. Pending the successful
achievement of a series of clinical, regulatory, and sales events,
Pfizer may pay Halozyme additional milestones as well as royalties
on potential future product sales. Under the collaboration, Pfizer
has access to Halozyme's expertise in developing and applying
rHuPH20 to Pfizer targets.
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 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.
Contact:
Jim
Mazzola
858-704-8122
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.