SAN DIEGO, April 9, 2014 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that the United
States Food and Drug Administration (FDA) informed the company
yesterday that a clinical hold has been placed on patient
enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial (Study
202) evaluating PEGPH20 in patients with pancreatic cancer.
According to the FDA, this action was being taken in view of the
company's recent decision to temporarily halt enrollment and dosing
of PEGPH20 in the Phase 2 trial.
"As announced earlier, we are gathering information relevant to
assessing the possible difference in the thromboembolic event rate
between the patients treated with PEGPH20 versus the patients
treated without PEGPH20 in the trial. We will be providing
this information to the Data Monitoring Committee and the FDA in
parallel so they can complete their respective assessments," stated
Dr. Helen Torley, President and
CEO. "Pancreatic cancer has one of the lowest survival rates
of any cancer. We remain committed to evaluating PEGPH20 as a
possible therapy to address this devastating disease."
About Halozyme
Halozyme Therapeutics is a
biopharmaceutical company dedicated to developing and
commercializing innovative products that advance patient care. With
a diversified portfolio of enzymes that target the extracellular
matrix, the Company's research focuses primarily on a family of
human enzymes, known as hyaluronidases, which increase the
dispersion and absorption of biologics, drugs and fluids.
Halozyme's pipeline addresses therapeutic areas, including
oncology, diabetes and dermatology that have significant unmet
medical need today. The Company markets Hylenex®
recombinant (hyaluronidase human injection) and has partnerships
with Roche, Pfizer and Baxter. Halozyme is headquartered in San
Diego, CA. For more information on how we are innovating,
please visit our corporate website at 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
future actions relating to the development of PEGPH20 and the
possibility that PEGPH20 may be used to address pancreatic cancer)
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 Annual Report on Form
10-K filed with the Securities and Exchange Commission on
February 28, 2014.
Investor Contact:
Schond Greenway
Halozyme Therapeutics
858-704-8352
ir@halozyme.com
Media Contact:
Denise
Powell
510-703-9491
dpowell@brewlife.com
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SOURCE Halozyme Therapeutics