SAN DIEGO, Oct. 3, 2014 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S.
Food and Drug Administration (FDA) has granted Orphan Drug
designation for PEGylated recombinant human hyaluronidase (PEGPH20)
for the treatment of pancreatic cancer. The FDA Office of Orphan
Products Development (OOPD) mission is to advance the evaluation
and development of products (drugs, biologics, devices, or medical
foods) that demonstrate promise for the diagnosis and/or treatment
of rare diseases or conditions. Halozyme is currently
investigating PEGPH20 in a Phase 2 study in combination with
gemcitabine and nab-paclitaxel (ABRAXANE®) in metastatic
pancreatic cancer.
"This designation follows the Fast Track designation and allows
us to collaborate more closely with the FDA to facilitate
development of PEGPH20 and is part of our core strategy to bring
this therapy to patients as rapidly as possible," stated Dr.
Helen Torley, President and Chief
Executive Officer. "Receiving Orphan Drug designation is an
important milestone for this clinical development program."
The FDA's Orphan Drug program provides orphan status to drugs
and biologics that are intended for the treatment of rare diseases
that affect fewer than 200,000 people in the U.S. This designation
provides eligibility for a seven-year period of market exclusivity
in the U.S. after product approval, FDA assistance in clinical
trial design, and an exemption from FDA user fees.
About PEGPH20
PEGPH20 is an investigational PEGylated
form of Halozyme's proprietary recombinant human hyaluronidase
under development for the systemic treatment of tumors that
accumulate hyaluronan.
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 delays in completion of clinical trials and other
development activities, the possibility of safety events,
unexpected expenditures and costs, unexpected results or delays in
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 on August 11,
2014.
Investor Contact:
Schond Greenway
Halozyme Therapeutics
858-704-8352
ir@halozyme.com
Media Contact:
Susan Neath
Francis
212-301-7182
sfrancis@wcgworld.com
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SOURCE Halozyme Therapeutics, Inc.