SAN DIEGO, Sept. 3, 2014 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S.
Food and Drug Administration (FDA) has granted Fast Track
designation for Halozyme's program investigating PEGPH20 (PEGylated
recombinant human hyaluronidase) in combination with gemcitabine
and nab-paclitaxel for the treatment of patients with metastatic
pancreatic cancer to demonstrate an improvement in overall
survival. The Fast Track designation process was developed by the
FDA to facilitate the development, and expedite the review of drugs
to treat serious or life-threatening diseases and address unmet
medical needs.
"The FDA's Fast Track designation for our PEGPH20 program in
pancreatic cancer underscores the significant need for new
treatment options for pancreatic cancer patients with advanced
disease," stated Dr. Helen Torley,
President and Chief Executive Officer. "We look forward to
continuing to work with the FDA on this program to explore whether
patients with metastatic pancreatic cancer can benefit from this
therapy."
The Fast Track Drug Development Program was established under
the FDA Modernization Act of 1997. The program is designed to
facilitate frequent interactions with the FDA review team to
expedite clinical development and submission of a Biologic License
Application (BLA) for medicines with the potential to treat serious
or life-threatening conditions and address unmet medical needs.
Specifically, Fast Track designation facilitates meetings to
discuss all aspects of development to support approval. It also
provides the opportunity to submit sections of a BLA on a rolling
basis as data become available. This permits the FDA to review
portions of the BLA as they are received instead of waiting for the
entire BLA submission.
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.