SAN DIEGO, Dec. 19, 2014 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that the European
Commission, acting on the recommendation from the Committee for
Orphan Medicinal Products of the European Medicines Agency (EMA),
has designated PEGylated recombinant human hyaluronidase (PEGPH20)
an orphan medicinal product for the treatment of pancreatic cancer.
Halozyme is currently conducting a Phase 2 study on the treatment
of metastatic pancreatic cancer with PEGPH20 in combination with
gemcitabine and nab-paclitaxel (ABRAXANE®). In
October 2014, the Company disclosed
that the U.S. Food and Drug Administration also granted Orphan Drug
designation for PEGPH20 for the treatment of pancreatic cancer.
"We are very pleased that PEGPH20 has received orphan drug
status in the EU," stated Dr. Helen
Torley, President and Chief Executive Officer. "This
designation is an important regulatory milestone for Halozyme and
aligns with our commitment to deliver innovative therapies that
transform the lives of cancer patients around the world."
The EMA Orphan Designation is a status assigned to a medicine
intended for use against a rare condition (prevalence of the
condition in the European Union must not be more than 5 in 10,000)
and allows a pharmaceutical company to benefit from incentives
offered by the EU to develop a medicine for the treatment,
prevention or diagnosis of a disease that is life-threatening or a
chronically debilitating rare disease. In addition to a 10-year
period of marketing exclusivity in the EU after product approval,
Orphan Drug Designation provides incentives for companies seeking
protocol assistance from the EMA during the product development
phase, and direct access to centralized marketing
authorization.
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, Janssen 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 November 10,
2014.
Investor Contact:
Schond Greenway
Halozyme Therapeutics
858-704-8352
ir@halozyme.com
Media Contact:
Susan Neath
Francis
212-301-7182
sfrancis@w2ogroup.com
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SOURCE Halozyme Therapeutics, Inc.