SAN DIEGO, July 19, 2019 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company
developing novel oncology and drug-delivery therapies, today
announced that Janssen-Cilag International NV (Janssen) has
submitted an extension application to the European Medicines Agency
(EMA) for the subcutaneous delivery of DARZALEX®
(daratumumab) for patients with multiple myeloma.
"We are pleased that Janssen's filing follows quickly after its
filing last week of a Biologics License Application (BLA) with the
U.S. Food and Drug Administration," said Dr. Helen Torley, President and CEO. "We are
particularly excited that, pending approval by the EMA, a greater
number of patients with multiple myeloma may soon have a new
therapeutic option that offers the potential of
DARZALEX® with a shorter administration time."
Janssen's submission follows the announcement of positive
results from its Phase 3 COLUMBA study, which investigated
subcutaneously administered DARZALEX® in comparison to
intravenous DARZALEX® in patients with relapsed and
refractory multiple myeloma. Subcutaneous DARZALEX®,
using ENHANZE® drug delivery technology, was found to be
non-inferior to intravenous DARZALEX® with regard to the
co-primary endpoints of overall response rate and Maximum
Ctrough concentration on day 1 of the third treatment
cycle prior to dose.
About ENHANZE® Technology
Halozyme's
proprietary ENHANZE® drug-delivery technology is
based on its patented recombinant human hyaluronidase enzyme
(rHuPH20). rHuPH20 has been shown to remove traditional limitations
on the volume of biologics that can be delivered subcutaneously
(just under the skin). By using rHuPH20, some biologics and
compounds that are administered intravenously may instead be
delivered subcutaneously. ENHANZE® may also benefit
subcutaneous biologics by reducing the need for multiple
injections. This delivery has been shown in studies to reduce
health care practitioner time required for administration and
shorten time for drug administration.
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
pegvorhyaluronidase alfa (PEGPH20), applies a unique approach to
targeting solid tumors, allowing increased access of
co-administered cancer drug therapies to the tumor in animal
models. PEGPH20 is currently in development for the treatment of
several cancers and has the potential to be used 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, AbbVie, Lilly,
Bristol-Myers Squibb, Alexion and argenx for its
ENHANZE® drug delivery technology. 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, the product development
and approval efforts of Halozyme's ENHANZE® partners and
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, and
statements concerning certain other potential benefits of
ENHANZE® including facilitating more rapid delivery of
injectable medications through subcutaneous delivery. These
forward-looking statements also include statements regarding
Halozyme's potential receipt of payments associated with future
collaborative target nominations, achievement of certain
milestones, and royalties on sales of commercialized products.
These forward-looking statements involve risks 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 uncertainties concerning whether
collaborative products are ultimately developed, approved or
commercialized, unexpected expenditures and costs, unexpected
results or delays in development and regulatory review, unexpected
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 most
recent Annual and Quarterly Reports filed with the Securities and
Exchange Commission. Except as required by law, Halozyme undertakes
no duty to update forward-looking statements to reflect events
after the date of this release.
DARZALEX® is a trademark of
Janssen Pharmaceutica NV.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.