SAN DIEGO, June 22, 2021 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that the European
Commission (EC) has granted the Janssen Pharmaceutical Companies of
Johnson & Johnson two marketing authorizations for the
subcutaneous formulation of daratumumab, known as
DARZALEX® SC in the European Union. The first
authorization is for the use of DARZALEX® SC in
combination with bortezomib, cyclophosphamide, and dexamethasone
(VCd) for the treatment of adults with newly diagnosed systemic
light-chain (AL) amyloidosis. The approval makes the
DARZALEX® SC based regimen the first approved therapy
for AL amyloidosis in Europe. The second authorization is for
the use of DARZALEX® SC in combination with pomalidomide
and dexamethasone (D-Pd) for the treatment of adults with multiple
myeloma (MM) who have received one prior therapy containing a
proteasome inhibitor and lenalidomide and were lenalidomide
refractory, or who have received at least two prior therapies that
included lenalidomide and a proteasome inhibitor, and have
demonstrated disease progression on or after the last therapy.
"We are pleased that Janssen received European Commission
marketing authorizations for these important new indications," said
Helen Torley, president and chief
executive officer at Halozyme. "These authorizations will provide
new treatment options for certain AL amyloidosis and multiple
myeloma patients in Europe."
DARZALEX® SC is co-formulated with recombinant human
hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug
delivery technology.
About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive
solutions to significantly improve patient experiences and outcomes
for emerging and established therapies. Halozyme advises and
supports its biopharmaceutical partners in key aspects of new drug
development with the goal of improving patients' lives while
helping its partners achieve global commercial success. As the
innovators of the ENHANZE® technology, which can reduce
hours-long treatments to a matter of minutes, Halozyme's
commercially-validated solution has touched more than 500,000
patient lives via five commercialized products across more than 100
global markets. Halozyme and its world-class partners are currently
advancing multiple therapeutic programs intended to deliver
innovative therapies, with the potential to improve the lives of
patients around the globe. Halozyme's proprietary enzyme rHuPH20
forms the basis of the ENHANZE® technology and is used
to facilitate the delivery of injected drugs and fluids,
potentially reducing the treatment burden of other drugs to
patients. Halozyme has licensed its ENHANZE® technology
to leading pharmaceutical and biotechnology companies including
Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers
Squibb, Alexion, argenx, Horizon Therapeutics and ViiV Healthcare.
Halozyme derives revenues from these collaborations in the form of
milestones and royalties as the Company's partners make progress
developing and commercializing their products being developed with
ENHANZE®. 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, 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 and
potentially lowering the treatment burden for patients. These
forward-looking statements also include statements regarding the
product development efforts of Halozyme's ENHANZE®
partner. 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 for the indications referred to in this press
release, unexpected expenditures and costs, unexpected results or
delays in development and regulatory review including any potential
delays caused by the current COVID-19 global pandemic, unexpected
regulatory approval requirements, unexpected adverse events or
patient outcomes from being treated with the ENHANZE®
co-formulated treatment referred to in this press release, 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.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com
View original content to download
multimedia:http://www.prnewswire.com/news-releases/halozyme-announces-janssen-receives-european-marketing-authorizations-for-darzalex-daratumumab-subcutaneous-formulation-for-newly-diagnosed-systemic-light-chain-amyloidosis-and-pre-treated-multiple-myeloma-301317659.html
SOURCE Halozyme Therapeutics, Inc.