SAN DIEGO, May 21, 2021 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen
Pharmaceutica N.V. (Janssen) received two positive opinions
from the Committee for Medicinal Products for Human Use (CHMP) of
the European Medicines Agency (EMA) recommending to broaden the
existing marketing authorization for the DARZALEX®
(daratumumab) subcutaneous (SC) formulation, which uses
ENHANZE® technology, in two new indications. One
recommendation is for the use in combination with cyclophosphamide,
bortezomib and dexamethasone (D-VCd), for the treatment of adult
patients with newly diagnosed systemic light chain (AL)
amyloidosis. The second recommendation is for the use of
daratumumab SC in combination with pomalidomide and
dexamethasone (D-Pd) for the treatment of adult patients with
multiple myeloma 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. These two positive opinions will next be reviewed by
the European Commission (EC), which has the authority to grant
final approval of the indications.
"Janssen's obtaining positive CHMP opinions is an important step
forward in the EU and we are delighted subcutaneous
DARZALEX® may soon be available in these important new
indications," said Helen Torley,
president and chief executive officer at Halozyme. "This would be
the first approval in Europe for
the treatment of AL amyloidosis and also introduces a new treatment
option for certain patients with multiple myeloma."
The Positive CHMP Opinion for the AL amyloidosis indication is
supported by data from Janssen's Phase 3 ANDROMEDA
study.1 Janssen reported that the study met the primary
endpoint of percentage of patients with hematologic complete
response.
The Positive CHMP Opinion for daratumumab SC in combination with
Pd in the treatment of relapsed or refractory multiple myeloma is
supported by data from the Phase 3 APOLLO study conducted in
collaboration with the European Myeloma
Network. 2 Janssen reported that the study
met its primary endpoint of improved progression-free survival
(PFS).
For more information related Phase 3 ANDROMEDA and APOLLO study
findings, please view Janssen's press release.
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 positively
impacted 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 and Horizon
Therapeutics. 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.
References
1 Comenzo RL et al., Reduction in Absolute
Involved Free Light Chain and Difference Between Involved and
Uninvolved Free Light Chain Is Associated with Prolonged Major
Organ Deterioration Progression-Free Survival in Patients with
Newly Diagnosed AL Amyloidosis Receiving Bortezomib,
Cyclophosphamide, and Dexamethasone With or Without Daratumumab:
Results From ANDROMEDA. Abstract #552. Presented at 2020 American
Society of Hematology Annual Meeting.
2 Dimopoulos, MA et al. APOLLO: Phase 3 Randomized
Study of Subcutaneous Daratumumab Plus Pomalidomide and
Dexamethasone (D-Pd) Versus Pomalidomide and Dexamethasone (Pd)
Alone in Patients (Pts) with Relapsed/Refractory Multiple Myeloma
(RRMM). Abstract #412. Oral presentation, presented at 2020
American Society of Hematology Annual Meeting.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.