SAN DIEGO, Sept. 10, 2020 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that its
collaborator Janssen Biotech, Inc. (Janssen) has submitted a
supplemental Biologics License Application (sBLA) to the U.S. Food
and Drug Administration (FDA) seeking approval of DARZALEX
FASPRO™ (daratumumab and hyaluronidase-fihj), a subcutaneous
formulation of daratumumab utilizing Halozyme's ENHANZE®
technology, for the treatment of patients with light chain (AL)
amyloidosis, a rare and potentially fatal disease for which there
are no currently approved therapies1,2. The sBLA is
supported by positive results from the Phase 3 ANDROMEDA study,
which were presented as a late-breaking abstract at the 25th
European Hematology Association Annual Congress in June 2020. Janssen's ANDROMEDA study evaluated
subcutaneous daratumumab in combination with bortezomib,
cyclophosphamide, and dexamethasone (D-VCd) compared to VCd alone
and met its primary endpoint of overall hematologic complete
response rate.
"We are excited that DARZALEX FASPROTM
utilizing our ENHANZE® technology has the potential to
be approved in a new indication," said Dr. Helen Torley, president and chief executive
officer. "Patients diagnosed with AL amyloidosis currently have no
approved therapeutic options and we are therefore pleased that a
new treatment for the disease may soon be available."
The sBLA is being reviewed under the FDA Real-Time Oncology
Review (RTOR) program, which allows data for certain applications
to be reviewed before the applicant formally submits the complete
application. The RTOR program aims to explore a more efficient
review process to help ensure treatments are available as soon as
possible for patients. Selection into the RTOR program does not
guarantee or influence approvability of the supplemental
application.
The submission is also being reviewed under Project Orbis, an
initiative of the FDA Oncology Center of Excellence, which provides
a framework for concurrent submission and review of oncology
medicine applications among international regulatory
agencies.3
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 400,000 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 and argenx. 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, 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 the
FDA Real-Time Oncology Review program and the potential for a more
efficient regulatory review process of the sBLA referenced in this
press release. 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.
1 National Organization for Rare Disorders.
Amyloidosis. Accessed August 20,
2020.
https://rarediseases.org/rare-diseases/amyloidosis/.
2 Lousada I, Comenzo RL, Landau H, et al. Light
chain amyloidosis: patient experience survey from the Amyloidosis
Research Consortium. Advances in Therapy. 2015;32(10):920-928.
3 Project Orbis. U.S. Food and Drug
Administration.
https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis.
Accessed July 2020.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.