- Study met primary endpoint, demonstrating
noninferior total IgG reduction at day 29 with subcutaneously
administered efgartigimod compared to intravenous (IV)
administration -
- Biologics License Application on track to be
submitted by argenx to U.S. Food and Drug Administration by end of
2022 -
SAN DIEGO,
March 22, 2022
/PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today
announced that data from argenx's Phase 3 ADAPT-SC study evaluating
subcutaneous (SC) efgartigimod (1000mg efgartigimod-PH20) for the
treatment of generalized myasthenia gravis (gMG) achieved the
primary endpoint of total IgG reduction from baseline at day 29,
demonstrating statistical non-inferiority to VYVGART®
(efgartigimod alfa-fcab) intravenous (IV) formulation in gMG
patients. Based on these results, argenx has stated it plans to
submit a Biologics License Application (BLA) to the U.S. Food and
Drug Administration (FDA) by the end of 2022.
"We are excited for the potential of the subcutaneous form of
efgartigimod to offer patients suffering from generalized
myasthenia gravis an additional treatment option for this
debilitating autoimmune disease," said Dr. Helen Torley, president and chief executive
officer. "We are pleased to see another partner generate strong
pivotal trial results with a therapy utilizing our
ENHANZE® technology. Subcutaneous efgartigimod has
the potential to be the first of our wave 3 products to
launch."
argenx has announced it will host an investor call at today
8.30 am ET. Detailed data from
the ADAPT-SC trial will be submitted by argenx for presentation at
a future medical meeting.
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 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 600,000
patient lives in post-marketing use 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, AbbVie,
Eli 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 using ENHANZE®. Halozyme
is headquartered in San Diego.
For more information
visit www.halozyme.com and connect with us
on LinkedIn and Twitter.
Safe Harbor Statement
In addition to historical information, the statements set forth
in this press release include forward-looking statements including,
without limitation, statements concerning the Company's
ENHANZE® drug delivery technology and the possible
benefits and attributes of ENHANZE®, its potential
application to aid in the dispersion and absorption of other
injected therapeutic drugs and facilitating more rapid delivery and
administration of larger volumes of injectable medications through
subcutaneous delivery. Forward looking statements also include
statements concerning the future development and commercialization
efforts of the Company's collaboration partner including the plans
to submit a Biologics License Application and a potential future
commercial launch of subcutaneous efgartigimod. These
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 and involve risk and
uncertainties that could cause actual results to differ materially
from those in the forward-looking statements. Actual results could
differ materially from the expectations contained in these
forward-looking statements as a result of several factors,
including unexpected levels of revenues, unexpected results or
delays in the growth of the Company's ENHANZE® business,
or in the development, regulatory review or commercialization of
ENHANZE® products, including any potential delays caused
by the current COVID-19 global pandemic, regulatory approval
requirements, unexpected adverse events or patient outcomes and
competitive conditions. These and other factors that may result in
differences are discussed in greater detail in the Company's most
recently filed Annual Report on Form 10-K filed with the Securities
and Exchange Commission.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.