argenx Enters Into Agreement To Acquire Priority Review Voucher
November 30 2022 - 01:00AM
GlobeNewswire Inc.
Amsterdam, the Netherlands –
November 30, 2022 – argenx SE (Euronext & Nasdaq: ARGX), a
global immunology company committed to improving the lives of
people suffering from severe autoimmune diseases, today announced
an agreement to acquire a U.S. Food and Drug Administration (FDA)
Priority Review Voucher (PRV) for $102 million. A PRV entitles the
holder to FDA priority review of a single Biologics License
Application (BLA), which reduces the target review period and may
lead to an expedited approval.
argenx expects to redeem the PRV for a future
marketing application for efgartigimod, its first-in-class neonatal
Fc receptor (FcRn) blocker.
“This purchase underscores our commitment to
transform the way people living with chronic, autoimmune diseases
are treated. We have demonstrated proof-of-concept in four
autoimmune diseases with our first-in-class FcRn blocker,
efgartigimod, and are planning to be active in fifteen disease
targets by 2025. With a priority review voucher available, we hope
to expedite the approval process for one of our current or future
indications to more quickly reach the patients who are in serious
need of a new treatment option,” said Tim Van Hauwermeiren, Chief
Executive Officer of argenx.
The closing of the acquisition of the PRV is
subject to customary closing conditions, including clearance under
the Hart-Scott Rodino (HSR) Antitrust Improvements Act.
About EfgartigimodEfgartigimod is an antibody
fragment designed to reduce pathogenic immunoglobulin G (IgG)
antibodies by binding to the neonatal Fc receptor and blocking the
IgG recycling process. Efgartigimod is being investigated in
several autoimmune diseases known to be mediated by disease-causing
IgG antibodies, including neuromuscular disorders, blood disorders,
and skin blistering diseases, in both an intravenous and
subcutaneous (SC) formulation. SC efgartigimod is co-formulated
with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's
ENHANZE® drug delivery technology.
About argenxargenx is a global immunology
company committed to improving the lives of people suffering from
severe autoimmune diseases. Partnering with leading academic
researchers through its Immunology Innovation Program (IIP), argenx
aims to translate immunology breakthroughs into a world-class
portfolio of novel antibody-based medicines. argenx developed and
is commercializing the first-and- only approved neonatal Fc
receptor (FcRn) blocker in the U.S., Japan and the EU. The Company
is evaluating efgartigimod in multiple serious autoimmune diseases
and advancing several earlier stage experimental medicines within
its therapeutic franchises. For more information, visit
www.argenx.com and follow us on LinkedIn, Twitter, and
Instagram.
Media:
Kelsey Kirkkkirk@argenx.com
Investors:
Beth DelGiaccobdelgiacco@argenx.com
Forward-looking Statements
The contents of this announcement include
statements that are, or may be deemed to be, forward-looking
statements. These forward-looking statements can be identified by
the use of forward-looking terminology, including the terms
believes, estimates, anticipates, expects, intends, may, will, or
should, and include statements argenx makes concerning the closing
of the acquisition of the PRV; the expected benefits of the PRV,
including the timing and outcome of FDA feedback and review; its
plans for current and future indications; the therapeutic potential
of its product candidates; and the intended results of its
strategy. By their nature, forward-looking statements involve risks
and uncertainties and readers are cautioned that any such
forward-looking statements are not guarantees of future
performance. argenx’s actual results may differ materially from
those predicted by the forward-looking statements as a result of
various important factors, including the
ability to satisfy closing conditions for the acquisition
of the PRV, the occurrence of any event that could give rise to the
termination of the PRV acquisition agreement and the ability to
recognize the anticipated benefits of the PRV acquisition. A
further list and description of these risks, uncertainties and
other risks can be found in argenx’s U.S. Securities and Exchange
Commission (SEC) filings and reports, including in argenx’s most
recent annual report on Form 20-F filed with the SEC as well
as subsequent filings and reports filed by argenx with the SEC.
Given these uncertainties, the reader is advised not to place any
undue reliance on such forward-looking statements. These
forward-looking statements speak only as of the date of publication
of this document. argenx undertakes no obligation publicly update
or revise the information in this press release, including any
forward-looking statements, except as may be required by law.
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