BREDA, the Netherlands and
GHENT, Belgium and SAN DIEGO,
Feb. 4, 2019 /PRNewswire/
-- argenx (Euronext & Nasdaq: ARGX) and Halozyme
Therapeutics, Inc. (Nasdaq: HALO) today announced a global
collaboration and license agreement that enables use by argenx of
Halozyme's ENHANZE® drug delivery technology to develop multiple
subcutaneous product formulations for current or future argenx
product candidates. The agreement provides argenx exclusive access
to ENHANZE® for any product targeting the human neonatal
Fc receptor FcRn, including argenx's lead asset efgartigimod
(ARGX-113) and up to two additional targets, potentially shortening
drug administration time, reducing healthcare practitioner time,
and offering additional flexibility and convenience for
patients.
Under the terms of the agreement, argenx will pay an upfront
payment of $30 million to Halozyme,
$10 million per target for future
target nominations and potential future payments of up to
$160 million per selected target
subject to achievement of specified development, regulatory and
sales-based milestones. Halozyme will also receive mid-single digit
royalties on sales of commercialized products.
"Through our collaboration with Halozyme, a company that has
transformed subcutaneous delivery of biologics, we now have the
potential to add optimal delivery capabilities to our profile of
building best-in-class antibodies against novel targets. By gaining
exclusive access to ENHANZE® technology for our anti-FcRn asset, we
also solidify our leadership position in this exciting new space
that has the potential to disrupt the way severe autoimmune
diseases are treated," commented Keith
Woods, Chief Operating Officer of argenx. "As we look
towards commercialization, if approved, efgartigimod is now
equipped with a well-established subcutaneous delivery technology
in addition to the clinical activity and favorable tolerability
profile we have observed in studies to date. We believe that by
offering both intravenous and subcutaneous formulations, we have
the opportunity to capture patient preferences across all
indications within our efgartigimod portfolio."
"We are excited to work with argenx to create new delivery
options for therapies being developed to improve the lives of
patients suffering from severe autoimmune diseases," said Dr.
Helen Torley, president and CEO of
Halozyme. "This collaboration is an example of the value
ENHANZE® can potentially bring while a product is still
in development where the benefits of subcutaneous administration
can be realized earlier by both patients and healthcare
providers."
argenx represents Halozyme's ninth global collaboration and
license partner for the ENHANZE® technology. These
collaborations cover more than 50 therapeutic targets and include
three commercialized products.
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 Therapeutics is a biotechnology company focused on
developing and commercializing novel oncology therapies that target
the tumor microenvironment. Halozyme's lead proprietary program,
investigational drug pegvorhyaluronidase alfa (PEGPH20), applies a
unique approach to targeting solid tumors, allowing increased
access of co-administered cancer drug therapies to the tumor in
animal models. PEGPH20 is currently in development for the
treatment of several cancers and has the potential to be used in
combination with different types of cancer therapies. In addition
to its proprietary product portfolio, Halozyme has established
value-driving partnerships with leading pharmaceutical companies,
including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly,
Bristol-Myers Squibb, Alexion and argenx, for its
ENHANZE® drug delivery technology. Halozyme is
headquartered in San Diego. For
more information visit www.halozyme.com.
About argenx
argenx is a clinical-stage biotechnology company developing a
deep pipeline of differentiated antibody-based therapies for the
treatment of severe autoimmune diseases and cancer. The company is
focused on developing product candidates with the potential to be
either first-in-class against novel targets or best-in-class
against known, but complex, targets in order to treat diseases with
a significant unmet medical need. argenx's ability to execute on
this focus is enabled by its suite of differentiated technologies.
The SIMPLE Antibody™ Platform, based on the powerful llama immune
system, allows argenx to exploit novel and complex targets, and its
three complementary Fc engineering technologies are designed to
expand the therapeutic index of its product candidates.
www.argenx.com
Halozyme 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. These
forward-looking statements also include statements regarding
Halozyme's potential receipt of payments associated with future
collaborative target nominations, achievement of certain
milestones, and royalties on sales of commercialized products.
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 the number of
additional collaborative targets nominated and whether milestones
will be achieved, uncertainties concerning whether collaborative
products are ultimately developed 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.
argenx 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
intended results of its strategy; the mechanism of action and
profile of, and timing and results of clinical trials with, and
potential commercialization of, efgartigimod and any other current
and future product candidates utilizing ENHANZE technology,
including those targeting receptors nominated in the future
pursuant to the Halozyme collaboration; and argenx's collaboration
with Halozyme, including argenx's ability to receive the expected
benefits thereof and obligations to make payments related to future
target nominations and milestones. 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
argenx's expectations regarding its the inherent uncertainties
associated with competitive developments, preclinical and clinical
trial and product development activities and regulatory approval
requirements; argenx's reliance on collaborations with third
parties; estimating the commercial potential of argenx's product
candidates; argenx's ability to obtain and maintain protection of
intellectual property for its technologies and drugs; argenx's
limited operating history; and argenx's ability to obtain
additional funding for operations and to complete the development
and commercialization of its product candidates. 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 to publicly update or
revise the information in this press release, including any
forward-looking statements, except as may be required by law.
argenx Contacts:
Joke Comijn, Director Corporate Communications & Investor
Relations (EU)
+32 (0)477 77 29 44
+32 (0)9 310 34 19
info@argenx.com
Beth DelGiacco, VP Investor
Relations (US)
+1 518 424 4980
bdelgiacco@argenx.com
Halozyme Contact:
Al
Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.