Global rights to pegzilarginase in development
for Arginase 1 Deficiency sold to Immedica Pharma for $15 million upfront cash proceeds and up to
$100 million of contingent milestone
payments
Marketing Authorisation Application for
pegzilarginase is under review by the European Medicines
Agency
WALTHAM,
Mass., July 27, 2023 /PRNewswire/ -- Aeglea
BioTherapeutics, Inc. ("Aeglea") (NASDAQ:AGLE), a biotechnology
company advancing a pipeline of antibody therapeutics with
best-in-class potential to transform the treatment of inflammatory
bowel disease ("IBD"), today announced that it has entered into an
agreement to sell the global rights to pegzilarginase, an
investigational treatment for the rare metabolic disease Arginase 1
Deficiency ("ARG1-D"), to Immedica Pharma AB ("Immedica") for
$15 million in upfront cash proceeds
and up to $100 million in contingent
milestone payments. The sale of pegzilarginase to Immedica
supersedes the previous license agreement between Aeglea and
Immedica.
"We are thrilled that Immedica will be continuing our efforts
with pegzilarginase and consolidating development of the potential
therapy for the treatment of ARG1-D," said Jonathan Alspaugh, President and Chief Financial
Officer of Aeglea. "Immedica has made substantial progress in
working towards a European market approval. We believe it is
ultimately in the best interest of the ARG1-D community that
Immedica will seek to continue the dialogue with the FDA to discuss
a path forward for pegzilarginase in the
United States while advancing the program globally."
The milestone payments are contingent on formal reimbursement
decisions by national authorities in key European markets and
pegzilarginase approval by the U.S. Food and Drug Administration
("FDA"), among other events. The upfront payment and contingent
milestone payments if paid, net of expenses and adjustments, will
be distributed to holders of Aeglea's Contingent Value Rights
("CVR") pursuant to the CVR agreement resulting from Aeglea's
acquisition of Spyre Therapeutics, Inc. ("Spyre").
About Pegzilarginase in ARG1-D
Pegzilarginase is a
novel recombinant human enzyme engineered to degrade the amino acid
arginine and has been shown to rapidly and sustainably lower levels
of the amino acid arginine in plasma. Pegzilarginase has been in
development for the treatment of people with ARG1-D, a rare
debilitating and progressive disease characterized by the
accumulation of arginine. ARG1-D presents in early childhood and
patients experience spasticity, seizures, developmental delay,
intellectual disability and early mortality. The PEACE Phase 3
clinical trial met its primary endpoint with a 76.7% reduction in
mean plasma arginine compared to placebo. Additionally, 90.5% of
pegzilarginase treated patients achieved normal plasma arginine
levels. Based on the results from PEACE and a previous Phase 1/2
clinical trial, a Marketing Authorisation Application was submitted
to the European Medicines Agency by Immedica. In April 2022, Aeglea announced the submission of a
Biologics License Application (BLA) to the FDA. In June 2022, Aeglea announced the receipt of a
Refusal to File letter from the FDA for the BLA of pegzilarginase
for the treatment of ARG1-D.
About Aeglea BioTherapeutics
In June 2023, Aeglea completed the asset acquisition
of Spyre and shifted its disease focus to IBD. Aeglea is advancing
a pipeline of antibody therapeutics with the potential to transform
the treatment of IBD. The approaches combine novel antibody
engineering, rational therapeutic combinations, and precision
immunology approaches to maximize efficacy, safety, and convenience
of treatments for IBD.
For more information, please visit http://aeglea.com.
Follow Aeglea BioTherapeutics on social media: @aegleabio and
LinkedIn.
Forward-Looking Statements
Certain statements in this
press release, other than purely historical information, may
constitute "forward-looking statements" within the meaning of the
federal securities laws, including for purposes of the safe harbor
provisions under the United States Private Securities Litigation
Reform Act of 1995, concerning Aeglea, the sale of pegzilarginase
by Aeglea and other matters. These forward-looking statements
include, but are not limited to, express or implied statements
relating to Aeglea's management team's expectations, hopes,
beliefs, intentions or strategies regarding the future including,
without limitation, statements regarding potential receipt of
contingent milestone payments and the distribution of such payments
to holders of CVRs, and the continued development of
pegzilarginase. In addition, any statements that refer to
projections, forecasts or other characterizations of future events
or circumstances, including any underlying assumptions, are
forward-looking statements. The words "opportunity," "potential,"
"milestones," "pipeline," "can," "goal," "aim," "strategy,"
"target," "seek," "anticipate," "achieve," "believe,"
"contemplate," "continue," "could," "estimate," "expect,"
"intends," "may," "might," "plan," "possible," "predict,"
"project," "should," "will," "would" and similar expressions
(including the negatives of these terms or variations of them) may
identify forward-looking statements, but the absence of these words
does not mean that a statement is not forward-looking. These
forward-looking statements are based on current expectations and
beliefs concerning future developments and their potential effects.
There can be no assurance that future developments affecting Aeglea
will be those that have been anticipated. These forward-looking
statements involve a number of risks, uncertainties (some of which
are beyond Aeglea's control) or other assumptions that may cause
actual results or performance to be materially different from those
expressed or implied by these forward-looking statements. These
risks and uncertainties include, but are not limited those
uncertainties and factors described under the heading "Risk
Factors," "Risk Factor Summary" and "Forward-Looking Statements" in
Aeglea's most recent Annual Report on Form 10-K filed with the
Securities and Exchange Commission (the "SEC") on March 2, 2023, the Quarterly Report on Form 10-Q
filed with the SEC on May 11, 2023,
as well as discussions of potential risks, uncertainties, and other
important factors included in other filings by Aeglea from time to
time. Should one or more of these risks or uncertainties
materialize, or should any of Aeglea's assumptions prove incorrect,
actual results may vary in material respects from those projected
in these forward-looking statements. Nothing in this press release
should be regarded as a representation by any person that the
forward-looking statements set forth herein will be achieved or
that any of the contemplated results of such forward-looking
statements will be achieved. You should not place undue reliance on
forward-looking statements in this press release, which speak only
as of the date they are made and are qualified in their entirety by
reference to the cautionary statements herein. Aeglea does not
undertake or accept any duty to release publicly any updates or
revisions to any forward-looking statements. This press release
does not purport to summarize all of the conditions, risks and
other attributes of an investment in Aeglea.
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SOURCE Aeglea BioTherapeutics, Inc.