XOMA Acquires Royalty and Milestone Economics to Phase 3 First-In-Class Orphan Disease Asset for Niemann-Pick Disease Type C (NPC) and Phase 2 Oncology Asset
22 Juin 2023 - 1:30PM
XOMA Corporation (NASDAQ: XOMA), announced today it has acquired
the royalty and milestone rights associated with two assets from
LadRx Corporation: arimoclomol, an oral therapeutic for
Niemann-Pick disease type C, and aldoxorubicin, an albumin-linked
formulation of doxorubicin.
Arimoclomol is a first-in-class investigational therapy that has
completed a randomized, placebo-controlled, multinational Phase 2/3
program in Niemann-Pick Disease Type C, an ultra-rare, genetic,
progressive neurogenerative disorder. The compound has
received Orphan Drug Designation for the treatment of NPC by the
Regulatory Authorities in the U.S. and EU. Additionally, the
U.S. Food and Drug Administration (FDA) has granted the compound
Fast-Track Designation, Breakthrough Therapy Designation and Rare
Pediatric Disease Designation. Zevra Therapeutics has
announced its intention to file a New Drug Application for
arimoclomol as early as the third quarter of 20231.
The second asset is aldoxorubicin, a Phase 2 program that is
being developed by ImmunityBio as a potential therapy for
pancreatic cancer. The FDA has granted aldoxorubicin Orphan
Drug Designation for the treatment of soft tissue sarcoma.
“This is a notable acquisition of the economics associated with
a therapy that has the potential to address a significant unmet
need in a devastating disease,” stated Owen Hughes, Executive
Chairman of XOMA. “This transaction is very much aligned with
our strategy of seeking assets that have the potential to establish
new standards of care for patients while driving cashflow
generation for XOMA shareholders.”
“NPC is an ultra-rare genetic disorder where patients can lose
their vision and hearing, their ability to walk and swallow, and it
leads to premature death. In the United States, there are no
approved treatments for NPC. Zevra is actively preparing to
file a New Drug Application1, as these patients clearly need access
to therapy as evidenced by over 150 patients receiving arimoclomol
therapy through expanded access,” stated Brad Sitko, Chief
Investment Officer at XOMA. “We provided a non-dilutive
capital solution to LadRx, which had been exploring strategic
alternatives. LadRx can now advance an internal pipeline of
new therapeutics to treat patients with high unmet needs.”
Under the terms of the agreement, XOMA will receive a mid-single
digit royalty on arimoclomol’s commercial sales upon approval and
up to $52.6 million, net, in potential milestone payments.
Should aldoxorubicin be approved for marketing, XOMA will receive a
mid-single-digit to mid-teens royalty rate on aldoxorubicin
commercial sales depending upon the indication, in addition to
potential milestone payments of up to $343 million in development
and commercial milestones. LadRx will be entitled to receive
up to $6 million in certain pre-specified milestones associated
with arimoclomol and aldoxorubicin. XOMA acquired these
royalty and milestone interests for $5 million.
XOMA was represented by Gibson Dunn & Crutcher LLP.
LadRx was represented by Roth Capital Partners and Haynes and Boone
LLP.
About XOMA CorporationXOMA is a biotechnology
royalty aggregator playing a distinctive role in helping biotech
companies achieve their goal of improving human health. XOMA
acquires the potential future economics associated with
pre-commercial therapeutic candidates that have been licensed to
pharmaceutical or biotechnology companies. When XOMA acquires
the future economics, the seller receives non-dilutive,
non-recourse funding they can use to advance their internal drug
candidate(s) or for general corporate purposes. The Company
has an extensive and growing portfolio with more than 70 assets
(asset defined as the right to receive potential future economics
associated with the advancement of an underlying therapeutic
candidate). For more information about the Company and its
portfolio, please visit www.xoma.com.
Forward-Looking Statements/Explanatory
NotesCertain statements contained in this press release
are forward-looking statements within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934, including statements regarding the timing and
amount of potential milestone and commercial payments to XOMA and
other developments related to arimoclomol and aldoxorubicin, and
the potential of XOMA’s portfolio of partnered programs and
licensed technologies generating substantial milestone and royalty
proceeds over time. In some cases, you can identify such
forward-looking statements by terminology such as “anticipate,”
“intend,” “believe,” “estimate,” “plan,” “seek,” “project,”
“expect,” “may,” “will,” “would,” “could” or “should,” the negative
of these terms or similar expressions. These forward-looking
statements are not a guarantee of XOMA’s performance, and you
should not place undue reliance on such statements. These
statements are based on assumptions that may not prove accurate,
and actual results could differ materially from those anticipated
due to certain risks inherent in the biotechnology industry,
including those related to the fact that our product candidates
subject to out-license agreements are still being developed, and
our licensees may require substantial funds to continue development
which may not be available; we do not know whether there will be,
or will continue to be, a viable market for the products in which
we have an ownership or royalty interest; if the therapeutic
product candidates to which we have a royalty interest do not
receive regulatory approval, our third-party licensees will not be
able to market them; and the impact to the global economy as a
result of the COVID-19 pandemic. Other potential risks to
XOMA meeting these expectations are described in more detail in
XOMA's most recent filing on Form 10-K and in other filings with
the Securities and Exchange Commission. Consider such risks
carefully when considering XOMA's prospects. Any
forward-looking statement in this press release represents XOMA's
beliefs and assumptions only as of the date of this press release
and should not be relied upon as representing its views as of any
subsequent date. XOMA disclaims any obligation to update any
forward-looking statement, except as required by applicable
law.
EXPLANATORY NOTE: Any references to “portfolio” in this press
release refer strictly to milestone and/or royalty rights
associated with a basket of drug products in development. Any
references to “assets” in this press release refer strictly to
milestone and/or royalty rights associated with individual drug
products in development.
As of the date of this press release, all assets in XOMA’s
milestone and royalty portfolio, except Vabysmo® and IXINITY®, are
investigational compounds. Efficacy and safety have not been
established. There is no guarantee that any of the investigational
compounds will become commercially available.
XOMA
Investor Contact |
|
XOMA
Media Contact |
Juliane Snowden |
|
Kathy Vincent |
XOMA Corporation |
|
KV Consulting & Management |
+1 646-438-9754 |
|
+1 310-403-8951 |
juliane.snowden@xoma.com |
|
kathy@kathyvincent.com |
1
https://investors.zevra.com/news-releases/news-release-details/zevra-therapeutics-reports-corporate-updates-and-first-quarter
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