FDA Acceptance of Zevra’s Arimoclomol NDA Filing for Niemann-Pick Disease Type C (NPC) Results in XOMA Making a $1 Million Milestone Payment to LadRx
12 1월 2024 - 6:05AM
XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator,
announced today that based upon the U.S. Food and Drug
Administration’s (FDA) acceptance of Zevra Therapeutics’ New Drug
Application (NDA) for arimoclomol, an orally-delivered,
first-in-class therapy for Niemann-Pick disease type C (NPC), XOMA
will make a $1 million milestone payment to LadRx.
“NPC is an ultra-rare, progressive, neurodegenerative genetic
disorder where those living with NPC lose independence due to
physical and cognitive limitations, with key neurological
impairments presenting in speech, cognition, swallowing,
ambulation, and fine motor skills. Arimoclomol has the
potential to be the first approved therapy designed to slow the
progress of this devastating disease,” stated Brad Sitko, Chief
Investment Officer at XOMA. “We, together with the NPC
community, support Zevra’s efforts to secure marketing approval for
arimoclomol in the U.S. and the EU.”
In June 2023, XOMA announced it had paid LadRx a $5 million
upfront payment plus a share of future event-based milestones to
acquire a mid-single digit royalty on arimoclomol’s commercial
sales and up to $52.6 million, net, in potential milestone payments
from Zevra.
The transaction also included a mid-single-digit to mid-teens
royalty rate on commercial sales of aldoxorubicin depending upon
the indication, in addition to potential payments of up to $343
million in development and commercial milestones from ImmunityBio.
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 and commercial assets 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 Notes
Certain 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 of FDA
review and approval of arimoclomol, the 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® (faricimab) and
IXINITY® [coagulation factor IX (recombinant)], 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 SnowdenXOMA Corporation+1
646-438-9754juliane.snowden@xoma.com |
Kathy VincentKV Consulting &
Management+1 310-403-8951kathy@kathyvincent.com |
XOMA Royalty (NASDAQ:XOMAO)
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