Zevra’s MIPLYFFA™ (arimoclomol) Receives Approval from U.S. Food and Drug Administration for Use in Patients with Niemann-Pick Disease Type C (NPC)
September 23 2024 - 6:30AM
XOMA Royalty Corporation (NASDAQ: XOMA), the biotech royalty
aggregator, announced today Zevra Therapeutics has received
approval from the U.S. Food and Drug Administration (FDA) for
MIPLYFFA™ (arimoclomol). MIPLYFFA™ is approved for use in
combination with miglustat for the treatment of neurological
manifestations of Niemann-Pick disease type C (NPC) in adult and
pediatric patients two years of age and older. It is the
sixth commercial asset in XOMA Royalty’s growing royalty and
milestone portfolio.
“With the approval of MIPLYFFA™, NPC patients in the United
States now have access to the first FDA approved therapeutic in
this rare, progressive and fatal neurodegenerative disease,” stated
Owen Hughes, Chief Executive Officer of XOMA Royalty. “Based
on the clinical data to date, we believe MIPLYFFA™ plus miglustat
has the potential to improve outcomes and slow disease progression
for many NPC patients.”
In June 2023, XOMA Royalty 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.
About XOMA Royalty CorporationXOMA Royalty is a
biotechnology royalty aggregator playing a distinctive role in
helping biotech companies achieve their goal of improving human
health. XOMA Royalty 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 Royalty 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 or follow XOMA Royalty Corporation on LinkedIn.
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 amount of potential
milestone and commercial payments to XOMA Royalty and other
developments related to MIPLYFFA™ (arimoclomol),
and the potential of XOMA Royalty’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
Royalty’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, and our third-party
licensees will not be able to market them. Other potential
risks to XOMA Royalty meeting these expectations are described in
more detail in XOMA Royalty's most recent filing on Form 10-Q and
in other filings with the Securities and Exchange Commission.
Consider such risks carefully when considering XOMA Royalty's
prospects. Any forward-looking statement in this press
release represents XOMA Royalty'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
Royalty 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, the commercial assets in
XOMA Royalty’s milestone and royalty portfolio are VABYSMO®
(faricimab-svoa), OJEMDA™ (tovorafenib), MIPLYFFA™ (arimoclomol),
XACIATO™ (clindamycin phosphate) vaginal gel 2%, IXINITY®
[coagulation factor IX (recombinant)], and DSUVIA® (sufentanil
sublingual tablet). All other assets in the milestone and
royalty portfolio are investigational compounds. Efficacy and
safety have not been established. There is no guarantee that
any of the investigational compounds will become commercially
available.
Investor Contact |
Media
Contact |
Juliane Snowden |
Kathy Vincent |
XOMA Royalty Corporation |
KV Consulting & Management |
+1 646-438-9754 |
+1 310-403-8951 |
juliane.snowden@xoma.com |
kathy@kathyvincent.com |
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