XOMA Expands its Commercial Royalty and Milestone Portfolio with DSUVIA® Acquisition
January 18 2024 - 8:30AM
XOMA Corporation (NASDAQ: XOMA) announced today it has
acquired an economic interest in DSUVIA® (sufentanil sublingual
tablet) from Talphera, Inc., for $8 million. DSUVIA®
was approved in 2018 by the U.S. Food and Drug Administration (FDA)
for use in adults in certified medically supervised healthcare
settings. In April 2023, Talphera divested DSUVIA® to Alora
Pharmaceuticals for an upfront payment, a 15 percent royalty on
commercial net sales, a 75 percent royalty on net sales to the U.S.
Department of Defense (DoD), and up to $116.5 million in milestone
payments.
“The Talphera transaction is consistent with XOMA’s business
model of acquiring royalty economics that we believe offer
attractive and asymmetric risk/reward profiles. DSUVIA® is an
important sublingual, single use pain management option addressing
moderate-to-severe acute pain when used in actively supervised
medical settings. We believe Alora has the resources and
expertise to relaunch and successfully commercialize DSUVIA® within
its expansive pain management portfolio,” stated Brad Sitko, Chief
Investment Officer at XOMA. “XOMA was able to structure an
attractive, non-dilutive royalty solution as an alternative to
traditional financing as Talphera repositions its strategy for
future growth.”
In April 2020, DSUVIA® received Milestone C approval from the
U.S. Department of Defense (DoD) for use in U.S. Army sets, kits,
and outfits (SKOs) and was added to the DoD Joint Deployment
Formulary in September 2020. Given the convenient sublingual
delivery via a single dose applicator and its ability to provide
effective pain relief for several hours, DSUVIA® could be an
effective tool for use by military medics to treat injured
personnel in contested environments.
Under the terms of the agreement, XOMA will receive 100 percent
of all royalties and milestones related to DSUVIA® sales until the
Company receives $20 million. Thereafter, XOMA fully retains
the 15 percent royalty associated with DSUVIA® commercial sales,
and the 75 percent royalties generated from DoD purchases will be
shared equally between XOMA and Talphera, as will the remaining
$116.5 million in potential milestone payments due from Alora
Pharmaceuticals.
About DSUVIA (sufentanil sublingual tablet), 30
mcgDSUVIA® is indicated for use in adults in certified
medically supervised healthcare settings, such as hospitals,
surgical centers, and emergency departments, for the management of
acute pain severe enough to require an opioid analgesic and for
which alternative treatments are inadequate. DSUVIA was designed to
provide rapid analgesia via a non-invasive route and to eliminate
dosing errors associated with intravenous (IV)
administration. DSUVIA is a single-strength solid dosage form
administered sublingually via a single-dose applicator (SDA) by
healthcare professionals. Sufentanil is an opioid analgesic
previously only marketed for IV and epidural anesthesia and
analgesia. The sufentanil pharmacokinetic profile, when
delivered sublingually, avoids the high peak plasma levels and
short duration of action observed with IV administration.
For more information, including important safety information and
black box warning for DSUVIA, please visit www.DSUVIA.com.
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 commercial payments to XOMA and other
developments related to DSUVIA®. 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, and our third-party
licensees will not be able to market them. 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),
IXINITY® [coagulation factor IX (recombinant)], and DSUVIA®
(sufentanil sublingual tablet) 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 ContactJuliane SnowdenXOMA Corporation+1
646-438-9754juliane.snowden@xoma.com |
XOMA
Media ContactKathy VincentKV Consulting & Management+1
310-403-8951kathy@kathyvincent.com |
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