In connection with closing, AcelRx received
approximately $2.7 million from Alora
Pharmaceuticals and Aguettant
AcelRx announces full repayment of its senior
loan with Oxford Finance
HAYWARD,
Calif., April 5, 2023 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for use in medically
supervised settings, today announced the closing of its divestment
of DSUVIA® to Alora Pharmaceuticals (Alora). In
connection with the closing of the transaction, AcelRx received a
total of approximately $2.7 million
from Aguettant and Alora.
On March 14, Alora agreed to
acquire all assets related to DSUVIA, including inventories,
equipment and intellectual property in exchange for consideration
at closing of $1.1 million, a 15%
royalty on commercial sales of DSUVIA, 75% royalty on sales of
DSUVIA to the Department of Defense and up to $116.5 million in sales-based milestones.
In connection with the closing, AcelRx also decided to fully repay
its senior loan with Oxford Finance, leaving the company debt-free
after the closing of the transaction.
"As previously announced, we are thrilled to begin the new
chapter of AcelRx focused on our late-stage development product
portfolio. We are confident we found the right partner in
Alora to accelerate the commercialization and fully realize the
potential of DSUVIA for our shareholders. Our complete
attention is now directed towards the approval of Niyad™ and
Fedsyra™, both of which we believe will address a clear unmet need
for physicians and generate long-term value for AcelRx,"
stated Vince Angotti, Chief Executive Officer of AcelRx.
About AcelRx Pharmaceuticals, Inc.
AcelRx
Pharmaceuticals, Inc. is a specialty pharmaceutical company
focused on the development and commercialization of innovative
therapies for use in medically supervised settings. AcelRx's lead
product candidate, Niyad is a lyophilized formulation of nafamostat
and is currently being studied under an investigational device
exemption, or IDE, as an anticoagulant for the extracorporeal
circuit, and has received Breakthrough Device Designation Status
from the FDA. AcelRx is also developing two pre-filled syringes
in-licensed from its partner Aguettant: Fedsyra™, a pre-filled
ephedrine syringe, with an expected NDA filing in the first half of
2023, and PFS-02, a pre-filled phenylephrine syringe with an
expected NDA filing in 2024.
This release is intended for investors only. For additional
information about AcelRx, please visit www.acelrx.com.
About Nafamostat
Nafamostat is a broad spectrum,
synthetic serine protease inhibitor with anticoagulant,
anti-inflammatory and potential anti-viral activities. Niyad™ is a
lyophilized formulation of nafamostat and is currently being
studied under an investigational device exemption, or IDE, as an
anticoagulant for the extracorporeal circuit, and has received
Breakthrough Device Designation Status from the FDA. LTX-608 is a
proprietary nafamostat formulation for direct IV infusion that will
be investigated and developed as a potential anti-viral for the
treatment of COVID, acute respiratory distress syndrome (ARDS),
disseminated intravascular coagulation (DIC) and acute
pancreatitis.
About DSUVIA (sufentanil sublingual tablet), 30
mcg
DSUVIA®, branded as DZUVEO®
in Europe, 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/DZUVEO was
designed to provide rapid analgesia via a non-invasive route and to
eliminate dosing errors associated with intravenous (IV)
administration. DSUVIA/DZUVEO 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. DZUVEO has been approved
by the European Medicines Agency and Aguettant markets
the drug in Europe.
For more information, including important safety information and
black box warning for DSUVIA, please visit www.DSUVIA.com.
About Alora Pharmaceuticals, LLC
Alora
Pharmaceuticals, LLC is the parent company of six specialty
pharmaceutical and pharmaceutical manufacturing companies.
Alora is headquartered in Alpharetta, GA.
Alora is the parent company of the following organizations
that comprise the Alora family of companies,
Avion Pharmaceuticals, Acella
Pharmaceuticals, Osmotica Pharmaceuticals,
Sovereign Pharmaceuticals, Trigen Laboratories and
Vertical Pharmaceuticals.
Forward-looking statements
This press release contains
forward-looking statements based upon AcelRx's current
expectations. These and any other forward-looking statements are
made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by the use of forward-looking terminology such as
"potential," "believe," "expect," "expects," "expected," "create,"
"created," "anticipate," "may," "will," "enable," "should," "seek,"
"approximately," "intends," "intended," "plans," "planned,"
"planning," "estimates," "benefits," or the negative of these words
or other comparable terminology. The discussion of financial
trends, strategy, plans or intentions may also include
forward-looking statements, which are predictions, projections and
other statements about future events that are based on current
expectations and assumptions. These forward-looking statements
involve risks and uncertainties that could cause actual results to
differ materially from those projected, anticipated or implied by
such statements, including: (i) risks relating to AcelRx's product
development activities and ongoing commercial business operations;
(ii) risks related to AcelRx's commercial partner's success; (iii)
risks related to the ability of AcelRx and its business partners to
implement development plans, launch plans, forecasts and other
business expectations; (iv) risks related to unexpected variations
in market growth and demand for AcelRx's and its business partner's
commercial and developmental products and technologies; (v) risks
related to AcelRx's liquidity and our ability to maintain capital
resources; (vi) AcelRx's ability to retaining its listing on the
Nasdaq exchange; and (vii) risks relating to our ability to obtain
regulatory approvals for our developmental product candidates.
Although it is not possible to predict or identify all such risks
and uncertainties, they may include, but are not limited to, those
described under the caption "Risk Factors" and elsewhere in
AcelRx's annual, quarterly and current reports (i.e., Form 10-K,
Form 10-Q and Form 8-K) as filed or furnished with
the Securities and Exchange Commission (SEC) and any
subsequent public filings. You are cautioned not to place undue
reliance on any such forward-looking statements, which speak only
as of the date such statements were first made. To the degree
financial information is included in this press release, it is in
summary form only and must be considered in the context of the full
details provided in AcelRx's most recent annual, quarterly or
current report as filed or furnished with the SEC.
AcelRx's SEC reports are available
at www.acelrx.com under the "Investors" tab. Except to
the extent required by law, AcelRx undertakes no obligation to
publicly release the result of any revisions to these
forward-looking statements to reflect new information, events or
circumstances after the date hereof, or to reflect the occurrence
of unanticipated events.
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SOURCE AcelRx Pharmaceuticals, Inc.
