Agreement with Alora Pharmaceuticals provides
AcelRx with 15% royalties on commercial sales, 75% royalties on
Department of Defense (DoD) sales, up to $116.5 million in potential sales-based milestone
payments, and a strong commercial partner experienced with
commercialization in hospital settings
Divestment allows AcelRx to prioritize
resources on its late stage development assets, led by Niyad™, the
lead nafamostat program with breakthrough device designation status
from FDA
Near-term corporate milestones expected by the
end of Q2 2023 include the Niyad Emergency Use Authorization
submission and the filing of a new drug application for the first
of our two pre-filled syringe product candidates
HAYWARD,
Calif., March 14, 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 divestment of its
FDA-approved drug, DSUVIA® to Alora Pharmaceuticals
(Alora). The agreement allows AcelRx to participate in the
long-term value expected to be created by Alora as they expand the
commercialization of DSUVIA.
The agreement provides AcelRx with a 15% royalty on commercial
sales of DSUVIA, a 75% royalty on sales of DSUVIA to the Department
of Defense, DSUVIA's single largest customer, and up to
$116.5 million in sales-based
milestones. Closing of the transaction is expected by the end
of the month, and AcelRx will provide, and be reimbursed for,
transition services during a period of up to 6 months
post-closing. In exchange for the 75% royalty on net sales to
the DoD, AcelRx will lead the relationship to ensure continued
engagement and expected expansion of sales to the DoD.
Importantly, the divestment will allow for AcelRx to focus
its operations and capital on its late stage, high-value asset
programs, with specific prioritization of its lead nafamostat
program, Niyad™, as an anticoagulant for the extracorporeal circuit
with peak sales potential of $200M.
AcelRx expects Alora will continue to build on AcelRx's previous
focus on procedural suites, with the employment of AcelRx's
existing sales representatives at closing, and the utilization of a
number of their own existing sales representatives that will also
expand into the hospital and surgery center settings, which both
companies believe to be the largest market opportunity for
DSUVIA.
"As stated previously, our goal has been to find a partner for
DSUVIA who is better resourced and has the experience to expand the
sales of DSUVIA to the hospital and surgery center markets and to
build on our current momentum in the procedural suites. In
addition, we believe the opportunity to maintain our relationship
with the DoD will benefit all parties and leverage years of effort
and education into incremental value for our shareholders,"
stated Vince Angotti, Chief Executive Officer of AcelRx. "We
believe that Alora is in a great position to deliver value given
their expertise in commercializing products in hospitals,
experience with manufacturing and selling controlled substances,
and a seasoned commercial team across their group of companies of
over 200 people."
Mr. Angotti continued, "The divestment of DSUVIA marks a new
chapter in the evolution of AcelRx enabling our laser focus on the
advancement of our high-value, late-stage development assets led by
Niyad. In particular, we have progressed our lead nafamostat
product candidate, Niyad™ to prepare for an Emergency Use
Authorization (EUA) submission in this first half of 2023. In
addition, we expect to submit our first ephedrine pre-filled
syringe NDA in the first half of this year. This transaction also
allows us to continue to reduce operating expenses while sharing in
the continued value of DSUVIA. We believe that the divestment of
DSUVIA, plus the advancement of both our nafamostat and pre-filled
syringe portfolio programs, builds long-term value for our
shareholders and sets us on the path to a new era for the Company
with multiple late-stage, and potentially commercial stage assets
within the next 12 months."
"We are proud to partner with AcelRx to continue the growth and
distribution of DSUVIA to ensure access by patients. This product
will help Alora Pharmaceuticals expand our pain management
portfolio. DSUVIA provides an effective solution for patients in a
certified medically supervised healthcare setting, such as
hospitals, surgical centers, and emergency departments, with
management of acute pain severe enough to require an opioid
analgesic," said Art Deas, CEO of
Alora Pharmaceuticals, LLC.
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.
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 AcelRx's European
commercialization partner, 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 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 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
proprietary, non-invasive sublingual formulation technology
delivers sufentanil with consistent pharmacokinetic profiles. The
Company has one approved product in the U.S., DSUVIA®
(sufentanil sublingual tablet, 30 mcg), known as DZUVEO®
in Europe, indicated for the management of acute pain severe
enough to require an opioid analgesic for adult patients in
certified medically supervised healthcare settings, and several
product candidates. The product candidates include: Zalviso®
(sufentanil sublingual tablet system, SST system, 15 mcg), an
investigational product in the U.S. being developed as an
innovatively designed patient-controlled analgesia (PCA) system for
reduction of moderate-to-severe acute pain in medically supervised
settings; two pre-filled, ready-to-use syringes of ephedrine and
phenylephrine licensed for the U.S. from Aguettant;
Niyad™, a regional anticoagulant for the extracorporeal circuit;
and LTX-608, for the potential treatment of COVID-19, disseminated
intravascular coagulation, acute respiratory distress syndrome and
acute pancreatitis. DZUVEO is an approved product
in Europe.
This release is intended for investors only. For additional
information about AcelRx, please visit www.acelrx.com.
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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/acelrx-pharmaceuticals-announces-divestment-of-dsuvia-to-alora-pharmaceuticals-301771123.html
SOURCE AcelRx Pharmaceuticals, Inc.
