HAYWARD, Calif., Jan. 10, 2022 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (NASDAQ: ACRX), 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 acquisition of Lowell
Therapeutics, Inc. (Lowell).
"We are thrilled to finalize the acquisition of Lowell as we
continue to execute on our strategy to expand our portfolio of
innovative therapies for use in medically supervised settings with
the addition of Niyad™, an investigational product that has
received Breakthrough Designation status from the FDA," said
Vince Angotti, CEO of AcelRx
Pharmaceuticals. "Niyad, as well as LTX-608, complement our
existing portfolio of commercial and late-stage investigational
products. We believe the peak sales for Niyad, once approved,
could have the potential to reach up to $200
million annually as there are currently no FDA-approved
products for anticoagulation of the dialysis circuit," said Mr.
Angotti.
"Lowell's acquisition by AcelRx provides Lowell's former
stockholders the opportunity to participate in the value creation
of Niyad, which was Lowell's founding vision," said James Wilke, Lowell's former CEO. "AcelRx is the
ideal partner for the development and commercialization of Niyad,
and we were excited by the opportunity to partner with them through
this transaction."
The law firm of Shearman & Sterling LLP represented AcelRx
in the transaction. Maxim Group LLC acted as financial advisor to
Lowell Therapeutics.
Transaction overview
AcelRx acquired all the
outstanding shares of capital stock, and options to purchase
capital stock, of Lowell for 9,009,538 shares of AcelRx common
stock and cash in the amount of approximately $3.5 million, which was cash acquired from
Lowell, plus $26.0 million of
contingent consideration payable in cash or stock at AcelRx's
option upon the achievement of certain regulatory and sales-based
milestones. The first milestone payment is expected to be paid upon
the achievement of FDA approval of Niyad. Three sales-based
milestones totaling $17.0 million
will be paid to Lowell based on achievement of specified sales
levels up to $100.0 million. Certain
obligations of Lowell were also paid in AcelRx stock in the amount
of 610,994 shares. AcelRx common stock amounting to 1,396,526
shares were held back to satisfy any potential indemnification and
other obligations of Lowell and its securityholders.
About Niyad and LTX-608
Niyad, a regional
anticoagulant for the dialysis circuit during continuous renal
replacement therapy for acute kidney injury patients in the
hospital, is being studied under an investigational device
exemption, or IDE, and has received Breakthrough Device Designation
status from the FDA. While not approved for commercial use in the
U.S., the active drug component of Niyad, nafamostat, has been
approved in Japan and South Korea as a regional anticoagulant for
the dialysis circuit, disseminated intravascular coagulation, and
acute pancreatitis. Niyad is a lyophilized formulation of
nafamostat, a broad-spectrum, synthetic serine protease inhibitor,
with anticoagulant, anti-inflammatory, and potential anti-viral
activities. The second intended indication for Niyad is as a
regional anticoagulant for the dialysis circuit for chronic kidney
disease patients undergoing intermittent hemodialysis in dialysis
centers. LTX-608 is AcelRx's proprietary nafamostat formulation for
direct IV infusion being developed for the treatment of acute
respiratory distress syndrome (ARDS) and disseminated intravascular
coagulation (DIC).
About DSUVIA (sufentanil sublingual tablet), 30
mcg
DSUVIA®, known 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 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. The European
Commission approved DZUVEO for marketing in Europe and it will be commercialized by
AcelRx's European partner, Aguettant.
This release is intended for investors only. For more
information, including important safety information and black box
warning for DSUVIA, please visit www.DSUVIA.com.
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, and
two pre-filled, ready-to-use syringes of ephedrine and
phenylephrine licensed for the U.S. from Aguettant. DZUVEO and
Zalviso are both approved products in Europe.
For additional information about AcelRx, please visit
www.acelrx.com.
Forward-Looking Statements
This press release contains
forward-looking statements, including, but not limited to,
statements related to the expected benefits of the acquisition of
Lowell, potential revenue opportunities, the expected market
opportunity for its product candidates, and plans to file NDAs.
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 "believes," "expects,"
"anticipates," "may," "will," "should," "seeks," "approximately,"
"intends," "plans," "estimates," "could" 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) the occurrence of any
event, change or other circumstance that could change the expected
benefits of the acquisition; (ii) risks that the acquisition
disrupts the current plans and operations of AcelRx; (iii) risks
relating to diverting AcelRx management's attention from ongoing
business operations; (iv) the ability of AcelRx to implement its
plans, forecasts and other expectations with respect to its newly
acquired product candidates and realize additional opportunities
for growth and innovation; (v) the ability to achieve the expected
benefits from the acquisition; (vi) the impacts of any breaches of
representations and warranties contained in the merger agreement
and whether adequate remedies exist therefor; and (vii) unexpected
variations in market growth and demand for AcelRx's products and
technologies. 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.