HAYWARD, Calif., July 14, 2021 /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 agreements with Laboratoire
Aguettant (Aguettant) providing Aguettant with a license to
commercialize DZUVEO in Europe,
and providing AcelRx with two innovative pre-filled syringe product
candidates for the U.S.
Under the DZUVEO licensing agreement, Aguettant will have the
right to commercialize DZUVEO in Europe. AcelRx is entitled to
receive up to approximately $55
million in a combination of up-front and sales-based
milestone payments at various annual sales levels from Aguettant,
along with revenue share payments ranging from 35% to 45% of net
sales. AcelRx will manufacture and supply DZUVEO to Aguettant at an
agreed supply price.
Under the terms of a separate licensing agreement, AcelRx
obtained the rights to file NDAs, and subject to U.S. Food and Drug
Administration approval, commercialize in the United States two of Aguettant's
innovative, EU-approved, pre-filled syringe products – ready-to-use
ephedrine and phenylephrine. Aguettant has the right to receive up
to $24 million in sales-based
milestone payments, at various annual sales levels up to
$60 million, along with revenue share
payments of 40 to 45% of the net sales of the two pre-filled
syringe products, if approved in the U.S. by the Food and Drug
Administration.
"We are excited to enter into a European collaboration for
DZUVEO with Aguettant, a well-known, innovative European
pharmaceutical company focused on the acute care space across
70 countries," said Vince Angotti, Chief Executive Officer at
AcelRx. "This collaboration provides a strategic fit for DZUVEO
given Aguettant's existing product portfolio. Having the ability to
commercialize two product candidates in the United States with a track record of
success in Europe aligns with our
strategy of building a complementary product portfolio to DSUVIA
while limiting the cost of development," continued Angotti.
"DZUVEO complements our existing product portfolio and we're
delighted about this strategic opportunity to partner with AcelRx,"
said Eric Rougemond, Chief Executive Officer at Laboratoire
Aguettant. "Our worldwide presence in the acute care space makes us
an ideal European partner for DZUVEO. Partnering with AcelRx
to commercialize two of our key acute care products in the U.S.
further reinforces our mutual commitment to this strategic
partnership."
The Fulford Group and Karana Biotech provided strategic and
transactional advisory services to AcelRx.
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 for the management of acute moderate to
severe pain in adults in medically monitored settings.
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 one product candidate, Zalviso®
(sufentanil sublingual tablet system, SST system, 15 mcg), an
investigational product in the U.S., is being developed as an
innovatively designed patient-controlled analgesia (PCA) system for
reduction of moderate-to-severe acute pain in medically supervised
settings. DZUVEO and Zalviso are both approved products in
Europe.
For additional information about AcelRx, please visit
www.acelrx.com.
About Laboratoire Aguettant
Aguettant is an
independent pharmaceutical company dedicated to the development,
manufacturing and distribution of innovative injectable
medicines. Aguettant specializes in acute care settings,
mainly anaesthesia, critical care and emergency, with a constant
focus on redefining drug delivery standards to reduce risk for
users and patients. Founded in Lyon,
France in 1903, Laboratoire Aguettant has a strong
foundation in Europe and is
present in 70 countries globally through its affiliates and
partners' network. For more information about the company,
visit its website: www.aguettant-corporate.com
Forward-Looking Statements
This press
release contains forward-looking statements, including, but not
limited to, statements related to the commercial opportunity of
AcelRx's agreements with Aguettant, the submission of new drug
applications, the potential approval of product candidates by the
U.S. Food and Drug Administration, and the ability to successfully
manufacture DZUVEO to meet the requirements of Aguettant. 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," or the
negative of these words or other comparable terminology. The
discussion of strategy, plans or intentions may also include
forward-looking statements. 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, without limitation, risks related to
delays in, or AcelRx's inability to obtain, regulatory approval for
product candidates, the ability to obtain sufficient financing to
commercialize product candidates, and the market potential for
product candidates. In addition, such risks and uncertainties may
include, but are not limited to, those described in the Company'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). 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. The Company's SEC
reports are available at www.acelrx.com under the "Investors" tab.
Except to the extent required by law, the Company undertakes no
obligation to publicly release the result of any revisions to these
forward-looking statements to reflect events or circumstances after
the date hereof, or to reflect the occurrence of unanticipated
events.
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SOURCE AcelRx Pharmaceuticals, Inc.