REDWOOD CITY, Calif. and
AACHEN, Germany, July 7, 2014 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (Nasdaq: ACRX) and Grunenthal Group announced
today that Grunenthal has submitted a Marketing Authorization
Application (MAA) to the European
Medicines Authority for ZALVISO™ for the management of moderate to
severe acute pain in adult patients in a medically supervised
environment. ZALVISOTM is a drug-device
combination product utilizing the opioid agonist sufentanil
formulated in a proprietary sublingual tablet formulation and
delivered through a pre-programmed, non-invasive proprietary
delivery device. AcelRx and Grunenthal entered into license
and supply agreements for ZALVISOTM in the EU,
Australia and certain other
countries in December 2013.
Under the terms of the license agreement, AcelRx will receive a
cash payment of $5 million for the
MAA submission. AcelRx is eligible to receive an additional
$15 million milestone payment upon
the approval of the MAA. After approval by EMA, AcelRx is eligible
to receive approximately $200 million
in additional milestone payments, based upon successful regulatory
and product development efforts and net sales target
achievements. Grunenthal will also make tiered royalty,
supply and trademark fee payments in the mid-teens up to the twenty
percent range, on net sales of ZALVISOTM in the
Grunenthal territory. With the partnership Grunenthal, a
family-owned global pharmaceutical company headquartered in Aachen,
Germany, significantly strengthens
its hospital franchise and underlines its strong market position as
a pain specialist in the pharmaceutical market.
"We are pleased with the timely progress and collaborative
nature of our relationship with Grunenthal which has enabled the
ZALVISO MAA to be submitted on schedule," said Richard King, President and CEO of AcelRx
Pharmaceuticals, Inc. "We look forward to the time when the
benefits of ZALVISO might be available to all medically supervised
patients in moderate to severe pain in the European Union."
"This important step is a key milestone in bringing a new
treatment option to patients. Through the license agreement
with AcelRx Grunenthal is again emphasizing its commitment to pain
patients as an independent, global pharmaceutical company with
long-time experience in the development of innovative and effective
pain treatments," said Prof. Dr. Eric-Paul Paques, Grunenthal's
Chief Executive Officer.
Under the terms of the collaboration, Grunenthal will be
responsible for all commercial activities for ZALVISO, including
obtaining and maintaining pharmaceutical product regulatory
approval in the Grunenthal territory. AcelRx will be
responsible for maintaining device regulatory approval in the
Grunenthal territory and manufacturing and supply of ZALVISO to
Grunenthal for commercial sales and clinical trials.
Currently, there are 19 million surgical procedures with
associated moderate-to-severe pain in the European Union on an
annual basis for which the use of ZALVISO could be suitable.
The regulatory review by EMA is expected to take twelve to sixteen
months.
About ZALVISO
ZALVISO is an investigational pre-programmed, non-invasive,
handheld system that allows hospital patients with
moderate-to-severe acute pain to self-dose with sublingual
sufentanil tablets to manage their pain. ZALVISO is designed
to help address certain problems associated with post-operative
intravenous patient-controlled analgesia, which has been shown to
cause harm to patients following surgery because of the side
effects of morphine, the invasive IV route of delivery and the
complexity of infusion pumps.
AcelRx retains all rights to ZALVISO in North America, Asia, Latin
America and Middle
East/Africa.
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical
company focused on the development and commercialization of
innovative therapies for the treatment of acute and breakthrough
pain. AcelRx's lead product candidate, ZALVISO, is designed
to improve the management of moderate-to-severe acute pain in adult
patients in the hospital setting by utilizing a high therapeutic
index opioid, through a non-invasive delivery route via a
pre-programmed, patient-controlled analgesia device. AcelRx has
announced positive results from each of the three completed Phase 3
clinical trials for ZALVISO, and has submitted an NDA to the FDA
seeking approval for ZALVISO in the treatment of moderate-to-severe
acute pain in adult patients in the hospital setting. AcelRx
plans to initiate a Phase 3 clinical trial for ARX-04, a product
candidate for the treatment of moderate-to-severe acute pain in a
medically supervised setting, during the second half of 2014. The
company has two additional pain treatment product candidates,
ARX-02 and ARX-03, which have completed Phase 2 clinical
development. For additional information about AcelRx's
clinical programs, please visit www.acelrx.com.
About Grunenthal
The Grunenthal Group is an independent, family-owned,
international research-based pharmaceutical company headquartered
in Aachen, Germany. Building on
its unique position in pain treatment, its objective is to become
the most patient-centric company in the field of pain and thus to
be a leader in therapy innovation.
Grunenthal is one of the last five remaining research-oriented
pharmaceutical companies with headquarters in Germany which sustainably invests in research
and development. Research and development costs amounted to about
27 percent of revenues in 2013. Grunenthal's research and
development strategy concentrates on selected fields of therapy and
state-of-the-art technologies. We are intensely focused on
discovering new ways to treat pain better and more effectively,
with fewer side-effects than current therapies.
Altogether, the Grunenthal Group has affiliates in 25 countries
worldwide. Grunenthal products are sold in more than 155 countries
and approx. 5,500 employees are working for the Grunenthal Group
worldwide. In 2013, Grunenthal achieved revenues of €901 mn.
More information: www.grunenthal.com.
Forward Looking Statements
This press release contains forward-looking statements,
including, but not limited to, statements related to potential
approval of the NDA for ZALVISO in the U.S. and the timing thereof,
the potential of approval of the MAA for ZALVISO in the EU and the
timing thereof, the ability to successfully manufacture ZALVISO to
meet the requirements of Grunenthal and the therapeutic and
commercial potential of ZALVISO in the Grunenthal territory.
These forward-looking statements are based on AcelRx's current
expectations and inherently involve significant risks and
uncertainties. AcelRx's actual results and the timing of
events could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, risks related to:
AcelRx's ability to receive regulatory approval for ZALVISO;
any delays or inability to obtain and maintain regulatory approval
of AcelRx's product candidates, including ZALVISO, in the United States, Europe, Australia and other countries; the ability to
attract additional funding partners or collaborators with
development, regulatory and commercialization expertise; the
ability to obtain sufficient financing to commercialize ZALVISO;
the market potential for AcelRx's other product candidates; the
accuracy of AcelRx's estimates regarding expenses, capital
requirements and needs for financing; and other risks detailed in
the "Risk Factors" and elsewhere in AcelRx's U.S. Securities and
Exchange Commission filings and reports, including its Quarterly
Report on Form 10-Q filed with the SEC on May 8, 2014. AcelRx undertakes no duty or
obligation to update any forward-looking statements contained in
this release as a result of new information, future events or
changes in its expectations.
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SOURCE AcelRx Pharmaceuticals, Inc.