REDWOOD CITY, Calif. and
AACHEN, Germany, Dec. 16, 2013 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (Nasdaq: ACRX) and Grunenthal GmbH announced
today that they have entered into a commercial collaboration,
covering the territory of the European Union, certain other
European countries and Australia
for ZALVISO™ (previously known as ARX-01) for potential use in pain
treatment within or dispensed by a hospital, hospice, nursing home
or other medically supervised setting. ZALVISO, 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 is AcelRx's lead program. AcelRx retains all
rights in remaining countries, including the U.S. and Asia.
Under the terms of the agreement, AcelRx will receive an upfront
cash payment of $30 million.
AcelRx is eligible to receive approximately $220 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 mid-twenties percent range, on net sales of ZALVISO in
the Grunenthal territory.
"As an established leader in providing pain management solutions
to patients throughout Europe,
Grunenthal is an excellent partner for AcelRx and for ZALVISO,"
said Richard King, President and
CEO. "Grunenthal's commercial track record across
Europe demonstrates their ability
to achieve commercial success in this large market, and will,
following regulatory approval, enable patients in Europe suffering with moderate-to-severe pain
in a medically supervised setting to receive the benefits of our
innovative, patient-centric product ZALVISO."
"We are extremely pleased to enter into this collaboration with
AcelRx and its proven concept of a patient-controlled analgesia
system to address a significant unmet medical need, thereby
allowing hospitals to avoid the challenges of intravenous
line-related infections, as well as freeing hospital personnel from
the need to program intravenous infusion pump systems. With
ZALVISO Grunenthal is building on its presence in the hospital
market, an area that provides us with significant growth
opportunities in the mid- and long-term," said Prof. Eric-Paul
Paques, Grunenthal's Chief Executive Officer.
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.
ZALVISO PDUFA Date
In addition, AcelRx announced today that the U.S. Food and Drug
Administration (FDA) has established a Prescription Drug User Fee
Act (PDUFA) action date of July 27,
2014, for AcelRx's New Drug Application (NDA) for
Zalviso. AcelRx announced on December 2,
2013 that FDA accepted for filing the Zalviso
NDA.
Conference Call at 8:30 a.m. Eastern
time on Monday, December 16,
2013
AcelRx will conduct a conference call and webcast today,
December 16, 2013 at 8:30 a.m. Eastern time (5:30 a.m. Pacific time) to discuss the Grunenthal
partnership. To listen to the conference call, dial in
approximately ten minutes before the scheduled call to (877)
870-4263 for domestic callers, (855) 669-9657 for Canadian callers,
or (412) 317-0790 for international callers. Those interested
in listening to the conference call live via the Internet may do so
by visiting the Investors section of the company's website at
www.acelrx.com and selecting the webcast link for Grunenthal
collaboration conference call. A webcast replay will be available
on the AcelRx website for 90 days following the call by visiting
the Investors section of the company's website at
www.acelrx.com
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 microtablets to manage their pain. ZALVISO is
designed to address the limitations of IV PCA by offering:
- A high therapeutic index opioid - ZALVISO uses the high
therapeutic index, highly lipophilic opioid sufentanil, enabling
delivery via a non-intravenous route, and also supporting fast
onset of effect.
- A non-invasive route of delivery - The sublingual route of
delivery used by ZALVISO eliminates the risk of IV-related
analgesic gaps and IV complications, such as catheter-related
infections in IV PCA treated patients. In addition, because
ZALVISO patients do not require direct connection to an IV PCA
infusion pump through IV tubing, ZALVISO allows for ease of patient
mobility.
- A simple, pre-programmed PCA solution – ZALVISO is a
pre-programmed PCA system designed to eliminate the risk of
programming errors.
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 solve the 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 has announced positive results from each of the
three Phase 3 clinical trials for ZALVISO and has submitted an NDA
to the FDA seeking its approval. AcelRx has also announced
positive top-line results for a Phase 2 trial for ARX-04, a
sufentanil formulation for the treatment of moderate-to-severe
acute pain, funded through a grant from the U.S. Army Medical
Research and Materiel Command. 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 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 26 percent of revenues in 2012.
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 26 countries worldwide. Grunenthal products are
sold in more than 155 countries. Today, approx. 4,400
employees are working for the Grunenthal Group worldwide. In
2012, Grunenthal achieved revenues of USD
1,251 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 November 5, 2013. 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.