REDWOOD CITY, Calif.,
March 20, 2015 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a
specialty pharmaceutical company focused on the development and
commercialization of innovative therapies for the treatment of
acute pain, today announced the appointment of Howard B. Rosen as interim Chief Executive
Officer of AcelRx, effective April 1,
2015. Mr. Rosen is a technically trained executive with over
25 years of success growing start-up and mid-size biopharmaceutical
companies. Mr. Rosen previously held senior-level general
management positions and functional roles in strategy, marketing,
finance, business development, and research and development at
Gilead Sciences and ALZA Corporation. Mr. Rosen has served on the
Board of Directors of AcelRx since 2008 and currently serves on the
Board of Directors of Alcobra and several private
biopharmaceutical companies.
In addition to the appointment of Mr. Rosen, AcelRx has
restructured its work force as part of a plan to reduce operating
costs and focus the Company's financial and development resources
on working with the U.S. Food and Drug Administration (FDA) to seek
marketing approval for Zalviso, as well as to continue the
development of ARX-04. This restructuring will reduce the Company's
workforce by 19 employees, or approximately 36% of its employee
work force, and primarily impacts the commercial team and
field-based medical personnel, who were hired in preparation for a
potential commercial launch of Zalviso.
"The Board of Directors would like to thank Richard King for his professionalism, leadership
and contributions throughout his tenure and also thank Howie
for agreeing to assume the CEO role on an interim basis to lead the
Company through this important transition," stated Adrian Adams, Chairman of AcelRx.
"While we seek to get clarity from the FDA regarding the
continued development of Zalviso, we are focusing on reducing
operating costs and conserving our capital resources. In addition,
our Phase 3 development of ARX-04 is proceeding on schedule and is
another exciting opportunity for the use of sublingual sufentanil
in the management of moderate-to-severe acute pain. With the
reduction in work force, we believe we retain the capabilities to
continue work on both Zalviso and ARX-04 with the ultimate goal of
gaining marketing approval for both products," stated Howie Rosen.
AcelRx estimates a charge of approximately $0.9 million associated with the reduction in
force, including severance payments and medical and health
benefits. The Company anticipates that this charge will be
reflected in the operating results for the quarter ending
March 31, 2015, with payment in the
second quarter of 2015. Following the one-time charges associated
with this restructuring plan, AcelRx estimates savings of
approximately $0.9 million per fiscal
quarter attributable to the reduction in force.
About Zalviso™
Zalviso is an investigational pre-programmed, non-invasive
system to allow hospital patients with moderate-to-severe acute
pain to self-dose with sufentanil sublingual tablets to manage
their pain. Zalviso consists of sufentanil tablets delivered by the
Zalviso System, a needle-free, handheld, patient-administered, pain
management system (together, "Zalviso"). Zalviso is designed
to help address certain problems associated with post-operative
intravenous patient-controlled analgesia, by
offering:
- A high therapeutic index opioid: Zalviso uses sufentanil, an
opioid that has a high therapeutic index. The therapeutic index is
the ratio of the effective dose versus the lethal dose. In animal
studies, the therapeutic index for sufentanil was approximately 100
times larger than fentanyl and 300 times larger than morphine.
- A non-invasive route of delivery: Zalviso utilizes a sufentanil
tablet which allows for a sublingual (under the tongue) route of
delivery. Sufentanil is highly lipophilic which provides for rapid
absorption in the fatty cells (or mucosal tissue) found under the
tongue and for rapid transit across the blood-brain barrier to
reach the mu-opioid receptors in the brain. The sublingual delivery
used by Zalviso provides rapid onset of analgesia. The sublingual
delivery system also eliminates the risk of IV-related analgesic
gaps and IV complications, such as catheter-related infections. In
addition, because patients do not require direct connection to an
IV PCA infusion pump through IV tubing, Zalviso allows for ease of
patient mobility.
- A pre-programmed PCA solution: Zalviso allows patients to
self-dose sufentanil sublingual tablets via a pre-programmed,
secure system designed to eliminate the risk of programming
errors.
About ARX-04
The ARX-04 Single Dose Applicator (SDA) is a non-invasive,
single-use, disposable, handheld applicator that allows healthcare
professionals to effectively administer tablets to a patient's
sublingual space to manage their moderate-to-severe acute pain.
ARX-04 consists of a 30 mcg sufentanil sublingual tablet, in a
pre-filled SDA. AcelRx's proprietary tablet formulation enables
sublingual sufentanil absorption when ARX-04 is placed under the
tongue. As a result, ARX-04 can provide analgesia in a non-invasive
method of administration and display a consistent pharmacokinetic
profile due to a high percentage of drug being absorbed
sublingually instead of through the gastrointestinal tract. We
believe ARX-04 may be a candidate for use in a variety of medically
supervised settings to manage moderate-to-severe pain, including in
the emergency room, or for post-operative patients, following
either short-stay or ambulatory surgery, who do not require more
long-term patient-controlled analgesia, as well as for battlefield
casualty treatment, and by paramedics during patient transport.
According to the National Emergency Department Sample, there were
more than 104 million adult emergency room visits in the U.S.
during 2011, of which it is estimated that more than 48 million
were associated with moderate-to-severe acute pain; while in the
EU-5 there were more than 91 million adult emergency room visits
during 2011, of which it is estimated that more than 34 million
were associated with moderate-to-severe acute pain.
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 for 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 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 and on July 25, 2014,
received a Complete Response Letter from the FDA. AcelRx recently
received correspondence from the FDA stating that in addition to
the bench testing and two Human Factors studies AcelRx has
performed, an additional clinical study is needed to assess the
risk of inadvertent dispensing and overall risk of dispensing
failures. AcelRx plans to meet with the FDA to discuss and clarify
the need and potential objectives of an additional clinical study
for Zalviso. AcelRx has initiated 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. 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.
Forward-Looking Statements
This press release contains forward-looking statements,
including, but not limited to, statements related to the process
and timing of anticipated future development of AcelRx's product
candidates, including Zalviso and ARX-04; the Zalviso NDA
submission and the CRL; the correspondence received from the FDA
requesting a clinical trial to address risk of inadvertent
dispensing and overall risk of dispensing failures; AcelRx's plans
to meet with the FDA to discuss and clarify the need and potential
objectives of an additional clinical study for Zalviso; the tasks
AcelRx has completed to address the issues raised in the CRL, and
anticipated resubmission of the Zalviso NDA to the FDA, including
the scope of the resubmission and the timing of the resubmission
and FDA review time; the impact, if any, of the FDA's review of the
amendments to the Zalviso NDA that were not previously reviewed;
the accounting and financial impact associated with the reduction
in force, including potential savings attributable to the reduction
in force; and the therapeutic and commercial potential of AcelRx
Pharmaceuticals' product candidates, including Zalviso and
ARX-04.
These forward-looking statements are based on AcelRx
Pharmaceuticals' current expectations and inherently involve
significant risks and uncertainties. AcelRx Pharmaceuticals' 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 Pharmaceuticals' ability to timely resubmit the
Zalviso NDA to the FDA; potential additional clinical trials
necessary in order to resubmit the Zalviso NDA; AcelRx's ability to
receive regulatory approval for Zalviso; any delays or inability to
obtain and maintain regulatory approval of its product candidates,
including Zalviso, in the United
States and Europe; its
ability to obtain sufficient financing to receive regulatory
approval for and commercialize Zalviso and complete clinical
development of ARX-04; the success, cost and timing of all product
development activities and clinical trials, including the Phase 3
ARX-04 trial; the market potential for its product candidates; the
accuracy of AcelRx's estimates regarding expenses, capital
requirements and needs for financing, as well as the charges and
savings attributable to the reduction in force; and other risks
detailed in the "Risk Factors" and elsewhere in AcelRx
Pharmaceuticals' U.S. Securities and Exchange Commission filings
and reports, including its Annual Report on Form 10-K filed with
the SEC on March 13, 2015. AcelRx
Pharmaceuticals 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.