REDWOOD CITY, Calif.,
Oct. 1, 2015 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical
company focused on the development and commercialization of
innovative therapies for the treatment of acute pain, today
announced the appointment of Gina
Ford, RPh to the role of Vice President of Commercial
Strategy. Ms. Ford has worked with AcelRx as a consultant from 2013
to the present and has been instrumental in the development of a
commercial strategy for Zalviso™ (sufentanil sublingual tablet
system), a drug-device combination product now approved in
Europe for the management of acute
moderate-to-severe post-operative pain in adult patients. As VP
Commercial Strategy, Ms. Ford will be responsible for developing
the commercial plan for ARX-04 in the U.S., Europe and other geographies.
"Gina's work with AcelRx to date, especially the market research
she has conducted to help us better understand the global
opportunities for Zalviso and ARX-04, has been invaluable," stated
Timothy E. Morris, chief financial
officer of AcelRx Pharmaceuticals. "As we advance ARX-04 into the
second planned Phase 3 study, SAP302, in the emergency room
setting, and prepare our regulatory filings in the U.S. and the
E.U., we will be relying heavily on Gina's expertise in market
access, pricing, payor relations and branding to promote a
successful launch, should ARX-04 be approved. We look forward to
welcoming her full-time to our team during this exciting period in
the Company's evolution."
Before joining the AcelRx management team, Ms. Ford was
principal and sole proprietor of One Joule, a commercial strategy
consulting company. During her tenure at One Joule, Ms. Ford
provided clients, including AcelRx, with strategic advice on
commercial, marketing and life-cycle management strategy. She also
led launch preparations, including forecasting, market sizing,
launch training and communications, and sales territory alignment
for One Joule clients. Before founding One Joule, Ms. Ford was
president of Accesia, a wholly owned subsidiary of Patient
Services, Inc., and held several leadership roles at Ipsen, a
global pharmaceutical company focusing on neurology, endocrinology
and urology-oncology. Ms. Ford received a Bachelor of Science in
pharmacy from Southwestern Oklahoma State
University and a Master of Business Administration from
Capella University.
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 pain. In the US,
the Company's late-stage pipeline includes ARX-04 (sufentanil
sublingual tablet, 30 mcg) for the treatment of moderate-to-severe
acute pain in a medically supervised setting; and Zalviso™
(sufentanil sublingual tablet system) for the management of
moderate-to-severe acute pain in adult patients in the hospital
setting. ARX-04 delivers 30 mcg sufentanil sublingual, a high
therapeutic index opioid, through a disposable, pre-filled,
single-dose applicator (SDA). AcelRx has reported positive results
from the pivotal Phase 3 SAP301 ambulatory surgery study, and will
be advancing ARX-04 into a study in emergency room patients in
2015. Zalviso delivers 15 mcg sufentanil sublingual tablets through
a non-invasive delivery route via a pre-programmed,
patient-controlled analgesia device. In response to the New Drug
Application (NDA) AcelRx submitted to the U.S. Food and Drug
Administration (FDA) seeking approval for Zalviso, the Company
received a Complete Response Letter (CRL) on July 25, 2014. The FDA has requested an
additional clinical study prior to the resubmission of the Zalviso
NDA. Zalviso is authorized for marketing in the European
Union as well as in the European Economic Union.
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; anticipated timing of the
completion of study SAP302 for ARX-04; the therapeutic and
commercial potential of AcelRx product candidates, including
Zalviso and ARX-04; AcelRx' plans to seek a pathway forward towards
gaining approval of Zalviso in the US; and anticipated resubmission
of the Zalviso NDA to the FDA, including the scope and timing of
resubmission. 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:
any delays or inability to obtain and maintain regulatory approval
of its product candidates, including Zalviso and ARX-04; the market
potential for its product candidates, including Zalviso and ARX-04,
in the United States and
Europe; its ability to timely
resubmit the Zalviso NDA to the FDA and to receive regulatory
approval for Zalviso; the fact that the FDA may dispute or
interpret differently positive clinical results obtained to date
from the pivotal Phase 3 SAP301 ambulatory surgery study of ARX-04;
its ability to complete Phase 3 clinical development of ARX-04; the
success, cost and timing of all product development activities and
clinical trials, including the planned Phase 3 ARX-04 emergency
room trial; 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 August 4, 2015.
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.