Healthcare Industry News: Zalviso
News Release - October 1, 2015
AcelRx Pharmaceuticals Appoints Gina Ford as Vice President Commercial StrategyREDWOOD CITY, Calif., Oct. 1, 2015 -- (Healthcare Sales & Marketing Network) -- AcelRx Pharmaceuticals, Inc. (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.
Source: AcelRx Pharmaceuticals
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