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AcelRx Appoints Howard B. Rosen as Interim CEO

AcelRx Announces Restructuring to Focus on Regulatory Approval of Zalviso and Clinical Development of ARX-04

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.

Timothy E. Morris, Chief Financial Officer, 650.216.3511, tmorris@acelrx.com, or Brian Korb, The Trout Group LLC, 646.378.2923, bkorb@troutgroup.com