AcelRx Pharmaceuticals Announces Hiring of Kim Gaumer as Vice President, Regulatory Affairs and Quality Assurance
Apr 17, 2012, 07:30 ET
REDWOOD CITY, Calif., April 17, 2012 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced the appointment of Kimberley Gaumer to the position of Vice President, Regulatory Affairs and Quality Assurance reporting to Richard King, President and Chief Executive Officer. In this role, Ms. Gaumer will lead all global regulatory, quality and compliance activities for AcelRx, including the development and prosecution of regulatory filings for ARX-01, the Sufentanil NanoTab® PCA System, a sublingual patient-controlled analgesia system, currently in Phase 3 clinical trials. In addition, Ms. Gaumer will manage regulatory and quality activities related to AcelRx's portfolio of Phase 2 sufentanil NanoTab products, including ARX-02 for cancer breakthrough pain, ARX-03 for procedural pain and sedation, and ARX-04 for acute pain.
"We are very fortunate to be able to identify and recruit someone of Kim's history, reputation and stature to this key role at AcelRx," said Richard King. "Kim has an excellent track record of enabling regulatory progression and approval for combination drug-device products in both the US and Europe. This includes Kim's experiences at ALZA, attaining regulatory approval for IONSYS® (fentanyl iontophoretic transdermal system), a drug-device product for the treatment of post-surgical pain. We are delighted to have Kim join our leadership team," added Mr. King.
Ms. Gaumer has over twenty years of US and European regulatory affairs and quality experience, covering both drug and drug-device product candidates. She joins AcelRx after three years at Zosano Pharmaceuticals, Inc., a company spun out of Johnson & Johnson (J&J), where she was Vice President, Regulatory Affairs and Quality Assurance, focused on establishing and leading their regulatory, quality assurance and quality control organizations. Prior to Zosano, Kim held positions of increasing regulatory responsibility at ALZA Corporation, a J&J company, most recently serving as Senior Director, Regulatory Affairs. At ALZA, Ms. Gaumer provided regulatory supervision for several development programs through Phase 3b including both NDA and MAA filing experiences. She holds a Bachelor of Arts Degree in Human Biology from Stanford University.
About AcelRx Pharmaceuticals, Inc.
Based in Redwood City, CA, AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) 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, the ARX-01 Sufentanil NanoTab PCA System, which is currently in Phase 3 clinical development, 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 inherent potential for programming and delivery errors associated with the complexity of infusion pumps. AcelRx has two additional product candidates which have completed Phase 2 clinical development: ARX-02 for the treatment of cancer breakthrough pain, and ARX-03 for providing mild sedation, anxiety reduction and pain relief for patients undergoing painful procedures in a physician's office. A fourth product candidate, ARX-04, is a sufentanil product for the treatment of moderate-to-severe acute pain that is expected to enter Phase 2 clinical development in the second quarter of 2012 under a grant from the USAMRMC.
Forward Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the planned or anticipated future clinical development of AcelRx Pharmaceuticals' product candidates, including the initiation of the Phase 2 clinical studies for ARX-04 and the therapeutic potential of AcelRx Pharmaceuticals' product candidates. 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: the success, cost and timing of AcelRx Pharmaceuticals' product development activities and clinical trials; the uncertain clinical development process, including the risk that planned clinical trials may not begin on time, have an effective design, enroll a sufficient number of patients, or be initiated or completed on schedule, if at all; any delays or inability to obtain, regulatory approval of its product candidates; its ability to obtain sufficient financing to complete development and registration of its product candidates in the United States and Europe; its ability to obtain and maintain regulatory approvals of its product candidates; the market potential for its product candidates; the accuracy of AcelRx Pharmaceuticals' estimates regarding expenses, capital requirements and needs for financing; 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 for the year ended December 31, 2011. 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.
SOURCE AcelRx Pharmaceuticals, Inc.
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