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AcelRx European Patent Covering its NanoTabŪ Sublingual Delivery Technology for Acute and Breakthrough Pain Pipeline Products Emerges From Opposition Period

Wednesday, May 11, 2011 General News J E 4
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REDWOOD CITY, Calif., May 10, 2011 /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 and breakthrough pain, announced that the opposition period for a patent granted by the European Patent Office expired on April 21 and to date there is no indication that the patent has been opposed. The patent (European patent EP2114383), covers small-volume NanoTabŪ dosage forms for transmucosal administration containing the opioid sufentanil. This patent covers elements of AcelRx's dispensing technology and also provides patent protection of specific pharmacokinetic parameters derived from sublingual administration using the NanoTab technology. AcelRx has exclusive rights to the patent, which covers key aspects of AcelRx's product candidates ARX-01, ARX-02 and ARX-03.  AcelRx registered the European patent in England, Germany, France, Spain, Italy, Switzerland / Lichtenstein, Denmark, Netherlands, Portugal, and Sweden.

AcelRx developed the NanoTab technology as a basis for delivering sufentanil, a highly lipophilic, high therapeutic index opioid, to control acute and breakthrough pain. The NanoTab provides for rapid uptake of the drug via sublingual tissues, enabling a rapid and consistent onset of effect.  

"This patent is the first to issue from our broad portfolio of pending intellectual property which provides long-term market exclusivity for AcelRx NanoTab technology and pipeline product candidates through at least 2027 in key markets" commented Richard King, AcelRx President and Chief Executive Officer. Mr. King added, "This patent is an important component of AcelRx's formidable intellectual property portfolio covering our sufentanil product candidates.  We see this patent issuance as a key milestone that underscores the durable commercial potential of our market-focused acute and breakthrough pain products."  

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 entering 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, which is designed to offer rapid onset of analgesia, appropriate offset of pain relief and mitigation of opioid abuse and misuse for the treatment of breakthrough pain experienced by cancer patients, and ARX-03 for providing mild sedation, anxiety reduction and pain relief for patients undergoing painful procedures in a physician's office.

Forward Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to AcelRx Pharmaceuticals' intellectual property, breadth and commercial potential of its patent portfolio, market for its products, its clinical trials and product candidate development. These forward-looking statements are based on the company's 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 Pharmaceutical's product development activities and clinical trials; its ability to obtain and maintain intellectual property protection for its product candidates in the United States and Europe; its ability to obtain and maintain regulatory approval of its product candidates; its plans to research, develop and commercialize its product candidates; the market potential for its product candidates; and other risks detailed in the "Risk Factors" and elsewhere in AcelRx Pharmaceuticals' Securities and Exchange Commission filings and reports, including its Annual Report on Form 10-K for the year ended December 31, 2010. 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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