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AcelRx Pharmaceuticals Provides Update on its Patent Portfolio for Zalviso™ and its Proprietary Platform Technologies

Patent estate includes thirteen issued U.S. patents, thirty patents worldwide

REDWOOD CITY, Calif., Oct. 16, 2014 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today provided an update regarding its growing patent estate which totals 30 issued patents worldwide. These issued patents cover AcelRx's sufentanil Nanotab®, medication delivery devices and platform technology, and include thirteen issued U.S. patents, four issued European patents and thirteen issued patents in other international territories including Japan and China. These issued patents are expected to provide coverage through 2027 – 2030.

"Since late last year, we have received 11 issued patents, including both pharmaceutical and device patents with a combination of composition and method claims which expand the scope of protection for both Zalviso and our pipeline programs," stated Richard King, president and CEO of AcelRx. "We will continue to pursue additional patent protection both through our existing applications and the filing of new applications in order to expand the depth, geographic coverage and duration of our intellectual property protection."

Newly Issued U.S. Patents

U.S. patent #8,778,393 entitled "Small Volume Oral Transmucosal Dosage Forms Containing Sufentanil for Treatment of Pain." Issued July 15, 2014, with coverage anticipated until 2027.

U.S. patent #8,778,394 entitled "Small Volume Oral Transmucosal Dosage Forms." Issued July 15 2014, with coverage anticipated until 2027.

U.S. patent #8,574,189 entitled "Storage and Dispensing Devices for Administration of Oral Transmucosal Dosage Forms" relates to our Single Dose Applicator technology utilized in our pipeline programs. Issued November 5, 2013, with coverage anticipated until 2030.

U.S. patent #8,753,308 entitled "Methods for Administering Small Volume Oral Transmucosal Dosage Forms Using a Dispensing Device." Issued June 17, 2014, with coverage anticipated until 2027.

Recently Issued European and International Patents

European patent #EP2099406B1 entitled "Storage and Dispensing Devises for Administration of Oral Transmucosal Dosage Forms." Issued July 30, 2014, with coverage anticipated until 2027.

Additionally, AcelRx has received 6 new patents outside the United States and European Union. We received newly issued patents in each of Japan, China, Canada and Korea with coverage anticipated until 2027, and new issued patents in China and Singapore with coverage anticipated until 2029. To date, we have received 13 issued patents in countries outside the United States and European Union.

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 to improve 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 announced positive results from each of the three completed Phase 3 clinical trials for Zalviso, and 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 25th, received a Complete Response Letter from the FDA. AcelRx plans to initiate 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, by the end of 2014. 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 therapeutic potential of AcelRx Pharmaceuticals' product candidates, including Zalviso; the extent to which our issued and pending patents may protect our product candidates and technology; the infringement potential on any third party intellectual property; and the potential of such product candidates to lead to the development of commercial products. 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 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; AcelRx's ability to build an effective commercial organization; its ability to obtain sufficient financing to commercialize Zalviso and proceed with 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 trial; the market potential for its product candidates; and other risks detailed in the "Risk Factors" and elsewhere in AcelRx Pharmaceuticals'U.S. Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q filed with the SEC on August 11, 2014. 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.  

AcelRx logo.

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SOURCE AcelRx Pharmaceuticals, Inc.

Timothy Morris, Chief Financial Officer, 650.216.3511, tmorris@acelrx.com