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

Patent estate includes nine issued U.S. patents, nineteen patents worldwide

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Oct 08, 2013, 07:30 ET

REDWOOD CITY, Calif., Oct. 8, 2013 /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 19 issued patents worldwide. These issued patents cover AcelRx's sufentanil Nanotab™, medication delivery devices and platform technology, and includes nine issued U.S. patents, three issued European patents with 27 national registrations and seven issued patents in other international territories including Japan and China. These issued patents are expected to provide coverage through 2027 – 2031.

"Over the last year and a half, we have established a broad portfolio of both drug and device patents covering the substantial majority of the potential markets for our products. Particularly, we believe we have established strong and enduring protection in both the U.S. and Europe, which are our initial areas of commercial focus," stated Richard King, president and CEO of AcelRx. "We anticipate further expansion of AcelRx's patent estate resulting from our pursuit of 13 U.S. patent applications and an additional 40 foreign national applications, which, if issued, will further strengthen the protection for our product pipeline."

Issued U.S. Patents in 2013

U.S. patent #8,357,114 entitled "Drug dispensing device with flexible push rod" relates to devices for dispensing a sublingual drug dosage form to a patient through a curved passage using a flexible rod to push a tablet. Issued January 22, 2013, with coverage anticipated through 2027.

U.S. patent #8,499,966 entitled "Method of moving a delivery member of a dispensing device for administration of oral transmucosal dosage forms" relates to a method of administering small, bioadhesive drug tablets and includes moving an end portion of a delivery member. Issued August 6, 2013, with coverage anticipated through 2028.

U.S. patent #8,535,714 entitled "Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain" relates to specific features of the sublingual sufentanil tablet formulation, including particular pharmacokinetic properties. Issued September 17, 2013, with coverage anticipated through 2027.

U.S. patent #8,548,623 entitled "Storage and dispensing devices for administration of oral transmucosal dosage forms" relates to key features of a simplified multiple dose delivery device suitable for use in an outpatient setting. Issued October 1, 2013, with coverage anticipated through 2031.

Issued European and International Patents in 2013

European patent #EP1973593B1 entitled "Drug storage and dispensing devices and systems comprising the same" relates to dispensing devices for administration of drug dosage forms and systems comprising them, and in particular a dispensing device for oral transmucosal administration of a drug dosage tablet to a subject including a means for detecting the identity of the patient, a lock-out feature and a means to prevent unauthorized access to stored drugs. Issued April 10, 2013 with coverage anticipated through 2027.

Additionally, AcelRx currently has two issued patents in China with coverage anticipated through 2028, and three issued patents in Japan with coverage anticipated through 2027. Further, we have received one patent in each Mexico and New Zealand with coverage anticipated through 2029.

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 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 complexity of infusion pumps. AcelRx has announced positive results from each of the three Phase 3 clinical trials for Zalviso and has submitted an NDA to the FDA seeking its approval. AcelRx has also announced positive top-line results for a Phase 2 trial for ARX-04, a sufentanil formulation for the treatment of moderate-to-severe acute pain, funded through a grant from the U.S. Army Medical Research and Materiel Command. 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 AcelRx Pharmaceuticals' patent portfolio, including the useful lives of the U.S. and rest-of-world patents for a method of treating pain by administering a small-volume solid tablet containing sufentanil delivered by the Company's proprietary delivery devices, the continue expansion of its portfolio of patent protection which could provide market exclusivity, its ability to protect is proprietary technology, the scopes of patent protection, and issued and planned, acceptance by the FDA of an NDA submission for Zalviso, the therapeutic benefits of Zalviso, the commercial potential of Zalviso and the anticipated timing and therapeutic and commercial potential of AcelRx Pharmaceuticals' other 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 fact that our patent portfolio will provide adequate protection; the fact that FDA may not accept for filing Zalviso NDA; ability to obtain regulatory approval for Zalviso, including whether the results of the Phase 3 clinical trials for Zalviso are sufficient to obtain marketing approval for Zalviso, which turns on the ability of AcelRx to demonstrate to the satisfaction of the FDA the safety and efficacy of Zalviso based upon its findings of the Phase 3 trials; any delays or inability to obtain and maintain regulatory approval of its product candidates in the United States and Europe; its ability to attract funding partners or collaborators with development, regulatory and commercialization expertise; its ability to obtain sufficient financing to complete registration of its product candidates in the United States and Europe; 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 12, 2013. 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.