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.
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SOURCE AcelRx Pharmaceuticals, Inc.