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.