NuPathe Announces Allowance of Additional U.S. Patent Application for
CONSHOHOCKEN, PA -- (Marketwire) -- 01/02/13 -- NuPathe Inc.
(NASDAQ: PATH), a specialty pharmaceutical company focused on the
development and commercialization of branded therapeutics for
diseases of the central nervous system, today announced that the
United States Patent and Trademark Office (USPTO) has issued a notice
of allowance for U.S. Patent application 12/214,555 titled "Polyamine
Enhanced Formulations for Triptan Compound Iontophoresis." This
application relates to methods of treating a migraine by
administering a triptan using an iontophoretic patch that contains
NuPathe's proprietary hydrogel polyamine formulation. Given this
action, NuPathe expects the patent to issue within the next few
months. Once issued, the patent will provide additional patent
protection for Zecuity(TM), NuPathe's lead product candidate for the
treatment of migraine.
This coverage is in addition to that provided by NuPathe's two U.S.
patents, Patent No. 7,973,058 titled "Transdermal Methods and Systems
for Delivery of Anti-Migraine Compounds" and Patent No. 8,155,737
titled "Pharmacokinetics of Iontophoretic Sumatriptan
Administration," both of which expire in April 2027. Upon approval of
NuPathe's New Drug Application (NDA) for Zecuity, NuPathe expects to
list each of these patents in the U.S. Food & Drug Administration's
(FDA) Orange Book. NuPathe also has additional patent applications
pending in the U.S. and other territories for its migraine patch.
"The issuance of this patent will further strengthen our intellectual
property position for Zecuity and extend patent protection through
June 2028," said Armando Anido, chief executive officer of NuPathe.
"We await the next regulatory milestone for Zecuity, our PDUFA date
on January 17, 2013, which is the target date for the FDA to complete
its review of our NDA."
Zecuity is an active, single-use, transdermal patch
in development for the treatment of migraine. If approved, it will be
the first transdermal patch for the treatment of migraine. The patch
actively delivers sumatriptan, the most widely prescribed migraine
medication. In three clinical trials involving more than 10,000
applications, Zecuity offered patients fast onset and sustained
relief of debilitating migraine symptoms including headache pain and
migraine-related nausea (MRN) and vomiting. Because Zecuity delivers
sumatriptan transdermally, it may be an attractive treatment option
for many frequent MRN sufferers and those patients who experience
gastroparesis, a slowing of gastric absorption. The patch utilizes
SmartRelief(TM), NuPathe's proprietary transdermal delivery
technology that allows the rapid yet tightly controlled transport of
medication through the skin using a process called iontophoresis. As
a result, in Zecuity clinical trials there was a low incidence of
triptan sensations that include chest tightness, flushing and
feelings of pressure and numbness.
NuPathe Inc. is a specialty pharmaceutical company
focused on innovative neuroscience solutions for diseases of the
central nervous system including neurological and psychiatric
disorders. NuPathe's lead product candidate, Zecuity (previously
referred to as Zelrix or NP101) is an active, single-use, transdermal
sumatriptan patch being developed for the treatment of migraine. In
addition to Zecuity, NuPathe has two proprietary product candidates
based on its LAD(TM), or Long-Acting Delivery, biodegradable implant
technology that allows delivery of therapeutic levels of medication
over a period of months with a single dose. NP201, for the continuous
symptomatic treatment of Parkinson's disease, utilizes a leading
FDA-approved dopamine agonist, ropinirole, and is being developed to
provide up to two months of continuous delivery. NP202, for the
long-term treatment of schizophrenia and bipolar disorder, is being
developed to address the long-standing problem of patient
noncompliance by providing three months of continuous delivery of
risperidone, an atypical antipsychotic. NuPathe is actively seeking
partnerships to maximize the commercial potential for its product
candidates in the U.S. and territories throughout the world.
For more information about NuPathe, please visit our website and our
blog at www.nupathe.com. You can also follow us on StockTwits
(stocktwits.nupathe.com), Twitter (twitter.nupathe.com), SlideShare
(slideshare.nupathe.com) and LinkedIn (linkedin.nupathe.com).
Cautionary Note Regarding Forward-Looking Statements
release contains "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995. All statements
that are not historical facts are hereby identified as
forward-looking statements for this purpose and include, among
others, statements relating to: the issuance of a patent for U.S.
patent application 12/214,555; the scope and duration of patent
protection afforded by the referenced patents and the Company's other
intellectual property; the potential benefits of, and commercial
opportunity for, NuPathe's product candidates; and other statements
relating to NuPathe's plans, objectives, expectations and beliefs
regarding its future operations, performance, financial condition and
other future events.
Forward-looking statements are based upon management's current
expectations and beliefs and are subject to a number of risks,
uncertainties and other factors that could cause actual results and
events to differ materially from those indicated herein including,
among others: NuPathe's ability to obtain FDA approval of Zecuity;
the extent to which the FDA may request or require additional
information, studies or redesign of Zecuity and the costs and time
required to complete such activities; NuPathe's ability to obtain
partners for its product candidates; NuPathe's ability to obtain
additional capital on a timely basis and on agreeable terms to
continue as a going concern; varying interpretation of trial, study
and market data; and the risks, uncertainties and other factors
discussed in NuPathe's Annual Report on Form 10-K for the year ended
December 31, 2011 and in NuPathe's Quarterly Report on Form 10-Q for
the quarter ended September 30, 2012 under the caption "Risk Factors"
and elsewhere in such reports, which are available on NuPathe's
website at www.nupathe.com in the "Investor Relations -- SEC Filings"
section. While NuPathe may update certain forward-looking statements
from time to time, it specifically disclaims any obligation to do so,
whether as a result of new information, future developments or
otherwise. You are cautioned not to place undue reliance on any
Westwicke Partners, LLC
Keith A. Goldan
Vice President & Chief Financial Officer
Sage Strategic Marketing
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