NuPathe Announces Allowance of Additional U.S. Patent Application for ZECUITY
CONSHOHOCKEN, PA -- (Marketwired) -- 05/28/13 -- NuPathe Inc.
(NASDAQ: PATH) today announced that the United States Patent and
Trademark Office has issued a notice of allowance for U.S. Patent
application 13/105,585 entitled "Transdermal Methods and Systems for
the Delivery of Anti-Migraine Compounds." This application relates to
methods for effectively treating migraine in a patient using an
iontophoretic patch containing a triptan without substantially
irritating the patient's skin.
Given this action, NuPathe expects the patent to issue within the
next few months. Once issued, the patent will provide additional
protection for ZECUITY(R) and will be the fifth patent listed in the
U.S. Food & Drug Administration's (FDA) Orange Book. NuPathe has
additional U.S. patents covering ZECUITY that expire between 2027 and
2029 and patent applications pending in the U.S. and other
"The issuance of this patent will further broaden our intellectual
property position for ZECUITY, providing long-term protection for
this breakthrough product that will help millions of migraine
sufferers," said Armando Anido, chief executive officer of NuPathe.
"We believe ZECUITY offers significant value, and we remain focused
on securing our commercial partner in advance of the planned 4Q13
launch in the U.S."
ZECUITY (sumatriptan iontophoretic transdermal
system) is indicated for the acute treatment of migraine with or
without aura in adults. ZECUITY is a single-use, battery-powered
patch applied to the upper arm or thigh during a migraine. Following
application and with a press of a button, ZECUITY initiates
transdermal delivery (through the skin), bypassing the
gastrointestinal tract. Throughout the four-hour dosing period, the
microprocessor within ZECUITY continuously monitors skin resistance
and adjusts drug delivery accordingly to ensure delivery of 6.5 mg of
sumatriptan, the most prescribed migraine medication in the U.S.,
with minimal patient-to-patient variability.
Important Safety Information
Patients should not take ZECUITY if
they have heart disease, a history of heart disease or stroke,
peripheral vascular disease (narrowing of blood vessels to your legs,
arms, stomach or kidney), transient ischemic attack (TIA) or problems
with blood circulation, uncontrolled blood pressure, migraines that
cause temporary paralysis on one side of the body or basilar
migraine, Wolff-Parkinson-White syndrome or other disturbances of
heart rhythm. Very rarely, certain people, even some without heart
disease, have had serious heart-related problems after taking
triptans like ZECUITY.
Patients should not use ZECUITY if they have taken other migraine
medications such as ergotamine medications or other triptans in the
last 24 hours or if they have taken monoamine oxidase-A (MAO-A)
inhibitors within the last 2 weeks.
Patients should not use ZECUITY during magnetic resonance imaging
Patients should not use ZECUITY if they have an allergy to
sumatriptan or components of ZECUITY or if they have had allergic
contact dermatitis (ACD) following use of ZECUITY. If patients
develop ACD, they should talk to their healthcare provider before
using sumatriptan in another form.
ZECUITY, like other triptans, may be associated with a potentially
life-threatening condition called serotonin syndrome, mainly when
used together with certain types of antidepressants including
serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine
reuptake inhibitors (SNRIs).
Patients should tell their healthcare provider before using ZECUITY
if they have heart disease or a family history of heart disease,
stroke, high cholesterol or diabetes; have gone through menopause;
are a smoker; have had epilepsy or seizures or if they are pregnant,
nursing or thinking about becoming pregnant.
The most common side effects of ZECUITY are application site pain,
tingling, itching, warmth and discomfort. Most patients experience
some skin redness after removing ZECUITY. This redness typically goes
away in 24 hours.
Please see full Prescribing Information for ZECUITY.
Patients are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call
Patients and healthcare providers interested in more information on
ZECUITY should visit www.zecuity.com.
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, Zecuity(R) (sumatriptan
iontophoretic transdermal system), has been approved by the FDA for
the acute treatment of migraine with or without aura in adults. 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 Zecuity and its
other product candidates in the U.S. and territories throughout the
For more information about NuPathe, please visit our website 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 13/105,585 and its listing in the FDA's Orange
Book; the scope and duration of patent protection afforded by the
referenced patents and the Company's other intellectual property; the
planned launch of ZECUITY in 4Q13; 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: risks and uncertainties relating to intellectual
property; NuPathe's ability to obtain commercial partners for Zecuity
and its product candidates; NuPathe's ability to obtain additional
capital to launch Zecuity and continue as a going concern; and the
risks, uncertainties and other factors discussed in NuPathe's Annual
Report on Form 10-K for the year ended December 31, 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 forward-looking statements.
Keith A. Goldan
Vice President, Chief Financial Officer
Sage Strategic Marketing
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