NuPathe Announces Allowance of Additional U.S. Patent for ZECUITY
CONSHOHOCKEN, PA -- (Marketwired) -- 09/10/13 -- 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 13/407,434. This application relates to NuPathe's
innovative iontophoretic patch that uses a two-stage delivery
sequence to transdermally deliver sumatriptan. This, and other
proprietary technology, is incorporated into NuPathe's lead product,
ZECUITY(R) (sumatriptan iontophoretic transdermal system), the first
and only FDA approved patch for migraine.
"This patent allowance is significant for NuPathe as a key
technological breakthrough of ZECUITY is its ability to transdermally
deliver the most commonly prescribed migraine medication, which
cannot be passively absorbed through the skin," said Armando Anido,
chief executive officer of NuPathe.
Given this action, NuPathe expects the patent to issue within the
next few months. Once issued, the patent will provide additional
protection for ZECUITY and will be the sixth 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
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 (sumatriptan iontophoretic
transdermal system), has been approved by the FDA for the acute
treatment of migraine with or without aura in adults. ZECUITY is
expected will to be available by prescription in the fourth quarter
of 2013. 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 designed to provide up to two months of continuous
delivery. NP202, for the long-term treatment of schizophrenia and
bipolar disorder, is designed 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 world.
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 13/407,434 and its listing in the FDA's Orange
Book; the scope and duration of patent protection afforded by the
referenced patents and NuPathe's other intellectual property; the
potential benefits of, and commercial opportunity for, ZECUITY and
NuPathe's other product candidates; partnering plans for ZECUITY and
NuPathe's other product candidates; the timing of the expected launch
and availability of ZECUITY; 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, assumptions 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 sufficient capital
to launch ZECUITY and continue as a going concern; NuPathe's ability
to obtain commercial and development partners for ZECUITY and its
other product candidates; NuPathe's reliance on third parties to
manufacture ZECUITY; NuPathe's ability to establish and effectively
manage its supply chain; NuPathe's ability to establish effective
marketing and sales capabilities; market acceptance among physicians
and patients; availability of adequate reimbursement from third party
payors for ZECUITY; 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 report, which is available on NuPathe's website at
www.nupathe.com in the "Investor Relations -- SEC Filings" section.
Consequently, you are cautioned not to place undue reliance on any
forward-looking statements. 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.
Keith A. Goldan
Senior Vice President, Chief Financial Officer
Sam Brown Inc.
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