CONSHOHOCKEN, PA--(Marketwired - September 10, 2013) - 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® (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 territories.
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 (MRI).
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 1-800-FDA-1088.
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™, 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
This press 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.
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