NuPathe Announces Allowance of Additional U.S. Patent for ZECUITY
CONSHOHOCKEN, PA, Sep 10, 2013 (Menafn - Marketwired via COMTEX) --NuPathe Inc. PATH today announced that the United StatesPatent and Trademark Office has issued a notice of allowance for U.S.Patent application 13/407,434. This application relates to NuPathe'sinnovative iontophoretic patch that uses a two-stage deliverysequence to transdermally deliver sumatriptan. This, and otherproprietary technology, is incorporated into NuPathe's lead product,ZECUITY(R) (sumatriptan iontophoretic transdermal system), the firstand only FDA approved patch for migraine.
"This patent allowance is significant for NuPathe as a keytechnological breakthrough of ZECUITY is its ability to transdermallydeliver the most commonly prescribed migraine medication, whichcannot be passively absorbed through the skin," said Armando Anido,chief executive officer of NuPathe.
Given this action, NuPathe expects the patent to issue within thenext few months. Once issued, the patent will provide additionalprotection for ZECUITY and will be the sixth patent listed in theU.S. Food & Drug Administration's (FDA) Orange Book. NuPathe hasadditional U.S. patents covering ZECUITY that expire between 2027 and2029 and patent applications pending in the U.S. and otherterritories.
About ZECUITY(R) ZECUITY (sumatriptan iontophoretic transdermalsystem) is indicated for the acute treatment of migraine with orwithout aura in adults. ZECUITY is a single-use, battery-poweredpatch applied to the upper arm or thigh during a migraine. Followingapplication and with a press of a button, ZECUITY initiatestransdermal delivery (through the skin), bypassing thegastrointestinal tract. Throughout the four-hour dosing period, themicroprocessor within ZECUITY continuously monitors skin resistanceand adjusts drug delivery accordingly to ensure delivery of 6.5 mg ofsumatriptan, the most prescribed migraine medication in the U.S.,with minimal patient-to-patient variability.
Important Safety Information Patients should not take ZECUITY ifthey 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 problemswith blood circulation, uncontrolled blood pressure, migraines thatcause temporary paralysis on one side of the body or basilarmigraine, Wolff-Parkinson-White syndrome or other disturbances ofheart rhythm. Very rarely, certain people, even some without heartdisease, have had serious heart-related problems after takingtriptans like ZECUITY.
Patients should not use ZECUITY if they have taken other migrainemedications such as ergotamine medications or other triptans in thelast 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 tosumatriptan or components of ZECUITY or if they have had allergiccontact dermatitis (ACD) following use of ZECUITY. If patientsdevelop ACD, they should talk to their healthcare provider beforeusing sumatriptan in another form.
ZECUITY, like other triptans, may be associated with a potentiallylife-threatening condition called serotonin syndrome, mainly whenused together with certain types of antidepressants includingserotonin reuptake inhibitors (SSRIs) or serotonin norepinephrinereuptake inhibitors (SNRIs).
Patients should tell their healthcare provider before using ZECUITYif 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 experiencesome skin redness after removing ZECUITY. This redness typically goesaway in 24 hours.
Please see full Prescribing Information for ZECUITY.
Patients are encouraged to report negative side effects ofprescription drugs to the FDA. Visit www.FDA.gov/medwatch or call1-800-FDA-1088.
Patients and healthcare providers interested in more information onZECUITY should visit www.zecuity.com.
About NuPathe NuPathe Inc. is a specialty pharmaceutical companyfocused on innovative neuroscience solutions for diseases of thecentral nervous system including neurological and psychiatricdisorders. NuPathe's lead product, ZECUITY (sumatriptan iontophoretictransdermal system), has been approved by the FDA for the acutetreatment of migraine with or without aura in adults. ZECUITY isexpected will to be available by prescription in the fourth quarterof 2013. In addition to ZECUITY, NuPathe has two proprietary productcandidates based on its LAD(TM), or Long-Acting Delivery,biodegradable implant technology that allows delivery of therapeuticlevels of medication over a period of months with a single dose.NP201, for the continuous symptomatic treatment of Parkinson'sdisease, utilizes a leading FDA-approved dopamine agonist,ropinirole, and is designed to provide up to two months of continuousdelivery. NP202, for the long-term treatment of schizophrenia andbipolar disorder, is designed to address the long-standing problem ofpatient noncompliance by providing three months of continuousdelivery of risperidone, an atypical antipsychotic. NuPathe isactively seeking partnerships to maximize the commercial potentialfor ZECUITY and its other product candidates in the U.S. andterritories throughout the world.
For more information about NuPathe, please visit our website atwww.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 pressrelease contains "forward-looking statements" within the meaning ofthe Private Securities Litigation Reform Act of 1995. All statementsthat are not historical facts are hereby identified asforward-looking statements for this purpose and include, amongothers, statements relating to: the issuance of a patent for U.S.patent application 13/407,434 and its listing in the FDA's OrangeBook; the scope and duration of patent protection afforded by thereferenced patents and NuPathe's other intellectual property; thepotential benefits of, and commercial opportunity for, ZECUITY andNuPathe's other product candidates; partnering plans for ZECUITY andNuPathe's other product candidates; the timing of the expected launchand availability of ZECUITY; and other statements relating toNuPathe's plans, objectives, expectations and beliefs regarding itsfuture operations, performance, financial condition and other futureevents. Forward-looking statements are based upon management'scurrent expectations and beliefs and are subject to a number ofrisks, uncertainties, assumptions and other factors that could causeactual results and events to differ materially from those indicatedherein including, among others: risks and uncertainties relating tointellectual property; NuPathe's ability to obtain sufficient capitalto launch ZECUITY and continue as a going concern; NuPathe's abilityto obtain commercial and development partners for ZECUITY and itsother product candidates; NuPathe's reliance on third parties tomanufacture ZECUITY; NuPathe's ability to establish and effectivelymanage its supply chain; NuPathe's ability to establish effectivemarketing and sales capabilities; market acceptance among physiciansand patients; availability of adequate reimbursement from third partypayors for ZECUITY; and the risks, uncertainties and other factorsdiscussed in NuPathe's Annual Report on Form 10-K for the year endedDecember 31, 2012 under the caption "Risk Factors" and elsewhere insuch report, which is available on NuPathe's website atwww.nupathe.com in the "Investor Relations -- SEC Filings" section.Consequently, you are cautioned not to place undue reliance on anyforward-looking statements. While NuPathe may update certainforward-looking statements from time to time, it specificallydisclaims any obligation to do so, whether as a result of newinformation, future developments or otherwise.
Keith A. Goldan
Senior Vice President, Chief Financial Officer
Sam Brown Inc.
SOURCE: NuPathe Inc.