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, 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, 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, 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.
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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 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 forward-looking statements.