CONSHOHOCKEN, PA--(Marketwired - May 13, 2013) - NuPathe Inc. (NASDAQ: PATH) today announced that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance for U.S. Patent application 11/784,526 entitled "Implants for the Treatment of Dopamine Associated States." This application relates to methods for treating dopamine associated states (such as Parkinson's disease) using a biodegradable polymer implant capable of delivering a dopamine modulating compound (such as ropinirole) gradually rather than with an initial burst and maintaining an effective plasma level of the compound for a specified delivery period. Given this action, NuPathe expects the patent to issue within the next few months. Once issued, it will provide patent protection into October 2027 for NP201, NuPathe's long-term biodegradable ropinirole implant for the treatment of Parkinson's disease and other dopamine associated disorders. NuPathe has additional licensed patent applications pending in the U.S. and other territories for NP201.
"This represents our second recent patent allowance from the USPTO as we continue to strengthen our intellectual property position around NP201," said Armando Anido, chief executive officer of NuPathe. "Seeking development partners for this program remains a business development objective for the Company."
The inventors of the allowed patent, which NuPathe exclusively licenses from the University of Pennsylvania, are Steven J. Siegel, M.D., Ph.D., Director of the University of Pennsylvania's Translational Neuroscience & Clinical Neuroscience Training Programs, and Terri B. Sebree, President of NuPathe.
NP201 is a long-acting formulation of ropinirole, a generic, FDA-approved dopamine agonist. Using NuPathe's long-acting delivery (LAD) technology, NP201 is designed to provide continuous delivery of Parkinson's disease medication for up to two months in an easy-to-administer and tolerable dose formulation. NuPathe is seeking a development partner for this product candidate.
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. 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 Zecuity and its other 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 11/784,526; the scope and duration of patent protection afforded by the referenced patent 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: 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.