CONSHOHOCKEN, PA--(Marketwire -02/29/12)- NuPathe Inc. (NASDAQ: PATH - News), a biopharmaceutical 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 11/183,232 entitled "Drug Containing Implants and Methods of Use Thereof." This application relates to a biodegradable polymer implant as well as novel methods of treating schizophrenia, bipolar disorder and other specified psychiatric disorders with the implant by delivering therapeutic levels of risperidone, 9-hydroxy-risperidone, or haloperidol for 20 to 190 days. Given this action, NuPathe expects the patent to issue within the next few months. Once issued, it will provide patent protection through January 2025 for NP202, NuPathe's long-term biodegradable risperidone implant for the treatment of schizophrenia and bipolar disorder. NuPathe has additional licensed patent applications pending in the U.S. and other territories for NP202.
"Non-compliance with currently available medications is high and is one of the most common causes of relapse in schizophrenia," said Jane Hollingsworth, chief executive officer of NuPathe. "By delivering risperidone for an unprecedented three months in an easy-to-administer, biodegradable implant, we believe that NP202 will be a breakthrough for patients struggling with this disease."
The inventors of the 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 Karen I. Winey, Professor of Materials Science and Engineering of the University of Pennsylvania's School of Engineering.
NP202 is a long-acting, biodegradable risperidone implant formulated with NuPathe's LAD technology. NP202 is being developed to provide long-term, steady, therapeutic levels of risperidone with a single dose in a small, easy-to-administer and tolerable implant to treat schizophrenia and bipolar disorder. By providing three months of continuous drug delivery compared to current therapies of two weeks to one month, NuPathe believes NP202 will improve patient compliance, reduce psychotic breaks, reduce physician visits and improve patient functionality. NuPathe expects to file an Investigational New Drug application with the United States Food and Drug Administration in 2013.
NuPathe Inc. is a biopharmaceutical company focused on innovative neuroscience solutions for diseases of the central nervous system including neurological and psychiatric disorders. NuPathe's lead product candidate, NP101, is an active, single-use, transdermal sumatriptan patch being developed for the treatment of migraine. In addition to NP101, NuPathe has two proprietary product candidates in preclinical development: NP201 for the continuous symptomatic treatment of Parkinson's disease and NP202 for the long-term treatment of schizophrenia and bipolar disorder. NuPathe is actively seeking partnerships to maximize the commercial potential for our pipeline products in the U.S. and territories throughout the world.
For more information about NuPathe, please visit our website and our blog at www.nupathe.com. You can also follow us on StockTwits (http://stocktwits.com/NuPatheIR), Twitter (https://twitter.com/#!/NuPathe), SlideShare (http://www.slideshare.net/NuPathe), and LinkedIn (http://www.linkedin.com/company/146880).
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 statements relating to: the issuance of a patent for U.S. patent application 11/183,232; the scope and duration of patent protection to be afforded by the issuance of the referenced patent; and the potential benefits of, and the timing of an Investigational New Drug filing for, NP202.
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; varying interpretation of study data; serious adverse events or other safety risks that could require NuPathe to abandon or delay development of, or preclude or limit approval of its product candidates; NuPathe's ability to obtain additional financing; and the risks, uncertainties and other factors discussed in NuPathe's Annual Report on Form 10-K for the year ended December 31, 2010 and in NuPathe's Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 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.