CONSHOHOCKEN, PA--(Marketwire - July 11, 2012) - NuPathe Inc. (NASDAQ: PATH), 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 11/195,845 titled "Drug Containing Implants and Methods of Use Thereof." The allowed claims relate to a rod-shaped implant or structure that delivers therapeutic levels of risperidone for 20 to 190 days as well as to methods for treating medication noncompliance-associated diseases including schizophrenia and bipolar disorder. Given this action, NuPathe expects the patent to issue within the next few months. Once issued, it will provide patent protection through December 2027 for NP202, NuPathe's long-term biodegradable risperidone implant for the treatment of schizophrenia and bipolar disorder. NuPathe has a portfolio of additional licensed patent applications pending in the U.S. and other territories for NP202.
"As we progress towards filing an IND application for NP202 next year, we continue to strengthen our intellectual property," said Jane Hollingsworth, chief executive officer of NuPathe. "Non-compliance with currently available schizophrenia medications is high, and the resulting patient relapse is serious and costly. With three-month dosing, 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., Professor of Psychiatry and Director of the University of Pennsylvania's Translational Neuroscience Program, 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 with 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 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 our pipeline products 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 statements relating to: the issuance of a patent for U.S. patent application 11/195,845; the scope and duration of patent protection to be afforded by the issuance of the referenced patent application; the timing of an IND filing for NP202; and the potential benefits of NP202 and the Company's other product candidates.
Forward-looking statements are based upon management's current expectations, plans 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 and drug development; 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 capital to 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, 2011 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. 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.