CONSHOHOCKEN, PA -- (Marketwire) -- 05/02/11 -- NuPathe Inc. (NASDAQ: PATH), a specialty pharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, including neurological and psychiatric disorders, today announced that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance for U.S. patent application 12/181,142 entitled "Transdermal Methods and Systems for the Delivery of Anti-Migraine Compounds." This application relates to methods of effectively treating a migraine using an iontophoretic patch containing a triptan. Given this action, NuPathe expects the patent to issue within the next few months.
Once issued, the patent will provide coverage for NuPathe's lead product candidate, Zelrix, through April 2027. This coverage is in addition to that provided by NuPathe's licensed U.S. Patent No. 6,745,071, which expires in February 2023. Upon approval of NuPathe's New Drug Application (NDA) for Zelrix, NuPathe expects to list both 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.
"This important allowance further validates the novelty of our sumatriptan transdermal patch and represents yet another significant achievement for NuPathe as we advance towards our goal of providing a tolerable, non-oral treatment for migraine patients," said Jane Hollingsworth, chief executive officer of NuPathe. "The next milestone for NuPathe is our PDUFA date in August, which is the target date for the FDA to complete its review of our NDA for Zelrix."
Zelrix is an active, single-use, transdermal sumatriptan patch being developed for the treatment of migraine. Zelrix is designed to provide migraine patients fast onset and sustained relief through a tolerable, non-oral route of administration. Zelrix may provide an attractive treatment option for millions of migraine patients because it avoids the need for oral administration. Many migraine patients delay or avoid treatment with oral medications as a result of underlying migraine-related nausea and vomiting. In addition, the absorption of oral medications may be compromised during a migraine which may adversely affect the efficacy of such medications. Zelrix is powered by SmartRelief, NuPathe's proprietary transdermal delivery technology. SmartRelief consists of a controlled delivery technology that uses a mild electrical current to actively transport medication through the skin using a process called iontophoresis.
NuPathe Inc. (www.nupathe.com) is a specialty pharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, including neurological and psychiatric disorders. NuPathe's lead product candidate, Zelrix, is an active, single-use, transdermal sumatriptan patch being developed for the treatment of migraine. In addition to Zelrix, 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.
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 12/181,142, the scope and duration of patent protection afforded by such patent and U.S. Patent No. 6,745,071, and the listing of such patents in the FDA's Orange Book.
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 marketing approval for and commercialize Zelrix; serious adverse events or other safety risks that could require NuPathe to abandon or delay development of, or preclude or limit approval of, Zelrix or its other product candidates; and the risks, uncertainties and other factors discussed in NuPathe's Annual Report on Form 10-K for the year ended December 31, 2010 under the caption "Risk Factors" and elsewhere in such report, which is available on the Company'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.
Keith A. Goldan
Vice President, Chief Financial Officer
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