SOURCE: NuPathe Inc.

NuPathe Inc.

January 19, 2012 16:05 ET

NuPathe Announces Allowance of Additional U.S. Patent Application for Its Migraine Patch

CONSHOHOCKEN, PA--(Marketwire - Jan 19, 2012) - NuPathe Inc. (NASDAQ: PATH), an emerging 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 has issued a notice of allowance for U.S. Patent application 12/142,604 entitled "Pharmacokinetics of Iontophoretic Sumatriptan Administration." This application relates to methods of treating a migraine by administering sumatriptan using an iontophoretic patch to achieve consistent therapeutic plasma levels with low patient-to-patient variability. Given this action, NuPathe expects the patent to issue within the next few months. Once issued, it will provide additional patent protection through April 2027 for NP101, NuPathe's lead product candidate for the treatment of migraine.

This coverage is in addition to that provided by NuPathe's U.S. Patent No. 7,973,058 entitled "Transdermal Methods and Systems for Delivery of Anti-Migraine Compounds," which expires in April 2027, and its U.S. Patent No. 6,745,071 entitled "Iontophoretic Drug Delivery System," which expires in February 2023. Upon approval of NuPathe's New Drug Application (NDA) for NP101, NuPathe expects to list all three patents in the U.S. Food & Drug Administration's (FDA's) Orange Book. NuPathe also has additional patent applications pending in the U.S. and other territories for its migraine patch.

"Issuance of this patent will further strengthen our intellectual property related to NP101," said Jane Hollingsworth, chief executive officer of NuPathe. "If approved, our breakthrough technology will offer the first-ever patch for migraine, providing rapid, consistent and controlled delivery through the skin of the most widely prescribed migraine medication. We look forward to re-submitting our NDA for the migraine patch in the first half of this year."

About the Migraine Patch (NP101 or Zelrix)
NP101 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 clinical trials involving more than 10,000 applications, NP101 offered patients fast onset and sustained relief of debilitating migraine symptoms including headache pain and migraine-related nausea (MRN). Because NP101 delivers sumatriptan transdermally, it may be an attractive treatment option for many of the approximately seven million migraineurs who might otherwise delay or avoid taking medication due to MRN. In addition, clinical trials suggest that many migraineurs fail to respond consistently to orally administered medications. This may result from a variety of causes including gastroparesis, which is low and inconsistent absorption of medication in the gut due to reduced gastric motility (or stomach slowing). 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 and based on clinical trial experience, the patch may offer a low incidence of triptan sensations that include chest tightness, flushing and feelings of pressure and numbness.

About NuPathe
NuPathe Inc. (www.nupathe.com) is an emerging 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 additional proprietary product candidates in preclinical development: NP201 for the continuous symptomatic treatment of Parkinson's disease, which the company plans to partner, 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 12/142,604; the scope and duration of patent protection afforded by the referenced patents and the Company's other intellectual property; the listing of the referenced patents in the FDA's Orange Book; the timing of the resubmission of the NDA for NP101; the potential benefits of, and market for, NP101; and NuPathe's plans to partner NP201.

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 successfully complete the additional trials, tests, device enhancement and other activities to support the resubmission of its NDA for NP101; varying interpretation of study data; 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.

Contact Information

  • Contact Information:

    John Woolford
    Westwicke Partners, LLC
    (443) 213-0506
    john.woolford@westwicke.com

    Keith A. Goldan
    Vice President & Chief Financial Officer
    NuPathe Inc.
    (484) 567-0130

    Media Contact:
    Jason Rando
    Tiberend Strategic Advisors, Inc.
    212-827-0020
    jrando@tiberend.com