NuPathe Announces Allowance of Additional U.S. Patent Application for Its Migraine Patch
January 19 2012 - 4:05PM
Marketwired
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: 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
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