ALISO VIEJO, Calif.,
April 30, 2014, 2014 /PRNewswire/ --
Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced
that the U.S. District Court for the District of Delaware has ruled in favor of Avanir in the
company's patent infringement lawsuit against Par Pharmaceuticals,
Inc. and Impax Laboratories, Inc. in conjunction with their
Abbreviated New Drug Applications ('ANDAs') for generic versions of
NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate)
capsules for the treatment of pseudobulbar affect.
Following a six day bench trial in the District of Delaware, Judge Leonard P. Stark issued a ruling upholding the
validity of the patents covering NUEDEXTA (US Patent Nos. RE38,115,
7,659,282 (the "'282 patent") and 8,227,484 (the "'484 patent"),
and holding that the proposed ANDA formulations infringe the claims
of the '282 patent and '484 patent.
"We are very pleased with the Court's decision, as it confirms
our continued belief in the strength of the patents covering
NUEDEXTA," said Keith A. Katkin,
president and chief executive officer of Avanir. "Our focus remains
on making NUEDEXTA available to patients suffering from the
debilitating condition of PBA. This decision provides twelve-plus
years of market exclusivity for NUEDEXTA."
NUEDEXTA remains the only FDA-approved product for the treatment
of pseudobulbar affect.
About NUEDEXTA
NUEDEXTA is an innovative combination
of two well-characterized components; dextromethorphan hydrobromide
(20 mg), the ingredient active in the central nervous system, and
quinidine sulfate (10 mg), a metabolic inhibitor enabling
therapeutic dextromethorphan concentrations. NUEDEXTA acts on
sigma-1 and NMDA receptors in the brain, although the mechanism by
which NUEDEXTA exerts therapeutic effects in patients with PBA is
unknown.
NUEDEXTA Important Safety Information
NUEDEXTA is
indicated for the treatment of pseudobulbar affect (PBA). PBA
occurs secondary to a variety of otherwise unrelated neurological
conditions, and is characterized by involuntary, sudden, and
frequent episodes of laughing and/or crying. PBA episodes typically
occur out of proportion or incongruent to the underlying emotional
state.
Studies to support the effectiveness of NUEDEXTA were performed
in patients with amyotrophic lateral sclerosis (ALS) and multiple
sclerosis (MS). NUEDEXTA has not been shown to be safe and
effective in other types of emotional lability that can commonly
occur, for example, in Alzheimer's disease and other dementias.
NUEDEXTA and certain other medicines can interact, causing
serious side effects. If you take certain drugs or have certain
heart problems, NUEDEXTA may not be right for you.
NUEDEXTA causes dose-dependent QTc prolongation. When initiating
NUEDEXTA in patients at risk for QT prolongation and torsades de
pointes, electrocardiographic (ECG) evaluation should be conducted
at baseline and 3-4 hours after the first dose.
The most common adverse reactions are diarrhea, dizziness,
cough, vomiting, asthenia, peripheral edema, urinary tract
infection, influenza, increased gamma-glutamyltransferase, and
flatulence. NUEDEXTA may cause dizziness.
These are not all the risks from use of NUEDEXTA. Please refer
to full Prescribing Information at www.NUEDEXTA.com.
About Avanir Pharmaceuticals, Inc.
Avanir
Pharmaceuticals, Inc. is a biopharmaceutical company focused on
bringing innovative medicines to patients with central nervous
system disorders of high unmet medical need. As part of our
commitment, we have extensively invested in our pipeline and are
dedicated to advancing medicines that can substantially improve the
lives of patients and their loved ones. For more information about
Avanir, please visit www.avanir.com.
AVANIR® and NUEDEXTA® are trademarks or
registered trademarks of Avanir Pharmaceuticals, Inc. in
the United States and other
countries. All other trademarks are the property of their
respective owners.
©2014 Avanir Pharmaceuticals, Inc. All Rights Reserved.
Forward Looking Statements
Except for the
historical information contained herein, the matters set forth in
this press release, including statements regarding Avanir's plans,
potential opportunities, financial or other expectations,
projections, goals objectives, milestones, strategies, market
growth, timelines, legal matters, product pipeline, clinical
studies, product development and the potential benefits of its
commercialized products and products under development are
forward-looking statements within the meaning of the "safe harbor"
provisions of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially,
including the risks and uncertainties associated with : the
difficulty in predicting the timing and outcome of an appeal of the
Court's decision; whether any other companies will submit ANDAs for
generic versions of NUEDEXTA; Avanir's operating performance and
financial position; the market demand for and acceptance of
Avanir's products domestically and internationally; research,
development and commercialization of new products domestically and
internationally; obtaining additional indications; obtaining and
maintaining regulatory approvals domestically and internationally;
and other risks detailed from time to time in the Company's most
recent Annual Report on Form 10-K and other documents subsequently
filed with or furnished to the Securities and Exchange Commission.
These forward-looking statements are based on current
information that may change and you are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date of this press release. All forward-looking
statements are qualified in their entirety by this cautionary
statement, and the Company undertakes no obligation to revise or
update any forward-looking statement to reflect events or
circumstances after the issuance of this press release.
Avanir Investor & Media Contact
Ian Clements, PhD
ir@avanir.com
+1 (949) 389-6700
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SOURCE Avanir Pharmaceuticals, Inc.