Avanir Pharmaceuticals Announces Settlement of NUEDEXTA Patent Litigation with Wockhardt

Avanir Pharmaceuticals Announces Settlement of NUEDEXTA Patent Litigation with

PR Newswire

ALISO VIEJO, Calif., Sept. 6, 2013

ALISO VIEJO, Calif., Sept. 6, 2013 /PRNewswire/ -- Avanir Pharmaceuticals,
Inc. (NASDAQ: AVNR) today announced that it has entered into a settlement
agreement with Wockhardt USA, LLC and Wockhardt Ltd. (collectively,
"Wockhardt") to resolve pending patent litigation in response to Wockhardt's
abbreviated new drug application (ANDA) seeking approval to market generic
versions of Avanir's NUEDEXTA® (dextromethorphan hydrobromide/quinidine
sulfate) capsules.

(Logo: http://photos.prnewswire.com/prnh/20130207/LA55901LOGO)

The settlement agreement grants Wockhardt the right to begin selling a generic
version of NUEDEXTA on July 30, 2026, or earlier under certain circumstances.
The parties have also agreed to file a stipulation and order of dismissal with
the United States District Court for the District of Delaware which will
conclude this litigation with respect to Wockhardt. The settlement does not
end Avanir's ongoing litigation against the other two ANDA filers.

In compliance with U.S. law, the settlement agreement will be submitted to the
U.S. Federal Trade Commission and the Department of Justice where it is
subject to review.

NUEDEXTA is an innovative combination of two well-characterized components;
dextromethorphan hydrobromide, the ingredient active in the central nervous
system, and quinidine sulfate, 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^® is a trademark or registered trademark of Avanir Pharmaceuticals,
Inc. in the United States and other countries.

©2013 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, the potential
benefits of its commercialized products and products under development, and
statements regarding the settlement of litigation with Wockhardt and the
review and approval of the settlement agreement by the U.S. Department of
Justice and/or the U.S. Federal Trade Commission 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 of predicting the timing and outcome of litigation; risks that
resolution of patent infringement litigation through settlement could result
in investigations and/or actions by third parties, including government
agencies; the market demand for and acceptance of Avanir's products
domestically and internationally, delay in qualifying our manufacturing
facilities that produce our products or production or regulatory problems with
either third party manufacturers or API suppliers upon whom we may rely for
some of our products or our own manufacturing facilities, obtaining and
maintaining regulatory approvals domestically, including but not limited to
the U.S. Federal Trade Commission and the Department of Justice, and
internationally, the validity and enforceability of issued and pending
patents, 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

Avanir Investor & Media Contact
Ian Clements, PhD
+1 (949) 389-6700

SOURCE Avanir Pharmaceuticals, Inc.

Website: http://www.avanir.com
Press spacebar to pause and continue. Press esc to stop.