Avanir Pharmaceuticals Prevails in NUEDEXTA Patent Trial Resulting in
Exclusivity Through 2026
ALISO VIEJO, Calif., April 30, 2014, 2014
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
Avanir Pharmaceuticals, Inc.
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
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
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
+1 (949) 389-6700
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SOURCE Avanir Pharmaceuticals, Inc.
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