Download deuterium-modified dextromethorphan and ultra

Avanir Pharmaceuticals, Inc. is a leading specialty biopharmaceutical company focused on bringing innovative
medicines to patients with central nervous system (CNS) disorders of high unmet medical need. We are
dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones.
Investment Highlights
NUEDEXTA® (dextromethorphan hydrobromide and quinidine sulfate)
Profitable Commercial Franchise
Avanir Quick Facts
Headquarters: Aliso Viejo, CA
Stock Listing: NASDAQ: AVNR
Staff: Approximately 300
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Large market with a high unmet medical need; ~2 million patients in the U.S.
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First and only FDA and EMA approved therapy for pseudobulbar affect (PBA), a
neurologic disorder causing sudden, disruptive outbursts of crying or laughing that
causes significant functional and quality-of-life impairment.
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Occurs in patients with key neurological conditions including amyotrophic
lateral sclerosis (ALS), multiple sclerosis (MS), stroke, traumatic brain
injury (TBI),and dementia
Market Capitalization: $914 million*
Share Outstanding: 159.8 million**
Cash, cash equivalents & restricted investments:
$56.5 million***
52-week Range: $2.62 - $6.00*
Fiscal Year End: September 30
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Robust and growing revenues
Executive Leadership Team
Keith A. Katkin
President & Chief Executive Officer
Gregory J. Flesher
Senior Vice President & Chief Business Officer
Rohan Palekar
Senior Vice President & Chief Commercial Officer
Joao Siffert, MD
Senior Vice President & Chief Medical Officer
Elona Kogan, Esq.
Vice President, Legal Affairs
Joanna L. Moore
Vice President & Chief Compliance Officer
Christine G. Ocampo, CPA
Vice President, Finance
Jesus Varela
Executive Director, Human Resources
Broad Development Pipeline Across Three Assets
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Pain: Migraine, DPN pain
Mood/Behavior: Agitation in Alzheimer’s disease, autism, depression
Movement Disorders: Dyskinesia, chorea, spasticity
A Leading CNS Biopharma
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Demonstrated commercial success
Investing in deep development pipeline to drive potential near and long-term value
Infrastructure to grow
Corporate Strategy
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Organic Growth
o Establish NUEDEXTA as a global brand and explore new indications to build
an un-paralleled CNS franchise
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Inorganic Growth
o Acquire rights to products that can leverage our commercial presence in
the neurology, psychiatry and long-term care settings as we did with our
recent Merck co-promote and OptiNose (AVP-825 in-license) collaborations.
*As of June 30, 2014
** As of April 30, 2014
*** As of March 31, 2014
Pipeline
Contact Details
Avanir Pharmaceuticals, Inc
30 Enterprise, Suite 400
Aliso Viejo, CA 92656
www.avanir.com
+1 (949) 389-6700
Investors/Media
Ian Clements, PhD
+1 (949) 389-6737
[email protected]
Research Coverage
Jefferies & Co.
Thomas Wei
JMP Securities
Jason Butler, PhD
About AVP-923
AVP-923 is a combination of two well-characterized compounds, the active CNS ingredient
dextromethorphan hydrobromide (an uncompetitive NMDA receptor antagonist and sigma-1
receptor agonist) plus low-dose quinidine sulfate (a CYP2D6 enzyme inhibitor), which
serves to increase the bioavailability of dextromethorphan. Several dose strengths of AVP923 are being studied in multiple ongoing clinical trials including agitation in Alzheimer's
disease, and levodopa-induced dyskinesia in Parkinson's disease. AVP-923 at the 20/10 mg
dose strength is approved by the FDA for the treatment of PBA and marketed under the
trade name NUEDEXTA (see important safety information below). AVP-923 is an
investigational drug not approved by the FDA for any uses other than PBA.
Piper Jaffray & Co.
Charles Duncan, PhD
Mizuho Securities
Mario Corso
Summer Street Research Partners
Carol Werther
About AVP-786
AVP-786, the company’s next-generation NUEDEXTA, is a novel investigational drug product
consisting of a combination of deuterium modified dextromethorphan and ultra-low dose
quinidine, used as a metabolic inhibitor. Incorporation of deuterium into specific positions
of the dextromethorphan molecule strengthens the chemical bonds and reduces
susceptibility to enzyme cleavage and first pass metabolism, but without altering its
pharmacology. AVP-786 is an investigational drug not approved by the FDA.
About AVP-825
AVP-825 is an investigational drug-device combination product consisting of low-dose
sumatriptan powder delivered intranasally utilizing a novel breath-powered delivery
technology. If approved, AVP-825 would be the first and only fast-acting, dry-powder
intranasal form of sumatriptan for the treatment of migraine. The Prescription Drug User
Fee Act (PDUFA) V goal date is November 26, 2014. AVP-825 is an investigational drug not
approved by the FDA.
This fact sheet is a summary of more detailed
disclosure that can be found in Avanir’s filings with the
U.S. Securities and Exchange Commission and its press
releases. This fact sheet contains forward-looking
statements that involve significant risks and
uncertainties, discussion of which can be found in
Avanir’s most recent Forms 10-K, 10-Q, and 8-K. The
information in this fact sheet is given as of the date
below, and Avanir does not undertake any obligation to
update any information in this document.
Revision Date: June 30, 2014
Important Safety Information
NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) is the first and only
FDA-approved treatment for pseudobulbar affect (PBA).
NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) 20/10 mg capsules
can interact with other medications and cause serious side effects. NUEDEXTA is
contraindicated in patients taking certain drugs and in patients with specific
cardiovascular risk factors. These are not all the risks from use of NUEDEXTA.
For additional Important Safety Information and the full Prescribing Information, please
visit www.NUEDEXTA.com
© 2014 Avanir Pharmaceuticals, Inc