AVANIR Pharmaceuticals Announces Issuance of New U.S. Zenvia Patent
Provides Patent Protection for PBA Indication into 2025
ALISO VIEJO, Calif., February 10, 2010 - AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the United States Patent and Trademark Office (USPTO) has issued the Company a new patent for its lead drug candidate Zenvia™ (dextromethorphan/quinidine), extending the period of patent protection in the United States into late 2025. U.S. patent number 7,659,282 titled "Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorders" was issued on February 9, 2010. The new patent will provide AVANIR with patent protection for low-dose quinidine formulations of Zenvia used to treat pseudobulbar affect (PBA).
"We are very pleased the USPTO has issued this patent for our new low-dose quinidine formulations of Zenvia in the treatment of PBA," said Greg Flesher, Vice President of Business Development at AVANIR. "The issuance of the new U.S. patent was a significant milestone for the Company and greatly enhances the intellectual property profile of Zenvia which includes patents and patent applications that claim methods of treating PBA, chronic pain, as well as other neurologic conditions."
"This new patent significantly extends the period of Zenvia patent protection in the U.S. and is an important part of our overall strategic plan," said Keith Katkin, AVANIR's President and CEO. "This new patent creates a foundation for our planned commercial launch in early 2011 and will provide approximately 15 years of revenue generation. The extended patent term is expected to considerably enhance the long-term value of our promising drug candidate Zenvia. With extensive IP protection, an FDA approval decision expected in the fourth calendar quarter of 2010, and a strong balance sheet, we are well positioned to create substantial value for our shareholders."
Zenvia™ (dextromethorphan/quinidine) is a combination of two well-characterized compounds: the therapeutically active ingredient dextromethorphan and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan. This first-in-class drug candidate is believed to help regulate excitatory neurotransmission in two ways: through pre-synaptic inhibition of glutamate release via sigma-1 receptor agonist activity and through postsynaptic glutamate response modulation via uncompetitive, low-affinity NMDA antagonist activity. Zenvia has completed a confirmatory Phase III trial in the treatment of pseudobulbar affect (PBA) and has successfully completed a Phase III trial for diabetic peripheral neuropathic (DPN) pain. In October 2006, the Company received an FDA approvable letter for Zenvia in the treatment of PBA. The Company conducted the confirmatory Phase III trial under a Special Protocol Assessment (SPA) agreement with the FDA with the goal of addressing safety concerns raised in the Agency's approvable letter for Zenvia in the treatment of PBA. AVANIR plans to file a full response to the approvable letter in the second calendar quarter of 2010, with an FDA approval decision expected in the fourth calendar quarter.
AVANIR Pharmaceuticals, Inc. is a biopharmaceutical company focused on acquiring, developing, and commercializing novel therapeutic products for the treatment of central nervous system disorders. AVANIR's lead product candidate, Zenvia, has completed a confirmatory Phase III trial in the treatment of pseudobulbar affect (PBA) and has successfully completed a Phase III trial for diabetic peripheral neuropathic (DPN) pain. AVANIR plans to file an application for regulatory approval in the PBA indication in the second calendar quarter of 2010, with an FDA approval decision expected in the fourth calendar quarter. AVANIR sold its anthrax monoclonal antibody program to Emergent BioSolutions. The Company's first commercialized product, Abreva® (docosanol), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at www.avanir.com and further information about pseudobulbar affect can be found at www.PBAinfo.org.
FORWARD LOOKING STATEMENTS
Statements in this press release that are not historical facts, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," "project," or similar statements, are forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from the future results expressed or implied by such statements. For example, there can be no assurance that the U.S. Food and Drug Administration (FDA) will approve Zenvia for any indication, that our patent rights will be enforceable, that the newly issued patent will prevent the introduction of a competitive product during the Zenvia patent term, or that the Company will meet projected timelines. Risks and uncertainties affecting the Company's financial condition and operations also include the risks set forth in AVANIR's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and from time-to-time in other publicly available information regarding the Company. Copies of this information are available from AVANIR upon request. AVANIR disclaims any intent to update these forward-looking statements.
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Feb 10, 2010