AVANIR Pharmaceuticals Announces Receipt of Notice of Allowance of New U.S. Patent on Zenvia
Provides Commercial Exclusivity for PBA Indication into 2025
ALISO VIEJO, Calif., October 7, 2009 - AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that it has received a "Notice of Allowance" from the United States Patent and Trademark Office (USPTO) announcing that it intends to grant the Company a new patent, extending the period of commercial exclusivity for its lead drug candidate Zenvia™ well into 2025. Upon issuance, U.S. patent application number 11/035,213 titled "Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorders" will provide AVANIR with patent protection for low-dose quinidine formulations of Zenvia used to treat pseudobulbar affect (PBA). AVANIR's low-dose quinidine formulation of Zenvia met its primary efficacy endpoint in the recently announced confirmatory Phase III STAR trial in PBA. There are currently no FDA approved treatments for PBA.
In addition to this newly allowed U.S. patent, the company has exclusive rights to a family of patents and patent applications that claim methods of treating PBA, chronic pain, as well as other neurologic conditions, using combinations of dextromethorphan and quinidine, the two active agents in Zenvia.
"We are very pleased with the decision by the USPTO to grant this patent for our low-dose quinidine formulations of Zenvia for treating pseudobulbar affect. The new Zenvia patent will strengthen our worldwide intellectual property portfolio and is expected to provide fifteen years of commercial exclusivity in the U.S. from the time of anticipated FDA approval," said Greg Flesher, Vice President of Business Development at AVANIR. "With this additional exclusivity, we have substantially enhanced the long-term value of this innovative CNS therapy."
"The granting of a new U.S. patent for Zenvia represents another successful milestone for AVANIR," said Keith Katkin, AVANIR's President and CEO. "With recently released positive Phase III data in PBA, an FDA approval decision expected in the second half of next year and our strong balance sheet, we are uniquely well positioned to create significant value for our shareholders."
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, is being developed for the treatment of pseudobulbar affect (PBA) and has successfully completed a Phase III trial for diabetic peripheral neuropathic (DPN) pain. AVANIR has licensed its MIF inhibitor program to Novartis International Pharmaceuticals Ltd. and has 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, 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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Oct 07, 2009