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."
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