Avanir Pharmaceuticals announced that the European Patent Office (EPO) has granted Avanir a new patent, extending the period of commercial exclusivity for its lead drug candidate Zenvia (dextromethorphan/quinidine) into 2023.
EPO patent number 1.539.166 titled "Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the treatment of neurological disorders" will be published in the European Patent Bulletin on July 2, 2008 and will be effective on that date. The new European patent expands the available Zenvia dose ranges under prior patent protection and encompasses the company's current clinical development programmes in pseudobulbar affect (PBA) and diabetic peripheral neuropathic (DPN) pain, as well as other neurologic conditions.
"We are extremely pleased with the decision by the European Patent Office to grant this application. This patent provides a significantly longer period of commercial exclusivity for Zenvia in Europe, and adds to Avanir's broad intellectual property portfolio," said Greg Flesher, vice president of business development at Avanir. "We have the corresponding patent application pending within the US Patent and Trademark Office, and based on the issuance of the European patent we are optimistic about receiving a similar response in the US as well".
"The granting of a new European patent for Zenvia is another important milestone for Avanir," said Keith Katkin, Avanir's president and CEO. "Our entire team is working diligently to complete the phase III clinical development of Zenvia for the PBA indication and prepare for our expected commercialization in the US. This new patent significantly extends the period of Zenvia commercial exclusivity throughout Europe and enhances the global potential of our primary asset."
Zenvia 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 is currently in development for the treatment of pseudobulbar affect (PBA) and diabetic peripheral neuropathic (DPN) pain. In October 2006, the company received an approvable letter for Zenvia in the treatment of PBA. The Company has initiated a confirmatory phase III study under a Special Protocol Assessment (SPA) agreement with the US Food and Drug Administration (FDA) utilizing a new lower quinidine dose formulation of Zenvia intended to address safety concerns raised in the Agency's approvable letter for Zenvia in the treatment of PBA.
Avanir Pharmaceuticals is focused on acquiring, developing, and commercializing novel therapeutic products for the treatment of chronic diseases. Avanir's products and product candidates address therapeutic markets that include the central nervous system, inflammation, and infectious diseases.