Biovail, Alexza develop inhaled mental health treatment

MOUNTAIN VIEW, Calif. An inhaled mental health drug could appear on the market in the near future under a collaboration announced Wednesday by Biovail Corp. and Alexza Pharmaceuticals.

Biovail subsidiary Biovail Labs International SRL and Alexza said they would work together to develop and commercialize AZ-004 (loxapine) in the United States and Canada. The drug is based on Alexza’s proprietary Staccato technology and is an inhaled drug designed to treat agitation in patients with bipolar disorder and schizophrenia. Alexza submitted an approval application for the drug to the Food and Drug Administration in December 2009.

Under the terms of the deal, Biovail will pay Alexza $40 million upfront and up to $90 million in milestone payments, if the drug is approved, as well as royalty payments of 10% to 25%.

“We are very excited to be partnering our lead program with Biovail,” Alexza president and CEO Thomas King said in a statement. “Their key strategic focus and their [central nervous system] commercial plans match our view of an ideal partner for AZ-004. We believe that AZ-004, if approved, has the potential to change the treatment practices for acute agitation, as the only product able to meet both the patients’ desire for quickly and comfortably gaining control of their agitation and the clinicians’ goal of rapidly and reliably calming an agitated patient.”

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