|Investors Agitated by Alexza Drug Prospects, Buy Shares Anyway|
|By Matthew Kennedy, Benzinga Staff Writer|
|Wednesday, 14 December 2011 10:03|
The new NDA featured a provision that would monitor Adasuve patients in an effort to identify those who could develop lung problems. However, the FDA stated that the provision could pose a problem, as many bipolar and schizophrenic patients who smoke could become too agitated to submit to the monitoring. "Psychotic patients who develop respiratory symptoms may not be able to notify health care personnel in a timely manner, and distress may be confused with acute agitation to the casual observer," added the FDA.
Alexza's NDA is based on the results of two Phase 3 clinical trials, as well as stability data obtained from drugs produced in late 2010. Alexza CEO Thomas King showed enthusiasm for the product, stating that, "If approved, Adasuve would be the first drug marketed based on the novel Staccato technology platform. We believe Adasuve can offer physicians and patients a new therapeutic option, which combines rapid onset of action and reliability of medication delivery in a non-invasive formulation that is easy to administer."
The FDA panel again questioned the drug's safety as the new proposal failed to solve the FDA's concerns over proper identification of respiratory issues. However, the panel found favor with the drug's efficacy and effectiveness. "This product offers the potential to be a significant contributor to an import need," said Andrew Winokur, a member of the panel. "The company presented impressive efficacy data and the FDA's risk mitigation proposal was reassuring."
The drug has a relatively small market, but still expects to generate sales of $150 million per year, according to RBC Capital analyst Jason Kantor. Kantor also believes that Alexza would need to find a partner or raise substantial capital to successfully launch Alexza, which may limit the company's short term upside. However, such a scenario could never occur if Alexza is unable to overcome many of the FDA's concerns over the drug's safety.