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AVNR still looks cheap to me

|Includes: Avanir Pharmaceuticals, Inc (AVNR)
Avanir Pharmaceuticals Inc (AVNR) said on Tuesday a reformulated version of its Zenvia drug reduced emotional outbursts tied to a neurological disorder, meeting the main goal of a late-stage study and nearly doubling the tiny company's stock price at one moment.

The results in the STAR clinical trial come nearly three years after the U.S. Food and Drug Administration dealt Avanir a blow by expressing safety concerns and asked the company to perform new trials with a reformulated version of Zenvia.

The drug treats pseudobulbar affect -PBA, a condition in which patients cannot control outbursts of crying or laughing. It affects an estimated 2 million Americans with multiple sclerosis, Lou Gehrig's disease -ALS, stroke and other neurological diseases or trauma that can cause brain lesions.

In the STAR trial, the drug cut emotional outbursts -- crying or laughing episodes -- by 47.2 percent compared to a placebo. The goal of the trial was a 36 percent improvement.

Zenvia, a pill, also reached secondary effectiveness goals in the study.

"It was all that we had hoped for and more," Avanir Chief Executive Officer Keith Katkin said in an interview. "It really exceeded our expectations from an efficacy perspective."

The Southern California-based company said the new data should be enough to satisfy the FDA and plans to submit a response to the agency in the first half of 2010.

Katkin said he would expect the agency would be on track to approve the drug in the second half of next year, with Avanir to launch three to six months after approval.

The drug could bring in $500 million in annual U.S. sales by 2015, said Summer Street Research analyst Carol Werther.

"They've got a much safer drug that looks efficacious in a condition that has basically nothing," Werther said. "It bodes very well for approval."

Reported "adverse events," or side effects, were "mild to moderate in nature," Avanir said, and occurred at about the same rate in the Zenvia patients as the control group. Dizziness, nausea and diarrhea, however, occurred at a more frequent rate in the Zenvia group.

As far as heart problems go, "there were no clinically significant" events, the company said.Avanir plans to submit the phase III findings to the FDA in the first half of 2010.

Avanir is also developing Zenvia to treat a kind of neuropathic pain associated with diabetes and multiple sclerosis. Another area of interest, Katkin said, is treating the agitation and irritability exhibited by people with dementia.

But the commercial focus, he quickly added, remains squarely on PBA, at least for now. He said a 12-week open-label study will begin once the company has digested the full data set from the just-ended trial, and that FDA approval could come as early as the second half of 2010. "We believe the new profile is approvable by the FDA," Katkin said, referring to the lower quinidine amount, "but they will be the judge and the jury."

He said the company has more than enough funds to pay for the studies and commercialization, largely from the $40 million kitty it raised when it sold shares to a group of venture capital funds in 2008.

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