Pharmas Market with Mike Huckman

Avanir's Not A Laughing Stock


I know it's trite and cliche, but I learn something new almost every day on this beat.

Take pseudobulbar affect. I'd never heard of it before. I had to Google it when I got a press release late yesterday announcing that Avanir Pharmaceuticals was going to unveil late-stage test results on a drug for it this morning.

While I have no doubt that it's an annoying, embarrassing and serious problem for people with neurologic disease and brain injury and for their loved ones, it's definitely a talkabout condition. PBA is also known as emotional lability. In other words, uncontrollable laughing and crying fits. AVNR's drug Zenvia cut the episodes by 47 percent. It was aiming for 36 percent. A neurology professor at UCLA is quoted in the company's press releaseestimating that two million people in the U.S. "live with the burden of PBA."

Avanir had received an approvable letter from the FDA for Zenvia. That means the agency might approve it if certain, often undisclosed, conditions are met. Sometimes the additional requirements are quick and easy and sometimes companies have to go back to square one. In this case, Avanir says it'll turn everything over to the FDA in the first half of next year.

AVNR is another one of those tiny biopharma companies with a very small market cap that suddenly pops out with good clinical trial data or a regulatory advance. The shares are nearly doubling in value in early trading. Not to make light of the topic, but long investors are laughing all the way to the bank.

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