Drug Development

Neurocrine steers its ‘breakthrough’ tardive dyskinesia drug to an FDA decision

San Diego-based Neurocrine Biosciences announced that it has filed their NDA on a new drug for tardive dyskinesia today, but the company isn’t waiting for the FDA to make up its mind before laying the groundwork on a marketing campaign.

Brian Skorney, Baird analyst

Brian Skorney, Baird analyst

Company execs noted in their Q2 call with analysts that they are already building a marketing group for the drug, valbenazine, which has achieved a breakthrough drug designation that could put it on track to an approval as early as next spring. The drug is a VMAT2 inhibitor, designed to modulate dopamine release during nerve communication. And it’s also in Phase II for Tourette syndrome.

Neurocrine $NBIX has a $4.3 billion market cap.

Tardive dyskinesia, though, is no easy affliction to market to. The disease is characterized by repetitive and uncontrollable body movements, like grimacing, tongue movements and lip smacking. And for Neurocrine to live up to analysts’ projects of a blockbuster billion dollars or more in revenue, the company has to overcome some built-in market hurdles while pursuing additional approvals. Chief among those hurdles will be the one-on-one education of doctors who currently don’t really know how to recognize or treat the condition.

Here’s Neurocrine’s Chief Medical Officer Chris O’Brien from the call:

(I)f you go out and talk to 100 docs or psychiatrists, you’ll find examples where you’ll find some docs say TD doesn’t exist anymore, we don’t see it. You’ll find other docs say, this problem is more pervasive than I ever realized it was. I’m seeing TD as commonly now as I did 20 years ago, but it’s just not as severe. You’ll then see docs that say, yes, my patients have TD, but I don’t want to do anything that is going to destabilize them and obviously that was a key focus of our trial designs is that we had a simple once-a-day add-on medication that required no changes in underlying therapy and we showed no worsening of psychiatric state.

So, once you talk to docs about what valbenazine has shown in trials to date, that is when as Kevin (Gorman) said, they start to get excited about it. They say, you mean, I can use something that’s once-a-day, easy to use and you’ve shown me videos about the phenomenology of what Tardive Dyskinesia is. I can do this safely. Then, their attitude changes. But this is obviously part of what has to happen for successful launch of the drug.

Baird’s Brian Skorney had this to say today:

Though valbenazine has yet to launch in tardive dyskinesia, we are eager to see what else the drug can do. Coming out of open-label results last year in Tourette, the upcoming Phase 2 data from children, adolescents, and adults (T-Force GREEN, T-Forward) will be able to give us a read on how the drug stacks up. Recall, the two studies are measuring tic severity through the Yale Global Tic Severity Scale. Because the placebo effect in neurological and psychiatric diseases, especially Tourette, can be high, this will be the first opportunity for us to see if the drug provides a benefit over placebo. We are not currently modeling the Tourette opportunity, but see potential for it to add an incremental $300-500M in peak sales on top of the over $1B peak potential we estimate in TD.

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