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Neurocrine plans movement disorder drug filing in 2016

NBI-98854 in trials for tardive dyskinesia

Neurocrine Biosciences saw its share rise steeply yesterday after it reported positive results for a movement disorder drug that has been tipped as a potential blockbuster.

NBI-98854 is a vesicular monoamine transporter-2 (VMAT2) inhibitor in trials for tardive dyskinesia, a movement disorder known to affect patients with underlying schizophrenia, schizoaffective disorder, bipolar or major depressive disorder.

Around 500,000 people in the US suffer from TD, which often develops as a complication of psychoactive drugs, and Neurocrine is vying to be the first company to bring a treatment for the condition to market.

Its main rival is Teva, which is aiming to bring its deutetrabenazine (SD-809) candidate - another VMAT2 inhibitor - to market next year.

The results of the KINECT 3 study showed that patients treated with an 80mg dose of NBI-98854 showed a statistically significant improvement from baseline in the Abnormal Involuntary Movement Scale (AIMS) compared to placebo after six weeks' treatment.

The AIMS scores in the intent-to-treat population were reduced by an average of 3.1 points more than placebo, almost exactly the same improvement reported by Teva in its recently-reported study.

Neurocrine's chief executive Kevin Gorman said the KINECT-3 trial completes its placebo-controlled trials programme for NBI-98854 and - after the company completes an ongoing open-label safety trial called KINECT 4 - it will file for approval of the drug in 2016.

Analysts at Nomura recently predicted that NBI-98854 could eventually become a $1.5bn product, even without a possible follow-up indication in Tourette's syndrome - and the announcement of the phase III data sparked a 12% increase in its shares to top $43. This time last year the stock was trading at around $15.

Neurocrine expects to complete its first phase Ib trial in Tourette's shortly, with a placebo-controlled trials programme due start later this year.

Article by
Phil Taylor

9th October 2015

From: Research



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