NEUROCRINE: NEW STUDY WILL DELAY INDIPLON AGAIN

Neurocrine Biosciences saw the price of its stock fall 30 percent after announcing more delays for its insomnia drug indiplon and a loss of $39.1 million for the third quarter of 2006.

Neurocrine said it will conduct an additional three-month safety and efficacy study for the drug and now expects to resubmit the new drug application for indiplon capsules in the summer of 2008.

The new trial, although voluntary, is the latest in a series of negative developments regarding indiplon. In May, Neurocrine received a not approvable letter for its 15-mg extended-release tablet and an approvable letter for its 5- and 10-mg immediate-release capsules of indiplon. After that announcement Neurocrine stock plummeted almost 60 percent. Also, following the letters, Pfizer informed Neurocrine it was pulling out of a collaborative agreement to develop and promote the drug.

Recently the company has been working with the FDA to determine the steps needed for approval of the capsules. The agency requested further analyses and modifications of previously submitted studies to address questions raised in the initial review. The analysis is ongoing, Neurocrine said.

At the FDA's request, the company has also completed a pharmacokinetic/food effect profile of indiplon capsules. Neurocrine hopes the additional three-month study will supplement the new analysis, providing additional support for the resubmission.

In their discussions, Neurocrine and the FDA noted positive efficacy data for sleep maintenance with both indiplon capsules and tablets, the company said. On the basis of these discussions, Neurocrine is forming a strategy to pursue a sleep maintenance claim for indiplon. The evaluation of indiplon for sleep maintenance will cover both indiplon capsules and tablets.