Neurocrine chronicles

Neurocrine last week lost 63% of its valuation after FDA issued an approvable letter for immediate-release indiplon and a not approvable letter for modified-release indiplon. The news sent NBIX to its lowest share price since the bear market of 2001. According to the company, FDA said it did not have an opportunity to review all the information submitted. Indeed, it was the second time the agency has blamed its process for delaying indiplon, as both versions were hit with non-approvable letters near the beginning of 2005. At that time, FDA cited snafus with the electronic filing process. This time, the good news is that neither letter told NBIX to run more clinical trials. The company told BioCentury that the agency already has much of the data requested, while NBIX already has a good deal of the other data the agency wants.

A. 7/9/98 - DOV (DOVP) grants exclusive worldwide rights to indiplon (NBI-34060), which has completed a Phase I trial for insomnia, for all indications. NBIX makes an undisclosed equity investment in DOVP, and will pay potential milestones and royalties.B. 11/29/99 - Indiplon meets primary endpoint in a Phase II trial for insomniaC. 7/17/01 - Indiplon meets primary endpoint in a Phase II trial for chronic insomniaD. 10/1/01 - Indiplon meets primary endpoint in a Phase II trial for transient insomniaE. 12/14/01 - Indiplon immediate-release (IR) meets primary endpoint in a Phase II trial for chronic insomnia in elderly patientsF. 1/18/02 - Indiplon modified-release (MR) meets primary endpoint in a Phase II trial for chronic insomniaG. 11/14/02 - Indiplon IR meets primary endpoint in first Phase III trial for insomnia...