Slowly rising from the ashes of an unexpected negative FDA decision on lead drug indiplon last year, Neurocrine Biosciences
The big positive for Neurocrine this quarter was the resubmission of the indiplon marketing application. The guidance for when the agency will be able to complete its class two review of Neurocrine's approvable letter response is approximately Dec. 12. If granted full approval, Neurocrine expects another eight-week holdup after that as it awaits Drug Enforcement Agency classification of the drug.
Neurocrine has no plans to fight alone against the heavy sales and marketing budgets of Sepracor
In the first six months of the year Neurocrine's cash and equivalents were reduced by $35 million. Indiplon is not likely to get Neurocrine to profitability once sales start up, considering the competitiveness of the insomnia drug market and the fact that Neurocrine has a number of early-stage clinical programs starting to ramp up development (this is a good thing).
What revenues from indiplon will do is help Neurocrine reduce its cash burn from these numerous pipeline candidates. Just last week the company in-licensed a preclinical stage potential epileptic and bipolar disease drug and plans to bring the compound into clinical stage testing in early 2008.
For better or worse Neurocrine is still a stock whose near-term future is based on indiplon. With an approvable letter response decision in the coming months, all eyes will remain focused on the drug's fate with the FDA.
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