Biotech Values

[Dub Narcotic]

Neurocrine expecting FDA decision today.

The FDA is set to decide today on approval for the re-submission of Neurocrine's sleep drug, Indiplon IR.

Neurocrine got an approvable/not-approvable letter for their first submission, with Pfizer, and afer Pfizer got scarce they decided to only resubmit the short-acting version at a 5mg/10mg dose and give it the IR suffix. They are going for a 'MOTN' label, e.g. middle-of-the-night awakenings, which will put them into competition with Sonata, which has the same label.

The 15 mg long-acting product is now called Indiplon MR and is back in PII studies. They have a Japanese partnership lined up, but nothing in NA or Europe.

They have promised to sign a NA partnership before year-end, and also a partnership for their PII GNRh antagonist endometriosis drug in the same time frame.