Neurocrine says two data re-analyses are all that block indiplon capsule approval

By Jennifer Lanning Drey

Portland, Ore., Nov. 14 - Neurocrine Biosciences, Inc. believes that statistical re-analyses of two previous indiplon capsule studies is now all that is blocking the company's path for gaining Food and Drug Administration approval of the drug, Gary Lyons, chief executive officer of Neurocrine, said Tuesday at the 2006 Stanford Growth Conference.

Neurocrine is working on the re-analyses and has also elected to conduct an additional three-month study of the insomnia drug immediate-release capsules as "an insurance policy" in the event that the FDA still has questions following the resubmission of statistical data, Lyons said Tuesday.

The company is now on track to launch indiplon capsules in the second half of 2008, he said.

At the growth conference, Lyons also outlined Neurocrine's GnRH program for treatment of moderate to severe endometriosis and said that the company plans to report data from its second phase 2 clinical trial of its product candidate NBI-56418 for endometriosis in December.

In addition, Lyons said Neurocrine has started a pivotal six-month phase 2/ 3 study of the compound to confirm its safety and efficacy as well as to establish the phase 3 dose.

"Our goal is to bring this through phase 2 proof of concept and then to partner with a large partner that dominates the female health care arena to help us commercialize this large market with significant unmet medical need and no competition as it relates to this mechanism in the field of endometriosis," Lyons said.

Lyons said Neurocrine expects to end 2006 with cash of $180 million to $185 million and demonstrate a cash burn rate of $70 million to $80 million for the next two years.

Neurocrine is a San Diego-based product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders.

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