Exploiting Connections and Navigating Bumps Along the Brain-Gut Axis

The Food and Drug Administration's intimation to Eli Lilly & Co. in late January that the regulator wouldn't approve Lilly's serotonin and norepinephrine reuptake inhibitor (SNRI) duloxetine as a treatment for stress urinary incontinence (SUI) could be a setback for more than just Lilly and partner Boehringer Ingelheim GMBH . [See Deal]

The FDA move surprised observers, particularly considering the lack of existing pharmacotherapy for SUI and duloxetine's safety profile, which have recently helped make it a regulatory success in other mass-market conditions like depression in the US and in SUI elsewhere in the world. Lilly's difficulties don't bode well for younger, smaller biotechs who've based their entire businesses around finding new uses for existing therapeutics. Noted one executive before the Lilly announcement: "The model is not a given—it's hard, it takes capital and it takes time. It's still clinical development