Eli Lilly and Co said on Thursday it would not seek approval for edivoxetine, its experimental drug to treat major depression, after it failed to meet its primary goal in three late-stage trials.
Edivoxetine, a member of a family of medicines called norepinephrine reuptake inhibitors, was tested in combination with a member of a widely used class of depression treatments known as selective serotonin reuptake inhibitors (SSRIs) in each of the three trials.
After eight weeks of treatment, the combination of drugs that included edivoxetine did not prove superior to the SSRIs alone, thereby failing the main goal of the studies.
The three trials enrolled patients with major depression who had achieved only a partial response to treatments with SSRIs, which include generic forms of Lilly's own Prozac (fluoxetine), Pfizer Inc's Zoloft (sertraline) and GlaxoSmithKline's Paxil (paroxetine).
"The lack of efficacy compared to SSRI alone in three separate clinical trials means that Lilly will not proceed with development of edivoxetine as an add-on treatment for depression," David Ricks, president of Lilly Bio-Medicines, said in a release.
The setback comes as the Indianapolis drug maker badly needs new medicines to offset plunging sales of its Zyprexa schizophrenia treatment which faces cheaper generics, and looming patent expirations on its Cymbalta depression medicine and Evista osteoporosis treatment.
Industry analysts had been hoping edivoxetine, which is a derivative of Lilly's Strattera drug for attention deficit disorder, would garner annual sales in the $200 million range by 2016, if approved, and grow from there.
But the depression drug has not been considered nearly as important, or potentially lucrative, as other experimental drugs being developed by Lilly, including treatments for Alzheimer's disease.
Derica Rice, Lilly's chief financial officer, said despite edivoxetine's failure the company remains on track to return to revenue growth and see improved profit margins in 2015 and beyond, after other drugs are introduced beginning next year to help bolster sales.
Lilly shares were little changed at the market open.
(Reporting by Ransdell Pierson; Editing by Gerald E. McCormick, Bernadette Baum and Chris Reese)