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By Ransdell Pierson
Dec 5 (Reuters) - Eli Lilly and Co said on Thursdayit would not seek approval for edivoxetine, its experimentaldrug to treat major depression, after it failed to meet itsprimary goal in three late-stage trials.
Edivoxetine, a member of a family of medicines callednorepinephrine reuptake inhibitors, was tested in combinationwith a member of a widely used class of depression treatmentsknown as selective serotonin reuptake inhibitors (SSRIs) in eachof the three trials.
After eight weeks of treatment, the combination of drugsthat included edivoxetine did not prove superior to the SSRIsalone, thereby failing the main goal of the studies.
The three trials enrolled patients with major depression whohad 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 threeseparate clinical trials means that Lilly will not proceed withdevelopment of edivoxetine as an add-on treatment fordepression," David Ricks, president of Lilly Bio-Medicines, saidin a release.
The setback comes as the Indianapolis drug maker badly needsnew medicines to offset plunging sales of its Zyprexaschizophrenia treatment which faces cheaper generics, andlooming patent expirations on its Cymbalta depression medicineand Evista osteoporosis treatment.
Industry analysts had been hoping edivoxetine, which is aderivative of Lilly's Strattera drug for attention deficitdisorder, would garner annual sales in the $200 million range by2016, if approved, and grow from there.
But the depression drug has not been considered nearly asimportant, or potentially lucrative, as other experimental drugsbeing developed by Lilly, including treatments for Alzheimer'sdisease.
Derica Rice, Lilly's chief financial officer, said despiteedivoxetine's failure the company remains on track to return torevenue growth and see improved profit margins in 2015 andbeyond, after other drugs are introduced beginning next year tohelp bolster sales.
Lilly shares were little changed at the market open.
