Eli Lilly and Takeda to terminate ruboxistaurin mesylate agreement

Eli Lilly and Takeda have announced the decision to terminate their co-marketing and development agreement for ruboxistaurin mesylate (PKC-beta inhibitor, LY333531) as a treatment for microvascular complications arising from diabetes.

Ruboxistaurin mesylate was discovered and developed by Lilly, with phase II clinical studies assessing the efficacy of the compound as a treatment for these conditions conducted by both firms.

“Eli Lilly and Takeda judged that the overall results of diabetic peripheral neuropathy and diabetic macular edema clinical studies did not meet its pre-specified go/no go decision criteria for phase III clinical studies,” the companies report

Consequently, both firms agreed to terminate their original partnership agreement.

In August 2006, Arxxant (ruboxistaurin mesylate) received an approvable letter from the US Food and Drug Administration as a treatment orally-administered treatment for diabetic retinopathy, with Lilly reporting it will cooperate with the administration to provide additional required clinical evidence.

Later that year, Lilly reported positive phase III clinical trial results, with the compound lowering the risk of sustained moderate vision loss in patients by 40 per cent.

Diabetic retinopathy occurs when the condition damages blood vessels in the retina, leading to vision loss and blindness.