AstraZeneca reported another late-stage pipeline blow just ahead of its third-quarter results meeting today after NXY-059 (formerly Cerovive), a candidate drug for stroke, failed to meet its objectives in a Phase III trial.
NXY-059, which was designed to work as a neuroprotectant by trapping free radicals, will now be dropped from development, said AstraZeneca, whose shares were down nearly 4.5% in mid-morning trading at £33.71. Consensus peak sales of the compound had been estimated at $3.8 billion.
The compound failed to show an improvement over placebo on disability scores in the SAINT-II study, which enrolled 3,200 patients suffering from acute ischaemic stroke trial.
The demise of NXY-059 comes after a tricky period for AstraZeneca’s pipeline. At its second-quarter results meeting the company said it had dropped an intravenous formulation of AZD7009 for the treatment of atrial fibrillation after disappointing Phase III results. These drugs join Galida (tesaglitazar) for diabetes and blood clot preventer Exanta (ximelegatran) among recent late-stage product failures at AstraZeneca, and the pressure is now on the company to buy in compounds to shore up its R&D portfolio.
Meanwhile, there have been “many Phase I and II failures from the pipeline (many of which were new chemical entity molecules) last year, [and this] is a major concern for the future growth prospects for the company,” according to analysts at Collins Stewart.
“We see the remaining pipeline continuing to disappoint: and would flag Zactima (ZD6474) for lung cancer, data on which is due early next year, as being the next drug to fall over for lack of efficacy reasons. The other projects in the Phase III pipeline are equally risky,” claim the analysts.
AstaZeneca has not launched an NCE – other than Exanta - since it debuted cholesterol-lowerer Crestor (rosuvastatin) in 2003.