The drug: Taspoglutide
The disease: Diabetes
The company: Roche and Ipsen
Ocrelizumab tarnished Roche's stellar reputation for late-stage development. Taspoglutide began to raise serious doubts about its ability to continue to defy the poor odds that any developer faces.
Back in the spring, analysts were confidently projecting billions in annual sales for the GLP-1 drug, part of a new wave of diabetes drugs in the pipeline. Troubling safety data from the Phase III study in June forced a serious delay. Then last month investigators at Roche and Ipsen announced that they would have to suspend therapy in the late stage study after tracking cases of GI reactions in the drug arm. That's the kind of safety issue that can derail any drug program. The odds for success plunged from probable to probably not in a matter of months.
Roche's may be losing its magic touch. Earlier this year the pharma giant made a bid to get an early approval for T-DM1 only to have the app handed back with a regulatory demand for more study. T-DM1 has produced stunningly positive data, but regulators will always have a hard time assessing a drug's risks and benefits without the big Phase III studies that typically make or break any new therapy.