Interneuron’s Stroke Drug Fails Test
Interneuron Pharmaceuticals Inc. said it will withdraw an application for Food and Drug Administration approval of its stroke-recovery drug, CerAxon, because it failed to provide benefits in a new study. The Lexington, Mass.-based biotechnology company’s shares lost nearly half of their value on the news, plummeting $7.13 to close at $7.96 on Nasdaq. Interneuron said preliminary analysis of a 100-patient study found that CerAxon failed to improve the condition of patients who had suffered a so-called ischemic stroke, the most common form. The results “weaken” the company’s application and will result in a “significant delay in the potential launch” of the drug, Interneuron said. The news comes less than three weeks after Interneuron said the FDA had placed CerAxon on the “fast track” for review because it is designed to treat a life-threatening disease for which inadequate treatment options exist.
* Johnson & Johnson failed to convince an FDA advisory panel of the safety or benefit of its Antocin drug for use in staving off labor in premature pregnancies. The FDA isn’t required to follow the advice of its expert panels, but it generally does so.