Roche Holding AG’s experimental schizophrenia drug bitopertin failed in two of six final-stage patient trials, putting its future at risk.
Adding bitopertin to an anti-psychotic therapy didn’t help patients overcome negative symptoms such as social withdrawal and lack of motivation more than placebo after 24 weeks of treatment, the Basel, Switzerland-based drugmaker said in an e-mailed statement today.
Bitopertin would be the first schizophrenia drug to treat negative symptoms of the disease. Roche said today it will wait for data from trials still being run before deciding whether to abandon the product, which had been the closest drug candidate to approval in its neuroscience program. If successful, the schizophrenia medicine could have generated as much as 2 billion Swiss francs ($2.19 billion) in annual sales, according to Andrew Weiss, an analyst for Bank Vontobel in Zurich.
“It is inherently high risk,” Weiss said in a telephone interview. “Negative symptoms are inherently very difficult to assess. You’re trying to assess mood.”
Without more information about patient outcomes on different doses of bitopertin, it’s difficult to tell whether the drug’s development will be delayed or halted entirely, he said.
The shares fell 0.6 percent to close at 248.40 francs in Zurich.
Roche had previously estimated that bitopertin would be submitted for regulators’ approval in 2015. Today’s failure won’t have an effect on near-term sales, Bloomberg Industries analysts wrote in a report.
The company is running a third study of the drug’s effects on negative symptoms, plus three more trials looking at whether it can help patients whose hallucinations and delusions linger despite treatment with anti-psychotic medications. Persistent negative symptoms occur in about 20 percent to 30 percent of people with the mental-health condition, according to Andrew Baum, a London-based pharmaceutical analyst for Citigroup Inc.